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Volume 27, Number 5, October 2016 FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF
405 “Three-parent” DNA Baby: A Revolutionary Technique or the Answer?
KK Aggarwal
AMERICAN FAMILY PHYSICIAN
407 Diagnosis and Management of Vertebral Compression Fractures
Jason McCarthy, Amy Davis
414 Practice Guidelines 417 Photo Quiz ANESTHESIOLOGY
421 A Comparative Study of Variable Speeds of Injection of Propofol on Induction in Adult Patients
Smaranika Choudhury, Parinita C Hazarika, Arun Kumar Gupta
COMMUNITY MEDICINE
426 Occupational Stress Among the Women Nurses at Various Government Hospitals in Chennai
B Prasila Leelavathy Pappathy, Ramachandran Narayanan
DIABETOLOGY
436 Advantages of Teneligliptin Compared with Other DPP-4 Inhibitors in T2DM
Srikant Sharma
ENDOCRINOLOGY
445 Primary Amenorrhea in a Young Female - Complete Androgen Insensitivity Syndrome: A Rare Cause
Rajesh Rajput, Deepak Jain, Laxminarayan Yadav, Tekchand Yadav
ENT
448 The “Tuberculosis” in Otorhinolaryngology as Extrapulmonary Sites
Shamendra Kumar Meena
INTERNAL MEDICINE
455 A Rare Case of Advanced Lupus Nephritis in the Absence of Clinical Features of Lupus Nephritis and Significant Proteinuria: Highlighting the Role of Early Kidney Biopsy in SLE
Anjum Mirza Chughtai, Muhammad Uwais Ashraf, MR Ajmal
459 An Interesting Case of Polyarthritis: Maturity-onset Seronegative Synovitis Syndrome
Bharath Raj Kidambi, Balasubramanian B
OBSTETRICS AND GYNECOLOGY
Published, Printed and Edited by Dr KK Aggarwal, on behalf of IJCP Publications Ltd. and Published at E - 219, Greater Kailash Part - 1 New Delhi - 110 048 E-mail: editorial@ijcp.com
463 Rare Case Report of Amniotic Band Syndrome
Deepika, Taru Gupta, Nupur Gupta
466 A Rare Case of Twin Pregnancy in the Noncommunicating Rudimentary Horn of Unicornuate Uterus: A Case Report
Printed at New Edge Communications Pvt. Ltd., New Delhi E-mail: edgecommunication@gmail.com
Nupur Gupta, Taru Gupta, Deepti Asthana
469 Rupture of Endometriotic Ovarian Cyst Causes Acute Hemoperitoneum in IVF Pregnancy
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Atul Ganatra, Vanashri Tatoba Bahade, Uday Kargar
ORTHOPEDICS
472 Swivel Subtype of Talonavicular Joint Dislocation of Foot: A Rare Occurrence
Editorial Policies
Ram Avtar, Mannan Ahmed, Irfan Malik
CONFERENCE PROCEEDINGS
The purpose of IJCP Academy of CME is to serve the medical profession and provide print continuing medical education as a part of their social commitment. The information and opinions presented in IJCP group publications reflect the views of the authors, not those of the journal, unless so stated. Advertising is accepted only if judged to be in harmony with the purpose of the journal; however, IJCP group reserves the right to reject any advertising at its sole discretion. Neither acceptance nor rejection constitutes an endorsement by IJCP group of a particular policy, product or procedure. We believe that readers need to be aware of any affiliation or financial relationship (employment, consultancies, stock ownership, honoraria, etc.) between an author and any organization or entity that has a direct financial interest in the subject matter or materials the author is writing about. We inform the reader of any pertinent relationships disclosed. A disclosure statement, where appropriate, is published at the end of the relevant article.
476 71st Annual Conference of The Association of Physicians of India (APICON 2016) 479 69th Indian Dental Conference (IDC 2016) 482 India’s Premier Interventional Experience (TCT India Next 2016) EXPERT VIEW
485 What Health Problems are Associated with Hypertension?
Rajiv Garg
MEDILAW
487 Death of a Patient While Undergoing Standard Treatment Protocol is Not Negligence AROUND THE GLOBE
490 News and Views
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INSPIRATIONAL STORY
495 A Story for Passover LIGHTER READING
496 Lighter Side of Medicine
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FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF
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Group Editor-in-Chief IJCP Group, eMedinewS and eMediNexus
“Three-parent” DNA Baby: A Revolutionary Technique or the Answer?
M
itochondrial diseases are caused by pathogenic mutations in the mitochondrial DNA or mutations in nuclear DNA involved in mitochondrial function and inherited only from the mother. They are debilitating and potentially fatal diseases involving multiple organ systems and cannot be diagnosed prenatally. And like autism, muscular dystrophy, chronic fatigue syndrome, they present predominantly with neurolgic and myopathic features. Several such diagnoses are usually investigated for first making it a difficult condition to diagnose and a very high index of clinical suspicion is required to even consider this diagnosis. A diagnosis of mitochondrial disease spells doom for the patient and fills the doctor with hopelessness as there is no cure for mitochondrial diseases, that is, until now. Recently, New Scientist magazine reported the groundbreaking story of a 5-month-old boy, who is the first baby in the world to be born to a couple from Jordan using "three-parent technique" that incorporates DNA from three people; the biological parents and an unknown female donor. The baby has nuclear DNA from his mother and father, and mitochondrial DNA from an unknown female donor, the “second” healthy mother. The mother is a carrier of the gene for Leigh syndrome in her mitochondrial DNA. Leigh syndrome is a mitochondrial disease which is progressive severe neurological disorder and fatal. She had already lost
two children to the same disease. Their baby boy born in April this year using this technique has so far shown no signs of the disease. Only 1-2% of his mitochondria carry the diseased mitochondrial DNA. It is believed that around 18% of mitochondria need to be affected before the disease begins to manifest itself. However, the child would undergo regular monitoring. An abstract in the September 2016 issue of the journal Fertility and Sterility gives a brief account of the technique that will be presented at the 2016 American Society for Reproductive Scientific Congress & Expo in Salt Lake City, Utah later this month. The team of doctors was led by Dr John Zhang, MD, PhD, Director of New Hope Fertility Center in New York, who performed this technique in Mexico as it is not yet approved by the United States Food and Drug Administration (FDA), which continues to weigh in on the ethical and social implications of the technique. The mitochondrial replacement therapy, mitochondrial transfer technique or three-person in vitro fertilization (IVF) is a controversial technique given that is legally approved only in the UK and that too as recent as last year following a heated debate in the parliament. An expert panel convened by the Institute of Medicine (IOM), however has recommended approval of this technique in the US subject to strict guidelines. “In a report issued February 3, and summarized in the journal Science, the IOM panel concludes that it is ethical to conduct the experiments, but recommends limiting the technique to making baby boys. That would prevent “germline
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FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF modification” of future generations because mitochondria are usually inherited from the mother. The committee also recommends the technique be limited to women with serious mitochondrial diseases, and that regulators should take the mother’s health and the expertise of the scientists into account before approving studies (Science News, February 3, 2016).” Two mitochondrial transfer techniques have been developed to prevent transmission of human mitochondrial DNA disease. ÂÂ
Pronuclear transfer technique: In this technique, the egg from the mother and a female donor egg are fertilized with the father’s sperm via IVF. The pronuclei are then removed from each embryo, still at the single-cell stage. The pronuclei from the embryo produced from the parents is then placed in the second embryo formed using the donor egg. Most of the mother’s mutated mitochondria are left behind in the enucleated embryo, which is discarded. The nucleus from the donor’s fertilized egg is discarded. This is the approved technique in the UK to prevent transmission of mitochondrial DNA disease.
Nuclear genome transfer and Polar body genome transfer are other techniques, but these are more at an experimental stage. Because of cultural reasons, the Dr Zhang and this team did not opt for the "pronuclear transfer" technique, as they were opposed to the destruction of embryos. Hence, they opted for the "spindle nuclear transfer" technique. Five embryos were created and embryos were not destroyed; a male embryo was used, so that the child born would not pass on any inherited mitochondrial DNA. This news generated lot of excitement and hope among researchers, especially those in the field of reproductive medicine. It has also come as a ray of hope for those parents with genetic diseases who otherwise are not able to conceive a healthy child. Regardless, safety is a concern and there are significant ethical issues associated with it that need to be answered.
Spindle transfer technique: In this technique, the nucleus (metaphase II spindle) from one of the unfertilized eggs of the mother is removed, which is then transferred into a healthy donor egg from which the nucleus is removed, leaving her healthy mitochondria in the cytoplasm. The reconstituted egg is then fertilized with the father’s sperm and the resulting embryo is implanted in the mother.
There may be inheritable genetic modifications that may be passed on to future generations. Even very small amounts of mutated mitochondrial DNA may be carried over, which may replicate later on in life. Evidence shows that mitochondria are not just "powerhouses of the cell", they also impact phenotypic traits. A mitochondrial-nuclear NDA mismatch may affect gene expression. And, this genetic manipulation is not reversible. A child born of three-person IVF would have three "genetic" parents. Bioethicists say that "interfering" with genetic code may alter the identity of the person.
Earlier studies reported in reputed journals like Science, Nature have shown encouraging results in preventing transmission of mitochondrial DNA disease using these techniques in animal models.
Many such questions and more need to be answered first before the technique would be available in reproductive clinics. But, it’s no longer "the stuff that fiction is made of".
ÂÂ
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AMERICAN FAMILY PHYSICIAN
Diagnosis and Management of Vertebral Compression Fractures JASON McCARTHY, AMY DAVIS
ABSTRACT Vertebral compression fractures (VCFs) are the most common complication of osteoporosis, affecting more than 700,000 Americans annually. Fracture risk increases with age, with four in 10 white women older than 50 years experiencing a hip, spine, or vertebral fracture in their lifetime. VCFs can lead to chronic pain, disfigurement, height loss, impaired activities of daily living, increased risk of pressure sores, pneumonia, and psychological distress. Patients with an acute VCF may report abrupt onset of back pain with position changes, coughing, sneezing, or lifting. Physical examination findings are often normal, but can demonstrate kyphosis and midline spine tenderness. More than two-thirds of patients are asymptomatic and diagnosed incidentally on plain radiography. Acute VCFs may be treated with analgesics such as acetaminophen, nonsteroidal antiinflammatory drugs, narcotics, and calcitonin. Physicians must be mindful of medication adverse effects in older patients. Other conservative therapeutic options include limited bed rest, bracing, physical therapy, nerve root blocks, and epidural injections. Percutaneous vertebral augmentation, including vertebroplasty and kyphoplasty, is controversial, but can be considered in patients with inadequate pain relief with nonsurgical care or when persistent pain substantially affects quality of life. Family physicians can help prevent vertebral fractures through management of risk factors and the treatment of osteoporosis.
Keywords: Vertebral compression fractures, osteoporosis, back pain, kyphosis, midline spine tenderness
V
ertebral compression fractures (VCFs) are the most common complication of osteoporosis, affecting more than 700,000 Americans annually.1 Patients with VCFs account for 66,000 physician office visits and 45,000 to 70,000 hospitalizations each year, with one-half requiring skilled nursing facility care.2 Fracture risk increases with age; in the United States, four out of 10 white women older than 50 years will experience a hip, spine, or vertebral fracture in their lifetime.2 Women with one or more VCFs have a 1.2-fold greater age-adjusted mortality rate compared with women without fractures, with the risk of death increasing with the number of fractures.3 Fracturerelated deaths occur after the fracture, often from pulmonary disease or cancer.3,4 Furthermore, patients report a lower quality of life at 12 and 24 months after a fracture.2 The estimated direct annual health care cost of managing osteoporotic spine and hip fractures is $10 billion to $15 billion.5
JASON McCARTHY, MD, is a faculty physician at the David Grant Medical Center Family Medicine Residency Program, Travis Air Force Base, Calif. AMY DAVIS, MD, is a faculty physician at the David Grant Medical Center Family Medicine Residency Program. Source: Adapted from Am Fam Physician. 2016;94(1):44-50.
RISK FACTORS Risk factors for VCFs include osteopenia, osteoporosis, older age, a history of VCFs or falls, inactivity, use of corticosteroids (more than 5 mg daily for three months) or other medications, weight less than 117 lb (53.1 kg), female sex, consumption of more than two alcoholic drinks per day in women or more than three per day in men, smoking, vitamin D deficiency, and depression.6-9 CLINICAL PRESENTATION More than two-thirds of patients with VCFs are asymptomatic, and are diagnosed incidentally.10 Symptomatic patients may present with back pain and fracture demonstrated on radiography, most commonly between T8 and L4.11 Patients with an acute fracture may report abrupt onset of pain with position changes, coughing, sneezing, or lifting.8,12,13 Physical examination findings are often normal, but may demonstrate kyphosis and midline spine tenderness.8,12 Chronic VCF may present with loss of height in addition to kyphosis. Complications include bone loss, muscle weakness, pressure sores, ileus, urinary retention, impaired respiratory function, venous thromboembolism, and spinal cord compression.12,14-17
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AMERICAN FAMILY PHYSICIAN The differential diagnosis includes musculoskeletal pain, osteoarthritis, spinal stenosis, multiple myeloma, metastatic disease, hyperparathyroidism, osteomalacia, primary bone neoplasms, infiltrative neoplasms, metastatic neoplasms, hematologic disease, trauma, and osteomyelitis.15,18 EVALUATION The physical examination should include a neurologic assessment. Compression fractures are typically diagnosed by lateral radiography of the vertebral column, with or without anteroposterior views.19 Radiographic criteria for VCFs include a decrease in vertebral body height of at least 20% or a 4-mm reduction from baseline height.14 The classic radiographic finding is an anterior wedge fracture8,12,19 (Figure 18). Magnetic resonance imaging (MRI) can help distinguish benign from malignant fractures and determine the timing of the fracture, because recent fractures display edema.14,15 MRI or computed tomography is useful for identifying suspected retropulsion, fractures extending to the posterior column, and spinal cord involvement.14,15 Computed tomography or MRI should also be considered in patients who do not improve with conservative care and in those with progressive symptoms.8,14,15,17 Dual-energy x-ray absorptiometry should be performed soon after the diagnosis of a VCF to evaluate for osteoporosis and determine disease severity.6,14,15 If secondary osteoporosis is suspected (e.g., in a younger patient or in one with symptoms of hypercalcemia or anemia), laboratory evaluation may include a complete blood count; complete metabolic panel with liver function testing; and measurement of erythrocyte sedimentation rate and thyroid-stimulating hormone, 25-hydroxyvitamin D, parathyroid hormone, and C-reactive protein levels.6 Blood cultures are recommended when infection is suspected. Serum and urine protein electrophoresis should be performed if multiple myeloma is suspected. There is a high prevalence of low testosterone levels in younger men with osteoporosis and low-trauma fractures, and measurement of the testoster one level may be 20 considered in these patients. TREATMENT Goals of treatment include pain relief, restoration of function, and prevention of future fractures.12,14 Treatment of VCFs should begin with discussion of patient goals and risks, and benefits of conservative
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care vs. percutaneous vertebral augmentation. Patients who wish to pursue conservative treatment will have more than a 50% chance of sufficient pain reduction, most of which occurs by three months.21 A study of 259 patients with VCFs showed that patients who had pain relief and reduced disability with three weeks of conservative therapy had a 95% chance of maintaining these improvements for up to 12 months.21
Conservative Care Early mobility should be encouraged as soon as it can be tolerated. Bed rest is sometimes recommended as part of initial management if pain is intolerable, but it can lead to loss of bone mass and muscle strength, pressure sores, and deep venous thrombosis.17 The American Academy of Orthopaedic Surgeons (AAOS) found inconclusive evidence regarding the benefits of bed rest in the treatment of VCFs.22 Medications Nonsteroidal anti-inflammatory drugs, acetaminophen, narcotics, lidocaine patches, and muscle relaxants are commonly used for pain relief.7,8,12,14 Medications facilitate patient mobility and participation in physical therapy, and should be tapered slowly as pain improves.12 The AAOS found inconclusive evidence to support specific analgesics for acute VCF pain.22 In neurologically intact patients with VCF, calcitonin sig nificantly reduces pain and facilitates earlier mobiliza tion for up to four weeks.22-25 Table 1 reviews common medications used to treat VCFs.26 Physicians should be mindful of medication adverse effects in older patients. Bracing Although bracing is commonly prescribed for six to eight weeks after a VCF, the evidence is limited.14,22 A small study of thoracolumbar bracing improved posture, strength, and quality of life.27 In another study, disability scores were not significantly improved in patients who wore a rigid brace or soft brace compared with those who did not wear a brace.28 Potential benefits of pain reduction should be balanced against the risks of muscle atrophy and skin complications.12,13 Physical Therapy and Exercise Physical therapy is likely to be useful in patients with VCFs and osteoporosis.12,14,29 Home exercise programs have a more limited evidence base, with some small trials demonstrating pain reduction, improved balance, and quality of life.22,30 Back extensor strengthening can improve strength and bone density, and reduce the risk
AMERICAN FAMILY PHYSICIAN Table 1. Medications for Acute Treatment of Vertebral Compression Fractures Medication
Dosage
Adverse effects
Cost*
Acetaminophen
500 to 1,000 mg every four to eight hours (maximum 3 g per day)
Analgesic-associated nephropathy (chronic), anemia, hepatotoxicity, hypersensitivity, renal tubular necrosis (acute), skin reactions, thrombocytopenia
$15
Calcitonin
200 IU per day intranasally
Anorexia, dizziness, flushing, gastrointestinal disturbance, headache, hypertension, hypocalcemia, rash, rhinitis (intranasal), weight gain
$45
Lidocaine 5% patch
Apply to affected area for 12 hours
Dermatitis, edema, exacerbation of pain, skin depigmentation, urticaria
$220
Muscle relaxants (e.g., cyclobenzaprine)
10 mg every eight hours
Abuse, anticholinergic effects, dependence, dizziness, sedation, serotonin syndrome when combined with other serotonergic medications
Varies
Narcotics (multiple brands)
Varies
Addiction, cognitive impairment, constipation, delirium, dizziness, hypogonadism, nausea, opioid-induced hyperalgesia, pruritus, respiratory depression, somnolence, urine retention
Varies
Atrial fibrillation, bleeding, cardiovascular disease, edema, gastritis, gastrointestinal bleeding, heart failure, hypertension, kidney disease, peptic ulcers
$11
Nonsteroidal anti-inflammatory` drugs Ibuprofen
200 to 800 mg every eight hours
Naproxen
500 mg every 12 hours
$4
*Estimated retail price for one month’s treatment based on information obtained at http://www.goodrx.com and http://www.drugstore.com (accessed January 4, 2016). Information from reference 26.
of future VCFs.31 Exercise is beneficial for all patients with osteoporosis.6 Nerve Root Blocks The AAOS gives a weak recommendation for the use of L2 nerve blocks for temporary pain reduction in patients with VCFs.22 Patients undergoing L2 selective nerve blocks have reduced pain for up to two weeks, with effects dissipating by one month.22 Patients with radicular pain may benefit from nerve root blocks or epidural injections.14 Family physicians should counsel patients to weigh the benefits of temporary pain relief against the risks of the procedure.
Vertebroplasty and Kyphoplasty Percutaneous vertebral augmentation, including vertebroplasty or kyphoplasty, can be considered in patients with inadequate pain relief from nonsurgical care, or when persistent pain substantially affects quality of life13,15,17,18,21; however, recent studies have questioned their effectiveness.32-34 Vertebroplasty entails injecting liquid cement into a collapsed vertebral body
through a needle inserted transpedicularly. Kyphoplasty involves percutaneously injecting a balloon into the vertebral body, inflating it to restore vertebral height, and injecting cement to reduce pain.15,17 Complications include extravasation of cement (more common with vertebroplasty), embolism, neurologic injury, bleeding, hematoma, infection, and an increased risk of VCFs at other levels.13,15,17 In 2010, the AAOS strongly recommended against vertebroplasty in neurologically intact patients with VCFs.22 Two randomized controlled trials comparing vertebroplasty with a sham procedure in patients with acute or chronic VCF found no benefit in pain reduction, function, or quality of life.32,33 In contrast, a 2013 metaanalysis of six randomized controlled trials (including those that found no benefits) found that vertebroplasty provided better pain relief, functionality, and quality of life compared with conservative care at 12 weeks, six months, and 12 months.35 Studies have demonstrated improved quality of life and physical abilities, and reduced back pain and
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AMERICAN FAMILY PHYSICIAN disability in patients with kyphoplasty compared with conservative therapy at one month.22,36 Benefits in pain reduction and quality of life may persist for up to one year after kyphoplasty.
health care utilization and complications associated with the procedures. Mortality benefits reported in studies of percutaneous vertebral augmentation may be linked to selection bias caused by the exclusion of patients at high risk of complications.34
A 2014 consensus statement from several U.S. and Canadian neurosurgical and radiologic groups supports offering vertebroplasty and kyphoplasty to patients receiving medical therapy who are unable to ambulate after 24 hours of treatment, who have pain intense enough to prevent participation in physical therapy, or who have adverse effects from analgesics.17 Potential benefits must be evaluated against the failure of percutaneous vertebral augmentation to improve mortality or major medical outcomes and the increased
Based on current evidence, most patients should not undergo percutaneous vertebral augmentation unless they present with acute MRI-confirmed fracture and debilitating pain or substantial functional limitations despite conservative therapy for at least three weeks. PREVENTION Optimal treatment of patients with VCFs includes pre vention of additional fractures and treatment
Table 2. Medications for the Prevention and Treatment of Osteoporosis Medication
Dosage
Relative risk reduction in vertebral fractures
Bisphosphonates
Mechanism of action
Used for
Antiresorptives; inhibit osteoclasts by inducing apoptosis
Prevention and treatment
Alendronate
5 mg per day (prevention) or 35 mg per week (treatment)
50% in patients with history of fracture; 48% in those without
Ibandronate
150 mg per month
50%
Risedronate
5 mg per day or 35 mg per week
41% to 49%
Zoledronic acid
5 mg intravenously every two years (prevention) or 5 mg intravenously per year (treatment)
70%
Calcitonin
50 to 100 IU per day intramuscularly or 200 IU per day intranasally
30% in patients with history of fracture
Antiresorptive
Treatment
Calcium
1,000 to 1,200 mg per day
-
-
Prevention
Estrogen
0.3 mg or 0.625 mg per day via pill or patch
34%
Antiresorptive
Prevention
Estrogen agonist/ antagonist (raloxifene)
60 mg per day
30% in patients with history of fracture; 55% in those without
Antiresorptive
Prevention and treatment
Parathyroid hormone (teriparatide)
20 mcg per day subcutaneously for up to 24 months
65%
Maintains osteocytes, increases intestinal calcium absorption, decreases urinary calcium, increases vitamin D production
Treatment
RANKL inhibitor (denosumab)
60 mg per day subcutaneously every six months
68%
Blocks formation, function, and survival of osteoclasts
Treatment
Vitamin D
800 to 1,000 IU per day
-
-
Prevention
RANKL = Receptor activator of nuclear factor kappa-B ligand. Information from references 3, 8, 34, 36, 37, and 39 through 41.
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AMERICAN FAMILY PHYSICIAN of osteo porosis. Family physicians can encourage weight-bearing and muscle-strengthening exercise, smoking cessation, and avoidance of excessive alcohol consumption; and assess the risk of falls.6
REFERENCES
Screening for osteoporosis can identify patients who are most likely to benefit from treatment to reduce the likelihood of VCFs. The Institute of Medicine recommends adequate intake of calcium (1,000 mg per day for men 50 to 70 years of age, and 1,200 mg per day for women 51 years and older and men 71 years and older) and vitamin D (600 IU per day up to 70 years of age, 800 IU per day after 70 years of age).6,37 However, the U.S. Preventive Services Task Force found insufficient evidence to recommend more than 400 IU per day of supplemental vitamin D or more than 1,000 mg per day of calcium for primary prevention of fractures in noninstitutionalized postmenopausal women, and they recommend against supplementation with lower amounts because of proven lack of benefit.38,39
2. U.S. Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, Md.: U.S. Department of Health and Human Services, Office of the Surgeon General; 2004: 1-404.
Patients with VCFs have a fivefold increased risk of subsequent VCFs and a two- to threefold increased risk of fractures at other sites.6 Those with a hip fracture or VCF should be evaluated for osteoporosis. Patients with a T-score of –2.5 or lower at the femoral neck, total hip, or lumbar spine; a T-score of –1 to –2.4 at the femoral neck or lumbar spine; a 10-year probability of hip fracture of 3% or more; or a 10-year probability of a major osteoporosis-related fracture (clinical vertebral, hip, forearm, or proximal humerus fracture) of 20% or more should receive treatment.6 Medications approved by the U.S. Food and Drug Administration for the treatment and prevention of osteoporosis include bisphosphonates, calcitonin, estrogen, selective estrogen receptor modulators, parathyroid hormone, and receptor activator of nuclear factor kappa-B ligand inhibitors6 (Table 23,8,34,36,37,39-41). Multiple bisphosphonates are approved for the primary and sec ondary prevention of VCFs.6,22,40,41 Although estrogen therapy has been approved for the prevention of osteoporosis, it should be considered only after nonestrogen treatments have been tried.6 The anabolic agent teripa ratide reduces the risk of subsequent VCFs, although it is expensive and must be administered by daily subcutaneous injection.6,42 Additionally, denosumab leads to a relative decrease in new VCFs compared with placebo in postmenopausal women with osteoporosis. Denosumab can be used as an alternative to other therapies for the primary prevention of VCFs in postmenopausal women with osteoporosis.43 Note: For complete article visit: www.aafp.org/afp.
1. Riggs BL, Melton LJ III. The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone. 1995;17(5 suppl):505S-511S.
3. Kado DM, Browner WS, Palermo L, Nevitt MC, Genant HK, Cummings SR; Study of Osteoporotic Fractures Research Group. Vertebral fractures and mortality in older women: a prospective study. Arch Intern Med. 1999;159(11):1215-1220. 4. Melton LJ III. Adverse outcomes of osteoporotic fractures in the general population. J Bone Miner Res. 2003;18(6):1139-1141. 5. Marwick C. Consensus panel considers osteoporosis. JAMA. 2000;283(16):2093-2095. 6. Cosman F, de Beur SJ, LeBoff MS, et al.; National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis [published correction appears in Osteoporosis Int. 2015;26(7):2045-2047]. Osteoporos Int. 2014;25(10):2359-2381. 7. Ensrud KE, Schousboe JT. Clinical practice. Vertebral fractures. N Engl J Med. 2011;364(17):1634-1642. 8. Old JL, Calvert M. Vertebral compression fractures in the elderly. Am Fam Physician. 2004;69(1):111-116. 9. Whooley MA, Kip KE, Cauley JA, Ensrud KE, Nevitt MC, Browner WS; Study of Osteoporotic Fractures Research Group. Depression, falls, and risk of fracture in older women. Arch Intern Med. 1999;159(5):484-490. 10. Fink HA, Milavetz DL, Palermo L, et al.; Fracture Intervention Trial Research Group. What proportion of incident radiographic vertebral deformities is clinically diagnosed and vice versa? J Bone Miner Res. 2005;20(7):1216-1222. 11. Patel U, Skingle S, Campbell GA, Crisp AJ, Boyle IT. Clinical profile of acute vertebral compression fractures in osteoporosis. Br J Rheumatol. 1991;30(6):418-421. 12. Longo UG, Loppini M, Denaro L, Maffulli N, Denaro V. Osteoporotic vertebral fractures: current concepts of conservative care. Br Med Bull. 2012;102:171-189. 13. Savage JW, Schroeder GD, Anderson PA. Vertebroplasty and kypho plasty for the treatment of osteoporotic vertebral compression fractures. J Am Acad Orthop Surg. 2014;22(10):653-664. 14. Prather H, Hunt D, Watson JO, Gilula LA. Conservative care for patients with osteoporotic vertebral compression fractures. Phys Med Rehabil Clin N Am. 2007;18(3): 577-591, xi. 15. McConnell CT Jr, Wippold FJ II, Ray CE Jr, et al. ACR appropriateness cri teria management of vertebral
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AMERICAN FAMILY PHYSICIAN compression fractures. J Am Coll Radiol. 2014;11(8): 757-763. 16. Varacallo MA, Fox EJ. Osteoporosis and its complications. Med Clin North Am. 2014;98(4):817-831, xii-xiii. 17. Barr JD, Jensen ME, Hirsch JA, et al. Position statement on percuta neous vertebral augmentation: a consensus statement developed by the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA), and the Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol. 2014;25(2):171-181. 18. Venmans A, Lohle PN, van Rooij WJ. Pain course in conservatively treated patients with back pain and a VCF on the spine radiograph (VERTOS III). Skeletal Radiol. 2014;43(1):13-18. 19. Kiel D; National Osteoporosis Foundation Working Group on Ver tebral Fractures. Assessing vertebral fractures [published correction appears in J Bone Miner Res. 1995;10(10):1605]. J Bone Miner Res. 1995;10(4): 518-523.
27. Pfeifer M, Begerow B, Minne HW. Effects of a new spinal orthosis on posture, trunk strength, and quality of life in women with postmenopausal osteoporosis: a randomized trial. Am J Phys Med Rehabil. 2004;83(3): 177-186. 28. Kim HJ, Yi JM, Cho HG, et al. Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial. J Bone Joint Surg Am. 2014;96(23): 1959-1966. 29. Dusdal K, Grundmanis J, Luttin K, et al. Effects of therapeutic exercise for persons with osteoporotic vertebral fractures: a systematic review. Osteoporos Int. 2011;22(3):755-769. 30. Papaioannou A, Adachi JD, Winegard K, et al. Efficacy of home-based exercise for improving quality of life among elderly women with symptomatic osteoporosisrelated vertebral fractures. Osteoporos Int. 2003;14(8): 677-682. 31. Sinaki M, Itoi E, Wahner HW, et al. Stronger back muscles reduce the incidence of vertebral fractures: a prospective 10 year follow-up of postmenopausal women. Bone. 2002;30(6):836-841.
20. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010;95(6):2536-2559.
32. Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of ver tebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557-568.
21. Lee HM, Park SY, Lee SH, Suh SW, Hong JY. Comparative analysis of clinical outcomes in patients with osteoporotic vertebral compression fractures (OVCFs): conservative treatment versus balloon kyphoplasty. Spine J. 2012;12(11):998-1005.
33. Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures [published correction appears in N Engl J Med. 2012;366(10):970]. N Engl J Med. 2009;361(6):569-579.
22. Esses SI, McGuire R, Jenkins J, et al. The treatment of symptomatic osteoporotic spinal compression fractures. J Am Acad Orthop Surg. 2011;19(3):176-182. 23. Lyritis GP, Ioannidis GV, Karachalios T, et al. Analgesic effect of salmon calcitonin suppositories in patients with acute pain due to recent osteo porotic vertebral crush fractures: a prospective double-blind, randomized, placebo-controlled clinical study. Clin J Pain. 1999;15(4):284-289. 24. Knopp JA, Diner BM, Blitz M, Lyritis GP, Rowe BH. Calcitonin for treating acute pain of osteoporotic vertebral compression fractures: a systematic review of randomized, controlled trials. Osteoporos Int. 2005;16(10):1281-1290. 25. Lyritis GP, Paspati I, Karachalios T, Ioakimidis D, Skarantavos G, Lyritis PG. Pain relief from nasal salmon calcitonin in osteoporotic vertebral crush fractures. A double blind, placebo-controlled clinical study. Acta Orthop Scand Suppl. 1997;275:112-114. 26. Lexicomp Online. http://online.lexi.com [subscription required]. Accessed March 30, 2015.
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34. McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal augmentation vs conservative therapy. JAMA Intern Med. 2013;173(16):1514-1521. 35. Anderson PA, Froyshteter AB, Tontz WL Jr. Meta-analysis of vertebral augmentation compared with conservative treatment for osteoporotic spinal fractures. J Bone Miner Res. 2013;28(2):372-382. 36. Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009;373(9668):1016-1024. 37. Institute of Medicine. Dietary Reference Intakes: Calcium, Vitamin D. Washington, DC: National Academies Press; 2011. 38. Chung M, Balk EM, Brendel M, et al. Vitamin D and calcium: a systematic review of health outcomes. Evid Rep Technol Assess (Full Rep). 2009;(183):1-420. 39. U.S. Preventive Services Task Force. Final recommendation statement: vitamin D and calcium to prevent fractures: Cont'd on page 416...
AMERICAN FAMILY PHYSICIAN
Practice Guidelines APA UPDATES GUIDELINES ON PSYCHIATRIC EVALUATION IN ADULTS The American Psychiatric Association (APA) recently released the third edition of its guide lines on psychiatric evaluation of adults. The nine-part guideline has been updated based on new evidence identified since the previous edition was released in 2006. Although the strength of the evidence supporting the recommendations in the updated guidelines is low, there is consensus that their benefits clearly outweigh the harms. In cases where the balance of benefits and harms is difficult to judge, or the benefits or harms are unclear, the APA made suggestions for care instead of recommendations. For more information about these guidelines, including tips for implemen tation, see the full report from the APA.
Guideline 1: Review Symptoms, Trauma History, and Treatment History The APA recommends that the initial psy chiatric evaluation include a review of the patient’s mood, anxiety level, thought content and process, perception, and cognition. The clinician should review the patient’s trauma history and his or her psychiatric history, including psychiatric diagnoses, treatments (type, duration, and medication dosages), adherence and response to treatments, and history of psychiatric hospitaliza tion and emergency department visits for psychiatric issues. The goal of this guideline is to improve the quality of the clinician-patient relationship, the accuracy of psychiatric diagnoses, and the appropriateness of treatment selection. Knowledge of prior psychiatric diagnoses can inform the current diagnosis because a patient may be presenting with a continuation of a previously diagnosed disorder, or may now have a different disorder that commonly co-occurs with the first. Past treatments are relevant because lack of effectiveness may suggest a need to reconsider the accuracy of the diagnosis. Symptoms that emerge during treatment (e.g., hypomania or mania in a patient with depression) may also require reassessment of the diagnosis.
Source: Adapted from Am Fam Physician. 2016;94(1):62-64.
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Guideline 2: Evaluate Substance Use To identify patients with substance use disorder and to facilitate treatment planning, the APA recommends that clinicians assess the patient’s use of tobacco, alcohol, and other substances (e.g., marijuana, cocaine, heroin, hallucinogens), as well as misuse of prescribed or overthe-counter medications or supplements. Ensuring that initial psychiatric evaluations include assessment of substance use may improve the differential diagnosis because substance use disorders, other psychiatric disorders, and other medical conditions may share similar presenting symptoms, such as anxiety, depression, mania, and psychosis.
Guideline 3: Assess Risk of Suicide The APA recommends that clinicians evaluate the patient’s current suicidal ideas, plans, and intent, including active or passive thoughts of suicide or death; prior suicidal ideas, plans, and attempts, including attempts that were aborted or interrupted; prior intentional self-injury in which there was no suicide intent; anxiety symptoms, including panic attacks; hopelessness; impulsivity; current or recent substance use disorder or change in use of alcohol or other substances; presence of psychosocial stressors (e.g., financial, housing, legal, school/occupational, or interpersonal/relationship problems; lack of social support; painful, disfiguring, or terminal illness); and aggressive or psychotic ideas, including thoughts of physical or sexual aggression or homicide. The clinician who conducts the initial psychiatric evaluation should document an estimation of the patient’s suicide risk, including factors influencing risk. If the patient reports having current suicidal ideas, the APA recommends that clinicians identify the intended course of action if symptoms worsen; determine the patient’s access to suicide methods, including firearms; identify possible motivations for suicide (e.g., attention or reaction from others, revenge, shame, humiliation, delusional guilt, command hallucinations) and reasons for living (e.g., sense of responsibility to children or others, religious beliefs); assess the quality and strength of the therapeutic alliance; and ask about the history of suicidal behaviors in the patient’s biological relatives. If the patient has attempted suicide in the past, the clinician should ask about details of each attempt (e.g., context, method, damage, potential lethality, intent).
AMERICAN FAMILY PHYSICIAN Guideline 4: Assess Risk of Aggressive Behaviors To identify patients at risk of aggressive behaviors, the APA recommends that the initial psychiatric evaluation of a patient include assessment of current or past aggressive or psychotic ideas, including thoughts of physical or sexual aggression or homicide; past aggressive ideas or behaviors (e.g., homicide, domestic or workplace violence, other physically or sexually aggressive threats or acts); legal or disciplinary consequences of past aggressive behaviors; exposure to violence or aggressive behavior, including combat exposure or childhood abuse; and current or past neurologic or neurocognitive disorders or symptoms. The clinician who conducts the initial psychiatric evaluation should document an estimation of the patient’s risk of aggressive behavior, including homicide, and factors influencing risk. If the patient reports having aggressive ideas, the APA recommends that clinicians assess the patient’s impulsivity, including anger management issues; determine the patient’s access to firearms; identify specific persons toward whom homicidal or aggressive ideas or behaviors have been directed; and ask about the history of violent behaviors in the patient’s biological relatives. There is no evidence that risk of aggression is increased by asking about past experiences, symptoms such as impulsivity, or current aggressive and homicidal ideas or plans. However, assessment could identify persons as being at risk when they are not, which could result in unneeded hospitalization or other consequences. Just as it is not possible to predict which persons will exhibit aggressive behaviors, there is no way to predict which ones would be incorrectly identified as being at risk, and no way to estimate the potential magnitude of this harm.
Guideline 5: Evaluate Cultural Factors To identify cultural factors that could influence the therapeutic alliance, promote diagnostic accuracy, and enable treatment planning, the APA recommends determining the patient’s need for an interpreter– even if the patient speaks the same language as the clinician–and assessing cultural factors related to the patient’s social environment. Persons from different backgrounds may have different explanations of illness, views of mental illness, and preferences for psychiatric treatment, particularly given the cross-cultural differences in the stigma of psychiatric disorders.
For this reason, the APA also suggests assessing the patient’s personal and cultural beliefs, and cultural explanations of psychiatric illness. For example, an individual’s self concept, response to stressors, or current symptoms may be shaped by racism, sexism, or discrimination; by traumatic experiences during or after migration from other countries; or by challenges of acculturation, including intergenerational family conflict. Cultural factors can also influence the patient’s style of relating with authority figures, such as health care professionals.
Guideline 6: Assess Medical Health The APA recommends that clinicians determine whether the patient has an ongoing relationship with a primary care health professional. Persons with psychiatric disorders can have medical conditions that influence their functioning, quality of life, and life span. Compared with the general population, mortality rates are increased in persons with mental illness, particularly those with psychotic disorders, depressive disorders, alcohol or substance use disorders, personality disorders, and delirium. To identify non-psychiatric medical conditions that could affect the accuracy of a psychiatric diagnosis and the safety of the treatment plan, the APA recommends that the initial psychiatric evaluation include assessment of the patient’s general appearance and nutritional status; involuntary movements or abnormal motor tone; coordination and gait; speech, including fluency and articulation; sight and hearing; physical trauma, including head injuries; past or current medical illnesses and related hospitalizations; relevant past or current treatments, including surgeries, other procedures, or complementary and alternative treatments; allergies or drug sensitivities; sexual and reproductive history; and past or current sleep abnormalities, including sleep apnea. It also recommends that clinicians document all current and recent medications (prescribed and nonprescribed, including herbal and nutritional supplements and vitamins) and adverse effects of these medications. In addition, the APA suggests that the initial psychiatric evaluation include assessment of the patient’s height, weight, and body mass index; vital signs; skin, including any stigmata of trauma, self-injury, or drug use; cardiopulmonary status; past or current endocrine disease; past or current infectious disease, including sexually transmitted diseases, human immunodeficiency virus infection, tuberculosis, hepatitis C, and locally endemic infectious diseases (e.g., Lyme disease); past
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AMERICAN FAMILY PHYSICIAN or current neurologic or neurocognitive disorders or symptoms; and past or current symptoms or conditions associated with significant pain and discomfort. The APA also suggests that clinicians review the patient’s constitutional symptoms (e.g., fever, weight loss), eyes, ears, nose, mouth, throat; and cardiovascular, respiratory, gastrointestinal, genitourinary, musculoskeletal, integumentary, neurologic, endocrine, hematologic, lymphatic, and allergic/immunologic symptoms.
Guideline 7: Use Quantitative Tools To improve clinical decision making and treatment outcomes, the APA suggests that the initial psychiatric evaluation include quantitative measures of symptoms, level of functioning, and quality of life (e.g., rating scales, patient questionnaires). Clinical decision making, including diagnosis and treatment planning, requires a careful and systematic assessment of the type, frequency, and magnitude of psychiatric symptoms, as well as an assessment of the effect of those symptoms on the patient’s day-to-day functioning and quality of life. There are several potential benefits to obtaining this information as part of the initial psychiatric evaluation through the use of quantitative measures. Compared with a clinical interview, these tools may help the clinician conduct a more consistent and comprehensive
review of the patient’s symptoms, which may prevent potentially relevant symptoms from being overlooked.
Guideline 8: Involve the Patient in Decision Making To improve patient engagement and knowledge about his or her diagnosis and treatment options, the APA recommends that during the initial psychiatric evaluation, the clinician should explain the differential diagnosis, risks of untreated illness, treatment options, and benefits and risks of treatment. The clinician should also ask about the patient’s treatment preferences and collaborate on decisions about treatment. Such collaboration may improve the therapeutic alliance, satisfaction with care, and adherence with treatment.
Guideline 9: Document the Psychiatric Evaluation When a patient’s care is being provided by multiple health care professionals using a shared treatment or treatment team approach, collaboration and coordination of care are crucial. To improve clinical decision making and increase coordination of psychiatric treatment with other clinicians, the APA recommends documenting the rationale for treatment selection, including the specific factors that influenced the treatment choice. It suggests that clinicians also document the rationale for clinical tests.
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...Cont'd from page 412 preventive medication, February 2013. http://www. uspreventiveservicestaskforce.org/Page/Document/ RecommendationStatementFinal/vitamin-d-and-calciumto-prevent-fractures-preventive-medication. Accessed February 6, 2015. 40. Wells GA, Cranney A, Peterson J, et al. Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev. 2008;(1):CD001155. 41. Wells G, Cranney A, Peterson J, et al. Risedronate for the primary and secondary prevention of osteoporotic
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fractures in postmenopausal women. Cochrane Database Syst Rev. 2008;(1):CD004523. 42. Cranney A, Papaioannou A, Zytaruk N, et al.; Clinical Guidelines Committee of Osteoporosis Canada. Parathyroid hormone for the treatment of osteoporosis: a systematic review. CMAJ. 2006;175(1):52-59. 43. Cummings SR, San Martin J, McClung MR, et al.; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis [published correction appears in N Engl J Med. 2009;361(19):1914]. N Engl J Med. 2009;361(8):756-765.
AMERICAN FAMILY PHYSICIAN
Photo Quiz PRURITIC RASH ON THE FOREARM AND LEGS A 37-year-old man presented with a three-day history of itching and erythema on his right forearm and legs. There were bumps, blisters, and swelling in the area of the redness. He first noticed the rash on his forearm after walking back to his car from an overnight fishing trip. The next day, he noticed the rash on his legs. He was otherwise feeling well. Physical examination revealed multiple papules and vesicles with erythema and edema (Figure 1). The erythema covered most of his legs, and some of the vesicles were oozing. There were no other physical findings. He was afebrile.
Question Based on the patient’s history and physical examination findings, which one of the following is the most likely diagnosis? A. Cellulitis. B. Herpes simplex virus infection. C. Poison ivy dermatitis. D. Urticaria.
Figure 1.
SEE THE FOLLOWING PAGE FOR DISCUSSION.
Source: Adapted from Am Fam Physician. 2016;94(1):51-52.
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AMERICAN FAMILY PHYSICIAN Discussion
Summary Table
The answer is C: poison ivy dermatitis, a type IV hypersensitivity allergic reaction to urushiol. Urushiol is the oleoresin contained in the stems, leaves, and roots of the poison ivy plant.1 In this case, the oleoresin first made contact with the right forearm and then with the legs shortly afterward.
Condition
Characteristics
Cellulitis
An enlarging warm, red, swollen, tender or painful plaque; may affect a limited or extensive area
Herpes simplex virus infection
Grouped vesicles on a red, swollen plaque that progress to pustules; commonly recurrent
Poison ivy dermatitis
Linear streaks that are pruritic, edematous, and erythematous, often with vesicles and large bullae on unclothed skin
Urticaria
Lesions are circumscribed, elevated, erythematous plaques, usually with central pallor; they may be round, oval, or serpiginous and range from 1 cm or less to several centimeters in diameter
Poison ivy is a type of Rhus dermatitis.1 The clinical presentation depends on the amount of the oleoresin that touches the skin, the way it touches the skin, and the patient’s susceptibility and skin responsive ness. Presentation includes linear streaks that are pruritic, edematous, and erythematous, often with vesicles and large bullae on unclothed skin. Injury to the skin some times leaves a transient black mark, which is a sign of contact with the plant and the consequence of oxidized urushiol.2 The rash may occur eight hours to one or more weeks after exposure. The oleoresin is not found in the blister fluid and thus does not propagate the inflammation. Prevention entails washing the area with soap and water as soon as the exposure occurs, removing the surface oleoresin. The diagnosis of poison ivy dermatitis is clinical, with the intense, linear, vesicular outbreak being diagnostic.1 Treatment of the inflammation may include wet compresses and topical or oral steroids.1 Cellulitis is a bacterial infection affecting the skin and dition presents as an subcutaneous tissue.1 The con enlarging red, warm, swollen, tender or painful plaque. The rash may affect a limited or extensive area.2 There is usually a history of trauma to the skin. Herpes simplex virus infection may pres ent as a primary or recurring outbreak. The infection presents as grouped vesicles on a red, swollen plaque that progress to pustules. The rash tends to recur near the
initial site of infection. The rash is caused by type 1 or 2 herpes virus infection.2 Urticaria, or hives, may present as an acute or chronic condition.2 The lesions are circumscribed, elevated, erythematous plaques, usually with central pallor. They may be round, oval, or serpiginous and range from 1 cm or less to several centimeters in diameter.3 REFERENCES 1. Habif TP, ed. Clinical Dermatology: A Color Guide to Diagnosis and Therapy. 5th ed. Edinburgh, Scotland: Mosby; 2010. 2. Habif TP, ed. Skin Disease: Diagnosis and Treatment. 3rd ed. Edinburgh, Scotland: Saunders/Elsevier; 2011.
3. Bingham CO. New-onset urticaria. UpToDate. May 14, 2015. http://www.uptodate.com/contents/new-onseturticaria (subscription required). Accessed December 7, 2015. ■■■■
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ANESTHESIOLOGY
A Comparative Study of Variable Speeds of Injection of Propofol on Induction in Adult Patients SMARANIKA CHOUDHURY*, PARINITA C HAZARIKA†, ARUN KUMAR GUPTA‡
ABSTRACT Objective: To examine the effect and efficacy of three different speeds of injection of propofol (1%) on induction in premedicated adult patients while comparing hemodynamic response of the drug and observing any untoward side effect, including effect on respiration. Material and methods: Ninety adult patients were randomly divided into 3 groups of 30 each (A, B and C), receiving propofol 2 mg/kg-1 intravenously in 40, 60 and 80 seconds, respectively by syringe infusion pump. Induction time was the interval from start of injection to the point of fall of 20 mL distilled water filled syringe from the dominant hand. Heart rate, blood pressure, oxygen saturation and end-tidal carbon dioxide were recorded continuously at 1, 2, 5 and 10 minutes. Results: The induction time with propofol (1%) was inversely proportional to the speed of injection. There was significant fall in blood pressure from the baseline in each of the 3 groups at 1, 5 and 10 minutes after giving the study drug (p < 0.05). However, there was no significant change in heart rate, oxygen saturation and end-tidal carbon dioxide from the baseline. Incidence of apnea with propofol infusion was directly proportional to the speed of injection. Side effects were comparable in all the 3 groups. Conclusion: Propofol, when given in the dose of 2 mg/kg-1 in the adult premedicated patients, causes decrease in induction time with increasing speed of injection without any significant difference in hemodynamics. The incidence of apnea was directly proportional to the speed of injection of the study drugs (maximum in Group A and least in Group C).
Keywords: Propofol, injection speed, induction, perioperative hemodynamics, apnea, pain
T
here is today a paradigm shift in the use of agents to induce anesthesia. Intravenous induction agents are being increasingly used to produce rapid, smooth and predictable loss of consciousness. The decrease in popularity of inhalational agents is due to, both their potential to produce environmental pollution and due to the feeling of suffocation that the patient experiences on mask application. Propofol (2,6-diisopropylphenol) is a well-accepted intravenously administered anesthetic agent which, by virtue of its pharmacodynamic properties, is considered
a popular choice both for induction and maintenance of anesthesia. Extensive clinical experience with propofol in a wide variety of patients during different surgical procedures has demonstrated its effectiveness. Studies have shown that the dose required and the speed of onset of anesthesia was affected by changes in the rate of injection.
*Senior Resident Dept. of Anesthesiology and Critical Care Lady Hardinge Medical College and Shrimati Sucheta Kriplani Hospital, New Delhi †Head of Department Dept. of Anesthesiology Mrs. Girdhari Lal Maternity Hospital, North MCD, New Delhi ‡Consultant Dept. of Anesthesiology and Critical Care Sharda Medical College, Greater Noida, Uttar Pradesh Address for correspondence Dr Smaranika Choudhury B-1/501, Milan Vihar Appts 72, IP Extension, Patparganj, Delhi -110 092 E-mail: smaranikach@gmail.com
MATERIAL AND METHODS
Many of these studies were done in unpremedicated patients. Probably, the addition of premedication would further change the incidence and rate of onset of anesthesia. The aim of the present study was to examine the effect and efficacy of three different speeds of injection of an emulsified formulation of propofol in premedicated adult patients.
The present study was approved by the Ethics Committee of Hindu Rao Hospital, Delhi and written informed consent was obtained from all the patients. In this prospective, single-blind study, a total of 90 patients (Between 20 and 50 years, of American Society of Anesthesiology [ASA] I-II, undergoing elective surgery [<2 hours]) were selected and randomized into three groups by a computer generated random number
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ANESTHESIOLOGY table, and sequentially numbered, sealed, opaque envelopes were used as method of concealment: ÂÂ
Group A: Patients received propofol 2 mg/kg-1 over 40 seconds
ÂÂ
Group B: Patients received propofol 2 mg/kg-1 over 60 seconds
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Group C: Patients received propofol 2 mg/kg-1 over 80 seconds.
Patients with a history of gastroesophageal disorder, weight <40 kg or >70 kg, ASA Grade III and IV, pregnant and lactating females, with known or predicted difficult airway (Mallampati Grade III and IV), history of anaphylaxis to propofol or exposure to propofol in previous 6 months, substance abuse and those undergoing emergency surgery or in whom elective surgery lasted for more than 2 hours were excluded. After the detailed preanesthetic check-up and investigations, patients were kept fasting overnight and premedicated with tablet alprazolam 0.25 mg and tablet ranitidine 150 mg night before surgery. On arrival in the operating room, pulse oximeter probe, electrocardiography leads and noninvasive blood pressure cuff were attached and the baseline readings of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP), peripheral oxygen saturation (SpO2) were recorded. A peripheral intravenous line with 18-gauge cannula in antecubital vein of nondominant hand was inserted and Ringers Lactate solution was started. All the patients were premedicated with injection midazolam 0.03 mg/kg-1 and injection fentanyl 2 µg/kg-1, 5 minutes prior to induction and preoxygenated with 100% oxygen (O2) for 3 minutes. Patients were asked to hold the tip of 20 mL syringe filled with distilled water between the thumb and index finger of the dominant hand. At this point, the predetermined strength of propofol (2 mg/kg-1) was given intravenously for induction through the side port of 3 way cannula at a particular infusion rate (for 40, 60 or 80 seconds) using the syringe infusion pump. Induction time was taken as the interval from the start of the injection to the point at which the syringe fell down. The full scheduled dose of propofol was given even if anesthesia was induced before the injection was completed. After induction, injection suxamethonium 2 mg/kg-1 was administered and the lungs were ventilated using 66% nitrous oxide in oxygen and isoflurane (0.5-1.0%) with Mapleson D system. Trachea was intubated with appropriate sized orotracheal cuffed tube and secured after confirming equal air entry bilaterally.
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Anesthesia was maintained with 66% nitrous oxide in oxygen and isoflurane (0.5-1.0%) and muscle paralysis was done with injection vecuronium (0.08 mg/kg-1 bolus followed by 0.02 mg/kg-1 repeated doses). At the end, reversal of neuromuscular blockade was achieved with injection neostigmine (0.05 mg/kg-1) and injection glycopyrrolate (0.01 mg/kg-1) and trachea extubated. The hemodynamic parameters such as HR, SBP, DBP, MAP, also SpO2 and EtCO2 were observed and recorded at the following time points - baseline (BL), 1 minute (PS1), 2 minutes (PS2), 5 minutes (PS5) and 10 minutes (PS10) after the start of injection of the study drug. Apart from these, presence of pain on propofol injection, apnea >15 seconds, hypertonus, myoclonus, cough/hiccough, spontaneous movements and flush/ rash if any, were also recorded.
Primary Objective To observe efficacy of propofol by comparing induction time with different rates of infusion of propofol.
Secondary Objective To compare the hemodynamic responses and side effects observed during the study.
Sample Size Calculation The study was designed to include 90 patients for 80% power at the 0.05 significance level to detect a minimum difference of 8 seconds in the mean induction time [Group A {43.7s (7.8)}, Group B {50.5s + (11.4)}, Group C {58.4s (11.4)}]. These 90 patients were then equally randomized into 3 groups that is A, B and C.
Statistical Analysis Descriptive statistics of the quantitative variables was presented in terms of range (minimum, maximum), mean ± SD/median (interquartile range) and frequency (%) for qualitative variables under each group separately. The statistical significance of quantitative variables (such as SBP, DBP, MAP, SpO2, EtCO2) was determined by one way analysis of variance (ANOVA) across the three groups/unpaired t-test/nonparametric MannWhitney test in case data did not follow normal distribution. The statistical significance of qualitative variables was determined by Chi-square/Fisher’s exact test across the three groups. The intragroup statistical significance was determined by paired t-test/ nonparametric Wilcoxon signed-rank test. The level of significance was considered statistical significant if p < 0.05. The data was analyzed by using SPSS statistical software version 16.0.
ANESTHESIOLOGY RESULTS
40 seconds
80 seconds
94
MAP (mmHg)
There were no statistical differences in the demographic data (age, sex, ASA status, weight and height). The induction time with propofol injection in Group A (44.20 ± 5.22 seconds) was significantly shorter than the induction time in Group B (50.23 ± 6.11 seconds) and the latter was significantly shorter than the induction time in Group C (57.43 ± 4.97 seconds). Thus, the induction time was inversely proportional to the speed of injection of propofol (p < 0.001) (Fig. 1). There was no significant change in the HR from the baseline at each point of time among all the groups (Fig. 2). There was significant fall in SBP, DBP and MAP from the baseline with propofol injection in each of the groups (p < 0.001) (Fig. 3). However, the HR, SBP, DBP, MAP were comparable at each point of time among all the groups on intergroup statistical analysis.
60 seconds
92 90 88 86 84 82 80 78 76 74 72 70 Baseline
1 minute (PS1)
2 minutes (PS2)
5 minutes (PS5)
10 minutes (PS10)
Time (minutes)
Figure 3. Effect of different speeds of injection of propofol on mean arterial pressure at different time intervals.
Table 1. Incidence of Side Effects in Various Groups 70 57.43
60
50.23
Seconds
50
44.20
40 30 20 10 0 Group A (40 seconds)
Group B (60 seconds)
Group C (80 seconds)
Groups
Figure 1. Induction time.
Heart rate (bpm)
40 seconds
60 seconds
80 seconds
94 93 92 91 90 89 88 87 86 85 84
Adverse effects
Group A No. (%)
Group B No. (%)
Group C No. (%)
Pain
2 (6.6)
1 (3.3)
1 (3.3)
Apnea
18 (60)
13 (43.3)
5 (16.6)
Myoclonus
1 (3.3)
1 (3.3)
2 (6.6)
Cough
1 (3.3)
1 (3.3)
0 (0)
Rash
0 (0)
0 (0)
0 (0)
Side effects occurring during propofol induction like pain, hypertonus, myoclonus, cough/hiccough, rash and spontaneous movement were comparable among all the groups (Table 1). The incidence of apnea in Group A was significantly higher than Group B and the latter was significantly higher than Group C (p < 0.002). DISCUSSION
Baseline
1 minute (PS1)
2 minutes (PS2)
5 minutes (PS5)
10 minutes (PS10)
Time (minutes)
Figure 2. Effect of different speeds of injection of propofol on heart rate at different time intervals.
In our study, we found that mean induction time was inversely proportional to the speed of injection of propofol. To provide an endpoint of induction of anesthesia, the patients were asked to hold the tip of a distilled water filled 20 mL syringe between their thumb and index finger as described by Cummings et al.1 Our results are similar to those of Rolly et al,2 who studied the effect of speed of injection on induction with propofol 2 mg/kg-1 given over 5, 20 and 60 seconds in a forearm vein in un premedicated adults and found that mean induction time was inversely proportional to the speed of injection of the drug
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ANESTHESIOLOGY (21.5, 34.7 and 50.5 seconds, respectively; p < 0.001). Gillies et al3 induced the premedicated patients by injecting propofol 2.5 mg/kg-1 at different speeds; over 20, 40 and 80 seconds and observed that the induction time was inversely related to speed of injection (30.8, 43.7 and 58.4 seconds, respectively; p < 0.001). Results similar to ours were also described by Uzun et al.4 In his study, propofol was administered at 200 (P200), 300 (P300) and 400 mL/h-1 (P400) until loss of consciousness occurred in 72 adult patients by using bispectral index (BIS) monitoring. The duration of induction was shortest with 400 mL/h-1 infusion rate and the total propofol dose was significantly higher in these patients. The induction dose required for loss of consciousness increased with a faster rate of infusion while time for induction was shorter in P400 (p < 0.003) compared to P200 and P300. Similarly, Peacock et al5 and Kaul et al6 have also observed that faster speeds reduced the time to induce.
into a large vein.8 This finding corresponds to our result in which it was statistically nonsignificant among the 3 groups (p > 0.05). This decrease in incidence could be due to the use of large size of the vein (antecubital vein) and also because the drug was injected by syringe infusion pump along with a running drip of 5% dextrose through a three way cannula. Gillies et al3 also found no effect of speed of injection on incidence of pain.
Following propofol injection mean HR values showed no significant change from the baseline at each point of time among all the groups. In our study; SBP, DBP and MAP were decreased in all the 3 groups at PS1 (p < 0.001), PS5 (p < 0.001) and PS10 (p < 0.001) minutes after start of propofol injection, which was found to be statistically significant when compared to baseline values. Our results are in accordance with Rolly et al2 and Zahoor et al7 who observed that fall in blood pressure during anesthesia induced with different injection speeds of propofol showed significant decrease from baseline values in all the groups (p < 0.05), but no statistically significant difference were found between the groups. This finding is in contrast to the observations of Peacock et al5 who administered propofol at 300, 600 or 1200 mL/h-1 and found statistically significant difference in SBP and DBP between the 3 groups.
1. Cummings GC, Dixon J, Kay NH, Windsor JP, Major E, Morgan M, et al. Dose requirements of ICI 35,868 (propofol, ‘Diprivan’) in a new formulation for induction of anaesthesia. Anaesthesia. 1984;39(12):1168-71.
Propofol produces apnea in 25-35% of patients after induction of anesthesia.8,9 We, in our study, observed increasing incidence of apnea with decreasing speeds of propofol. A higher incidence of apnea in Group A was found as compared to Group B and C (p = 0.002). This is in accordance with Peacock et al5 and Gillies et al3 who also reported an increasing incidence of apnea with increasing speed of injection of propofol. However, it is in contrast to studies done by Rolly et al2 and Zahoor et al7 who found no statistical significant differences between the 3 groups with respect to the incidence and duration of apnea.
6. Kaul TK, Gautam PL, Narula N, Babra JK. Effect of different rates of infusion of 1% and 2% propofol for induction of anaesthesia in elderly patients. Indian J Anaesth. 2002;46(6):460-4.
CONCLUSION Increasing the speed of propofol injection in the adult premedicated patients causes a decrease in induction time without significant difference in hemodynamic variables and the incidence of apnea is directly proportional to the speed of injection of propofol. REFERENCES
2. Rolly G, Versichelen L, Huyghe L, Mungroop H. Effect of speed of injection on induction of anaesthesia using propofol. Br J Anaesth. 1985;57(8):743-6. 3. Gillies GW, Lees NW. The effects of speed of injection on induction with propofol. A comparison with etomidate. Anaesthesia. 1989;44(5):386-8. 4. Uzun S, Ozkaya BA, Yilbas OS, Ayhan B, Sahin A, Aypar U. Effect of different propofol injection speeds on blood pressure, dose and time of induction. Turk J Med Sci. 2011;41(3):397-401. 5. Peacock JE, Lewis RP, Reilly CS, Nimmo WS. Effect of different rates of infusion of propofol for induction of anaesthesia in elderly patients. Br J Anaesth. 1990;65(3):346-52.
7. Zahoor A, Ahmed N. The effects of duration of Propofol injection on hemodynamics.Middle East J Anaesthesiol. 2010;20(6):845-50. 8. Stoelting Robert K, Flood P, Rathmell JP, Shafer S (Eds.). Pharmacology and Physiology in Anaesthetic Practice. 5th Edition, Philadelphia: Lippincott Williams and Wilkins; 2015. pp. 165-6.
9. Bouillon T, Bruhn J, Radu-Radulescu L, Andresen C, Cohane C, Shafer SL. Mixed-effects modeling of the Pain, an unpleasant side effect of propofol according to intrinsic ventilatory depressant potency of propofol in the non-steady state. Anesthesiology. 2004;100(2):240-50. text, occurs in fewer than 10% of patients when injected ■■■■
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2016
COMMUNITY MEDICINE
Occupational Stress Among the Women Nurses at Various Government Hospitals in Chennai B PRASILA LEELAVATHY PAPPATHY*, RAMACHANDRAN NARAYANAN†
ABSTRACT In the system of hospital services, the role of nursing is inevitable. This study verified the opinion of women nurses about their occupational stress in terms of its sources, channel, factors influencing stress, outcome of occupational stress on various dimensions and finally the strategies employed by women nurses to manage and reduce occupational stress. In order to describe the framed objectives, the necessary hypotheses have been tested through selected statistical tools. The hypotheses were framed and tested in the aspects of significant difference in the opinion of women nurses about their organizational performance and support, reasons for occupational stress, level of factors and its influences, impact of stress on personal, psychological and health grounds. The structured questionnaire used for data analysis contained questions of personal, career profile, opinion about sources of stress, impact, factors that lead to stress and way of managing the same. The obtained data from the sample size of 125 have been analyzed with the help of selected descriptive and inferential statistical tools according to the aptness of application. The obtained findings provide valuable suggestions to the women nurses’ community, hospitals and government bodies.
Keywords: Organizational performance and support, occupational stress, impact of stress on personal
T
oday, the healthcare industry is considered as one of the largest industries throughout the world. It includes thousands and thousands of hospitals and institutions which provide primary, secondary and tertiary level of care. It is seen that, throughout the past decades, nurses have manually adjusted their personal activities to provide care to the patients. In a country like India, nursing jobs in various hospitals are occupied by women employees. According to a recent statistics disclosed by Indian Medical Association (IMA), 65% of nursing occupation in India is filled and continuously balanced by women nurses. The demand for healthcare among
*Research Scholar Dept. of Business Administration Wing Annamalai University, Annamalai Nagar, Tamil Nadu †Assistant Professor Research Advisor Dept. of Business Administration Wing, Directorate of Distance Education, Annamalai University, Tamil Nadu Address for correspondence Dr B Prasila Leelavathy Pappathy Research Scholar Dept. of Business Administration Wing, Annamalai University, Annamalai Nagar, Tamil Nadu - 608 002 E-mail: Prasilaramani@gmail.com
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the modern day people paves way for the growth of healthcare industry. Due to the fierce competition that prevails in the hospital sector, especially due to the participation of private and foreign investments, the nurses are expected to focus on delivering more sophisticated services. In addition to that, the structures of service delivery processes have also changed in terms of approach, attitude and time, reporting and dealing with technology. Considering this, the researcher decided to conduct a study under the title of “Occupational stress among the women nurses at various hospitals in Chennai”. STATEMENT OF PROBLEM Due to these changes in the working pattern and environment of work, female nurses working in multiple categories of government, private and foreign hospitals face a lot occupational pressure. These aspects are again coupled with the personal, social, family and environmental issues among nurses. Female nurses also encounter issues on the basis of work place attitude, care process and gender discrimination. All these together contribute to stress among them. But the consequences of occupational stress among female nurses add to the disadvantages in terms of their personal, health, social, family and work-related
COMMUNITY MEDICINE avenues. It is also observed that the attitude of female nurses about occupational stress and its impact on their outcomes at various levels significantly differs. FACTORS INFLUENCING OCCUPATIONAL STRESS AMONG WOMEN NURSES ÂÂ
Women nurses provide round-the-clock services to patients in hospitals, nursing homes, long-term care facilities, visiting old age homes as well as to clients using supportive and preventative programs and related community service. Work load, shift work, overtime and covering for absent colleagues are the most commonly identified stressors.
ÂÂ
Working with different patients, the nurses’ feelings about life, interpersonal conflicts, managing the patients’ pain and the presence of the family also contribute to occupational stress.
ÂÂ
Nurses undergo emotional exhaustion which leads to negative feelings towards their care. Anxiety, frustration, anger, feelings of inadequacy and helplessness or powerlessness are emotions often associated with occupational stress.
CAUSES OF OCCUPATIONAL STRESS ÂÂ
Women nurses’ participation in teams, attendance during rounds and meetings, field trips, palliative work, providing counseling to patients and their families and social services.
ÂÂ
Conditions such as poor physical working conditions, overcrowding, noise, lack of proper ventilation, air pollution, reduced lighting, poor ergonomics and inflexible or unpredictable hours have been recorded as contributory factors.
ÂÂ
A number of medical conditions are related to, or exacerbated by, stress and include: Chronic pain, migraines, ulcers, heartburn, high-blood pressure, heart disease, diabetes, asthma, obesity, premenstrual syndrome, musculoskeletal conditions, anxiety, depression, eating disorders and substance abuse.
Physical symptoms can include: Headaches or backaches, muscle tension and stiffness, diarrhea or constipation, nausea, dizziness, insomnia, chest pain, rapid pulse, weight gain or loss, skin breakout (i.e., hives or eczema), loss of sex drive and frequent colds. REVIEW OF LITERATURE Eakin1 in his research, studied the determinants of economic efficiency in hospitals. For this purpose,
the estimated values of allocative inefficiency were regressed on several hospital and market-related characteristics considered to be the determinants of efficiency based on economic theory. Duggal2 in his research framework on the utilization of healthcare in India, revealed that India had a plurality of healthcare systems as well as different systems of medicine. The government and local administrations provide public healthcare in hospitals and clinics. Public healthcare in rural areas is concentrated on prevention and promotion services to the detriment of curative services. Dasgupta and Kumar3 in their study concluded that role overload, self-role distance, role isolation, interrole distance, role stagnation, role expectation conflict, role ambiguity and role inadequacy are the factors causing role stress among nurses. Turan and Singh4 in their study examined the association between different manifestations (headache, diabetes, depression, general stress, high blood pressure, ulcer, fatigue, backache or pain) of stress and employees’ demographic variables (age, gender, education and length of work experience). Srimathi and Kumar5 in their publication examined the level of psychological well-being among working women in different professions. Women working in different organizations - industries, hospitals, banks, educational institutions and in call centers/ BPOs were randomly selected. Results revealed that women employees working in industries had least psychological well-being followed by women working in health organizations. Tlaiss6 in his research publication explored the overall status of women managers in an industry that is overpopulated with women employees and underpopulated with women managers. This study suggested that although women constituted the majority of the workforce in the healthcare sector, they were not fairly represented in management. Their careers in management were often hindered by macrosocial and meso-organizational obstacles and barriers. Similarly, the attitudinal and structural barriers that women faced at the meso-level were almost inseparable from the macro-sociocultural factors and the overall conditions of the healthcare sector. Negeliskil and Lautert7 aimed to evaluate the relationship between occupational stress and the work capacity index of nurses of hospital group. Social support constituted a pillar of the occupational
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COMMUNITY MEDICINE conjuncture and a strategy of social organization in the institutions in order to prevent and/or to reduce occupational stress. RESEARCH METHODOLOGY
Objectives of the Study ÂÂ To identify the factors that cause stress among women nurses in the different categories of hospitals in Chennai. ÂÂ To understand the consequences of stress and the effects on both personal and professional life of nurses. ÂÂ To identify the health-related issues encountered by nurses due to occupational stress. ÂÂ To know the occupational stress management strategies adopted by nurses at personal, family and organizational levels. Hypotheses ÂÂ There was no significant difference in the influence of frequent patient interaction on job stress among the women nurses based on their designation. ÂÂ The impact of occupational stress due to personal, job-related, economic, family-related and psychological aspects did not differ significantly based on designation, marital status, type of organization, education and nature of family. ÂÂ The changes in communication pattern and contribution to the job due to occupational stress did not significantly differ among the women nurses based on their designation and type of organization. ÂÂ The level of occupational stress among the respondents did not significantly differ based on the nature of their family. Research Design The research design of present study was descriptive and causal in nature, since the study identified the opinion of women nurses about their occupational stress and also the impact of occupational stress on their job-related activities. The study had been carried out among the women nurses in various hospitals at Chennai. Period of the Study The study period ranges over the years 2015 to 2016. The review part of the study covers period from 2009 to 2014. The primary data collection was carried out between the periods from 2015 to 2016.
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Study Population The study population included women nurses in government, private and other forms of funded hospitals in Chennai. The population sources list for the present study had been obtained from the District Medical Office, private hospitals, Indian Nursing Council (Chennai Chapter) and urban hospital centers. Sampling Unit The sampling units were so chosen as to cover nurses belonging to different cadres and designations in government, private and other forms of hospitals in the study location. The original sample size for the present study was determined through proportion during the time of pilot study as 200, but later due to the poor response among the selected samples and non-reach ability, the sample size for the present study was to 125. Sampling Design For the present study, stratified disproportionate random sampling has been used. The required sample for the study was taken from government and private hospitals. The women nurses working in hospitals had been selected from the existing designation levels like auxiliary nurse maids, staff nurse, head nurse, matron or nursing superintendent. Sources of Data The required data for the study were obtained from both primary and secondary sources. The primary data required for the study were obtained from the female nurses working in government, private and corporate hospitals on various designations with the help of a structured questionnaire. The secondary data required for the present study were obtained through earlier research works, journals, magazines, periodicals, books, manuals obtained from the hospital sources and web-related sources. The obtained secondary sources were helpful for framing the research problem, conduct pilot research, construct and evaluate reviews related to study, framing of questionnaire with apt scales for designing of the profile to hospital industry and occupational stress of nurses. Nature of Questionnaire The questionnaire used for the collection of primary data from the nurses in the selected study area was structured, pre-tested and constructive in nature.8 Tools Employed for Analysis The socioeconomic profile of nurses like age, educational qualification, marital status, designation,
COMMUNITY MEDICINE monthly income, nature of family, family size, nature of location, number of children, type of organization employed and total experience were analyzed with the help of simple percentage analysis. The career profile of the respondents and their opinion about the purpose of choosing the career like reason, influence to chose, ability to optimize the career, career wisdom and opinion about their present organization and its working background were analyzed with the help of cross table. The satisfaction of respondents about their career output, delegation, job rotation and level of stress management were analyzed. The analysis of variance was applied to verify and test the opinion of nurses about the sources of occupational stress related to personal, job-related, economic, family and psychological factors with the help of type of organization and nature of occupation. The causes of occupational stress and its consequences were analyzed with the help of garret ranking. RESULTS AND DISCUSSION The collected responses through structured questionnaire were edited, coded and tabulated for studying the personal profile of nurses, their career profile and reason for choosing the medical career. The opinion about occupational stress, causes, factors influencing stress and its impact was also tested for its significance based on factors like type of organization, nature of job; marital status and age. Independent sample t-test was used for this purpose.
Age and Educational Background of the Respondents The influences of age on stress significantly differed. In order to understand this aspect, the age background of nurses working in different categories of organization in the study unit was collected.9 The age composition of nurses in the selected study area was as follows: Percent of the nurses in the age category of 23-25 years was 8.8%, percentage in the age category of 26-30 years was 13.5, percentage in the age category of 31-35 years was 15.4, percentage in the age category of 36-40 years was 15.2, percentage in the age category of 41-45 years was 14.7, percentage in the age category of 46-50 years was 28.0 and percentage in the age category of 50 and above was 4.4 (Table 1). These results are supported by the findings of a study conducted by Antoniou et al.9 Based on the level of education, the ability to manage work-related issues would differ among the individuals. In order to verify the influence, the educational
Table 1. Characteristics of Study Respondents Particulars
Number of respondents
Percentage to Total
Age category of the respondents 23-25 years
11
08.8
26-30 years
17
13.5
31-35 years
20
15.4
36-40 years
19
15.2
41-45 years
18
14.7
46-50 years
35
28.0
50 and above
05
04.4
Total
125
100
Educational background of the respondents HSC
06
05.0
Diploma
43
34.0
Degree
29
23.0
PG
35
28.0
Certificate Course
12
10.0
Total
125
100
Marital status of the respondents Single
33
26.4
Married
74
59.2
Others
18
14.4
Total
125
100
Auxiliary nurse maid
25
20.0
Staff nurse
30
24.0
Head nurse
43
34.4
Matron or nursing superintendent
27
21.6
Total
125
100
Designation of the respondents
Monthly income of the respondents <20k
13
11
21-30k
35
28
31-50k
40
32
50k and above
37
29
Total
125
100
Nature of the family respondents Nuclear
60
48
Joint
65
52
Total
125
100
<3 members
40
32
4-7 members
42
34
Above 7 members
43
34
Total
125
100
Family size of the respondents
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COMMUNITY MEDICINE background of nurses was collected and analyzed in the study. As regards the educational background of the respondents, 5% were having HSC qualifications, 34% had Diploma, 23% were having Degree qualification, 28.9% had Postgraduate qualifications and 10% had Certificate course as their qualifications (Table 1). These results are supported by the findings of the study conducted by Sliskoric and Sersdic.10
Marital Status and Designation of the Respondents The marital status also influences the psychological background of the individuals. The personality, perception and attitude undergo changes in every individual after marriage. It causes different forms of stress due to the imbalances of family, social, environmental and organization dimensions. In this aspect, the marital status of nurses has been studied by Riedel et al.11 The details of the marital status of the nurses in the selected study area were - 26.4% of the nurses were not married, 59.2% were married and 14.4% were in the other status like widow, divorce and so on (Table 1). These findings are supported by the study conducted by Riedel et al.11 The designation background of the nurses was collected for the study. Of all the respondents, 20% were working as auxiliary nurse maids, 24% were staff nurses, 34.4% were serving as head nurses and 21.6% as matron or nursing superintendent (Table 1). These findings are supported by the study conducted by and Quick and Quick.12
Monthly Income of the Respondents Income helps to attain materialistic status in life and acts as the instrument for self and family management. Monthly income also contributes to stress. In view of this, the income background of nurses was analyzed in the study.13 The brief the monthly income status of the respondents was that 11% of the respondents were getting monthly salary less than ` 20,000; 28% were having income between ` 21,000-30,000, and 32% had income between ` 31,000 and 50,000 and 29% obtained more than ` 50,000 (Table 1). These findings were in parallel with the study conducted by Khurshid et al.13
Nature of Family and Number of Children of Respondents Depending upon the nature of family, the responsibility level, system of sharing, acquiring wealth and
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welfare differs and it also brings different categories of pressures. Based on the response obtained from the families, an individual can manage work place situations.14 This pattern portraits the nature of family of the nurses in the selected study area. Forty-eight percent of them were in joint family category and 52% were in nuclear family category (Table 1). The role of family members also influences an individual at the family and at the occupational level. In order to understand this aspect, the family sizes of nurses have been analyzed.15 The family size of the respondents in this study was as follows: Thirty-two percent had less than 3 members in the family, 34% had 4-7 members and 34% had more than 7 members in their family (Table 1). The number of children in the family is also reflected at their work places in the form of poor concentration and occupational stress. By keeping this view, the number of children of nurses in the study unit were reviewed.16 As regards the number of children of the respondents, 9% did not have children, 23% had one child, 46% had two children and 22% had more than three children (Table 2). These data are supported by the findings of Greenhaus and Beutell, Oâ&#x20AC;&#x2122;Connor and Bailey.14-16
Nature of the Location and Type of Organization Employed Geographical location of work place is also an important factor for job-related stress among individuals. In this aspect, the nature of geographical location of women nurses has been reviewed for the study. As regards the nature of location of the nurses in the selected study area, 42% of them belonged to the urban background, 40% belonged to semi-urban base and 18% were of the rural background. The type of organization brings different forms of working environment and working condition, which changes the contribution and attitude of employees at work places. It leads to different forms of stress among the individuals. In this aspect, in order to know the occupational stress difference among the nurses, the details of types of organizations they worked in were analyzed. Regarding the respondentsâ&#x20AC;&#x2122; employment related to type of hospitals, from the Table 2, it is observed that 36% were working in private hospitals, 39% in government, 16% in public healthcare centers and 9% in funded hospitals in the selected study area. All these results are supported by the results of studies conducted by Grant and Griffiths.17,18
COMMUNITY MEDICINE Table 2. Characteristics of Study Respondents (Cont'd...) Particulars
Number of respondents
Percentage to Total
Number of children of the respondents None
11
09
One
28
23
Two
58
46
More than three
28
22
Total
125
100
experience and only 22% had more than 20 years of work experience (Table 1). All these results were supported by the results of study conducted by Velnampy.19
Opinion About the Changes Due to Occupational Stress
Urban
53
42
Semi urban
50
40
Rural
22
18
Total
125
100
Private
45
36
Government
48
39
Public healthcare centers
20
16
The responsibility level of job, nature of job, type of work, hours of stretched work, individual contribution, support of family, economical status, prevailing working condition, age, gender, marital status are also aspects which have influence on occupational stress. In order to verify these aspects among the nurses, a table had been designed. The respondentsâ&#x20AC;&#x2122; opinion about the psychological changes due to occupational stress revealed that 36% experienced changes in their attitude, 31% experienced changes in conflict and 24% had changes in their personality and 9% experienced the changes in their motivational levels due to occupational stress. These results are supported by the results of study conducted by Lazarus and Folkman.20
Funded
12
09
Total
125
100
Managing of Occupational Stress
Nature of the location of the respondents
Type of organization employed
Total experience of the respondents <5 years
13
11
6-10 years
26
21
11-15 years
22
18
16-20 years
36
28
> 20 years
28
22
Total
125
100
Opinion about the changes due to occupational stress Personality
30
24
Attitude
45
36
Level of motivation
12
09
Conflict
38
31
Total
125
100
Total Experience of the Respondents Experience is the cultivating channel for individual development. In addition, it is the factor that helps the individual to especially manage occupation-related stress with suitable strategies. To review this aspect, the background of experience of women nurses working in different categories of hospitals in the study unit was analyzed. As regards the total experiences of the nurses, working in different categories of hospitals in the selected study area, 11% had less than 5 years of experience, 21% had 6-10 years of experience, 18% had 11-15 years of experience, 28% had 16-20 years
The way of managing the stress is influenced by individual attitude, value proposition, perception, personality and situation needed to be managed, for which the strategies employed by various individuals also differ at personal, organizational and psychological levels.21 It was seen that 83% managed by meditation, 89% by yoga, 72% by mind diversion, 79% by exercise, 69% by counseling and 31% by therapies. In organizational level, 48% of the respondents managed occupational stress by medical counseling offered by organizations, 81% by workshop/training, 39% by sabbatical leave, 73% by mediclaims and 69% managed by job rotation. As regards the managing of occupational stress by the respondents based on psychological balance, 92% managed by personality reshaping, 43% by perceptual change, 56% by attitude formation, 89% by self-motivation, 93% by relationship management and 84% managed by new learning avenues. These findings are in parallel and supported by the results of study conducted by Craig and Hancock.21
Motivational Instrument to Chose the Nursing Career Based on Educational Background of the Respondents The motivational sources behind the reason for choosing nursing as career are influenced by family, self, friends, relatives and existing employee sources. The choice of Doctorsâ&#x20AC;&#x2122; career is also highly influenced by the possession of educational qualification. In order
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COMMUNITY MEDICINE to understand the influence of educational background for choosing the Doctorsâ&#x20AC;&#x2122; career a table designed by Salami22 was used and interpreted. As regards the motivational sources for choosing nursing based on their educational background, 7% of the respondents with the educational background of degree chose the career due to their self-interest, 6% due to the influence of friends and relatives, 6% due to family and 4% through the sourcing of employees in the sector; 5% of the respondents with the educational background of diploma were influenced by their family, 8% due to self-interest, 7% due to friends and relatives and 4.8% through employees in present jobs. These findings are supported by the study conducted by Salami.22
Types of Stress Encountered by Respondents Based on Age Category Nursing profession is a kind of relentless service where stress in job is highly influenced by age. In order to understand this impact, the types of stress encountered by doctors based on their age were analyzed by Gmelch et al.23 The types of stress encountered by the nurses based on their age category in this study were as follows: Four percent of the respondents in the age group of less than 25 years encountered physical stress, 3.2% psychological and 4.5% encountered both physical and psychological stress. Among respondents in the age group of 26-30 years; 6.4% faced both physical and psychological, 6.25% psychological and 4.8% physical stress. In the age group of 31-35 years; 4% faced physical, 7% psychological and 8% both, 7% of the respondents in the age group of 36-40 suffered both physical and psychological stress, 7% physical stress and 8% psychological stress. Regarding the age group of 41-45; 6% encountered both physical and psychological stress, 6% psychological and 8% physical stress; 9% of the respondents in the age group of 46-50 encountered stress due to both physical and psychological reasons and 8% in the age group of above 50 also encountered stress due to the same reasons. These findings are supported by the results of study conducted by Gmelch et al.23
Realization of Occupational Stress Based on the Age Category of Respondents Age is the factor which invokes different situations for encountering the stress. The realization of occupational stress based on age is also influenced by nature of job,
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time and duration of work, outcome and methods of performing job.24 The realization of occupational stress by the respondents based on their age category was as follows: Among respondents in age category of <25, 6% had stress due to inconvenient working hours, 6% due to shift system, 3% due to deadline work pressure, 4% attributed it to family remembrance and 3% had stress due to heavy work place complaints. Regarding the public healthcare centers, 6% managed occupational stress through redesigned working hours, 5% through peer group sharing, 7% through periodical training and 7% through counseling; 7% of nurses in funded hospitals managed occupational stress through redesigned working hours, 5% through peer group sharing and 4% through periodical training. These findings are supported by the results of study conducted by Kahn et al.24 SUMMARY OF FINDINGS Demographic profile of respondents regarding the age category of nurses in hospital sector revealed that 8.8% of nurses were in the age group of less than 25 and only 4.4% were above the age group of 50. Since, the sector inducted moderate age group in recent years, the role of maturity and age plays a significant role. As regards the educational background of doctors in the study location, it was found that 5% had degree qualification and only 39% had postgraduation background. It was found that the qualification of specialized hospital courses help the nurses to equip themselves on technical aspects. As regards the monthly income of nurses, it was found that 11% were earning less than ` 20,000 which would have led be a cause of economic insecurity for them and leads to occupational stress. Regarding the nature of family of nurses in the selected study location, 52% lived in joint family and 48% in nuclear family. The constitution of family system as nuclear may yield additional responsibility that may lead to work life imbalances for nurses. It was also found that 34% of respondents had 4-7 members in their family and nearly 34% had more than 7 family members. Regarding the caring responsibilities, it was found that almost 39.9% had 1-2 children. It was seen that 42% of nurses belonged to urban background and 18% belonged to rural base of residential location. Regarding the type of organization of nurses, 36% were employed in private hospitals and 39% in government hospitals. The employment avenues for nurses were higher in private hospitals than other forms like government, public health. It was found
COMMUNITY MEDICINE that 21% of nurses had 6-10 years of work experience and 18% had 11-15 years of experience. It was also found that only 28% had 16-20 years of experience, 11% had less than 5 years of experience and it could be a reason for encountering occupational stress due to lack of experience in the category of less than 5 years. Regarding the changes due to occupational stress among nurses, 36% found attitude changes, 24% observed personality changes and 9% felt change in the level of motivation.
SUGGESTIONS TO FAMILIES
It was found that the major changes due to occupational stress among the nurses were psychological aspects. In the category of auxiliary nurse maids, 4% chose for growth in career and 2% chose with service in mind. Regarding staff nurses, 2% chose for service attitude and 8% chose for ambition; 3% of head nurses chose with service in mind and 7% chose for ambition; whereas at matron or nursing superintendent level, 2% chose nursing profession for ambition. Majority of nurses chose the career for growth. As regards the causes of occupational stress, after application of Garrett ranking, it was found that survival was the major cause, psychological background and economic factors were the others, whereas workrelated factors were minor causes among the nurses. It was found that work affinity was high among nurses. It was also seen that the impact due to status in society on occupational stress significantly differed among nurses based on their designation and the impact on occupational stress due to temporary disablement, mild diseases, major health hazards and ruts out due to health dimension significantly differed among nurses based on their marital status. SUGGESTION TO MEDICAL FRATERNITY ÂÂ
Psychological changes are required among nurses especially in terms of personality grooming, perceptual and attitudinal moderations.
ÂÂ
The participative and collaborative approach towards work and work places is needed among nurses to manage occupational stress.
ÂÂ
The feeling of pride of being a part of nursing community helps them to attain the social image and that will help to establish the character of selfmanagement.
ÂÂ
The spouse counseling helps the nurses to make their counterpart better understand their work place issues and gain exposure. It helps them to share their emotional feelings. It reduces the level of work stress.
ÂÂ
The understanding of work place issues encountered by nurses should be realized by family members and proper moral support should be extended.
ÂÂ
The frequent interaction and emotional sharing should be followed by family members.
ÂÂ
The climate of personal faith and individual care should be expressed by the family members towards nurses.
ÂÂ
Responsibility sharing attitude by the spouses helps nurses to enhance their confidence level in the family and as well as at work places.
SUGGESTIONS TO HOSPITALS ÂÂ
The job place autonomy should be given for nurses that will make them act with identity at work places.
ÂÂ
The motivational program on special pay, allowances, compensation schemes, health insurance schemes may be constituted at hospitals.
ÂÂ
Flexible working hours with frequent job rotation help the nurses to face work heterogeneity.
ÂÂ
If mandatory, they should be trained abroad by the management, on advanced treatment for various cropping diseases like - MERS, Ebola and so on.
CONCLUSION The patient relationship management has become an imperative tool in present day hospital services. The emergence of substitution-based medicine practices shift the loyalty of patients from one service to multiple services. We must remember that nurses need to nurture themselves, address their own spiritual needs and engage in self-care practices, in order to be able to give their best to patients. Peer support and a sense of community are important. Sometimes, nurses feel that their problems cannot be understood by people outside of the profession; therefore, developing and maintaining a professional network is valuable. The nursing profession, facing a sense of professional isolation in India, may need to follow in the footsteps of other countries e.g., Australia and Britain in developing multifaceted support services for nurses under stress. Although the current study provides an improved understanding of the stress sources among the nurses of government, private hospitals and multispecialty nursing homes in Chennai, Tamil Nadu; yet there is room for more in depth study of the sources of stress among nurses of public and private hospitals across
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COMMUNITY MEDICINE the entire country. Further research can also be done for exploring the coping strategies for stress among doctors. We quote a wise and insightful comment from Firth-Cozens “Getting things right for patients means first getting things as good as we can for those who deliver their care”. REFERENCES 1. Eakin BK. Allocative inefficiency in the production of hospital services. Southern Economic Journal. 1991;58(1):240-8. 2. Duggal R. Health care utilisation in India. Health Millions. 1994;2(1):10-2. 3. Dasgupta H, Kumar S. Role stress among nurses working in a government hospital in Shimla. Euro J Soc Sci. 2009;9(3):356-70.
11. Riedel JE, Lynch W, Baase C, Hymel P, Peterson KW. The effect of disease prevention and health promotion on workplace productivity: a literature review. Am J Health Promot. 2001;15(3):167-91. 12. Quick JC, Quick JD. Organizational stress and preventive management. New York: McGraw Hill; 1984. 13. Khurshid F, Butt ZU, Malik SK. Occupational role stress of the public and private sector universities teachers. Language in India: Strength for Today and Bright Hope for Tomorrow. 2011;11:353-66. 14. Greenhaus JH, Beutell NJ. Sources of conflict between work and family roles. Acad Manag Rev. 1985;10(1):76-88. 15. O’Connor R. Undoing Perpetual Stress: The Missing Connection Between Depression, Anxiety and 21st Century Illness. New York: Berkley Pub Group; 2006. 16. Bailey RD. Coping with Stress in Caring. Oxford: Blackwell Scientific Publications; 1985.
4. Turan N, Singh S. Association of organisational stress symptoms with employees’ demographic variables. NICE J Business. 2011;6(1):87-96.
17. George Farid G. Stress Factors Among College Educators. Master’s Thesis, Brock University, St. Catharines, Ontario. December 1991. p. 104.
5. Srimathi NL, Kumar SK. Psychological well being of employed women across different organizations. J Indian Acad Appl Psychol. 2010;36(1):89-95.
18. Griffiths A. The psychosocial work environment. In: McCaig RC, Harrington MJ (Eds.). The Changing Nature of Occupational Health. Sudbury: HSE Books; 1998.
6. Tlaiss HA. Women in healthcare: barriers and enablers from a developing country perspective. Int J Health Policy Manag. 2013;1(1):23-33.
19. Velnampy T. Job attitude and employees performance of public sector organizations in Jaffna district, Sri Lanka. GITAM J Manag. 2008;6(2):66-74.
7. Negeliskil C, Lautert L. Occupational stress and work capacity of nurses of a hospital group. Revista LatinoAmericana de Enfermagem. 2011;19(3):606-13.
20. Lazarus RS, Folkman S. Stress, Appraisal and Coping. New York: Springer Publishing Company; 1984. p. 456.
8. Sveinsdóttir H, Biering P, Ramel A. Occupational stress, job satisfaction, and working environment among Icelandic nurses: a cross-sectional questionnaire survey. Int J Nurs Stud. 2006;43(7):875-89. 9. Antoniou AS, Polychroni F, Vlachakis AN. Gender and age differences in occupational stress and professional burnout between primary and high-school teachers in Greece. J Manager Psychol. 2006;21(7):682-90.
21. Craig A, Hancock K. The influence of a healthy lifestyle program in a work environment: a controlled long-term study. J Occup Health Saf. 1996;12:193-206. 22. Salami SO. Career development in the workplace. In: Oladele JO (Ed.). Psychology Principles for Success in Life and Workplace. Ibadan: Stirling-Horden; 2002. pp. 114-30. 23. Gmelch WH. Wilke PK, Lovrich NP. Dimensions of stress among university faculty: factor analytic results from a national study. Res High Educ. 1986;24(3):266-86.
10. Slišković A, Maslić Seršić D. Work stress among university 24. Kahn RL, Wolfe DM, Quinn RP, Snoek JD, Rosenthal teachers: gender and position differences. Arh Hig Rada RA. Organisational Stress: Studies in Role Conflict and Toksikol. 2011;62(4):299-307. Ambiguity. New York: John Wiley; 1964. ■■■■
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DIABETOLOGY
Advantages of Teneligliptin Compared with Other DPP-4 Inhibitors in T2DM SRIKANT SHARMA
ABSTRACT Diabetes is a serious, chronic disease that has emerged to be an important public health problem. The two most important goals in the management of diabetes is prevention of further complications and improvement in the individual’s quality-of-life. The current treatment strategies for type 2 diabetes are based on reducing insulin resistance and increasing insulin secretion. The most recent therapeutic options for the management of type 2 diabetes mellitus include the use of incretin-based therapies. Exploiting the incretin effect has led to the development of new class of drugs - dipeptidyl peptidase-4 (DPP-4) inhibitors. These agents enhance the incretin effect by preventing the degradation of glucagon-like peptide-1 (GLP-1) and glucosedependent insulinotropic polypeptide (GIP). Evidence suggests that DPP-4 inhibition may be more effective in patients with mild-to-moderate hyperglycemic type 2 diabetes than in severe diabetes. Teneligliptin is a third-generation DPP-4, which has been approved for the treatment of adults with type 2 diabetes. This article describes the advantages of teneligliptin over other DPP-4 inhibitors.
Keywords: Type 2 diabetes, insulin resistance, incretin based therapies, DPP-4 inhibitors, teneligliptin
D
iabetes is a serious, chronic disease that has emerged to be an important public health problem. It is considered as one of four priority noncommunicable diseases worldwide. Over the past few decades, there has been a gradual increase in both, the incidence as well as the prevalence of diabetes. According to Global Report in Diabetes, WHO 2016, in 2014, 422 million adults were estimated to be living with diabetes globally, compared to 108 million in 1980. This surge in the incidence of diabetes reflects an increase in the risk factors associated with diabetes such as being overweight or obese. Over the past decade, low- and middle-income countries have seen a faster rise in diabetes prevalence as compared to highincome countries.1 This rising prevalence has caused it to gain the status of potential health threat worldwide. The International Diabetes Federation (IDF) estimates the total number of diabetic subjects is set to rise to 69.9 million by the year 2025.2
GOAL OF DIABETES MANAGEMENT The two most important goals in the management of diabetes is prevention of further complications and
improvement in the individual’s quality-of-life. Diabetes adversely affects quality-of-life of affected patients and is associated with risk of cardiovascular disease (CVD) and mortality, and microvascular complications such as retinopathy, nephropathy and neuropathy. Chronic hyperglycemia as well as by fluctuations in glucose levels are responsible for the complications associated with diabetes. Hyperglycemia is responsible for increasing the complications associated with diabetes, whereas fluctuations in glucose levels affects the endothelial function, which triggers oxidative stress. Hence the factor which is gaining increasing importance, in the prevention of diabetic complications, is the control of fluctuations in blood glucose levels that is, improvement in the control of postprandial glucose levels, while avoiding inducing hypoglycemia. Glycosylated hemoglobin (HbA1c) is a quantitative marker for overall glycemic control which monitors glucose levels throughout the day, including those during fasting and between and after meals. Glycemic variability can be taken into consideration in strategies designed to reduce the complications associated with diabetes.3 CURRENT STRATEGIES IN THE MANAGEMENT OF TYPE 2 DIABETES
Dept. of Internal Medicine Moolchand Medcity, New Delhi
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The current treatment strategies for type 2 diabetes are based on reducing insulin resistance and increasing
DIABETOLOGY insulin secretion. Since many years, the mainstay of therapy of diabetes included biguanides (metformin) and sulfonylureas. Thiazolidinediones have recently been found to have an important role in augmenting the amelioration of insulin resistance, although there have been recent concerns over their safety. Meglitinide analogs and α-glucosidase inhibitors also have some role in treatment of diabetes, although their role is limited by cost and side effects. Many people with long duration of type 2 diabetes, may frequently require insulin therapy, due to inevitable β-cell decline. Only a lesser percentage of diabetes patients achieve a HbA1c despite the availability of plethora of therapeutic options.4
Antidiabetic effects of GLP-1 on distinct tissues
Pancreas
Muscle ↑ Glucose uptake and storage
Incretins are secreted from the L cells of the enteric endocrine system in response to ingestion of food. GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) are the two main incretin hormones, with GLP-1 being responsible for most of the incretin effect on pancreatic β-cell function. Glucose homeostasis in the postprandial period is regulated by GLP-1 by a number of mechanisms, including stimulation of insulin synthesis, inhibition of glucagon secretion, delay in gastric emptying and promotion of satiety which results in weight loss in the most of treated subjects.4 However, in spite of the effective action of native GLP-1 amide in lowering blood glucose, it is rapidly degraded by the ubiquitous serine protease dipeptidyl peptidase-4 (DPP-4). The two N-terminal amino acids of GLP-1 are cleaved by DDP-4. Its close proximity to GLP-1-secreting endocrine cells can result in the rapid degradation of GLP-1 within minutes of release.4 ROLE OF GLIPTINS IN THE MANAGEMENT OF TYPE 2 DIABETES Exploiting the incretin effect has led to the development of new class of drugs - DPP-4 inhibitors. These agents enhance the incretin effect by preventing the
Liver ↓ Glucose production
Brain ↓ Appetite ↑ Satiety
Other metabolic effects
Incretins and Glucose Homeostasis The most recent therapeutic options for the management of type 2 diabetes mellitus (T2DM) include the use of incretin-based therapies. These can modify various elements of the disease, including hypersecretion of glucagon, abnormal gastric emptying, postprandial hyperglycemia and, possibly, pancreatic β-cell dysfunction. The major biological actions of glucagonlike peptide-1 (GLP-1) on pancreas and on tissues involved in their metabolic antidiabetic effects are presented in Figure 1.5
↑ Insulin synthesis (β-cell) ↓ Glucagon secretion (α-cell) ↑ β-cell proliferation ↓ β-cell apoptosis
+
Adipocytes ↑ Lipogenesis ↓ Glycemia
Stomach ↓ Gastric emptying
Improve glycemia, insulinemic and lipidic control Control of diabetes progression
Figure 1. Antidiabetic insulin-dependent and insulinindependent effects of GLP-1 on metabolic tissues, which are potentiated by inhibition of DPP-4, thus improving the glycemic, insulinemic and lipidic profile and the progression of the disease.5
degradation of GLP-1 and GIP. These agents are also able to potentiate the secretion of insulin and inhibit the release of glucagon by the pancreas by preventing the inactivation of GLP-1 and GIP. This causes the blood glucose levels towards normal. The amounts of insulin released and glucagon suppressed diminishes as the blood glucose level approaches normal, thus tending to prevent hyperglycemia as well as hypoglycemia, which is usually observed in case of other oral hypoglycemic agents. Evidence suggests that DPP-4 inhibition may be more effective in patients with mild-to-moderate hyperglycemic type 2 diabetes than in severe diabetes. This may help in preventing β-cell loss in earlier stages of disease development.5 TENELIGLIPTIN FOR THE TREATMENT OF TYPE 2 DIABETES Teneligliptin is a third-generation DPP-4, which has been approved for the treatment of adults with type 2 diabetes.6 ÂÂ
Oral teneligliptin 20 or 40 mg once-daily, as monotherapy or in combination with metformin, glimepiride or pioglitazone improved glycemic control, including in patients with end-stage renal disease (ESRD) and was generally well-tolerated as demonstrated by 12- or 16-week, placebocontrolled phase 2 and 3 trials.
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DIABETOLOGY ÂÂ
Adverse events associated with teneligliptin use were of mild intensity and comparatively only few patients discontinued treatment because of these events.
ÂÂ
Short-term trials demonstrated improvements in glycemic control which were maintained even at 52 weeks in extension phases of these trials and in 52-week interventional studies, with no new safety concerns arising during this period.
with S1’, S2’ and S2 extensive site may further increase the DPP-4 inhibition. Teneligliptin extensively binds with S1, S2 and S2 extensive subsites and exhibits strong binding owing to its J-shaped structure and ‘anchor lock domain’ (Table 1).3,7 ÂÂ
Class 1 inhibitors (vildagliptin and saxagliptin) interact with S1 and S2 subsites and are considered as fundamental/basic inhibitors.
ÂÂ
Class 2 (alogliptin and linagliptin) interact with additional site of S1, S2 and S1’ and may produce more DPP-4 inhibition than Class 1, linagliptin additionally binds to the S2’ subsite.
This article describes the advantages of teneligliptin over other DPP-4 inhibitors.
ÂÂ
Class 3 inhibitors (sitagliptin and teneligliptin) interact with S1, S2 and additional site of S2 extensive and are the most potent DPP-4 inhibitors.
Pharmacodynamic Advantage of Teneligliptin
Introduction of the ‘anchor lock domain’ for teneligliptin, which binds to the S2 extensive subsite, increased the activity by 1,500-fold over the corresponding fragment that binds to S1 and S2 only. Teneligliptin has 5-fold higher activity than sitagliptin for DPP-4 enzymes despite of both the drugs falling under Class 3 and both binding to S2 extensive subunit. Teneligliptin inhibits the DPP-4 substrate in a manner that involves formation of a reversible covalent enzyme-inhibitor complex. This complex causes persistent DPP-4 inhibition even after the drug is inactivated due to its strong affinity and slow and gradual dissociation from the catalytic site of the DPP-4 substrate. This means that the catalytic activity remains inhibited even after the free drug has been cleared from the circulation.7
ÂÂ
Teneligliptin is effective and well-tolerated and may have an important role in the management of T2DM.6
Unique Structural Advantage All DPP-4 inhibitors resemble with respect to their mechanism of action and safety profile; however, they significantly vary with respect to their pharmacokinetic and pharmacodynamic profiles. Figure 2 demonstrates the DPP-4 enzyme binding sites namely S1, S2, S1’, S2’ and S2 extensive subunit.7 DPP-4 inhibitors are classified as Class 1, Class 2 and Class 3 according to their interaction with DPP-4 binding subsites on the DPP-4 enzymes. A fundamental interaction required for DPP-4 interaction is their binding with S1 and S2 subsites. Additional interaction
Sustained DPP-4 Inhibition: 24-hour Glucose Control
S2 Extensive subunit S1, S2 subunit S1', S2' subunit Class 3
Class 2
Class 1
S2 Extensive
S2
S1
S1'
S2'
DPP-4 enzyme
Teneligliptin significantly improved 24-hour blood glucose control in Japanese patients with type 2 diabetes. Eto et al assessed blood glucose control of teneligliptin 10 and 20 mg over 24 hours, in Japanese patients with T2DM inadequately controlled with diet and exercise. Among the 99 patients who participated, 32 were treated with a placebo, 34 were treated with teneligliptin at a dose of 10 mg and 33 were treated with teneligliptin at a dose of 20 mg before breakfast for 4 weeks. The results of this study demonstrated that:7 ÂÂ
After administration of teneligliptin, the maximum percentage of the inhibition in plasma DPP-4 activity was achieved within 2 hours and was 81.3% and 89.7% with teneligliptin 10 and 20 mg, respectively.
ÂÂ
After 24 hours of administration, the percentage inhibition of DPP-4 activity was 53.1% in
Class 1-binding to S1, S2 subunit Class 2-binding to S1, S2, S1' and/or S2' subunit Class 3-binding to S1, S2, S2 extensive subunit
Figure 2. DPP-4 enzyme with binding sites.
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DIABETOLOGY Table 1. Summary of the Interactions of Various DPP-4 Inhibitors with DPP-4 Enzymes Class
DPP-4 inhibitors
Binding at DPP-4
1
Vildagliptin and saxagliptin
S1 and S2 subsites
Interaction with DPP-4 at various sites Details Fundamental/basic interaction required for DPP-4 inhibition:
Class 1 inhibitors vildagliptin, saxagliptin
S2 Extensive
S2
S1
S1'
S2'
DPP-4 enzyme
Alogliptin and linagliptin
2
S1, S2, S1’ and S2’ subsites
Class 2 inhibitors algoliptin, linagliptin
S2 Extensive
S2
S1
S1'
S2'
DPP-4 enzyme
Sitagliptin and teneligliptin
3
S1, S2 and S2 extensive subsites
Class 3 inhibitors sitagliptin, teneligliptin
S2 Extensive
S2
S1
S1'
S2'
DPP-4 enzyme
yy Cyanopyrrolidine moieties bind to S1 yy Hydroxyadamantyl groups bind to S2 yy Saxagliptin has 5-fold higher activity than vildagliptin yy Alogliptin binds to S1, S2 and S1’ yy Linagliptin binds to S1, S2, S1’ and S2’ yy Linagliptin has 8-fold higher activity than alogliptin yy Teneligliptin has 5-fold higher activity than sitagliptin due to yy J-shaped anchor-lock domain, strong covalent bonds with DPP-4 and more extensive S2 extensive binding than sitagliptin
Placebo (n = 32)
Plasma DPP-4 inhibition (%)
100
Teneligliptin 10 mg (n = 33) Teneligliptin 20 mg (n = 33)
75 50 25 0
-25 0
2
4
6
8
10
12 Time (hours)
14
16
18
20
22
24
Figure 3. The percentage inhibition of plasma DPP-4 activity in teneligliptin 10 and 20 mg groups as compared to placebo are shown. Data for teneligliptin 10 mg is represented in open circles, Teneligliptin 20 mg in open triangles and placebo in closed circles. Values are mean + SD. Differences between teneligliptin 10 and 20 mg group were not tested statistically.7
7.9 and 8.6 pmol.h/L respectively, in teneligliptin 20 mg group.
teneligliptin 10 mg group and 61.8% in teneligliptin 20 mg group (Fig. 3). ÂÂ
Teneligliptin group had a higher active plasma GLP-1 concentration than placebo throughout the day, even at 24 hours after administration.
ÂÂ
Teneligliptin 20 mg group had a slightly higher increase in AUC0-2h for active GLP-1 concentration as compared to teneligliptin 10 mg group.
ÂÂ
After breakfast, lunch and dinner the area under the curve (AUC)0-2h values for the active GLP1 concentration were 8.0, 8.4 and 7.8 pmol.h/L respectively, in teneligliptin 10 mg group and 8.3,
ÂÂ
Both the teneligliptin treated groups and the placebo group were statistically significant (p < 0.001) differences in the AUC0-2h for the active GLP-1 concentration.
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DIABETOLOGY These results indicate that the once-daily administration of teneligliptin before breakfast improved blood glucose control, even at dinnertime.7
ÂÂ
Teneligliptin also significantly improved IGI30min and the AUC120min SUIT index (Fig. 5).
ÂÂ
Teneligliptin was found to improve the HOMA-β in another study.
ß-cell Preservation and Insulin/Glucagon Modulator In addition to the β-cell protective effects, DPP-4 inhibitors also promote β-cell proliferation, thus resulting in functional improvements. Teneligliptin attains its glycemic effect by activating β-cell function as well as decreasing insulin resistance. Teneligliptin also causes an improvement in the markers of β-cell function including homeostatic model assessment of β-cell function (HOMA-β), insulinogenic index (IGI; an estimate of early insulin secretion), secretory units of islets in transplantation (SUIT) index, HOMA for insulin resistance (HOMA-IR).7 Ito et al investigated the changes in insulin secretion before and after treatment with the DPP-4 inhibitor teneligliptin in patients with T2DM with a low IGI determined by the oral glucose tolerance test (OGTT). The results of this open-label, prospective clinical study demonstrated that:7 ÂÂ
Treatment of 12-week teneligliptin 20 mg/day provided a substantial reduction in HbA1c and incremental AUC120min plasma glucose in drug-naïve Japanese patients with inadequately controlled type 2 diabetes (Fig. 4).
ÂÂ
Teneligliptin also significantly increased insulin secretion and improved insulin sensitivity without inducing clinically significant hypoglycemia or weight alteration.
Reduction in Short-term Glycemic Fluctuations Swings in blood glucose levels (fasting plasma glucose [FPG] and postprandial glucose [PPG]) that occur throughout the day is referred to as glycemic variability. Patients tend to have marked glycemic variability throughout the day despite having same HbA1c levels at 3 months, which is directly linked to micro- and macrovascular complications. Glycemic variability can be assessed through various parameters: mean amplitude of glycemic excursions (MAGE), glycated albumin (GA) and 1,5-anhydroglucitol (1,5-AG). Daily fluctuations in glucose causes a more specific triggering action on oxidative stress than chronic hyperglycemia. Since daily glucose fluctuation is attributed to dietary lifestyle and irregular eating habits, it is important to normalize daily blood glucose fluctuations by suppressing postprandial hyperglycemia at all three meals daily.7 The effects of teneligliptin 20 mg daily for ameliorating glucose fluctuations were assessed by Seiichi Tanaka et al in 26 type 2 diabetic patients receiving insulin therapy, with or without other antidiabetes drugs and using continuous glucose monitoring (CGM). Figure 6 shows the variations in 24hour blood glucose levels measured by CGM during
Before treatment
Before treatment
350
60
300
50
250 200 **
150 100
**
**
**
**
Insulin (µU/mL)
Glucose (mg/dL)
Teneligliptin 12 weeks
Teneligliptin 12 weeks
40 30
* *
20
*
10
50
0
0 0
30
60
90
120
0
Time (min)
30
60
90
120
Time (min)
Figure 4. Changes in a plasma glucose and beta serum insulin levels in response to the OGTT before and after 12 weeks of teneligliptin administration. Values are expressed as means ± standard error (SE). *P < 0.05, **P < 0.01, before administration vs. teneligliptin administration for 12 weeks (12W).
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DIABETOLOGY
Before treatment Teneligliptin 12 weeks 120 100 SUIT
80 60 40 20 0
*
0
**
**
**
30
60 Time (min)
90
**
add-on treatment with teneligliptin 20 mg. On Days 5-7, add-on treatment with teneligliptin 20 mg significantly decreased both FPG and PPG levels as well as the 24hour mean glucose levels (p < 0.001). Add-on treatment with teneligliptin led to improvement in parameters of short-term glycemic fluctuations over 3 days like decrease in MAGE, decrease in GA and increase in 1,5-AG. Several other studies also demonstrated an improvement in GA and 1,5-AG over 3-6 months after add-on teneligliptin treatment (Fig. 7).7
Pharmacokinetic Advantage of Teneligliptin 120
Figure 5. Changes in SUIT in response during OGTT before and after 12 weeks of teneligliptin administration. Values are expressed as means ± standard error (SE). *P < 0.05, **P < 0.01, before administration vs. teneligliptin administration for 12 weeks (12W).
In healthy volunteers, teneligliptin was rapidly absorbed after a single radiolabeled 20 mg dose, with maximum plasma concentrations achieved in 1.33 hours. The drug is 78-80% protein bound. Table 2 mentions an overview of the pharmacokinetics of teneligliptin. Despite of teneligliptin being a weak inhibitor of CYP2D6, CYP3A4 and FMO, it shows
180
Meal
Glucose (mg/dL)
170
(Black line) represents the average of glucose levels prior to teneligliptin administration
160 150
(Gray line) represents 24 hours glucose levels after teneligliptin administration
140 130 120 110 100 0.00
7.00
12.00
18.00
24.00
Figure 6. The 24-hour glucose profiles before and after administration of teneligliptin in patients with placebo type 2 diabetes receiving insulin therapy, with or without other antidiabetes drugs.7
14
23.4 ± 6.1
Changes in GA (%) over 6 months
23 22 21 19.8 ± 3.1
20 19 18
Changes in 1,5-AG (µg/mL) over 3 months (p < 0.01)
24
12.53 ± 1.6
12 10 8
6.48 ± 1.3
6 4 2 0
Before teneligliptin treatment
After teneligliptin treatment
Before teneligliptin treatment
After teneligliptin treatment
Figure 7. Mean changes with administration of teneligliptin in indexes of blood glucose control - glycated albumin and 1,5-anhydroglucitol: n = 11, p < 0.01.7
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DIABETOLOGY no inhibitory effect on CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C8/9, CYP2C19 and CYP2E1. Nor does it induce CYP3A4 or CYP1A2. Teneligliptin did not show any drug-to-drug interactions when coadministered with ketoconazole (a potent CYP3A4 and P-glycoprotein inhibitor), metformin or canagliflozin in healthy volunteers. Teneligliptin did not affect the pharmacokinetics of glimepiride or pioglitazone.7 Teneligliptin follows a dual mode of excretion with 45.4% excreted in the urine and 46.5% excreted in the feces. The long half-life of 26.9 hours of teneligliptin offers convenient once-daily administration.7 Efficacy in Special Patient Groups Pharmacokinetic studies of teneligliptin have been carried out in patients with renal and hepatic impairment. Nephropathy is a common complication of T2DM. Hence, the presence of possible renal failure restricts the medical therapy for diabetic patients on dialysis. HbA1c cannot be considered as a suitable index of glycemic control in patients with ESRD. Thus, it has often been difficult to control hyperglycemia in diabetic ESRD patients. Otsuki et al carried out a prospective study in hemodialysis patients with poor glycemic control in two centers in Japan. Fourteen patients received teneligliptin (the treatment group) and 29 patients continued with their existing medication (the control group). The teneligliptin group demonstrated a significant decrease in blood glucose levels from Week 4. The differences in GA (at Week 28) and HbA1c (at Week 24) between the teneligliptin group and the control group were ₋3.1% (p < 0.05) and ₋0.57% (p = 0.057), respectively. One patient experienced constipation, but there were no discontinuations as a result of adverse effects, indicating that teneligliptin was well-tolerated and effective in diabetic patients undergoing dialysis.3,7
Pleiotropic Effects of Teneligliptin Improvement in Endothelial Function Fluctuations in daily blood glucose may lead to endothelial dysfunction and arteriosclerosis by increasing the oxidative stress and inflammatory markers. Postprandial glycemic state has also been shown to contribute to atherosclerotic risk. Due to the potent, sustained effects of teneligliptin on glycemic control, it ameliorates the effects of hypoglycemia and postprandial hyperglycemia and prevents the development of diabetic complications. The effects of teneligliptin on left ventricular (LV) function were assessed by Takehiro Hashikata et al in 29 type 2 diabetic patients for 3 months. Teneligliptin demonstrated an improvement not only in LV function (LV ejection fraction, 62.0% ± 6.5% to 64.5% ± 5.0%; p = 0.01; peak early diastolic velocity/basal septal diastolic velocity [E/e] ratio, 13.3 ± 4.1 to 11.9 ± 3.3; p = 0.01) but also in endothelial function (reactive hyperemia peripheral arterial tonometry [RHPAT] index; 1.58 ± 0.47 to 2.01 ± 0.72; p < 0.01). Circulating adiponectin levels increased (27.0 ± 38.5 pg/mL to 42.7 ± 33.2 pg/ mL; p < 0.01) without changes in patient body weight after treatment with teneligliptin. Adiponectin receptor regulates glucose uptake promotion and increases fatty acid oxidation. Enhanced adiponectin levels, increases protection against inflammation, insulin resistance and cardiovascular disorders.7 Improvement in Lipid Profile Teneligliptin 20 mg/day was found to have a beneficial effect on lipid profile along with improvement in blood glucose and HbA1c in a study by M Kusunoki et al (Table 3).7 Natriuretic and Diuretic Effects of Teneligliptin DPP-4 inhibitors have been reported to exhibit diuretic and natriuretic effects, which might contribute in reducing blood pressure. The diuretic and natriuretic
Table 2. Abridged Pharmacokinetics of Teneligliptin7 Parameters Absorption
Oral Cmax 180.20 ng/mL Tmax 1.8 hours for 20 mg Not affected by food
Table 3. Effects of 14-week 20 mg/day Administration of Teneligliptin on Serum Lipids in Japanese Patients with Type 2 Diabetes7 Lipid parameters (mg/dL)
Before
After 14-week P value administration
Protein binding
78-80%
Metabolism
CYP450 3A4 and FMO 1-3
Total cholesterol
196 ± 43
174 ± 29
0.105
Excretion
45.4% excreted in the urine and 46.5% excreted in the faces
HDL cholesterol
55 ± 15
62 ± 16
0.032
LDL cholesterol
122 ± 43
103 ± 29
0.164
T1/2
26.9 hours
Triglyceride
189 ± 140
114 ± 44
0.080
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DIABETOLOGY effects of teneligliptin were assessed by Masao Moroi et al. Oral administration of teneligliptin resulted in a reduction of plasma DPP-4 activity over 6 hours, as well as an induction of diuresis and natriuresis. Furthermore, the natriuretic effect of teneligliptin was inhibited by the GLP-1R antagonist, exendin 9-39, whereas the diuresis was not affected. These results demonstrate that the mechanism of natriuresis was different from that of diuresis, and the natriuresis is associated with the stimulation of GLP-1R.7
Additional diuretic and natriuretic effect Effective in diabetic patients undergoing dialysis Effectiveness in obesity and metabolic syndrome
Safety of Teneligliptin In a study involving 99 patients on teneligliptin monotherapy, adverse events occurred in 28.1% (9/32), 23.5% (8/34) and 18.2% (6/33) of patients in the placebo and teneligliptin 10 and 20 mg groups, respectively. The incidence of adverse events was not significantly different between the teneligliptin and placebo groups. None of the patients in any group experienced hypoglycemic symptoms or serious adverse events. There were no clinically significant abnormal changes in vital signs, electrocardiograms (ECGs) or laboratory measurements, nor were there any notable differences between the treatment groups.7
Place of Teneligliptin in Therapy Diabetes is a chronic progressive disorder. The management of diabetes should be initiated with lifestyle modification i.e., diet and exercise however, its management requires the inclusion of antidiabetic drugs eventually. Antidiabetic agents like metformin and sulfonylureas remain mainstay therapy in management of type 2 diabetes. Metformin therapy in clinical scenario has been associated with gastrointestinal adverse effects whereas sulfonylureas, although effective in lowering plasma glucose, work in glucose-independent manner and have been associated with variable severities of hypoglycemia, weight gain and β-cell death. DPP4 inhibitors as a class does not adversely affect the survival of β cells and its efficacy is well-established in therapy. These agents offer convenient once-daily dosing, are weight neutral and associated with a low risk of hypoglycemia. The use of teneligliptin based on recommendation of various guidelines, could be postulated as an add-on second-line drug in type 2 diabetes patients already on one of the following antidiabetic drugs-metformin, sulfonylurea, thiazolidinediones, α-glucosidase inhibitors, glinide and insulin. Teneligliptin could be beneficial if started early in the treatment of type 2 diabetes. Owing to its
Sustained DPP-4 inhibition
TENELIGLIPTIN
Improvement in endothelial function
24 hours glucose control
β-cell preservation
Reduction in short-term glucose fluctuations
Figure 8. Benefits of teneligliptin.
pharmacodynamic, pharmacokinetic and pleiotropic benefits (Fig. 8), in patients with diabetic nephropathy, diabetic patients with CVD, elderly diabetic patients and patients in whom metformin therapy is intolerable or contraindicated.7 CONCLUSION ÂÂ
The IDF estimates the total number of diabetic subjects to be around 40.9 million, which is further set to rise to 69.9 million by the year 2025.
ÂÂ
The occurrence of the complications associated with diabetes can be prevented by managing chronic hyperglycemia as well as by avoiding fluctuations in glucose levels.
ÂÂ
Only a lesser percentage of diabetes patients achieve an HbA1c despite the availability of plethora of therapeutic options.
ÂÂ
Incretin-based therapies can modify various elements of diabetes, including hypersecretion of glucagon, abnormal gastric emptying, postprandial hyperglycemia and, possibly, pancreatic β-cell dysfunction.
ÂÂ
Exploiting the incretin effect has led to the development of new class of drugs - DPP-4 inhibitors.
ÂÂ
Teneligliptin is a third-generation DPP-4 inhibitor which is effective, well-tolerated and may have an important role in the management of T2DM.
ÂÂ
Teneligliptin has 5-fold higher activity than sitagliptin for DPP-4 enzymes despite of both the drugs falling under Class 3 and both binding to S2 extensive subunit.
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DIABETOLOGY ÂÂ
Once-daily administration of teneligliptin improved 24-hour blood glucose control.
ÂÂ
Teneligliptin may be beneficial in delaying progression of type 2 diabetes by the virtue of its β-cell preserving properties. Clinical studies have found improvement in β-cell function as depicted by increase in HOMA-β, IGI, SUIT index and decrease in insulin resistance as depicted by decrease in HOMA-IR parameter.
ÂÂ
Add-on treatment with teneligliptin led to improvement in parameters of short-term glycemic fluctuations.
ÂÂ
The unique pharmacokinetic advantage of teneligliptin with a long half-life of 26.9 hours allows a convenient once-daily administration irrespective of food.
ÂÂ
ÂÂ
ÂÂ
Teneligliptin can be administered safely in patients with renal impairment due to its unique dual mode of hepatic and renal elimination. Owing to its effects on vascular function, teneligliptin may show benefits with improvement in endothelial function, LV function, lipid levels in addition to being weight neutral and having least chances of hypoglycemia.
ÂÂ
Teneligliptin serves as an appropriate add-on to metformin early in therapy to delay exhaustion of pancreatic islet function.
REFERENCES 1. Alwan A. Global status report on noncommunicable diseases 2010. World Health Organization; 2011. Available at: http://www.who.int/nmh/publications/ncd_report_ full_en.pdf. 2. Mohan V, Sandeep S, Deepa R, Shah B, Varghese C. Epidemiology of type 2 diabetes: Indian scenario. Indian J Med Res. 2007;125(3):217-30. 3. Morishita R, Nakagami H. Teneligliptin: expectations for its pleiotropic action. Expert Opin Pharmacother. 2015;16(3):417-26. 4. Kannan G, Rani NV, Janardhan V, Patel P, Reddy C. Gliptins - the novel players in glucose homeostasis. Indian J Clin Pract. 2013;23(9):505-7. 5. Godinho R, Mega C, Teixeira-de-Lemos E, Carvalho E, Teixeira F, Fernandes R, et al. The place of dipeptidyl peptidase-4 inhibitors in type 2 diabetes therapeutics: a “me too” or “the special one” antidiabetic class? J Diabetes Res. 2015;2015:806979. 6. Scott LJ. Teneligliptin: a review in type 2 diabetes. Clin Drug Investig. 2015;35(11):765-72.
7. Maladkar M, Sankar S, Kamat K. Teneligliptin: heralding change in type 2 diabetes. J Diabetes Mellitus. 2016;6(2):113-31. ■■■■
No major safety issues were observed with teneligliptin treatment.
A Two-way Depression-Diabetes Relationship Observed in Pregnant Women: Study Depression and gestational diabetes may occur together, demonstrating a two-way depression-diabetes relationship, suggests a study published online in the journal Diabetologia. The results reported that the risk for gestational diabetes increases 3 fold in women with the highest depression scores during the first and second trimesters of their pregnancy, compared to those with low scores of depression. Senior author Dr Cuilin Zhang, PhD, says: "Of particular note, persistent depression from the first to second trimester set women at even greater risk for gestational diabetes." It is usually observed that obesity is the main cause of gestational diabetes (GD), but it is skeptical, that GD risk was higher for nonobese women with depression than obese women with depression, demonstrated by the study.
Role of Hepatic FOXQ1 in Regulating Hepatic Gluconeogenesis in Mice Hepatic forkhead box q1 (FOXQ1) is significantly involved in regulating hepatic gluconeogenesis, highlights a study published online in the journal Diabetologia. The study was conducted on mice to assess the role of FOXQ1 in the regulating the expression of gluconeogenic genes, and cellular and hepatic glucose production. The results demonstrated that over expression of FOXQ1 halts the expression of gluconeogenic genes and decreases the cellular glucose output. An increased blood glucose levels and impaired glucose tolerance was observed in wild type mice, in contrast with high-fat diet-induced obese mice, wherein the Hepatic FOXQ1 rescue resulted into reduction in blood glucose level and improved glucose intolerance. It was also found that FOXQ1 interacts with and blocks the activity of FOXO1 on hepatic gluconeogenesis, preventing it from directly binding to insulin response elements mapped in the promoter region of gluconeogenic genes.
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ENDOCRINOLOGY
Primary Amenorrhea in a Young Female - Complete Androgen Insensitivity Syndrome: A Rare Cause RAJESH RAJPUT*, DEEPAK JAIN†, LAXMINARAYAN YADAV‡, TEKCHAND YADAV#
ABSTRACT Androgen insensitivity syndrome (AIS) is a rare X-linked recessive disorder that occurs in phenotypically normal woman with male karyotype (46,XY), with an incidence of 1:20,000-64,000 male births. Syndrome may have varied presentation from male infertility to completely normal external female genitalia. Syndrome has been linked to mutations in gene for the human androgen receptor, located at Xq11-12 leading to the insensitivity of the receptor to testosterone. We report a case of a 22-year-old girl who presented with primary amenorrhea. Further examination and investigation revealed complete female external genitalia and presence of testis internally leading to diagnosis of complete AIS. Patient underwent gonadectomy with vaginoplasty followed by hormone replacement therapy.
Keywords: Androgen insensitivity syndrome, X-linked recessive disorder, testosterone, primary amenorrhea, hormone replacement therapy
A
ndrogen insensitivity syndrome (AIS) is defined as female or ambiguous phenotype in a 46,XY male with testes as internal gonads and normal testosterone production and metabolism.1 It is an X-linked recessive disorder with an incidence of 1:20,000-64,000 male births. This genetic disorder is caused by mutation of the androgen receptor gene located on X chromosome resulting in complete loss of the androgen to bind to its receptor.2 It is generally accepted that defects in the androgen receptor gene prevent the normal development of both internal and external genital structures in 46,XY individuals, causing a variety of phenotypes ranging from male infertility to completely normal female external genitalia. Precise diagnosis requires clinical, hormonal and molecular investigation and is of great importance for appropriate gender assignment and management in general. The
complexity of phenotypic presentation of AIS with genotype-phenotype variability of identical mutations complicates both the diagnostic procedure and genetic counseling of the affected families. In complete AIS patients are complete women phenotypically with breast development, normal external genitalia, vagina of varied depth, absent uterus as a result of normal anti-mullerian hormone action and sparse to complete absence of axillary and pubic hairs. Partial androgen insensitivity present as male infertility to ambiguous external genitalia. Internal gonads are testis which may be intra-abdominally, inguinal or labial. Management includes detailed psychological counseling about the sexual mentation and infertility. In view of a high incidence of gonadal malignancy associated with dysgenetic gonads; gonadectomy is advocated. CASE REPORT
*Senior Professor and Head †Assistant Professor ‡Resident Dept. of Endocrinology and Medicine VI #Senior Resident Dept. of Endocrinology Pt. BD Sharma University of Health Sciences, Rohtak, Haryana Address for correspondence Dr Deepak Jain Assistant Professor Dept. of Endocrinology and Medicine VI Pt. BD Sharma University of Health Sciences, Rohtak - 124 001, Haryana E-mail: jaindeepakdr@gmail.com
A 22-year-old unmarried girl presented to Endocrine OPD of Post Graduate Institute of Medical Sciences with complaint of primary amenorrhea. There was no history of prior medical consultation for it in past. There was no other positive relevant medical history. On examination, her vitals were stable, height - 168 cm, weight - 95 kg, body mass index (BMI) - 33.6 kg/m2. Patient had well-developed breasts (Tanner stage 4), with sparse axillary and pubic hair as shown in Figure 1.
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ENDOCRINOLOGY On local examination, external genitalia were normal, per speculum vagina 3-4 cm long with normal rugae and ending in blind pouch, cervix was not visualized. Uterus and adnexa could not be revealed on per vaginal and per rectum examination. Routine blood investigations were normal. Serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) were 19.54 mIU/mL (1.9-12.5) and 2.24 mIU/mL (1.411.5). Serum testosterone and 5α-dihydrotestosterone (5α-DHT) levels were raised 448.03 ng/dL (14-76) and 554.32 pg/mL (24-368), respectively. Karyotype revealed normal male karyotype (46,XY). USG revealed absence of uterus and ovaries. Magnetic resonance imaging (MRI) pelvis and abdomen showed an oval
Figure 1. Well-developed breasts with sparse axillary and pubic hair.
mass on right and left posterolateral aspect of urinary bladder, which appeared to be testis with absence of uterus and ovaries. Prostate and seminal vesicles were not seen (Fig. 2). In view of elevated testosterone, 5α-testosterone and LH with 46,XY karyotype and presence of bilateral intra-abdominal testis, a diagnosis of complete AIS was made. Since patient was reared as a female, so after discussion with patient and parents, in view of risk of malignancy of intra-abdominal testis, and after explaining risk and taking proper consent gonadectomy was planned and performed. After that patient was put on hormone replacement therapy. DISCUSSION Primary amenorrhea is the failure of menses to occur by age 16 years, in the presence of normal growth and secondary sexual characteristics. If by age 13, menses has not occurred and the onset of puberty, such as breast development, is absent, a work-up for primary amenorrhea should start. The relative prevalence of primary amenorrhea includes hypergonadotropic hypogonadism (48.5% of cases), hypogonadotropic hypogonadism (27.8%) and eugonadism (pubertal delay with normal gonadotropins; 23.7%).3 Out of all, androgen insensitivity contributes 1.5% only. AIS is an X-linked disease characterized by variable defects in virilization of 46,XY individuals due to loss-of-function mutations in the androgen receptor gene. Androgens exert their effects by mediating the differentiation and development of the normal male phenotype via a single receptor protein, the androgen receptor.4 The most common causes of AIS are the point mutations in the androgen receptor gene resulting in a defective receptor protein, which is unable to bind hormone or bind to DNA.5 This alteration in the gene blocks the body’s response to androgen during fetal development and after birth. The body can respond to feminizing hormones (estrogen), but not androgen. The clinical phenotypes of AIS are variable and are classified into three main categories: complete IAS (CAIS), partial IAS (PAIS) and mild IAS (MAIS) form, the designations reflecting the severity of androgen resistance.
Figure 2. MRI pelvis and abdomen showing an oval mass on right and left posterolateral aspect of urinary bladder, which appeared to be testis with absence of uterus and ovaries. Prostate and seminal vesicles were not seen.
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Individuals affected by CAIS present with normal female external genitalia with a short blind ending vagina. Subjects with CAIS are born unambiguously female and are not suspected of being abnormal until the onset of puberty, when breast development is normal but pubic and axillary hair is not developed and menses do not occur. All the above features
ENDOCRINOLOGY were present in our case. Like in our case most of the cases are diagnosed in the post-pubertal stage due to primary amenorrhea. A recent retrospective study of 9 post-pubertal individuals with CAIS suggests that these individuals enter puberty at an age closer to that of females.6 In contrast, PAIS patients present with genital ambiguity. Such individuals with predominantly female external genitalia have mild clitoromegaly, some fusion of the labia and pubic hair at puberty, while those of predominantly male appearance of external genitalia exhibit micropenis, perineal hypospadias and cryptorchidism (also called Reifenstein syndrome).7 Because of variability of clinical manifestations and the existence of subtle or atypical forms of androgen resistance such as male infertility, the prevalence of partial forms of AIS is unknown. At puberty, elevated LH, testosterone and estradiol levels are observed, but in general, the degree of undervirilization is less as compared with individuals with CAIS. At puberty MAIS takes two phenotypic forms, both presenting with various degrees of gynecomastia, high-pitched voice, sparse sexual hair and impotence. In one form of MAIS, spermatogenesis and fertility are impaired, while in another spermatogenesis is normal or sufficient to preserve fertility.8 In patients with clinically suspecting CAIS one should do serum LH, FSH, testosterone, 5α-DHT with karyotype and ultrasonography. Laparoscopy should be done in all such patients to examine internal genital organs. Measurement of serum 17-hydroxyprogesterone and its sulfate should be done to detect testosterone biosynthetic defects.9 Successful management of patients with this condition requires counseling, gonadectomy, vaginal enlargement and estrogen replacement. Gonadectomy is best delayed until after puberty is completed as pubertal development generally proceeds more smoothly in response to endogenous hormonal production10 and the overall risk of gonadal tumor development is 3.6% and 33% at the age of 25 years and 50 years, respectively. Once the testes have been removed, estrogen needs to be taken in order to maintain feminity.
CONCLUSION Androgen insensitivity syndrome, although very rare, is extremely distressing to the concerned individual and requires expert and sympathetic handling. Patients can be helped to achieve an excellent quality-of-life as a female by a multispecialty approach including gonadectomy, surgical correction, detailed and repeated psychological counseling along with estrogen replacement. REFERENCES 1. Hensle TW. Genital anomalies. In: Gillenwater JY, Grayback JT, Howards SS (Eds.). Adult and Pediatric Urology. 3rd Edition, St. Luis: Mosby Inc.; 1996. pp. 2529-48. 2. Rajender S, Singh L, Thangaraj K. L859F mutation in androgen receptor gene results in complete loss of androgen binding to the receptor. J Androl. 2007;28(5): 772-6. 3. Reindollar RH, Tho SPT, McDonough PG. Delayed puberty: an updated study of 326 patients. Trans Gynecol Obstet Soc. 1989;8:146-62. 4. McPhaul MJ, Griffin JE. Male pseudohermaphroditism caused by mutations of the human androgen receptor. J Clin Endocrinol Metab. 1999;84(10):3435-41. 5. Nitsche EM, Hiort O. The molecular basis of androgen insensitivity. Horm Res. 2000;54(5-6):327-33. 6. Papadimitriou DT, Linglart A, Morel Y, Chaussain JL. Puberty in subjects with complete androgen insensitivity syndrome. Horm Res. 2006;65(3):126-31. 7. Ferlin A, Vinanzi C, Garolla A, Selice R, Zuccarello D, Cazzadore C, et al. Male infertility and androgen receptor gene mutations: clinical features and identification of seven novel mutations. Clin Endocrinol (Oxf). 2006;65(5):606-10. 8. Migeon CJ, Brown TR, Lanes R, Palacios A, Amrhein JA, Schoen EJ. A clinical syndrome of mild androgen insensitivity. J Clin Endocrinol Metab. 1984;59(4):672-8. 9. Viner RM, Teoh Y, Williams DM, Patterson MN, Hughes IA. Androgen insensitivity syndrome: a survey of diagnostic procedures and management in the UK. Arch Dis Child. 1997;77(4):305-9.
10. Silverstein AM, Jones RT. Testicular feminization syndrome with pelvic seminoma. J Ultrasound Med. 1988;7(8):477-9. ■■■■
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ENT
The “Tuberculosis” in Otorhinolaryngology as Extrapulmonary Sites SHAMENDRA KUMAR MEENA
ABSTRACT Tuberculosis (TB) is a disease with a very long history and one which has sprung up again and been affecting various countries. Among the factors responsible for this resurgence, human immunodeficiency virus (HIV) should be mentioned. HIV has been regarded as responsible for changing the characteristics of TB, such as its epidemiology, natural history, clinical presentation and resistance to drugs. The manifestations of TB in cervicocephalic regions are frequent and have aroused interest. TB may present in ear, nose, larynx, pharynx and also in the neck region.
Keywords: Tuberculosis, human immunodeficiency virus, extrapulmonary TB, otorhinolaryngology
T
uberculosis (TB) is one of the oldest diseases that afflicts mankind, and has re-emerged as a significant cause of morbidity and mortality in several countries.1 It is an infectious and contagious disease caused by a bacterium, Mycobacterium tuberculosis, also called Koch’s bacillus (KB).2 According to the location of the outbreak, it can be classified as pulmonary TB, primary TB, TB reactivation and extrapulmonary TB.3 Primary TB of the ear has rarely been reported, and the disease is usually secondary to infection in lungs, larynx, pharynx and nose.4-6 EAR TB may occur in ear, secondary to pulmonary TB. It is too slow and insidious in nature, multiple perforations are found on tympanic membrane, which merge in a large central perforation in advanced cases. In middle ear, pale granulation is found; also osteomyelitis due to formation of bony sequestra. In advanced cases, profound hearing loss may be seen in pure-tone audiometry (PTA). Culture of discharge for TB bacilli and histopathological examination also confirms the diagnosis. Treatment involves use of antitubercular
Medical Officer (Clinical Tutor) Dept. of ENT Government Medical College Kota, Kota, Rajasthan Address for correspondence Dr Shamendra Kumar Meena KR-21 Civil Line, Nayapura, Kota, Rajasthan - 324 001 E-mail: shamendrameena82@gmail.com
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drugs, local treatment and mastoid surgery if needed. Direct involvement of the mastoid bone may occur producing necrosis and it may progress to involve the middle ear.7,8 Histopathology of granulation tissue, when abundant, is the most reliable diagnostic method; however, biopsies are frequently required to be done for confirmation.9 NOSE Primary TB of nose is very rare. It is mostly secondary to lungs, commonly occurring in anterior part of nose like septum, inferior turbinate. Sequence of the events that take place are that first there is nodular stage, then ulceration and after that perforation, which is mostly confirmed to cartilaginous part of septum. Diagnosis is based on biopsy, staining for acid-fast bacilli and also culture. Treatment is always antitubercular. In cases of nasal TB, common symptoms are epistaxis, nasal crusting, nasal congestion, runny nose and recurrent polyps.10,11 Nasal vestibule and the external nose may cause nasal deformity too12 and there may be epistaxis, itching and sneezing.11 By anterior rhinoscopy, nasal TB appears as a discrete, soft granular swelling of the nasal septum, which often ulcerates.12 Lupus vulgaris is just like low-grade TB, which commonly effects nasal vestibule or skin of nose/face. Apple jelly nodule is found on skin, which is brown in color. On long or in chronic stages it is present as chronic vestibulitis, perforation of cartilaginous part. Biopsy is diagnostic. Treatment is always use of antitubercular drugs.
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Every citizen of India should have the right to accessible, affordable, quality and safe heart care irrespective of his/her economical background
Sameer Malik Heart Care Foundation Fund An Initiative of Heart Care Foundation of India
E-219, Greater Kailash, Part I, New Delhi - 110048 E-mail: heartcarefoundationfund@gmail.com Helpline Number: +91 - 9958771177
“No one should die of heart disease just because he/she cannot afford it” About Sameer Malik Heart Care Foundation Fund
Who is Eligible?
“Sameer Malik Heart Care Foundation Fund” it is an initiative of the Heart Care Foundation of India created with an objective to cater to the heart care needs of people.
Objectives Assist heart patients belonging to economically weaker sections of the society in getting affordable and quality treatment. Raise awareness about the fundamental right of individuals to medical treatment irrespective of their religion or economical background. Sensitize the central and state government about the need for a National Cardiovascular Disease Control Program. Encourage and involve key stakeholders such as other NGOs, private institutions and individual to help reduce the number of deaths due to heart disease in the country. To promote heart care research in India.
All heart patients who need pacemakers, valve replacement, bypass surgery, surgery for congenital heart diseases, etc. are eligible to apply for assistance from the Fund. The Application form can be downloaded from the website of the Fund. http://heartcarefoundationfund.heartcarefoundation. org and submitted in the HCFI Fund office.
Important Notes The patient must be a citizen of India with valid Voter ID Card/ Aadhaar Card/Driving License. The patient must be needy and underprivileged, to be assessed by Fund Committee. The HCFI Fund reserves the right to accept/reject any application for financial assistance without assigning any reasons thereof. The review of applications may take 4-6 weeks. All applications are judged on merit by a Medical Advisory Board who meet every Tuesday and decide on the acceptance/rejection of applications. The HCFI Fund is not responsible for failure of treatment/death of patient during or after the treatment has been rendered to the patient at designated hospitals.
To promote and train hands-only CPR.
Activities of the Fund Financial Assistance
The HCFI Fund reserves the right to advise/direct the beneficiary to the designated hospital for the treatment.
Financial assistance is given to eligible non emergent heart patients. Apart from its own resources, the fund raises money through donations, aid from individuals, organizations, professional bodies, associations and other philanthropic organizations, etc.
The financial assistance granted will be given directly to the treating hospital/medical center.
After the sanction of grant, the fund members facilitate the patient in getting his/her heart intervention done at state of art heart hospitals in Delhi NCR like Medanta – The Medicity, National Heart Institute, All India Institute of Medical Sciences (AIIMS), RML Hospital, GB Pant Hospital, Jaipur Golden Hospital, etc. The money is transferred directly to the concerned hospital where surgery is to be done.
Drug Subsidy
The HCFI Fund has the right to print/publish/webcast/web post details of the patient including photos, and other details. (Under taking needs to be given to the HCFI Fund to publish the medical details so that more people can be benefitted). The HCFI Fund does not provide assistance for any emergent heart interventions.
Check List of Documents to be Submitted with Application Form Passport size photo of the patient and the family A copy of medical records Identity proof with proof of residence Income proof (preferably given by SDM)
The HCFI Fund has tied up with Helpline Pharmacy in Delhi to facilitate
BPL Card (If Card holder)
patients with medicines at highly discounted rates (up to 50%) post surgery.
Details of financial assistance taken/applied from other sources (Prime Minister’s Relief Fund, National Illness Assistance Fund Ministry of Health Govt of India, Rotary Relief Fund, Delhi Arogya Kosh, Delhi Arogya Nidhi), etc., if anyone.
The HCFI Fund has also tied up for providing up to 50% discount on imaging (CT, MR, CT angiography, etc.)
Free Diagnostic Facility
Free Education and Employment Facility
The Fund has installed the latest State-of-the-Art 3 D Color Doppler EPIQ 7C Philips at E – 219, Greater Kailash, Part 1, New Delhi.
HCFI has tied up with a leading educational institution and an export house in Delhi NCR to adopt and to provide free education and employment opportunities to needy heart patients post surgery. Girls and women will be preferred.
This machine is used to screen children and adult patients for any heart disease.
Laboratory Subsidy HCFI has also tied up with leading laboratories in Delhi to give up to 50% discounts on all pathological lab tests.
About Heart Care Foundation of India
Help Us to Save Lives The Foundation seeks support, donations and contributions from individuals, organizations and establishments both private and governmental in its endeavor to reduce the number of deaths due to heart disease in the country. All donations made towards the Heart Care Foundation Fund are exempted from tax under Section 80 G of the IT Act (1961) within India. The Fund is also eligible for overseas donations under FCRA Registration (Reg. No 231650979). The objectives and activities of the trust are charitable within the meaning of 2 (15) of the IT Act 1961.
Heart Care Foundation of India was founded in 1986 as a National Charitable Trust with the basic objective of creating awareness about all aspects of health for people from all walks of life incorporating all pathies using low-cost infotainment modules under one roof. HCFI is the only NGO in the country on whose community-based health awareness events, the Government of India has released two commemorative national stamps (Rs 1 in 1991 on Run For The Heart and Rs 6.50 in 1993 on Heart Care Festival- First Perfect Health Mela). In February 2012, Government of Rajasthan also released one Cancellation stamp for organizing the first mega health camp at Ajmer.
Objectives Preventive Health Care Education Perfect Health Mela Providing Financial Support for Heart Care Interventions Reversal of Sudden Cardiac Death Through CPR-10 Training Workshops Research in Heart Care
Donate Now... Heart Care Foundation Blood Donation Camps The Heart Care Foundation organizes regular blood donation camps. The blood collected is used for patients undergoing heart surgeries in various institutions across Delhi.
Committee Members
Chief Patron
President
Raghu Kataria
Dr KK Aggarwal
Entrepreneur
Padma Shri, Dr BC Roy National & DST National Science Communication Awardee
Governing Council Members Sumi Malik Vivek Kumar Karna Chopra Dr Veena Aggarwal Veena Jaju Naina Aggarwal Nilesh Aggarwal H M Bangur
Advisors Mukul Rohtagi Ashok Chakradhar
Executive Council Members Deep Malik Geeta Anand Dr Uday Kakroo Harish Malik Aarti Upadhyay Raj Kumar Daga Shalin Kataria Anisha Kataria Vishnu Sureka
This Fund is dedicated to the memory of Sameer Malik who was an unfortunate victim of sudden cardiac death at a young age.
Rishab Soni
HCFI has associated with Shree Cement Ltd. for newspaper and outdoor publicity campaign HCFI also provides Free ambulance services for adopted heart patients HCFI has also tied up with Manav Ashray to provide free/highly subsidized accommodation to heart patients & their families visiting Delhi for treatment.
http://heartcarefoundationfund.heartcarefoundation.org
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ENT Very few cases of maxillary sinus TB have been reported till date.13-15 TB of paranasal sinuses is usually a disease of adults. TB PAROTID Salivary gland can also be involved by TB. It is usually present as a nontender mass. Sometime underlying skin undergoes necrosis leading to fistula formation. Treatment is excision of involved gland or tissue and antitubercular drugs for control of disease. Salivary gland mycobacterial infections are very rare, they result from an infected intraparotid lymph node. These nodes are infected either through lymphatic channels draining the tonsil or nasopharyngeal area or there may be retrograde migration of disease through Stensenâ&#x20AC;&#x2122;s duct. Patients are usually asymptomatic. Lymphadenitis mimics sialadenitis. Diagnosis is by fine-needle aspiration cytology (FNAC). Treatment: Antitubercular treatment; surgical intervention should be avoided in these patients. TB TONSIL Tonsillar TB still exists and may be a diagnostic challenge to otolaryngologists. TB of tonsil is suspected in a patient if the tonsil is enlarged, with rough and granular surface with or without cervical lymph node enlargement, and there is pain in throat and pain on swallowing. And more so if patient is also a diabetic. When tonsil is enlarged, proper investigations and biopsy can confirm the diagnosis. Early detection and treatment are essential for cure. Decreased host immune mechanisms like diabetes mellitus can predispose to tubercular infection and tonsillar granulomata with or without cervical lymph node enlargement. Isolated unilateral tubercular infection of the tonsil without cervical lymph node in a diabetic patient is rare. TB LARYNX Laryngeal TB is very rare. It accounts for less than 1% of all extrapulmonary TB.16 It is always secondary to pulmonary TB. Mostly found in middle age group, via bronchogenic or hematogenous route for the larynx. Posterior part involvement is more common than anterior part, sequence of involvement is: Interarytenoid fold, ventricular band, vocal fold and epiglottis. Weakness of the voice is the earliest symptom followed by hoarseness. Severe pain occurs in ulcerative TB. Marked dysphagia occurs in later stages. On vocal cords, ulceration is seen as mouse-nibbled appearance, pseudoedema of epiglottis, turban epiglottis is found.
Chest X-ray, sputum examination and biopsy from lesion is required for confirmation. Treatment is voice rest and antitubercular drugs. Recently, it has been reported that laryngeal involvement is more commonly caused by hematogenous or lymphatic spread of the organism.17 Lupus of larynx is indolent tubercular but found in anterior part like epiglottis first and is painless. There is no pulmonary TB. Treatment is antitubercular drugs. It should be kept in mind that TB and malignancy of larynx may co-exist.18 Any patient presenting with ulceroproliferative lesion of the oropharynx should be subjected for histopathological examination to rule out malignancy and a differential diagnosis of TB should be kept in mind. Secondary TB of pharynx is quite a rare condition. It is said to be present as an ulcerated, lipoid lesion or as a granuloma. It is secondary to TB elsewhere, usually pulmonary and may be associated with cervical lymphadenopathy. TB LYMPH NODE In the neck, any group of lymph nodes may be involved. Any age group or sex may be involved. The involved lymph nodes may be single or multiple, matted due to periadenitis, when neck nodes caseate they form abscess. They may then adhere to skin or underlying structure like vessels, nerve, etc.; after involvement of skin it may present as discharging sinus. FNAC or lymph node biopsy reveals granulomatous lesion. Acid-fast bacilli may be positive. Chest X-ray, skin test and other lymph node groups may be examined for involvement in acquired immune deficiency syndrome (AIDS), since TB is also common in human immunodeficiency virus (HIV) positive patients. Treatment involves for 2 months of 4 drugs (isoniazid [H], rifampin [R], pyrazinamide [Z] and ethambutol [E]; HRZE) regimen and 4 months of 2 drugs (H and R) regimen. Nodes initially increase in size when treatment is started and then decrease. If not cured by drugs, you should excise the node or the abscess. Fistula formation is seen in nearly 10% of the mycobacterial cervical lymphadenitis.19,20 Cervical nodes in the submandibular region are most commonly affected in children.21,22 HIV WITH TB ENT evaluation by clinicians among HIV-infected patients is highly recommended. HIV replication in CD4 positive cells renders the body more susceptible to opportunistic infections and neoplastic disorders.
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ENT Such pathogens spread quickly in the vulnerable host, resulting in the emergence of uncommon symptoms and malignancies reported in immunocompromised patients.23-25 Therefore, further investigations should be required in all complicated cases, particularly consultations with ENT specialists given the high prevalence of ENT manifestations. It is particularly crucial to diagnose these symptoms early to ensure prompt treatment.26 Early diagnosis of HIV infection via recognition of manifestations ensures longer survival of patients. It is particularly important to note that ENT conditions may occur in both HIV-positive and -negative patients; however, specific symptoms are only reported in unusual locations and in a more aggressive fashion among HIV-positive infected individuals. Recognition of localized manifestations of the head and neck may improve the clinician’s ability to diagnose HIV infection clinically and provide the patients with the best chances for timely and effective treatment. CONCLUSION TB of the head and neck region, though not very frequent, still remains an important clinical entity, which should be kept in mind especially in developing countries. Involvement of the cervical lymph nodes remains one of the commonest manifestations. FNAC has proved to be a very valuable investigation in the diagnosis of the tuberculous lymphadenitis. TB of the head and neck region need may not always occur secondary to pulmonary TB. Low standards of living, overcrowding, poor hygiene and sanitation are the main contributors for the failure of eradication of this disease. FNAC has proved to be a very valuable investigation in the diagnosis of cervical lymph node involvement. Antitubercular drugs form the mainstay of the treatment although some patients might need surgical intervention. REFERENCES 1. Prado TN, Caus AL, Marques M, Maciel EL, Golub JE, Miranda AE. Epidemiological profile of adult patients with tuberculosis and AIDS in the state of Espírito Santo, Brazil: cross-referencing tuberculosis and AIDS databases. J Bras Pneumol. 2011;37(1):93-9. 2. Ministério da Saúde (Brasil). Cadernos de Atenção Básica/ Vigilância em saúde: dengue,esquistossomose, hanseníase, malária, tracoma e tuberculose. 2º Ediçãorevisada:2008, Brasília/DF. 3. Antunes AA, Antunes AA, Antunes AP. Tuberculose da laringe: estudo retrospectivo e revisão de literatura.
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Rev. Bras de Cirurgia de Cabeça e Pescoço. 2001; 25(1-2):19-22. 4. MacAdam AM, Rubio T. Tuberculous otomastoiditis in children. Am J Dis Child. 1977;131(2):152-6. 5. Sharan R, Isser DK. Primary tuberculosis of the middle ear cleft. Practitioner. 1979;222(1327):93-5. 6. Windle-Taylor PC, Bailey CM. Tuberculous otitis media: a series of 22 patients. Laryngoscope. 1980;90(6 Pt 1): 1039-44. 7. Miller FJW, Seal RME, Taylor Mary D. Tuberculosis in children London: J and A Churchill Ltd. 1963. 8. Sinha A. Tuberculosis of ear, nose and throat. In: Rao KN, Deshmukh MD, Panira SP, Sen PK, Bordia NL, Dingley HB (Eds.). Textbook of Tuberculosis. New Delhi: Vikas Publishing House; 1981. p. 493. 9. Singh B. Role of surgery in tuberculous mastoiditis. J Laryngol Otol. 1991;105(11):907-15. 10. Aksoy F, Yıldırım YS, Taşkın U, Bayraktar G, Karaaslan O. Primary nasal tuberculosis: a case report. Tuberk Toraks. 2010;58(3):297-300. 11. Blanco Aparicio M, Verea-Hernando H, Pombo F. Tuberculosis of the nasal fossa manifested by a polypoid mass. J Otolaryngol. 1995;24(5):317-8. 12. Choi YC, Park YS, Jeon EJ, Song SH. The disappeared disease: tuberculosis of the nasal septum. Rhinology. 2000;38(2):90-2. 13. Jain MR, Chundawat HS, Batra V. Tuberculosis of the maxillary antrum and of the orbit. Indian J Ophthalmol. 1979;27(1):18-20. 14. Shukla GK, Dayal D, Chabra DK. Tuberculosis of maxillary sinus. J Laryngol Otol. 1972;86(7):747-54. 15. Vrat V, Saharia PS, Nayyer M. Co-existing tuberculosis and malignancy in the maxillary sinus. J Laryngol Otol. 1985;99(4):397-8. 16. Alvarez S, McCabe WR. Extrapulmonary tuberculosis revisited: a review of experience at Boston City and other hospitals. Medicine (Baltimore). 1984;63(1):25-55. 17. Soda A, Rubio H, Salazar M, Ganem J, Berlanga D, Sanchez A. Tuberculosis of the larynx: clinical aspects in 19 patients. Laryngoscope. 1989;99(11):1147-50. 18. Richter B, Fradis M, Köhler G, Ridder GJ. Epiglottic tuberculosis: differential diagnosis and treatment. Case report and review of the literature. Ann Otol Rhinol Laryngol. 2001;110(2):197-201. 19. Kanlikama M, Mumbuç S, Bayazit Y, Sirikçi A. Management strategy of mycobacterial cervical lymphadenitis. J Laryngol Otol. 2000;114(4):274-8. 20. Konishi K, Yamane H, Iguchi H, Nakagawa T, Shibata S, Takayama M, et al. Study of tuberculosis in the field of otorhinolaryngology in the past 10 years. Acta Otolaryngol Suppl. 1998;538:244-9. Cont'd on page 458...
INTERNAL MEDICINE
A Rare Case of Advanced Lupus Nephritis in the Absence of Clinical Features of Lupus Nephritis and Significant Proteinuria: Highlighting the Role of Early Kidney Biopsy in SLE ANJUM MIRZA CHUGHTAI*, MUHAMMAD UWAIS ASHRAF*, MR AJMALâ&#x20AC;
ABSTRACT Lupus nephritis is known to occur in up to 60% of patients suffering from systemic lupus erythematosus (SLE). Previous studies have demonstrated that clinical features alone cannot be relied upon for ruling out renal involvement in SLE. It is largely accepted that renal biopsy is an important method to document and diagnose early, the involvement of kidneys in patients of SLE. We present here a rare case of lupus nephritis in which there was no dipstick proteinuria yet the patient had stage 4 lupus nephritis. Our case has demonstrated that advanced stage renal disease may be present in a patient of SLE even in the absence of clinical features suggesting renal involvement or even in the absence of dipstick proteinuria. This case highlights the importance of an early renal biopsy in patients of SLE.
Keywords: Lupus nephritis, systemic lupus erythematosus, renal biopsy, no dipstick proteinuria
L
upus nephritis is known to occur in up to 60% of patients suffering from systemic lupus erythematosus (SLE).1 The clinical presentation of lupus nephritis as well as the histopathological pattern of kidney involvement is highly variable in patients of SLE. The focal and diffuse forms of lupus nephritis (Class III and IV, respectively) usually manifest as nephritic urinary sediments and are known to culminate into renal failure. However, membranous nephritis (Class V) usually presents with nephroticrange proteinuria. Previous studies have demonstrated that clinical features alone cannot be relied upon for ruling out renal involvement in SLE.2,3 It is largely accepted that renal biopsy is an important method to document and
*Assistant Professor â&#x20AC; Professor and Chairman Dept. of Medicine JN Medical College, AMU, Aligarh, Uttar Pradesh Address for correspondence Dr Muhammad Uwais Ashraf Assistant Professor Dept. of Medicine JN Medical College, AMU, Aligarh - 202 002, Uttar Pradesh E-mail: uwaisashraf@gmail.com
diagnose early, the involvement of kidneys in patients of SLE. It is also necessary to make a definitive diagnosis of lupus nephritis and to grade the histopathological subtype as well as to decide the line of proper treatment. However, the timing of performing biopsy is crucial and sometimes this decision to perform a renal biopsy may be controversial. In some previous studies, renal biopsy was recommended in patients with proteinuria >500 mg/24 hours in the absence of acute renal failure.4 However, other studies have recommended biopsy only in patients with levels of proteinuria >1,000 mg/24 hours and abnormal urinary sediment.5 Also, many important case studies have suggested that significant kidney damage may occur in the setting of active proliferative lupus nephritis without clinical signs of renal involvement or even in the absence of significant proteinuria.6,7 An early intervention is crucial to prevent poor outcome in patients of lupus nephritis, therefore, it is opined that kidney biopsies be performed early, so that diagnoses can be made at an appropriate point and definitive treatment can be initiated well in time.8 We present here a rare case of lupus nephritis where there was no dipstick proteinuria yet the patient had stage 4 lupus nephritis.
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INTERNAL MEDICINE CASE REPORT A 22-year-old female patient presented to us with complaints of fever on and off for the past 1½ years, associated with generalized weakness and loss of hair for 6 months. There was also a history of distension of abdomen for the last 20 days. On taking a detailed history, the patient revealed that she also had recurrent oral ulcers and had swelling over feet off and on. There was also a history of intake of antituberculous medication for 6 months. On examination, her vitals were stable. Pallor was present, alopecia was noted and there was rash associated with dark pigmentation of the skin over the malar area. Oral ulcers and pedal edema were also present. On doing a per abdomen examination, moderate ascites was appreciated along with splenomegaly. The central nervous system, cardiovascular system and respiratory system were normal on examination. Routine investigations were ordered which revealed a hemoglobin of 6.7 g/dL, total leukocyte count of 2,400/mm3. Differential leukocyte count was P80L26 and the platelet count was 37,000/mm3. Mean corpuscular volume was 92.6 fl, erythrocyte sedimentation rate was 58 mm in the first hour. General blood picture revealed a normocytic, normochromic smear with a reticulocyte count of 0.8%. Blood urea was 22 mg% and serum creatinine was 0.6 mg%. Liver function tests, blood glucose, serum proteins and iron studies were normal. Urine examination was normal with no evidence of proteinuria. Serum thyroid-stimulating hormone was 5.002. Coombs test was negative. Keeping in view of the clinical presentation and the initial laboratory investigations, antinuclear antibodies (ANA) and double-stranded DNA (ds-DNA) were ordered, which came out to be positive. In view of the clinical and laboratory findings a diagnosis of SLE was made as the patient had 5 out of 11 criteria of SLE (malar rash, oral ulcers, alopecia, hematological findings in the form of normocytic anemia and thrombocytopenia and immunological findings in the form of positive ANA and ds-DNA). Since the patient had ascites and palpable spleen, an ultrasound of the abdomen was ordered which revealed a coarse echotexture of liver, with a portal vein diameter of 5 mm along with splenomegaly and ascites. The kidney size was normal bilaterally with a maintained corticomedullary differentiation. As the patient had florid signs of SLE without any direct evidence of renal involvement, it was planned to aggressively investigate the involvement of the kidneys, because incipient
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nephropathy is known to exist in patients having active and florid manifestations of SLE, even in the absence of proteinuria. Keeping in view of the above fact, a urinary albumin:creatinine ratio was ordered, which came out to be 151.12 mg/g. In the light of microalbuminuria and florid features of SLE, it was decided to go for a kidney biopsy, which revealed mesangial and endocapillary cell proliferation with neutrophil infiltration in capillary tufts. All the viable glomeruli revealed segmental subendothelial fuchsinophilic deposits (wire loop lesions). Tubules showed focally prominent cytoplasmic vacuolar change (Fig. 1). Few inspissated hyaline casts were seen in tubular lamina. Focal and mild chronic interstitial inflammation was noted. Arteries showed medial thickening and subintimal sclerosis while the arterioles exhibited focal hyalinosis and vacuolization in smooth muscle cells of media. On direct immunofluorescence, following pattern was observed: ÂÂ
IgA: 2+ Capillary wall granular and mesangial
ÂÂ
IgG: 3+ Capillary wall granular and mesangial
ÂÂ
IgM: 2+ Capillary wall granular and mesangial
ÂÂ
C3: 3+ Capillary wall granular and mesangial
ÂÂ
C1q: 3+ Capillary wall granular and mesangial
ÂÂ
Kappa light chains: 3+ Capillary wall granular and mesangial
ÂÂ
Lambda light chains: 3+ Capillary wall granular and mesangial.
The overall impression of the kidney biopsy was: Diffuse lupus nephritis with active lesions: ISN/RPS Class IV G A. Indices (NIH) of disease activity 10/24 and chronicity 1/12 were reported.
Figure 1. Renal biopsy showing diffuse lupus nephritis with active lesions.
INTERNAL MEDICINE Since the patient had evidence of altered liver echotexture on ultrasonography, a gastroduodenoscopy was performed, which was normal. Patient was advised a liver biopsy; however, he refused the same. DISCUSSION It is already known that nephritis is the most serious complication of SLE. In most of the SLE patients, nephritis is asymptomatic and hence it is generally accepted that urinalysis should be ordered in any patient suspected of having SLE. Renal biopsy should be considered in any patient of SLE who has clinical or laboratory evidence of active nephritis, especially upon the first episode of nephritis.9 Early clinical and histologic diagnosis of lupus nephritis is pivotal in order to minimize the risk of end-stage renal disease (ESRD). Our case was interesting in many ways. First, the decision to go for an early renal biopsy in the presence of normal urinalysis is indeed debatable. However, it has already been opined in previous studies that some patients with lesser amount of proteinuria may also manifest active disease and biopsy should be considered in the presence of new proteinuria/ hematuria.10 However, our case becomes much more significant and rare as our patient did not even have dipstick proteinuria. All that could suggest a very early renal involvement in our patient was microalbuminuria. However, renal biopsy revealed extensive renal involvement with severely active florid lupus nephritis. If renal involvement in our patient was missed at this stage, a few months later, the patient would have presented with ESRD or at least with massive proteinuria and advanced renal disease, and there would have been very limited therapeutic options and renal replacement therapy might have become unavoidable. This case highlights the fact that dipstick proteinuria should not be the only screening tool for lupus nephritis and any patient presenting with SLE should be investigated thoroughly for renal involvement. This case also strengthens the paradigm shift towards performing renal biopsy even in the absence of dipstick proteinuria. A few more interesting observations were noted in this patient, which make this case even more interesting. The presence of ascites, coarse liver echotexture and splenomegaly demand an explanation in our patient. Serositis is one of the presenting features of SLE;
however, pleural and pericardial involvement are more common compared to ascites.11 In other words, serositis in SLE, presenting as ascites in the absence of pleural or pericardial involvement is rare in literature. Splenomegaly is known to be present in most immunemediated disorders and is common in SLE. However, in the presence of a coarse liver echotexture, it needs to be settled whether splenomegaly was actually due to an immune-mediated mechanism as part of SLE or due to an underlying cirrhosis and portal hypertension because the ultrasound of the patient had revealed an altered liver echotexture. However, upper gastroduodenoscopy was normal with no evidence of portal gastropathy or esophageal varices. However, a liver biopsy was indicated as it would have clarified the nature of liver involvement as autoimmune hepatitis could have been the cause of an altered echotexture, which has a clinical association with SLE. Since the patient refused liver biopsy, the nature of liver involvement remained obscure; however, not much difference could have been made in either case, especially if there was evidence of cirrhosis. What was more important was the early detection of renal involvement, which prevented chronic kidney disease and ESRD in this patient. CONCLUSION Renal involvement is the most serious complication of SLE. Most of the time, it is the clinical presentation which makes a physician suspect renal involvement. However, our case has demonstrated that advanced stage renal disease may be present in a patient of SLE even in the absence of clinical features suggesting renal involvement or even in the absence of dipstick proteinuria. This case highlights the importance of an early renal biopsy in patients of SLE. REFERENCES 1. Cameron JS. Lupus nephritis. J Am Soc Nephrol. 1999;10(2):413-24. 2. Huong DL, Papo T, Beaufils H, Wechsler B, BlĂŠtry O, Baumelou A, et al. Renal involvement in systemic lupus erythematosus. A study of 180 patients from a single center. Medicine (Baltimore). 1999;78(3):148-66. 3. Nossent JC, Henzen-Logmans SC, Vroom TM, Huysen V, Berden JH, Swaak AJ. Relation between serological data at the time of biopsy and renal histology in lupus nephritis. Rheumatol Int. 1991;11(2):77-82. 4. Grande JP, Balow JE. Renal biopsy in lupus nephritis. Lupus. 1998;7(9):611-7.
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INTERNAL MEDICINE 5. Salach RH, Cash JM. Managing lupus nephritis: algorithms for conservative use of renal biopsy. Cleve Clin J Med. 1996;63(2):106-15. 6. Leehey DJ, Katz AI, Azaran AH, Aronson AJ, Spargo BH. Silent diffuse lupus nephritis: long-term follow-up. Am J Kidney Dis. 1982;2(1 Suppl 1):188-96. 7. Mahajan SK, Ordóñez NG, Feitelson PJ, Lim VS, Spargo BH, Katz AI. Lupus nephropathy without clinical renal involvement. Medicine (Baltimore). 1977;56(6):493-501.
agents in lupus nephritis. J Rheumatol. 1994;21(11): 2046-51. 9. Zickert A, Sundelin B, Svenungsson E, Gunnarsson I. Role of early repeated renal biopsies in lupus nephritis. Lupus Sci Med. 2014;1:e000018. 10. Christopher-Stine L, Siedner M, Lin J, Haas M, Parekh H, Petri M, et al. Renal biopsy in lupus patients with low levels of proteinuria. J Rheumatol. 2007;34(2):332-5.
11. Giannico G, Fogo AB. Lupus nephritis: is the kidney 8. Esdaile JM, Joseph L, MacKenzie T, Kashgarian M, Hayslett biopsy currently necessary in the management of lupus JP. The benefit of early treatment with immunosuppressive nephritis? Clin J Am Soc Nephrol. 2013;8(1):138-45. ■■■■
A Handheld Device to Evaluate Traumatic Brain Injury A handheld device to assess the full spectrum of traumatic brain injury (TBI), including concussion will now be available after the US FDA cleared it for marketing. The Ahead 300 device from BrainScope developed in partnership with the US Department of Defense combines proprietary electroencephalography (EEG) technology, sophisticated algorithms and machine learning with smartphone technology and a disposable electrode headset to provide rapid and objective assessment of the likelihood of the presence of TBI in patients who present with mild symptoms at the point of care.
Stereotactic Body Radiotherapy Improves Outcomes in Patients with Early Lung Cancer A retrospective review of Dept. of Veterans Affairs data has shown that compared to conventional radiotherapy, stereotactic body radiotherapy was associated with a significantly improved overall survival and disease-specific survival (DSS) in patients with stage I non-small cell lung cancer (NSCLC). At 4 years, the overall survival was 30% with stereotactic body radiotherapy vs. 19.2% with conventional radiotherapy. The DSS was 54.7% with SBRT vs. 33.7 with conventional radiotherapy. These findings were presented at ASTRO 2016, the American Society for Radiation Oncology meeting in Boston, which concluded yesterday.
IAEA Report Highlights Global Disparities in Access to Cancer Care A revamped global database launched by the International Atomic Energy Agency (IAEA) highlights startling disparities across the world when it comes to access to treatment and care for cancer. Conclusions inferred from the Directory of Radiotherapy Centres (DIRAC) show that most radiotherapy facilities are located in high-income countries and at least 36 countries do not have such radiotherapy facilities. With information from 141 countries, DIRAC is the most comprehensive database on radiotherapy infrastructure worldwide, showing centers where cancer can be treated and drawing attention to locations where patients have limited or no access at all…(UN, IAEA, 28 September 2016)
...Cont'd from page 454
21. Dhooge I, Dhooge C, De Baets F, Van Cauwenberge P. Diagnostic and therapeutic management of atypical mycobacterial infections in children. Eur Arch Otorhinolaryngol. 1993;250(7):387-91. 22. Danielides V, Patrikakos G, Moerman M, Bonte K, Dhooge C, Vermeersch H. Diagnosis, management and surgical treatment of non-tuberculous mycobacterial head and neck infection in children. ORL J Otorhinolaryngol Relat Spec. 2002;64(4):284-9. 23. Lucente
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FE.
Otolaryngologic
aspects
of
acquired
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immunodeficiency syndrome. Med Clin North Am. 1991;75(6):1389-98. 24. Youngs R. Human immunodeficiency virus otolaryngology. J Laryngol Otol. 1997;111(3):209-11.
in
25. Corey JP, Seligman I. Otolaryngology problems in the immune compromised patient - an evolving natural history. Otolaryngol Head Neck Surg. 1991;104(2):196-203. 26. Birchall MA, Horner PD, Stafford ND. Changing patterns of HIV infection in otolaryngology. Clin Otolaryngol Allied Sci. 1994;19(6):473-7.
INTERNAL MEDICINE
An Interesting Case of Polyarthritis: Maturity-onset Seronegative Synovitis Syndrome BHARATH RAJ KIDAMBI*, BALASUBRAMANIAN Bâ&#x20AC;
ABSTRACT Polyarthritis sometimes becomes a diagnostic challenge to the treating physician. It can be the sole clinical manifestation to a lot of diverse disease processes and the differential diagnosis is understandably broad. A thorough history and examination with relevant investigations will reveal the diagnosis directly in some cases, whereas in others the diagnosis will become evident after a prolonged time. Herein, we present an interesting case of polyarthritis in an elderly patient with a very peculiar course of events, which lead to the diagnosis of maturity-onset seronegative synovitis (MOSS) syndrome. MOSS also presents as peripheral synovitis, indistinguishable from rheumatoid arthritis but typically affects elderly people aged more than 60 years, has an acute onset and responds well to corticosteroids.
Keywords: Polyarthritis, MOSS syndrome, rheumatoid arthritis, seronegative spondyloarthropathy, rheumatoid factor negative, inflammatory polyarthritis, RS3PE syndrome
P
olyarthritis is defined as inflammation of five or more joints.1 Polyarthritis has a multifactorial etiology. It can vary from a simple self-limited acute viral illness to one having a chronic sinister underlying disease. The usual etiology are classified as infectious or post-infectious, inflammatory autoimmune or a manifestation of a systemic disease. Polyarthritis can be acute or chronic. Viral polyarthritis (for e.g., human immunodeficiency virus [HIV], hepatitis B virus [HBV] and parvovirus B19 in children) are usually acute in onset and self-limited.1,2 Septic polyarthritis can occur due to direct invasion of joints by bacteria namely staphylococcal and streptococcal infections, Gramnegative sepsis and after bacterial endocarditis. Reactive arthritis usually occurs following a genitourinary infection following Chlamydia infection and has associated urethritis and uveitis. Other inflammatory polyarthritis like rheumatoid arthritis, systemic lupus erythematosus and human leukocyte antigen B27
*Assistant Professor â&#x20AC; Professor Dept. of Internal Medicine Shri Sathya Sai Medical College and Research Institute, Chennai, Tamil Nadu Address for correspondence Dr Bharath Raj Kidambi No. 5 Gokulam Colony, No. 2 Ramavaram Main Road Valasaravakkam, Chennai - 600 087, Tamil Nadu E-mail: drbkid@gmail.com, drbkid@icloud.com
(HLA-B27) associated spondyloarthropathy have a more insidious onset and usually persist for more than 6 weeks.1,2 CASE REPORT An 80-year-old male patient came with complaints of sudden onset of multiple joint pain and swelling, involving both hands, wrist, ankles and foot for a duration of 6 weeks. He was referred to our institution by a nearby nursing home because the swelling and joint pains persisted despite the symptomatic trial of therapy with an adequate dose of nonsteroidal antiinflammatory drugs (NSAIDs). There was history of low-grade fever which started along with the joint pain and swelling. He also complained of some degree of morning stiffness in the shoulder and wrist joint, which had become better during the course of the day. Past history was significant for a left intertrochanteric fracture following a fall, which was treated surgically with a proximal femoral nail. Postoperative period was uneventful. There was no history suggestive of any underlying infectious etiology like HIV, tuberculosis or hepatitis B. There was no history of skin diseases like psoriasis, no associated urinary complaints or new eye complaints, no history of jaw claudication or headache, and no complaints suggestive of inflammatory bowel disease. He did not have any other comorbid conditions.
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INTERNAL MEDICINE Examination revealed an anxious elderly patient, who was well-oriented to time, place and person. Temperature was 1000F, blood pressure was 130/80 mmHg, pulse rate was 100/min and respiratory rate was 18/min. Musculoskeletal examination revealed swelling and tenderness involving the metacarpophalangeal joints and proximal interphalangeal joints of both hands involving left more than right (Fig. 1) along with tenderness and swelling of both ankle joints (Fig. 2) with restriction of motion due to pain and stiffness. There were no deformities in any joint. Rest of the systemic examination was unremarkable.
culture and urine culture were sterile. HLA-B27 also turned out to be negative. Serum uric acid levels of 4.0 mg/dL were within normal limit (3.2-7.4 mg/dL). There was no evidence of sacroiliitis or any erosion (Figs. 3 and 4) on X-ray of lumbar spine both in
Routine investigations of complete blood count was significant for a markedly elevated erythrocyte sedimentation rate (ESR) - 123 mm/hour and mild anemia with hemoglobin of 10 g/dL. Rest of the values were unremarkable. Specific investigations had the following findings, rheumatoid factor was negative, C-reactive protein (CRP) was positive and highly elevated (49.1 mg/L compared to a normal value of <10 mg/L), anti-cyclic citrullinated peptide (anti-CCP) and antinuclear antibody were negative. Malarial antigen and hepatitis B surface antigen was negative. Routine fever profile of immunoglobulin M (IgM) ELISA (enzyme-linked immunosorbent assay) for dengue, Widal for typhoid, IgM for scrub, ELISA for HIV were negative. Blood
Figure 2. Swelling in both ankle and metatarsophalangeal joints.
Figure 1. Swelling of metacarpophalangeal joints and proximal interphalangeal joints more on left compared to right hand.
Figure 3. X-ray lumbar spine AP view is unremarkable except for a proximal femoral nail on left side. No evidence of inflammation or erosion in sacroiliac joint or axial skeleton.
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Figure 5. X-ray chest PA view which is normal, no evidence of any systemic illness as a cause for the polyarthritis.
Figure 4. X-ray spine lateral view with no radiological evidence of any inflammatory arthropathy.
anteroposterior view and lateral view. Chest X-ray was normal (Fig. 5). X-ray of both the hands were normal (Fig. 6). Joint aspiration was uneventful. During the course of hospital stay patient was started on oral ibuprofen and subsequently oral hydroxychloroquine, methotrexate were added and titrated to adequate dose without much response. The ESR and CRP continued to be elevated. Suspecting maturity-onset seronegative synovitis (MOSS) based on the onset and age, other drugs were withdrawn and patient was started on low-dose steroids of 15 mg/day. The patient had a dramatic recovery following the steroid initiation and ESR had fallen from 123 mm/hour to 70 mm/hour in 3 days. Patientâ&#x20AC;&#x2122;s symptoms had improved markedly and patient became ambulant. Further imaging studies were done to rule out any underlying malignancy. Patient was eventually discharged and walked home. DISCUSSION Maturity-onset seronegative synovitis is a close differential diagnosis for rheumatoid arthritis. Age of affliction and mode of onset are distinctly different from rheumatoid arthritis. Typically adults older than 60 years are affected, and it has a sudden onset compared to the more insidious onset of rheumatoid
Figure 6. X-ray hand AP and oblique view of the involved left hand showing no evidence of erosions, deformities suggestive of any of the common inflammatory arthritis.
arthritis. MOSS is considered by some to be a spectrum of polymyalgia rheumatica (PMR), which shares some similarities to MOSS like dramatic response to corticosteroids and the age of onset. However, PMR involves the shoulder and pelvic girdle more and has a clinically absent synovitis and are more common in females, whereas the peripheral synovitis of MOSS is indistinguishable from rheumatoid arthritis and are more common in males.3 Atypical presentation of gout was considered, but there was no history of recurrent attacks, renal functions and imaging was normal, serum uric acid was persistently normal and joint aspirate was inconclusive. Other differential diagnosis considered were lateonset seronegative rheumatoid arthritis, systemic
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INTERNAL MEDICINE lupus erythematosus (SLE), crystal-induced arthritis, inflammatory bowel disease associated arthritis but was eventually ruled out after appropriate investigations. CONCLUSION In conclusion, MOSS is a disease of unknown etiology but, environmental factors and possibly infectious diseases have an impact.4 In literature, the criteria for diagnosing MOSS5,6 is: ÂÂ
Age of onset >65 years
ÂÂ
Negative rheumatoid arthritis factor, ANA test
ÂÂ
Symmetrical polyarthritis involving wrists, metacarpophalangeal, interphalangeal, tarsal, metatarsophalangeal joints, tenosynovitis of the flexor and extensor joints of the hands
ÂÂ
Rapid response to corticosteroids
ÂÂ
Exclusion of other pathologies.
X-ray in MOSS, typically shows no destruction or erosion or deformities. MOSS is a definite syndrome which physicians should know as it is a subset of polyarthritis with a good prognosis and responds rapidly to low-dose steroids.
REFERENCES 1. Sergent JS. Approach to the patient with pain in more than one joint. In: Kelley WN, Harris ED, Ruddy S, Sledge CB (Eds.). Textbook of Rheumatology. 5th Edition, Philadelphia: WB Saunders; 1997. pp. 381-7. 2. Tighe H, Carson D. Rheumatoid factors. In: Kelley WN, Harris ED, Ruddy S, Sledge CB (Eds.). Textbook of Rheumatology. 5th Edition, Philadelphia: WB Saunders; 1997. pp. 241-9. 3. Gladman DD. Psoriatic arthritis. In: Kelley WN, Harris ED, Ruddy S, Sledge CB, editors. Textbook of Rheumatology. 5th Edition, Philadelphia: WB Saunders; 1997. pp. 999-1005. 4. Olivieri I, Salvarani C, Cantini F. Remitting distal extremity swelling with pitting edema: a distinct syndrome or a clinical feature of different inflammatory rheumatic diseases? J Rheumatol. 1997;24(2):249-52. 5. Olivé A, del Blanco J, Pons M, Vaquero M, Tena X. The clinical spectrum of remitting seronegative symmetrical synovitis with pitting edema. The Catalán Group for the Study of RS3PE. J Rheumatol. 1997;24(2):333-6.
6. Sayarlioglu M. Remitting serongative symmetrical synovitis with pitting oedema (RS3PE) syndrome and malignancy. Eur J Ger Med. 2004;1:3-5. ■■■■
Faster the Intervention, Better the Outcomes in Patients with Ischemic Stroke According to a meta-analysis of five trials reported September 27, 2016 in the Journal of the American Medical Association, earlier treatment with endovascular thrombectomy plus medical therapy compared with medical therapy alone had better patient outcomes with lower degrees of disability at 3 months in patients with ischemic stroke due to intracranial large-vessel occlusions. After 7.3 hours, this benefit became nonsignificant and the outcomes were more likely to be inferior to medical therapy alone, the longer it took for patients to get from onset of symptoms to the procedure.
Endocrine Society Guideline Recommends Continuous Glucose Monitors for Type 1 Diabetes New clinical practice guidelines from the Endocrine Society recommend continuous glucose monitors (CGMs) for adults with type 1 diabetes who are able and willing to use the monitors. In patients with type 2 diabetes, CGMs can be used on a short-term, intermittent basis if their blood glucose is above target levels. Titled “Diabetes Technology—Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline,” the guideline was published online September 2, 2016 and will be published in the November 2016 print issue of The Journal of Clinical Endocrinology & Metabolism (JCEM), a publication of the Endocrine Society.
Study Shows Congenital Hypothyroidism Often Diagnosed Late Data presented at the American Thyroid Association (ATA) 2016 Annual Meeting on September 22, 2106 in Denver, Colorado suggest that there is often a delay in the diagnosis of congenital primary hypothyroidism. Consequent to this, the inadequate treatment increases the risks of neurocognitive losses. According to the American Academy of Pediatrics (AAP), congenital primary hypothyroidism (TSH ≥20 mIU/L) should be diagnosed no later than the 14th day of life, and by 6 weeks, children should be biochemically euthyroid, with a serum TSH level below 5 mIU/L.
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Rare Case Report of Amniotic Band Syndrome DEEPIKA*, TARU GUPTA†, NUPUR GUPTA‡
ABSTRACT Amniotic band syndrome (ABS) is a destructive fetal complex caused by the disruption of the amnion followed by entanglement of the fetal parts in the amniotic bands resulting in bizarre and asymmetrical defects. Probable mechanisms involved include germ disc disruption, genetic disruption, vascular disruption and amniotic disruption. We report the case of a 25-year-old female G3P2L2 with 29-week period of gestation was referred from a peripheral center in view of severe oligohydramnios. Patient was induced in view of severe oligoamnios with ? abruption. She delivered a preterm female baby of weight 1.2 kg. Baby had left foot amputated with no bleeding from stump. Cyanosed baby foot was expelled separately from uterine cavity, which was suggestive of ABS.
Keywords: Amniotic band syndrome, rupture of the amnion, oligohydramnios, destructive fetal complex
A
mniotic band syndrome (ABS) and/or limb body wall complex (LBWC) is considered to be caused by rupture of the amnion with secondary effects on the fetus producing malformation due to interruption of normal morphogenesis, deformation due to distortion of established structures and disruption of structures already formed.1,2 It may be associated with loss of amniotic fluid, producing secondary effects due to oligohydramnios.3 It is seen in 1 in 70 spontaneous abortions.4,5 In newborns, it has been estimated to occur 1 in 1,300-2,000 births.6,7 The syndrome is underdiagnosed and its presentation is so variable that no two cases are exactly alike. Pathogenesis of this defect is probably heterogeneous. Probable mechanisms involved include germ disc disruption,8-11 genetic disruption, vascular disruption12 and amniotic disruption. CASE REPORT A 25-year-old female G3P2L2 with 29-week period of gestation was referred from a peripheral center in
*Senior Resident †Professor ‡Assistant Professor Dept. of Obstetrics and Gynecology ESI-PGIMSR, Basaidarapur, New Delhi Address for correspondence Dr Nupur Gupta Assistant Professor Dept. of Obstetrics and Gynecology ESI-PGIMSR, Basaidarapur, New Delhi - 110 015 E-mail: drnupurgupta@gmail.com
view of severe oligohydramnios. She had previous two normal vaginal deliveries, both babies were alive and healthy. She conceived spontaneously with no history of drug intake or fever in first trimester. She reported quickening at 5th month of gestation and received two doses of tetanus toxoid. The obstetric scan revealed presence of severe oligohydramnios amniotic fluid index (AFI) <2 (estimated fetal weight [EFW]-1,419 g). Two doses of injection betamethasone 12 mg IM, 24 hours apart were given for lung maturity. She had no significant past medical or surgical history. Her menstrual cycles were regular. On examination, there was no pallor, icterus, cyanosis or clubbing. Her vitals were stable. Systemic examination was normal. On per abdomen examination, uterus corresponded to 26 weeks, relaxed with cephalic presentation. Clinically liquor was decreased. Fetal heart rate was 140 bpm and regular. On per speculum examination, liquor mixed with blood was seen through os. On p/v, cervix was soft, uneffaced, dilated one finger, membrane present and flat over vertex at -3 station blood mixed liquor(+). Her laboratory parameters were all within normal range. Her hemogram, urine routine, serum electrolytes, liver function tests and kidney function tests were normal. USG obstetric revealed single live intrauterine fetus biparietal diameter (BPD) 29 weeks pog, cephalic placenta posterior upper segment, no retroplacental clot seen, severe oligohydramnios (<2). Patient was induced in view of severe oligoamnios with ? abruption. She delivered a preterm female baby of weight 1.2 kg normally with Apgar score 6/10, assessed
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OBSTETRICS AND GYNECOLOGY or spine.1 At present, we consider that defective neoangiogenesis results in the disruption of vascular supply and internal organ dysfunction.13,14 Typically, ABS is associated with rupture of the amnion either due to spontaneous rupture or possible iatrogenic septostomy. Rupture of the amnion can lead to entrapment of fetal structures by sticky mesodermic bands that originate from the chorionic side of the amnion, followed by disruption.1 Entrapment of fetal parts may cause amputation or slash defects in random sites, unrelated to embryologic development. The estimated date of insult ranges from 8 to 18 weeks after the last menstrual period.15 However, the case presented here is an evidence of late occurring destruction never described elsewhere. This may give an insight about the pathogenesis of ABS. Figure 1. Baby with left foot amputated.
Amniotic band theory of Torpin (1965)1 supports the exogenous nature of defects that result from rupture of the amniotic sac. He supposed that once the amnion is ruptured the fetus lies outside amniotic cavity. From the chorionic side of amnion, mesodermal bands emanate, which entrap various parts of the fetus and disturb normal development. Early rupture would lead to more severe malformations (e.g., craniofacial and visceral), whereas later rupture would lead to milder forms. Oligohydramnios may aggravate the deformity through compression. Higginbottom in 1979, described 79 patients that supported the band theory resulting from observations of unusual facial clefts, which were not along the planes of facial closure.2 Also in support of the band theory Bhat, in his case report, described the presence of a well-formed amputated distal portion of one leg and fibrous bands coiling around the fingers of the amputated segment.
Figure 2. No bleeding from stump seen.
by pediatrician. Baby had left foot amputated with no bleeding from stump (Figs. 1 and 2). Cyanosed baby foot was expelled separately from uterine cavity, which was suggestive of ABS; baby was shifted to nursery. DISCUSSION Amniotic band syndrome is a destructive fetal complex caused by the disruption of the amnion followed by entanglement of the fetal parts in the amniotic bands resulting in bizarre and asymmetrical defects that can involve several organs, especially limbs, cranium
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Russo and colleagues have tried to divide this entity into two distinct phenotypes, the first consisting of craniofacial defects with amniotic bands and the second lacking craniofacial defects, though associated with urogenital anomalies, anal atresia, abdominal placental attachment and persistence of the extraembryonic coelom. The number of cases of miscarriages that can be attributed to ABS is unknown, although it has been reported that it may be the cause of 178 in 10,000 miscarriages. Bands which wrap around fingers and toes can result in syndactyly and amputations of the digits. In other instances, bands can wrap around limbs causing restriction of movement resulting in clubbed feet. In more severe cases, the bands can constrict the limb causing decreased blood supply and amputation. Amniotic bands can also sometimes attach to the face
OBSTETRICS AND GYNECOLOGY or neck causing deformities such as cleft lip and palate. If the bands become wrapped around the head or umbilical cord it can be life-threatening for the fetus. CONCLUSION Amniotic band syndrome is often difficult to detect before birth as the individual strands are small and hard to see on ultrasound. Often the bands are detected indirectly because of the constrictions and swelling upon limbs, digits, etc. Misdiagnosis is also common, so if there are any signs of amniotic bands, further detailed ultrasound tests should be done to assess the severity. 3D ultrasound and magnetic resonance imaging can be used for more detailed and accurate diagnosis of bands and the resulting damage/danger to the fetus. The prognosis depends on the location and severity of the constricting bands. Every case is different and multiple bands may be entangled around the fetus. Amniotic band syndrome is considered an accidental event and it does not appear to be genetic or hereditary, so the likelihood of it occurring in another pregnancy is remote. The cause of amnion tearing is unknown and as such there are no known preventative measures. REFERENCES 1. Torpin R. Amniochorionic mesoblastic fibrous strings and amnionic bands: associated constricting fetal malformations or fetal death. Am J Obstet Gynecol. 1965;91:65-75.
3. Torpin R. Fetal malformations. In: Amniotic Bands. 1st Edition, Springfield, Illinois: WB Saunders Co.; 1968. pp.130-7. 4. Byrne J, Blanc WA, Baker D. Amniotic band syndrome in early fetal life. Birth Defects Orig Artic Ser. 1982;18(3B):43-58. 5. Kalousek DK, Bamforth S. Amnion rupture sequence in previable fetuses. Am J Med Genet. 1988;31(1):63-73. 6. Ossipoff V, Hall BD. Etiologic factors in the amniotic band syndrome: a study of 24 patients. Birth Defects Orig Artic Ser. 1977;13(3D):117-32. 7. Froster UG, Baird PA. Amniotic band sequence and limb defects: data from a population-based study. Am J Med Genet. 1993;46(5):497-500. 8. Streeter GL. Focal deficiency in fetal tissues and their relation to intrauterine amputation. Contrib Embryol. 1930;33:41. 9. Herva R, Karkinen-Jääskeläinen M. Amniotic adhesion malformation syndrome: fetal and placental pathology. Teratology. 1984;29(1):11-9. 10. Bamforth JS. Amniotic band sequence: Streeter’s hypothesis reexamined. Am J Med Genet. 1992;44(3):280-7. 11. Hartwig NG, Vermeij-Keers C, De Vries HE, Kagie M, Kragt H. Limb body wall malformation complex: an embryologic etiology? Hum Pathol. 1989;20(11):1071-7. 12. Miller ME, Graham JM Jr, Higginbottom MC, Smith DW. Compression-related defects from early amnion rupture: evidence for mechanical teratogenesis. J Pediatr. 1981;98(2):292-7. 13. Donnai D, Winter RM. Disorganisation: a model for ‘early amnion rupture’? J Med Genet. 1989;26(7):421-5.
14. 2. Higginbottom MC, Jones KL, Hall BD, Smith DW. The amniotic band disruption complex: timing of amniotic rupture and variable spectra of consequent defects. 15. J Pediatr. 1979;95(4):544-9. ■■■■
Lockwood C, Ghidini A, Romero R, Hobbins JC. Amniotic band syndrome: reevaluation of its pathogenesis. Am J Obstet Gynecol. 1989;160(5 Pt 1):1030-3. Seeds JW, Cefalo RC, Herbert WN. Amniotic band syndrome. Am J Obstet Gynecol. 1982;144(3):243-8.
USPSTF Recommends BP Measurements to Screen for Pre-eclampsia All Through Pregnancy The US Preventive Services Task Force (USPSTF) continues to recommend screening for pre-eclampsia in pregnant women with blood pressure measurements throughout pregnancy, according to draft recommendation statement, unlike the American College of Obstetricians and Gynecologists (ACOG) Task Force on Hypertension in pregnancy, which says that screening to predict pre-eclampsia beyond obtaining an appropriate medical history to evaluate for risk factors is not recommended. The draft recommendation statement on pre-eclampsia screening is posted on the website of the USPSTF for views and comments till October 24, 2016.
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A Rare Case of Twin Pregnancy in the Noncommunicating Rudimentary Horn of Unicornuate Uterus: A Case Report NUPUR GUPTA*, TARU GUPTA†, DEEPTI ASTHANA‡
ABSTRACT Background: Twin pregnancy in a noncommunicating rudimentary uterine horn is rare and is difficult to diagnose antenatally. Case report: We report a case of twin pregnancy in a noncommunicating rudimentary uterine horn. The patient presented at 9 weeks’ gestation with acute abdominal distress and was antenatally diagnosed as a case of twin tubal ectopic pregnancy. On laparotomy, it was detected to have a noncommunicating thinned out left rudimentary horn with twin pregnancy. Conclusion: Pregnancies in a rudimentary uterine horn rarely reach viability and often result in rupture of the horn, causing significant fetal and maternal mortality and morbidity. The incidence, diagnosis and management of such cases are discussed.
Keywords: Twin pregnancy, noncommunicating rudimentary uterine horn, acute abdominal distress, laparotomy, fetal,
mortality
A
unicornuate uterus is a mullerian anomaly of which the true incidence is unknown. According to recent calculation, it appears higher than previously estimated, accounting for about 4%. Most unicornuate uteruses have a rudimentary horn without communication to the uterine cavity. Pregnancy in the rudimentary horn is rare1 and occurs most commonly in the noncommunicating horn. The incidence of rudimentary horn pregnancy is difficult to calculate. However, an incidence of 1 in 76,000-1,50,000 pregnancies has been reported in the literature. A twin pregnancy with both fetuses in the rudimentary horn is extremely rare.
CASE REPORT A 29-year-old female, G3P2L2 with 10 weeks amenorrhea presented to our casualty with complaint of pain
*Assistant Professor †Professor ‡Senior Resident Dept. of Obstetrics and Gynecology ESI-PGIMSR, Basaidarapur, New Delhi Address for correspondence Dr Nupur Gupta Assistant Professor, Dept. of Obstetrics and Gynecology ESI-PGIMSR, Basaidarapur, New Delhi - 110 015 E-mail: drnupurgupta@gmail.com
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abdomen. On elaborate history-taking, it was revealed that she had consumed MTP pills, taken over-thecounter, about 1 month back. There was no history of bleeding after that. Previous two deliveries of the patient were full-term normal vaginal deliveries not associated with any pre- or postpartum complications. On per vaginum examination, uterus was felt to be of multiparous size, with about 6 × 6 cm left adnexal mass, which was tender to touch. Diagnosis of left ectopic pregnancy was suspected. Pelvic ultrasound showed normal size uterus with unruptured twin gestational sac in left fallopian tube of 9 weeks 5 days. No free fluid was present. After baseline investigations and arranging adequate blood, patient was taken up for laparotomy. On laparotomy, instead of finding twin sacs in fallopian tube, rudimentary horn with unicornuate uterus was discovered with both gestational sacs in left horn and a nonpregnant right horn. Serosa of left horn was much thinned out and about to rupture. To check the communication from vagina, patient was put in lithotomy position and dilatation of cervix was done. Vagina had communication with only right horn of uterus and left horn with twin sacs was noncommunicating. Patient was again laid straight and decision of left horn excision was taken after taking consent from the husband. Need for hysterectomy,
OBSTETRICS AND GYNECOLOGY
Figure 1. Rudimentary horn showing two fetuses.
a
Figure 2. Rudimentary horn with unicornuate uterus.
b
Figure 3 a and b. Twin ectopic in rudimentary horn.
if bleeding gets uncontrolled, was also explained. Left horn was ligated at the base and excision done. Complete hemostasis was checked. Simultaneously right fallopian tube ligation was done. Postoperative period was uneventful and patient was discharged in a weeks time. DISCUSSION
Figure 4. Ectopic pregnancy in rudimentary horn.
A rudimentary horn with a unicornuate uterus results from the failure of the complete development of one of the mullerian ducts and incomplete fusion with the contralateral side. In 83% of the cases, the rudimentary horn has been found to be noncommunicating. Pregnancy in a noncommunicating rudimentary horn occurs through the transperitoneal migration of the sperm or the fertilized ovum.2 The prevalence of
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OBSTETRICS AND GYNECOLOGY associated urological anomalies is as high as 50-60%. It is associated with intrauterine growth retardation, intraperitoneal hemorrhage and uterine rupture.3 A diagnosis prior to the rupture is unusual, but it could be made with ultrasonography and magnetic resonance imaging. Tsafrir et al outlined a set of criteria for diagnosing pregnancy in the rudimentary horn.4 They are: (1) A pseudo pattern of asymmetrical bicornuate uterus; (2) absent visual continuity tissue surrounding the gestational sac and the uterine cervix and (3) presence of myometrial tissue surrounding the gestational sac. Nonetheless, most of the cases remain undiagnosed until it ruptures and presents as an emergency. The patient in our case also was misdiagnosed as twin tubal pregnancy. The usual outcome of the rudimentary horn pregnancy is rupture in the second trimester in 90% of the cases, with fetal demise. In our case, laparotomy was performed just on time, when rudimentary horn was about to rupture. However, cases of pregnancies which progressed to the third trimester and resulted in live births after cesarean section have been documented.3 A rare case of twin pregnancy in the same horn of a bicornuate uterus has been documented by Narlawar et al.5 In this the patient’s uterine malformation was detected for the first time when she experienced abdominal pain at 6 weeks of amenorrhea. Transabdominal and transvaginal sonographic examinations were performed. Both embryos showed cardiac motion on transvaginal sonography. The patient was re-examined monthly. Her pregnancy ended in spontaneous abortion at 22 weeks. Two live male fetuses were delivered, but they both died immediately after their birth. It has been recommended by most
of the obstetricians, that immediate surgery must be performed whenever a diagnosis of pregnancy in a rudimentary horn is made, even if it is unruptured.6 However, conservative management until viability is achieved, has been advocated in very few selected cases with a larger myometrial mass, if emergency surgery can be performed anytime and if the patient is well-informed. Pregnancy in a rudimentary horn carries a grave risk to the mother. There is a need for an increased awareness on this rare condition and to have a high index of suspicion, especially in developing countries where the possibility of an early detection before the rupture is unlikely. REFERENCES 1. Ural SH, Artal R. Third trimester rudimentary horn pregnancy. A case report. J Reprod Med. 1998;37: 919-21. 2. Panayotidis C, Abdel-Fattah M, Leggott M. Rupture of rudimentary uterine horn of a unicornuate uterus at 15 weeks’ gestation. J Obstet Gynaecol. 2004;24(3):323-4. 3. Shin JW, Kim HJ. Case of live birth in a non-communicating rudimentary horn pregnancy. J Obstet Gynaecol Res. 2005;31(4):329-31. 4. Tsafrir A, Rojansky N, Sela HY, Gomori JM, Nadjari M. Rudimentary horn pregnancy: first-trimester prerupture sonographic diagnosis and confirmation by magnetic resonance imaging. J Ultrasound Med. 2005;24(2):219-23. 5. Narlawar RS, Chavhan GB, Bhatgadde VL, Shah JR. Twin gestation in one horn of a bicornuate uterus. J Clin Ultrasound. 2003;31(3):167-9.
6. Jayasinghe Y, Rane A, Stalewski H, Grover S. The presentation and early diagnosis of the rudimentary uterine horn. Obstet Gynecol. 2005;105(6):1456-67. ■■■■
Probiotics are Ineffective in the Treatment of Bacterial Vaginosis in Pregnant Women Oral probiotics had no effect on vaginal microbiota during mid gestation period, suggests a study published online in American Journal of Obstetrics & Gynecology. The study was conducted to find out the role of oral probiotics (Oral Lactobacillus rhamnosus GR-1 and L reuteri RC-14) in the maintenance of a normal vaginal microbiota and in the treatment of bacterial vaginosis in pregnant women. The result reports a decreased proportion of vaginal microbiota from 82.6% to 77.8% in the treatment group and from 79.1% to 74.3% in the placebo group.
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Rupture of Endometriotic Ovarian Cyst Causes Acute Hemoperitoneum in IVF Pregnancy ATUL GANATRA*, VANASHRI TATOBA BAHADE†, UDAY KARGAR‡
ABSTRACT Endometriosis occurs in about 10% of women of reproductive age and carries an infertility rate of 50%. Severe endometriosis used to be a rare event in patients with spontaneously conceived pregnancies; however, during the last decade, the increased use of assisted reproductive technologies has led to higher fertility rates in patients with endometriosis and to a higher incidence of multiple gestations. Therefore, the number of pregnant women with endometriosis and associated complications is bound to rise. We report an interesting case of an acute hemoperitoneum caused by a ruptured ovarian cyst in a late in vitro fertilization (IVF) pregnancy in a woman who presented to us at RJ Ganatra Nursing Home, Mulund West, Mumbai with acute abdominal pain. The woman had a history of surgery for endometriosis and was currently pregnant after IVF. USG and MRI-revealed a massive hemoperitoneum that was caused by ruptured endometriotic ovarian cyst. Diagnostic laparoscopy followed by emergency laparotomy was performed. Laparotomy led to operative hemostasis, pregnancy was conserved, maternal and fetal monitoring was performed till 37 weeks, and elective LSCS performed at 37 weeks.
Keywords: Hemoperitoneum, endometriosis, pregnancy, ultrasound, MRI, in vitro fertilization
E
ndometriosis occurs in about 10% of women of reproductive age and is frequently associated with variable abdominal pain, infertility and early pregnancy complications. Rupture of endometriotic lesions is a rare event but may cause acute hemoperitoneum.1 Although endometriosis has been the subject of wide investigation, only a few cases of massive hemoperitoneum in late pregnancy are mentioned in literature.2-4 We report a case of spontaneous rupture of an endometriotic ovarian lesion leading to hemoperitoneum in an advanced in vitro fertilization (IVF) pregnancy. CASE REPORT A 28-year-old primipara at 29 weeks of gestation with IVF pregnancy came to our hospital in 1st week of September 2013, complaining of acute pain all over
abdomen, starting from epigastric region and spreading to right iliac fossa region. The woman had a history of hospitalization for severe dysmenorrhea and pain in abdomen with clinical diagnosis of endometriosis with bilateral ovarian endometriotic cysts for 6 years and operated on 27/9/2008 in view of bilateral endometriotic cysts with severe dysmenorrhea. Laparoscopy was carried out and it demonstrated a distinctive endometriosis with adhesions between the sigmoid colon. Bilateral endometrioma drainage, cyst wall fulguration and adhesiolysis were performed. There was evidence of adhesions on posterior wall of uterus, both ovaries showed endometriomas and both ovaries were adherent to the tubes. Both fallopian tubes were dilated and adherent to uterus and ovaries. Pouch of Douglas showed dense adhesions and endometriotic spots. Subsequent IVF treatment led to present pregnancy in February to March 2013.
*Obstetrician and Gynecologist and Laparoscopic Surgeon †Clinical Fellow ‡Ex-Clinical Fellow RJ Ganatra Nursing Home, Mulund, Mumbai, Maharashtra Address for correspondence Dr Vanashri Tatoba Bahade A-1 605, Sai Paradise Building, Khadakpada, Kalyan (West), Maharashtra E-mail: dr.vanashribahade@gmail.com
After admission to our hospital, there were no signs of uterine contractions, vaginal bleeding, rupture of membranes or abdominal trauma; however, the woman complained of pain of variable intensity in lower abdomen. Therefore, an urgent abdominal ultrasound was performed and surgery reference also performed.
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OBSTETRICS AND GYNECOLOGY Ultrasound displayed a hint of free fluid in lower abdomen. Differential diagnosis of appendicitis was kept as per surgery reference. All other parameters were within the normal range and fetal heart rate was reassuring. Magnetic resonance imaging (MRI) was
advised; till then patient was kept on conservative management. MRI report suggested appendicular lump as diagnosis. Decision of laparoscopic appendicectomy was taken after taking consent from the patient. Diagnostic laparoscopy was done by introducing opti-port from incision taken midway between epigastrium and uterus. Two side ports were also created; findings were suggestive of hemoperitoneum with clotted blood seen in right iliac fossa, pelvis and both paracolic gutters (Fig. 1 a-c). Bowel and omentum appeared normal, clots were suctioned with 10 mm suction cannula. Near about 700 cc total plus liquid blood of 200-300 cc was drained out. Decision of laparotomy was taken. Oblique incision was taken in right iliac fossa, abdomen opened in layers and laparoscopic findings were confirmed. Bowel and appendix appeared normal. About 400 g of blood clots were again suctioned out. There was evidence of bleeder at right ovarian fossa, bleeder was identified, cauterized and hemostasis achieved till bleeding stopped. There was evidence of endometriotic spots over posterior of surface of uterus. Blood transfusion was given postoperatively. Patient was managed well postoperatively, fetal monitoring done, fetal well-being assured and patient was discharged on 12/9/2013.
a
Patient had regular antenatal check-up (ANC) followup, after surgery. ANC period was uneventful for both mother and fetus. Elective lower segment cesarean section (LSCS) was performed at 37 weeks to give a healthy female child of 2.45 kg; a positive outcome. DISCUSSION
b
c
Figure 1 a-c. Laparoscopic pictures showing evidence of massive blood collection in the form of clots in both paracolic gutters, anterior aspect of gravid uterus, amongst coils of intestines, upper and under surface of liver too.
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Acute hemoperitoneum is a rare obstetrical emergency that definitely requires rapid diagnosis and immediate surgical intervention. Interpretation of abdominal or pelvic pain as uterine contractions as well as hasty administration of analgesics may delay definite diagnosis and lead to life-threatening situations for mother and fetus. Symptoms are often nonspecific and laboratory values may remain stable for a long period, which requires additional diagnostic tools; ultrasound as well as MRI assessment of the maternal abdomen seems to be a valuable modality for detecting hemoperitoneum. The technique is readily available and without teratogenic impact and offers a high sensitivity and specificity in detecting abdominal fluid accumulation, especially when used in serial manner.5-7 Moreover, ultrasound can be performed without major time loss or need for patient transfer; however,
OBSTETRICS AND GYNECOLOGY sensitivity may be limited by maternal obesity or impaired visualization due to advanced gestational age.
during pregnancy. J Gynecol Obstet Biol Reprod (Paris). 2011;40(1):81-4.
Endometriosis occurs in about 10% of women of reproductive age8 and carries an infertility rate up to 50%. Severe endometriosis used to be a rare events in patients with spontaneously conceived pregnancies; however, during the last decade, the increased use of assisted reproductive technologies9 has led to higher fertility rates in patients with endometriosis and to a higher incidence of multiple gestations. Therefore, the numbers of pregnant women with endometriosis and complications may rise.
3. Passos F, Calhaz-Jorge C, Graça LM. Endometriosis is a possible risk factor for spontaneous hemoperitoneum in the third trimester of pregnancy. Fertil Steril. 2008;89(1):251-2.
There is little knowledge about growth dynamics and activity of ovarian endometriotic lesions in pregnancy. Most investigators report regression or cessation of growth during pregnancy.10 Women with a history of endometriosis may carry an elevated risk for hemorrhagic complications, but enlargement and rupture remain rare events, nevertheless a patient with a history of endometriosis needs close monitoring. In most cases,11 the source of active bleeding is reported to be ruptured uterine or utero-ovarian vessels. As a result, the first approach during operative investigation is to look for a ruptured vessel. In addition, Ueda et al10 reported an incidence of 0.52% for ovarian endometriotic mass during pregnancy and Evangelinakis et al,12 calculated that the incidence of hemoperitoneum caused by ruptured endometriotic cysts in a group of nonpregnant women in reproductive age is 2.22%. In our case, it was not a single bleeding vessel but a solid mass with diffuse massive hemorrhage that was located. Despite these data, little is known about the incidence of ovarian ruptures caused by endometriosis in late pregnancy and further investigation is required. REFERENCES
4. Ismail KM, Shervington J. Hemoperitoneum secondary to pelvic endometriosis in pregnancy. Int J Gynaecol Obstet. 1999;67(2):107-8. 5. Nordenholz KE, Rubin MA, Gularte GG, Liang HK. Ultrasound in the evaluation and management of blunt abdominal trauma. Ann Emerg Med. 1997;29(3):357-66. 6. Sirlin CB, Brown MA, Andrade-Barreto OA, Deutsch R, Fortlage DA, Hoyt DB, et al. Blunt abdominal trauma: clinical value of negative screening US scans. Radiology. 2004;230(3):661-8. 7. Blackbourne LH, Soffer D, McKenney M, Amortegui J, Schulman CI, Crookes B, et al. Secondary ultrasound examination increases the sensitivity of the FAST exam in blunt trauma. J Trauma. 2004;57(5):934-8. 8. Holoch KJ, Lessey BA. Endometriosis and infertility. Clin Obstet Gynecol. 2010;53(2):429-38. 9. Barri PN, Coroleu B, Tur R, Barri-Soldevila PN, Rodríguez I. Endometriosis-associated infertility: surgery and IVF, a comprehensive therapeutic approach. Reprod Biomed Online. 2010;21(2):179-85. 10. Ueda Y, Enomoto T, Miyatake T, Fujita M, Yamamoto R, Kanagawa T, et al. A retrospective analysis of ovarian endometriosis during pregnancy. Fertil Steril. 2010;94(1):78-84. 11. Ginsburg KA, Valdes C, Schnider G. Spontaneous uteroovarian vessel rupture during pregnancy: three case reports and a review of the literature. Obstet Gynecol. 1987;69(3 Pt 2):474-6.
12. Evangelinakis N, Grammatikakis I, Salamalekis G, Tziortzioti V, Samaras C, Chrelias C, et al. Prevalence of acute hemoperitoneum in patients with endometriotic ovarian cysts: a 7-year retrospective study. Clin Exp 2. Tourette C, Carcopino X, Taranger-Charpin C, Boubli L. Obstet Gynecol. 2009;36(4):254-5. An unexpected aetiology of massive haemoperitoneum ■■■■ 1. Brosens IA, Fusi L, Brosens JJ. Endometriosis is a risk factor for spontaneous hemoperitoneum during pregnancy. Fertil Steril. 2009;92(4):1243-5.
Addition of Misoprostol to Oxytocin is Associated with Increased Risk of Postpartum Hemorrhage Adding misoprostol to oxytocin immediately after childbirth is associated with increased risk of postpartum hemorrhage, suggests a study published online in the journal, Obstetrics & Gynecology. The postpartum hemorrhage was 8.4% in the misoprostol and 8.3% in the placebo group. Rate of severe postpartum hemorrhage in the misoprostol and placebo group were 1.8% and 2.4%, respectively. Therefore, simultaneous addition of misoprostol to oxytocin as part of the active management of the third stage of labor is not recommended.
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ORTHOPEDICS
Swivel Subtype of Talonavicular Joint Dislocation of Foot: A Rare Occurrence RAM AVTAR*, MANNAN AHMED†, IRFAN MALIK‡
ABSTRACT Dislocation of the talonavicular joint is a rare occurrence. The swivel subtype dislocation is reported throughout the literature. Most are the result of an abductory or adductory force applied to the forefoot. This region is usually resistant to injury because of the strong ligamentous structures around the midtarsal joint. The strongest ligamentous structures of the midtarsal joint are on the plantar side which is protected by the long and short plantar ligament, bifurcate ligament and the plantar calcaneonavicular (spring) ligament, which are important as supports for the arch of the foot.1 Therefore, dorsal midtarsal dislocation resulting from disruption of these plantar ligaments is less common than other types of midtarsal dislocation. Kennedy reported a case of navicular fracture dislocation which, by the description of the incident and the reduction maneuver employed, suggests that plantar flexion combined with inversion were the forces required to produce the deformity. He also concluded that understanding of the mechanism of injury in these fractures may lead to easier closed reduction and improved outcome.2 We are presenting a case of pure talonavicular joint dislocation without dislocation or fracture of other tarsal bones or calcaneum and is very rare. This variant of subtalar dislocation was termed as swivel injury by Main and Jowett.3
Keywords: Talonavicular joint, bifurcate ligament, calcaneonavicular ligament
A
medially or laterally directed force applied to the foot causes dislocation of the talonavicular joint and subluxation but not the dislocation of the subtalar joint. The calcaneum along with remaining foot swivels on the intact interosseous talocalcaneal ligament causing swivel subtype of dislocation. We herein describe a patient who sustained an isolated talonavicular joint dislocation and how we managed him.
CASE REPORT A 25 year-old male came to OPD with history of fall from height injuring his right foot. There was diffuse swelling and tenderness; crepitus was felt within the talonavicular joint. Physical examination revealed an obvious deformity with lateral displacement of
*Consultant †Resident ‡Senior Resident ESI-PGIMSR, Basaidarapur, New Delhi Address for correspondence Dr Ram Avtar Consultant ESI-PGIMSR, Basaidarapur, New Delhi -110 015 E-mail: docramavtar@gmail.com
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the foot on the head of talus. The skin overlying the talar head on the medial foot was taut. There was no neurovascular deficit. Anteroposterior and oblique radiographs showed a complex talonavicular dislocation (Fig. 1 a and b). Close reduction was tried under conscious anesthesia but it failed and then the open reduction of the talonavicular dislocation was performed under spinal anesthesia. Anteromedial longitudinal incision was given, centered over talonavicular joint. Extensor hallucis longus tendon and dorsalis pedis artery was retracted medially and extensor digitorum longus tendons were retracted laterally. Talonavicular joint was exposed and reduced by traction and lateral rotation of forefoot and stabilized (Fig. 2 a and b) by two percutaneous K-wires using image intensifier. The postoperative period went uneventful. Wound dehiscence occurred and there was superficial infection which was treated with serial dressing and antibiotics, the patient was immobilized in a plaster of Paris cast for 6 weeks. Gradual physiotherapy was performed to the ankle and foot (Fig. 3). The cast and surgical pins were removed after 6 weeks (Fig. 4). Tolerable weight-bearing ambulation began at 8 weeks. The patient made a quick recovery and was
ORTHOPEDICS
a
b
Figure 1 a and b. Anteroposterior and oblique X-rays of the patient showing talonavicular dislocation.
a
b
Figure 2 a and b. Postoperative anteroposterior and oblique X-rays of the patient showing reduction and fixation with two K-wires.
Figure 3. Physiotherapy performed to the ankle and foot.
Figure 4. After removal of surgical pins.
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ORTHOPEDICS Table 1. Classification of a Series of 71 Midtarsal Joint Injuries Described by Main and Jowett Direction of Deforming force
Resulting displacement/deformity
Prognosis
Medial
Fracture-sprains, fracture-subluxation/dislocation and swivel
Good
Longitudinal
Undisplaced fractures of the navicular, displaced fractures of the navicular, crushing injuries to the navicular, cuneiforms and talus
Lateral longitudinal: Poor
Lateral
Fracture-sprains, fracture subluxations and swivel
Poor
Plantar
Fracture-sprains and fracture-subluxation/dislocations
Crush
No constant pattern of injury
allowed to fully weight bear at 12 weeks. He returned to his previous job without incident and no long-term complication was identified. After a 1 year follow-up, no complications were reported. This patient is still successfully employed as a manual worker performing normal activities. DISCUSSION Midtarsal joints, including the talonavicular and calcaneocuboid joints, are functionally related to the subtalar and Lisfranc joints. Talonavicular joint dislocation is a rare injury of the foot and ankle with most cases reported occurring after major trauma. Medial talonavicular joint dislocation, like the one described, are among the more common types of deformity occurring at the talonavicular joint after trauma with a prevalence of 30%.4 Main and Jowett classified a series of 71 midtarsal joint injuries into 5 groups according to the direction of the deforming force and the resulting displacement: medial forces, longitudinal forces, lateral forces, plantar forces and crush injury (Table 1).3 Only two cases of midtarsal dislocation were reported: pure plantar midtarsal dislocation and plantar subtalar dislocation associated with plantar dislocation of the talonavicular joint caused by a plantar force. Cases of isolated midtarsal dislocation in medial, lateral or plantar directions have been reported.5-8 The combination of dorsal dislocation of the navicular from the talus and an associated comminuted fracture of the calcaneus (transcalcaneal, talonavicular dislocation) is an unusual and severe injury and 6 cases have been described previously.9 A swivel dislocation is an uncommon variant of a subtalar dislocation, where a medially or laterally directed force dislocates the talonavicular joint and subluxates but does not dislocate the subtalar joint. The calcaneus rotates or swivels on an intact interosseous talocalcaneal ligament without tearing it.
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Medial longitudinal: Good
Variable
Main and Jowett described this dislocation type injury occurring at the midtarsal joints with a classification system to help the physician decide the best course of treatment.3 It is important to recognize this injury as the treatment and prognosis are different form a subtalar dislocation.10 Even in these complex injuries, an early anatomic reduction and stable fixation can minimize the percentage of long-term impairment.11,12 Open reduction and internal fixation gives a better outcome allowing repair of the plantar ligamentous structures, especially the plantar calcaneonavicular or spring ligament. This improves the stability of the talonavicular joint, which is critical to normal foot biomechanics. Primary fusion of the talonavicular joint after fracture dislocation of the navicular bone is also described. CONCLUSION Complex talonavicular dislocation is rare especially swivel type. It represents a severe injury to the plantar ligamentous structures. An early anatomic reduction, stable fixation and immobilization can minimize the long-term impairment and complications. REFERENCES 1. McMinn RMH. Lastâ&#x20AC;&#x2122;s Anatomy: Regional and Applied. 8th Edition, London: Churchill Livingstone; 1990. pp. 204-17. 2. Kennedy JG, Maher MM, Stephens MM. Fracture dislocation of the tarsal navicular bone: a case report and proposed mechanism of injury. Foot Ankle Surg. 1999;5(3):167-70. 3. Main BJ, Jowett RL. Injuries of the midtarsal joint. J Bone Joint Surg Br. 1975;57(1):89-97. 4. Miller CM, Winter WG, Bucknell AL, Jonassen EA. Injuries to the midtarsal joint and lesser tarsal bones. J Am Acad Orthop Surg. 1998;6(4):249-58. 5. Ruthman JC, Meyn NP. Isolated plantar midtarsal dislocation. Am J Emerg Med. 1988;6(6):599-601.
ORTHOPEDICS 6. Gaddy B, Perry CR. Chopart dislocation: a case report. J Orthop Trauma. 1993;7(4):388-90. 7. Hosking KV, Hoffman EB. Midtarsal dislocations in children. J Pediatr Orthop. 1999;19(5):592-5. 8. Milgram JW. Chronic subluxation of the midtarsal joint of the foot: a case report. Foot Ankle Int. 2002;23(3): 255-9. 9. Ricci WM, Bellabarba C, Sanders R. Transcalcaneal talonavicular dislocation. J Bone Joint Surg Am. 2002;84-A(4):557-61.
10. Pillai A, Chakrabarti D, Hadidi M. Lateral swivel dislocation of the talo-navicular joint. Foot Ankle Surg. 2006;12(1):39-41. 11. Richter M, Wippermann B, Krettek C, Schratt HE, Hufner T, Therman H. Fractures and fracture dislocations of the midfoot: occurrence, causes and long-term results. Foot Ankle Int. 2001;22(5):392-8. 12. Richter M, Thermann H, Huefner T, Schmidt U, Goesling T, Krettek C. Chopart joint fracture-dislocation: initial open reduction provides better outcome than closed reduction. Foot Ankle Int. 2004;25(5):340-8.
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Study Identifies Patient Factors that may Predict Nonunion of Fractures The probability of fracture nonunion can be based on patient-specific risk factors at presentation. Risk of nonunion is a function of fracture severity, fracture location, disease comorbidity and medication use, says a new study reported online September 7, 2016 in JAMA Surgery, which analyzed 3,09,330 fractures in 18 bones. Increased risk of nonunion was associated with severe fracture (e.g., open fracture, multiple fractures), high body mass index, smoking and alcoholism. While women experienced more fractures, men were more prone to nonunion.
NSAIDs + TNF Inhibitors may Delay Progression of Ankylosing Spondylitis New research presented at the International Congress on Spondyloarthritides 2016 in Ghent, Belgium has suggested that addition of tumor necrosis factor (TNF) inhibitors to high-dose nonsteroidal anti-inflammatory drugs (NSAIDs) may delay progression of ankylosing spondylitis. A synergistic action has been put forth as a possible explanation for this effect.
Eat Yogurt Daily for Stronger Bones Healthy postmenopausal women who eat at least one serving of yogurt a day have a lower body mass index (BMI), less fat than women who never eat yogurt, according to a new research (Abstract 1112) presented September 18, 2016 at the American Society of Bone and Mineral Research 2016 Annual Meeting in Atlanta, USA. The bone density at the distal radius in these women was 3.4% greater, 4.4% higher at the lumbar spine and 5.3% greater at the tibial cortical areas compared to women who never ate yogurt. They also had a lower risk of traumatic fractures, 19% vs. 29% for nonconsumers.
Persistent Arthritis Post-Lyme Disease may be a Systemic Autoimmune Joint Disease Results of a retrospective study suggest that persistent arthritis following Lyme disease may not be refractory Lyme arthritis, but may be a new-onset systemic autoimmune disease. Development of polyarthritis after antibiotic-treated erythema migrans, previous psoriasis, or low-titer Borrelia burgdorferi antibodies are clues to the correct diagnosis. The study is published online September 16, 2016 in Arthritis & Rheumatology.
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CONFERENCE PROCEEDINGS
71st Annual Conference of The Association of Physicians of India (APICON 2016) HYPERTENSIVE DISORDERS IN PREGNANCY: NEWER MECHANISMS
Aortic Regurgitation: When to Intervene? ÂÂ
Aortic valve replacement is highly recommended for symptomatic patients with severe AR regardless of LV systolic function.
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Asymptomatic patients with chronic severe AR and LVEF <50%.
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Severe AR while undergoing cardiac surgery for other indications.
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Patients with suspected acute AR should undergo a rapid evaluation to determine the need for an emergent surgical intervention.
Dr C Venkata S Ram, Hyderabad ÂÂ
HT disorders include chronic HT, gestational HT, pre-eclampsia superimposed on chronic HT and pre-eclampsia/eclampsia syndrome.
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HT disorders are the leading cause of maternal morbidity, mortality and perinatal morbidity. It is therefore important to understand the etiopathophysiological mechanisms. Although pre-eclampsia is of placental origin, it is a systemic disorder with multiorgan involvement. It affects the CVS, brain, liver and the kidneys. BP is only an outward sign.
CARDIOVASCULAR RISK ASSESSMENT: PARAMETERS AND CLINICAL PRACTICE
ÂÂ
Emerging evidence implicates placenta as the central source of visual disturbances in preeclampsia.
Key areas in which practitioners should be required to demonstrate competence include:
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The abnormal cytotrophoblast invasion of spinal arteries is the fundamental mechanism which triggers a sequential cascade of pressor mechanisms → maternal disorder.
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Imbalance between the vasodilatory and vasoconstrictory forces at the blood vessel site creates an unfavorable milieu → vascular manifestations of pre-eclampsia.
ECHOCARDIOGRAPHIC EVALUATION FOR VALVULAR HEART DISEASE
Prof Dr ME Yeolekar, Mumbai
ÂÂ
Demonstrating the correct technique for BP measurement, being able to explain what can go wrong during BP measurement and knowing how to resolve these problems.
ÂÂ
Being able to explain to patients the relevance of BP level measured and give appropriate advice and recommendations on follow-up.
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Understanding how to identify CV risk factors and explain their relevance to patients.
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Being able to formally quantify CV risk using an approved risk assessment tool.
ÂÂ
Giving appropriate lifestyle advice to address CV risk including advice on diet, physical activity, alcohol, salt intake and smoking cessation and signpost additional relevant services in the locality.
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Identifying patients appropriate for referral to a GP (or other HCP) for follow-up and ensure appropriate communication regarding this with both GP and patient.
Dr Navin C Nanda, USA Aortic Stenosis: When to Intervene? ÂÂ
Symptomatic severe AS.
ÂÂ
Asymptomatic severe AS with LVEF <50%, the patient has abnormal BP response to exercise stress test, is scheduled for other surgeries or is a low surgical risk of ∆ Vmax >0.3 m/s/year, Vmax ≥5 m/s and pulmonary systolic arterial pressure ≥60 mmHg.
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476
cm2
Moderate stenosis with AVA ≤1 ≥4 m/s during other cardiac surgeries.
and Vmax
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LUPUS NEPHRITIS Dr Uma Kumar, New Delhi ÂÂ
There has been significant advances in the understanding of etiopathogenesis, treatment
CONFERENCE PROCEEDINGS strategies and development of newer therapeutic agents for lupus nephritis (LN). ÂÂ
Lot of gray areas still exist, which need further elucidation.
ÂÂ
Clinical presentation of LN range from asymptomatic hematuria and/or proteinuria, frank nephrotic/ nephritis syndrome to glomerulonephritis.
ÂÂ
LN is a major predictor of poor prognosis in patients with SLE. If untreated → high morbidity and mortality.
ÂÂ
Periodic screening of SLE patient for nephritis is critical to management.
ÂÂ
Renal biopsy serves as a guide to decide about appropriate course of treatment.
ÂÂ
Immunosuppressive therapy is indicated in patients with focal/diffuse proliferative LN (Class II or IV) and some patients with membranous LN (Class V) disease.
ÂÂ
Nonimmunosuppressive therapy: Hydroxychloroquine, control of BP (<130/80 mmHg), treatment of hyperlipidemia (LDL <100 mg/dL) and treatment of proteinuria (<60% of baseline), treatment of all comorbidities.
ÂÂ
Monitor every week in patients with active disease; in quiescent disease, monitor every 6-12 months.
ÂÂ
Although many patients achieve remission, risk of relapse is considerably high.
ÂÂ
Newer therapies: Belimumab, IVIG, stem cell transplantation, plasmapheresis.
RECURRENT UTI IN THE ELDERLY
ACUTE STEMI: CURRENT CONCEPTS Dr Ashok Seth, New Delhi ÂÂ
The foremost aim of management in AMI is to restore the blood supply to the infarcting myocardium as soon as possible and reperfusion treatment.
ÂÂ
Reperfusion strategies for STEMI: Pharmacologic (widely available, quickly administered, less effective), PCI (limited availability, treatment delay, more effective, lower bleeding risk).
ÂÂ
We cannot say that thrombolysis is better and takes care of all our needs, nor can we say that primary PCI is the ideal strategy for AMI patients. Ideal treatment is fibrinolysis + primary angioplasty.
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Limitations of thrombolytics for AMI: 20% of vessels remain occluded, 45% have TIMI flow <3, median time to reperfusion is 45 min, no reliable marker of reperfusion, recurrent ischemia in 15-30%, intracranial bleeds occur in 0.5-1.5%.
ÂÂ
ST-segment resolution at 60 or 90 min is a useful marker of a patent infarct.
ÂÂ
Successful thrombolysis: 70% ST resolution (in the index lead is highly suggestive of restoration of normal myocardial blood flow.
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Lack of improvement in ST resolution by at least 50% in the worst lead at 60 to 90 min is associated with worse prognosis; should prompt strong consideration of a decision to proceed with immediate coronary angiography and “rescue” PCI.
ÂÂ
Patients unfit for lytics: Cardiac arrest, cardiogenic shock and contraindications for lytics.
ÂÂ
When >120 min delay from FMC to PPCI is likely → thrombolyse the patient → transfer for angiography after fibrinolysis → elective PCI → rescue PCI.
Dr Y Sathyanarayana Raju, Hyderabad ÂÂ
Elderly with recurrent UTI can present to GPs, internists, obstetrician and gynecologists, geriatricians and urologists.
ÂÂ
Recurrent UTI is ≥3 UTIs in 12 months. A UTI is considered recurrent when it follows complete clinical resolution of a previous episode of UTI.
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They often present with non-specific or atypical symptoms e.g., absence of fever → delay in accurate diagnosis and institution of appropriate treatment.
ÂÂ
Urine analysis and c/s should be done at least once while the patient is symptomatic in uncomplicated recurrent UTI.
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It is important to correctly recognize lower UTI, upper UTI and urosepsis as this has therapeutic implications. All risk factors should be corrected where possible.
COMMON PITFALLS IN DAY-TO-DAY MANAGEMENT OF DIABETES MELLITUS Dr Siddharth N Shah, Mumbai ÂÂ
The incidence of diabetes is escalating throughout the world and also in India. The prevalence of micro- and macrovascular complications of diabetes is also rising.
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The Indian patient with diabetes is young and has higher rates of CV complications.
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ICMR data - DM causes AMI (9%), stroke (4%), neuropathy (2%), cataract (32%).
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CONFERENCE PROCEEDINGS ÂÂ
Management of DM is a challenge due to the chronicity of the disease, multiorgan involvement and need for long-term care. Patient education to self-manage their diabetes continues to be a challenge.
ÂÂ
A stepwise grade approach should be followed for management of DM (ADA, EASD).
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The common pitfalls in day-to-day management of DM include: Delayed diagnosis, poor awareness of disease and its complications, adherence to lifestyle changes or prescribed treatment, poor follow-up, fear of hypoglycemia and weight gain, delayed initiation of insulin therapy, delayed recognition of diabetes complications, sick days and travel days, feasting and fasting, mismatch of insulin dose due to errors in insulin vial and syringe.
ÂÂ
Various studies have shown remarkable results in closed loop insulin delivery systems (artificial pancreas) in both inpatients as well as outpatients.
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But the jury is still out, longer term studies with head-to-head trials under real world home conditions need to be done before the final word is out on this futuristic technology.
THERAPEUTIC GASTROINTESTINAL ENDOSCOPY: WHAT PHYSICIANS SHOULD KNOW? Dr Nageshwar Reddy, Hyderabad ÂÂ
GI endoscopy is an important and indispensable tool both for diagnostics and therapeutics.
ÂÂ
Improvement in instrumentation and refinement in techniques in the last decade have resulted in many disorders, which were surgically managed earlier, being treated endoscopically now → ↓morbidity and mortality.
ÂÂ
Massive GI bleeds (variceal and non-variceal), Barrett’s esophagus, early esophageal and gastric cancers, UGI strictures, closure of GI wall defects are now managed with innovative endoscopic techniques.
ÂÂ
Some of the innovative technologies are: Endoscopic visualization (to detect early cancer) tissue approximation (closure of perforation/ fistulae), hemostasis (bleeding), sonographically assisted endoscopic procedures (biliary strictures, pancreatic necrosectomy), stenting (re-opening of strictures), device-assisted enteroscopy (mid-GI bleed, polyps/tumors and ulcers).
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We have transformed from endoscopic physicians to endoscopic surgeons.
BIONIC PANCREAS SYSTEM IN DIABETES MANAGEMENT Dr Rajeev Chawla, New Delhi ÂÂ
The ultimate panacea for diabetes would be prevention as well as permanent cure for this condition.
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Most patients with T1DM are not able to achieve their glycemic targets despite advancements in insulin pump devices and CGM systems, designer analog insulins.
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Currently used devices are patient dependent for decision making and insulin delivery; as they are not automated, they are not free of human interference and error.
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A completely automated artificial pancreas system for insulin treated T1DM and T2DM patients has the potential of achieving optimal glycemic control with reduced risk of hypoglycemia vs. conventional insulin pump therapy (CSII).
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CONFERENCE PROCEEDINGS
69th Indian Dental Conference (IDC 2016) DENTAL CARIES: A DISEASE OF MODERN CIVILIZATION? Prof SG Damle, Chandigarh ÂÂ
Oral diseases are caused or influenced by the same preventable risk factors as over 151 noncommunicable diseases.
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Dental caries is one of the infectious diseases that has been observed in human remains retrieved from archaeological excavations. Untreated tooth decay accounts for the most common condition among 291 diseases study.
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Worldwide, 60-90% of children are affected by tooth decay.
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Despite a low mortality rate associated with dental diseases, they have a considerable impact on selfesteem, eating ability, nutrition and over all wellbeing of an individual.
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Although rarely life-threatening, dental diseases are a major problem for health service providers in both developed and developing countries because of their high prevalence and high treatment costs.
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Therefore, a proper understanding of the pathological process and a coherent knowledge of the preventive measures is of utmost importance.
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Dental surgeons play a pivotal role in the early diagnosis and timely management of the carious process.
A NEW ERA FOR RESTORATIVE DENTISTRY: TOOTH PRESERVATION Dr Amid I Ismail, USA Ever since GV Black developed his widely adopted principals for cavity preparation, which were developed after years of experimentation with restorative materials in the later part of the 19th century, evidence has emerged showing that caries can be controlled and treated using conservative or tooth preservation methods. GV Black, just before his death, recognized the need and urgency for investigating “enamel caries”. The concepts developed over 100 years ago are no longersuitable for the 21st century. The International Caries Classification and Management System (ICCMS) was developed to bring the best current science to
promote an integrated model for caries management. ICCMS is built on the following key principals: (1) Staging of caries to allow for identification of needed nonsurgical or surgical restorative care; (2) risk assessment and management to prevent the development of new caries lesions; (3) treatment plans that identify the needs for prevention, control of initial lesions, surgical restorative care and recall for caries prevention and (4) assessment of outcomes of care to promote oral health. Using this approach would most likely achieve the ICCMS’ mission, which is to “preserve tooth structure and restore only when indicated”. Dental caries is a disease where social, general health and educational factors impact the micro-environment surrounding a tooth structure leading to loss of structure. Dental caries is a chronic and prevalent disease that has been managed, by and large, through restorative care. The current understanding of caries is changing. The emergence of microbiome ecology as a determinant of caries will lead to new therapies including behavioral and natural therapies to shift the oral microbiome to become noncariogenic. We are at a new transformational point in caries management that will challenge and change the current paradigm. MUTILATED DENTITION: WHAT IS THE BEST APPROACH IN RESOLVING THE PROBLEM? Dr Rekha Gehani, New York ÂÂ
Proper diagnosis and treatment planning of the case is very essential.
ÂÂ
Know the limitations in planning of your patient’s treatment. Please get informed consent from your patients before you start any treatment.
ÂÂ
Please incorporate other specialties as needed to achieve perfect result.
ÂÂ
Proper occlusion is the key to success.
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Lastly, believe in yourself! You provide the best possible treatment and you deserve the best rewards as well!!!! Enjoy!!
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CONFERENCE PROCEEDINGS Universal infection control procedures have hence gained prime importance while treating patients.
MANAGEMENT OF PERIAPICAL PATHOSIS Dr Chad P Gehani, New York ÂÂ
Proper diagnosis is very important.
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No bacteria, no endodontic problems.
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It is NOT what you put in, it is what you take out?
ÂÂ
Proper irrigation with pulp tissue solvent and antibacterial.
ÂÂ
Endodontic periapical pathosis is manageable by conservative root canal therapy regardless of the size of pathosis.
TMD Dr Curtis Westersund, Canada ÂÂ
The days are past, where we can look at any part of the body to be separate from the rest of the body.
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Occlusion has profound effects on the structural, muscular, neural and respiratory function of our patients.
ÂÂ
It is not the temporomandibular joint (TMJ) we treat. It is the cervical cranial mandibular complex that is affected by occlusion.
ÂÂ
My patients learn to never trust a healthcare provider that states he or she can provide all treatments required by themselves.
ÂÂ
Occlusion is a consequence of epigenetics: The factors of growth upon the genetic potential of the patient.
ÂÂ
The largest epigenetic component upon occlusion is the ability to breathe nasally. Mouth breathing creates short, narrow palates that alter the entire body’s function through life.
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Occlusion is the most sensitive and fastest of the neural loops from teeth to the brainstem to the jaw and neck muscles.
ÂÂ
Humans can sense a change in occlusion down to 30-50 microns.
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Ultra low frequency transcutaneous electrical nerve stimulation is a therapy that can help restore physiologic muscle function to help create a physiologic occlusal pattern.
BIO-AEROSOL CONTAMINATION “RECOGNIZE, PREVENT, MINIMIZE” Dr Praveen Kudva, Jaipur ÂÂ
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Cross infection during healthcare delivery has concerned healthcare professionals for centuries.
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ÂÂ
In recent years, ultrasonics and high speed power driven hand pieces have become an integral part of the dentist’s armamentarium.
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The dental operatory hence has become a rich source of contaminated bio-aerosol, which plays a vital role in cross infection.
ÂÂ
The Centers for Disease Control and Prevention (CDC) recommends addressing aerosol contamination to control cross infection.
USE OF ALTERNATE DIAGNOSTIC MARKERS IN THE DIAGNOSIS OF ORAL SQUAMOUS CELL CARCINOMA Dr Gareema Prasad, Mumbai ÂÂ
Five-year survival following diagnosis of oral malignancy - 15-50%.
ÂÂ
Increase in survival rates and decrease in morbidity associated with the treatment of oral cancer is expected, if lesions are detected at an early stage, or preferably if the potentially malignant lesion is discovered.
ÂÂ
Currently, the gold standard in diagnosis of malignant and potentially malignant oral mucosal lesions is incisional biopsy and histopathological assessment but there are problems associated with histology and there is a need for a more accurate system to predict progression of lesions to cancer.
ÂÂ
Although many clinical aids (toluidine blue, chemiluminescent light, VELscope) and biomarkers (DNA ploidy, chemokines, IHC markers and microRNAs) have been researched till date, no single or multiple markers have been identified that routinely identify progression of a lesion towards malignancy and can serve as an alternative to histology.
LEARN NEUROMUSCULAR DENTISTRY Dr Rajesh Raveendranathan, Bangalore ÂÂ
It’s high time dentists learn that they are not just “Tooth-Doctors”.
ÂÂ
Temporomandibular joint dysfunction (TMJD) is 90% myogenous.
ÂÂ
TMJD can only be correctly treated if the muscles of mastication are in isotonicity.
ÂÂ
Obstructive sleep apnea (OSA) will lead to cardiac problems.
CONFERENCE PROCEEDINGS ÂÂ
Not all snorers suffer from OSA.
ÂÂ
Mild OSA sufferers (AHI 5-20) also have bruxing/ clenching.
ÂÂ
Sleep appliances, if constructed without muscle relaxation, will end up in facial pain.
NONSURGICAL ENDODONTIC TREATMENT OF TEETH ASSOCIATED WITH LARGE PERIAPICAL LESION: A CASE SERIES
POSTERIOR MAXILLA: A CHALLENGE IN IMPLANT DENTISTRY Dr Ashish Kakar, New Delhi ÂÂ
The posterior maxilla is always a challenge to the dentist due to the quality and quantity of bone available post-extraction.
ÂÂ
Pneumatization of the maxillary sinus also causes a challenge with the bone height available for implant placement thus warranting the sinus lift procedure, or subantral augmentation. The technique was developed in the mid-1970s.
ÂÂ
It is a well-accepted technique to treat the loss of vertical bone height in the posterior maxilla.
ÂÂ
A lateral window technique and an osteotome sinus floor elevation technique are two approaches to achieve this procedure by placing bone-graft material in the maxillary sinus to increase the height and width of the available bone.
ÂÂ
Experience in the rehabilitation of severely resorbed maxilla is growing.
ÂÂ
Various bone-grafting materials have been studied for use in maxillary sinus grafts to accelerate the bone healing process, like: autogenous bone, frozen bone, freeze-dried bone, xenogeneic bone demineralized freeze-dried bone, and β-TCP and hydroxyapatite.
ÂÂ
Also trans-crestal osteotome technique without any graft has also been employed and widely studied and is found to be successful.
ÂÂ
An ideal maxillary sinus bone-grafting material should provide biologic stability, ensure volume maintenance and allow the occurrence of new bone infiltration and bone remodeling.
ÂÂ
Over time, bone-grafting materials and implants should achieve osseo-integration. After the restoration of the implant has been completed, there should be no bone loss and the materials should be stable; there should be a predictable success rate.
Dr Sanjeev Kunhappan, Chhattisgarh To avoid the trauma of surgery to patient and to attain uneventful healing, nonsurgical endodontic treatment must be considered as the treatment of first choice in cases of large periapical lesions. The key to success is: ÂÂ
Thorough debridement
ÂÂ
Disinfection
ÂÂ
Three-dimensional obturation.
INTEGRATED ENDODONTICS: ULTRASONICS IN ENDODONTICS Dr Anish Naware, Mumbai ÂÂ
Removal of the tooth structure is a routine procedure in endodontic treatment. One has to be conservative in their approach.
ÂÂ
Endodontic therapy includes removal of tooth structure to reach the apex. Different cutting instrument like air rotor or slow speed diamond cutting instruments are used during endotherapy.
ÂÂ
All of us would accept that we do a lot of tooth destruction while entering the pulp chamber and while locating the canal orifice.
ÂÂ
In case of calcification in the chamber, use of air rotor has chances of perforation at the furcal area or chances of thinning the floor of the chamber.
ÂÂ
Ultrasonic tips have emerged as an effective and conservative alternative to high-speed instruments.
ÂÂ
Ultrasonics are safe, conservative and less accident prone. ■■■■
Indian Journal of Clinical Practice, Vol. 27, No. 5, October 2016
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CONFERENCE PROCEEDINGS
India’s Premier Interventional Experience (TCT India Next 2016) HOW TO PREVENT AND MANAGE COMPLICATIONS AT TAVR? Dr Ashok Seth, New Delhi ÂÂ
TAVR related complications: Vascular access, cardiac perforation and rupture, aortic dissection and aortic annulus rupture, paravalvular regurgitation, conduction blocks, malpositioned malapposition/ device embolization, stroke, myocardial infarction and acute kidney injury.
ÂÂ
Factors for vascular complications: Vessel anatomy, device size, operator technique, access closure technique.
ÂÂ
Evaluation of vascular access is crucial to prevent vascular injury: Tortuosity, calcium, arterial diameter ≥6 mm.
ÂÂ
Cardiac perforation/rupture is a lethal avoidable and manageable complication.
ÂÂ
To avoid LV perforation, never extend the wire up to the apex, make sure that the wire does not bend. Always have an assistant to keep an eye on the wire tip.
ÂÂ
Avoid deep engagement of device. Monitor patients up to 24-48 hours post-procedure for conduction disturbances and arrhythmias.
ÂÂ
ÂÂ
but
ÂÂ
Multiple modalities are increasingly being used for image guided interventions.
ÂÂ
Image fusion and image integration are becoming major drivers in clinical applications.
ÂÂ
Limitations of current EVAR devices: Access vessel morphology is a limiting factor despite device improvements, deployment accuracy is a problem despite major advancements in imaging techniques.
ÂÂ
Next Generation LP EVAR Devices: Common design characteristics are 3-piece modular, suprarenal stent with hook fixation and lower-profile delivery (12-16F OD).
ÂÂ
Lower profile means more patients and reduced risk with increased efficacy, may eliminate endoleaks, improved fixation (Endostaples).
ÂÂ
Robotic technology offers potential to make some interventional procedures more precise and safer.
METABOLIC MANAGEMENT: ROLE IN PRE- AND POST-PCI Dr Sundeep Mishra, New Delhi ÂÂ
PCI offers a mechanical approach to a blocked artery.
Prevention of stroke: Embolic protection devices are in trial.
ÂÂ
Mere mechanical opening of the artery may not be enough.
The patient should be under the care of a multidisciplinary heart team - Interventional cardiologist, cardiac surgeon, Echo cardiologist, and anesthesiologist - preoperatively and postoperatively.
ÂÂ
Tissue perfusion after procedure correlates with improved outcomes after PCI.
ÂÂ
Tissue perfusion improves myocardial energetics but cannot be visualized by cine imaging because it occurs at a cellular level.
ÂÂ
Other pharmacological agents like b-blockers indirectly affect myocardial energetics but reduce the demand-supply mismatch.
ÂÂ
Metabolically active agents act at cellular level and directly affect myocardial energetic favorably.
ÂÂ
Ranolazine acting at cellular level (at late Na currents) reduces cellular ischemia but has no effect on clinical outcomes.
ÂÂ
Trimetazidine reduces both cellular and clinical ischemia and improves outcomes.
The responsibility of Success lies with us! If you have complications, be prepared to handle them! AAA: WHERE ARE WE AND WHAT IS AHEAD? Dr (Prof) NN Khanna, New Delhi ÂÂ
Potential access issues: Tortuous arteries, vessel diameter, calcification.
ÂÂ
Hybrid approaches are intended to expand the landing zone for endoluminal grafting by rerouting arterial branches.
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Indian Journal of Clinical Practice, Vol. 27, No. 5, October 2016
CONFERENCE PROCEEDINGS A BRIEF HISTORY OF CORONARY INTERVENTION: PAST, PRESENT AND FUTURE Dr Gregg Stone, USA ÂÂ
Andreas Gruentzig (1939-1985) is the Father of PTCA. His dream was the catheter-based percutaneous treatment of vascular disease in alert, awake patients!
ÂÂ
Balloon angioplasty initially got a bad name due to frequent dissections, poor outcomes, acute closure (surgical backup required), it was ineffective in calcified lesions and then restenosis.
ÂÂ
Then came stents in 1998. “Just Stent it”
ÂÂ
BMS had numerous issues of restenosis, strut fracture, durability.
ÂÂ
DES came as a transforming technology. 1st generation DES (TAXUS, Cypher) - then issues began to come up: Late DES thrombosis, delayed healing, incomplete apposition. Forbes described DES as “a million ticking time bombs”. So, in 2006 “Just Destent it”. Second-generation DES (Resolute, Xience V).
ÂÂ
EXCEL study: Enrollment closed on March 6th, 2014; 1905 patients randomized to either PCI with everolimus-eluting stent or CABG, SYNTAX score ≤32. Results will be presented at TCT 2016.
ÂÂ
Emerging exciting areas in coronary intervention: Polymer-free DES and BRS, coronary lithoplasty, coronary sinus reducer, vulnerable plaque to prevent MI and death.
ÂÂ
BioFreedom drug-coated stent (DCS): Avoids possible polymer-related AEs, drug is rapidly transferred to BV wall; LEADERS FREE trial (Urban P, et al. NEJM. 2015).
ÂÂ
Coronary sinus reducer: Hourglass-shaped stainless stent implanted in the coronary sinus; COSIRA trial (Verheye S, et al. NEJM. 2015;372:519-27).
Interventional Cardiology is an evolving landscape … The next 5 years will “explode” with more meaningful changes than at any time in the history of interventional cardiology! CAN TAVI REPLACE SAVR IN LOW-RISK PATIENTS? Dr Susheel Kodali, USA ÂÂ
To treat low-risk patients, TAVI has to demonstrate predictable results, low frequency of procedural complications and death.
ÂÂ
Limitations of TAVR: Stroke, paravalvular regurgitation, durability, conduction abnormalities.
ÂÂ
Contemporary clinical practice has already evolved in the EU and in the US. Risk strata have already ‘downshifted’ to include intermediate risk patients even before clinical trial data available.
ÂÂ
Lower surgical risk patients in the EU are being treated by TAVR.
ÂÂ
Risk assessment must take into account age and TAVI risk and not just surgical risk.
ÂÂ
TAVI is evolving rapidly in contrast to surgical AVR resulting in more predictable results and better outcomes.
ÂÂ
However, several questions still remain unanswered such as bicuspid valves, concomitant CAD, AVR/ CABG vs. TAVI/PCI, increased pacemaker risk and long-term consequences of chronic pacing, and is durability important if TAVI results continue to be superior to SAVR.
Reasons why TAVR will Continue to Move into Lower Risk Population TAVR is in its adolescence and will continue to improve. Patients always prefer less invasive therapy. Option for valve-in-valve allows a bailout for valve failure.
ÂÂ
Drug-filled stent (DFS): Made from polymer-free tri-layer wire. Outer cobalt alloy layer for strength, middle tantalum layer for radiopacity and inner layer core material is removed and becomes a lumen that is filled with drug (sirolimus).
ÂÂ
Vulnerable plaque to prevent MI and death; PROSPECT.
The paradigm will change…it’s just a matter of when and what data is needed.
ÂÂ
Coronary lithoplasty: Lesion modification predilation using lithotripsy in a balloon, disrupts both superficial and deep calcium, tissue selective.
EVIDENCE FOR REVASCULARIZATION OF COMPLEX CAD (INCLUDING LMCA)
ÂÂ
Advanced catheter-based hemodynamic support devices (Impella CP, St. Jude PHP) will be a mainstay of acute HF, shock therapy and protected PCI in the future!
Dr Ajay Kirtane, USA ÂÂ
The clogged pipe analogy of stable coronary heart disease has been particularly difficult to dislodge (Circ Cardiovasc Qual Outcomes. 2013;6(1):129-32).
Indian Journal of Clinical Practice, Vol. 27, No. 5, October 2016
483
CONFERENCE PROCEEDINGS ÂÂ
ÂÂ
ÂÂ
Lesions that are actually causing symptoms or reducing QOL should be revascularized. It should be possible to carry out the intervention safely and with high quality and/or durability. Goals of therapy in stable CAD: Improve symptoms and QOL as measured by ‘soft endpoints’ such as angina/QOL scales and improve prognosis as measured by ‘harder endpoints’ such as MI, death. BARI 2D: Revascularization strategy reduced cumulative incidence of worsening angina compared to medical therapy (Dagenais et al. Circulation. 2011).
ÂÂ
TRIUMPH: Multivessel revascularization improved symptoms and QOL at 1 year (J Am Coll Cardiol. 2015;66:2104-13).
ÂÂ
Diagnosing and treating prognostically important!
ÂÂ
Despite 32% crossover to PCI in the optimal medical therapy (OMT) group, PCI + OMT vs. OMT significantly reduced use of nitrates and CCBs at 1, 3 and 5 years (Boden WE, et al. NEJM. 2007;356:1503-16).
ÂÂ
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severe
CAD
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WHICH TWO-STENT TECHNIQUE FOR DISTAL BIFURCATION STENOSIS Prof DS Gambhir, Noida ÂÂ
Left main distal bifurcation stenosis (65-70%) are technically more challenging to treat.
ÂÂ
A single stent strategy should be preferred wherever possible, because of fewer adverse outcomes compared to two-stent strategy.
ÂÂ
Indications of elective two-stent strategy: Large size LCx (>2.5 mm) with significant area of distribution (dominant LCx), significant stenosis, extending beyond LCx ostium (10-20 mm), side branch loss may result in fatal complications and the angle for recrossing after LMCA implantation is unfavorable → LAD stent.
ÂÂ
Two-stent techniques: V-stenting, SKS technique, Culotte, mini crush/DK crush, TAP/T-stenting.
ÂÂ
No single two-stent strategy is universally applicable in all left main distal bifurcation lesions.
ÂÂ
Choice of two-stent strategy is influenced by plaque distribution assessed by IVUS(±), bifurcation angle, relative diameter of LAD/LCx and LMCA, length of lesion in LCx starting from its ostium, extent of viable myocardium subserved by LCx, development of dissection in MB or SB after predilatation.
is
CABG vs. medical therapy in LM disease: Risk reduction greater in patients with LM disease (n = 150) with CABG vs. medical therapy (Yusuf S, et al. Lancet. 1994;344:563-70). FAME 2: Landmark analysis of death or MI; fewer deaths or MI in PCI group versus medical therapy group (3.4 vs. 3.9% or 15 vs. 17 events, respectively), hazard ratio of 0.42 in favor of PCI (De Bruyne B, et al. NEJM. 2012).
■■■■
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Indian Journal of Clinical Practice, Vol. 27, No. 5, October 2016
Results of two RCTs of LM PCI vs. CABG (NOBEL, EXCEL) are awaited.
EXPERT VIEW
What Health Problems are Associated with Hypertension? RAJIV GARG
H
ypertension is the most important modifiable risk factor for coronary heart disease, stroke, congestive heart failure (CHF), end-stage renal disease (ESRD) and peripheral vascular disease. Hypertension, if left untreated, is associated with an increased risk of mortality and is often described as a silent killer. Mild-to-moderate hypertension may lead to atherosclerotic disease in 30% of people and organ damage in 50% of people within 8-10 years after onset. It has been demonstrated that for every 20 mmHg systolic or 10 mmHg diastolic increase in blood pressure (BP) above 115/75 mmHg, the mortality rate for both ischemic heart disease and stroke doubles.1
Uncontrolled and prolonged hypertension can lead to detrimental changes in the myocardial structure, coronary vasculature and conduction system of the heart. These changes in turn can lead to the development of left ventricular hypertrophy (LVH), coronary artery disease (CAD), various conduction system diseases and systolic and diastolic dysfunction of the myocardium. Clinically, these changes present as angina or myocardial infarction, cardiac arrhythmias (especially atrial fibrillation) and CHF. Thus, hypertensive heart disease is a term applied generally to heart diseasesâ&#x20AC;&#x201D; such as LVH, CAD, cardiac arrhythmias and CHFâ&#x20AC;&#x201D; that are caused by direct or indirect effects of raised BP. Although these diseases generally develop in response to chronically elevated BP, marked and acute elevation of BP can also lead to accentuation of an underlying predisposition to any of the symptoms traditionally associated with chronic hypertension. In the Framingham Heart Study, it was seen that the age-adjusted risk of CHF was 2.3 times higher in men and three times higher in women when the highest BP was compared to the lowest BP.2 Data from Multiple Risk Factor Intervention Trial (MRFIT) revealed that the relative risk for CAD mortality was 2.3-6.9 times higher
Senior Medical Specialist and Head Dept. of Medicine, ESI Hospital, Noida, Uttar Pradesh
for persons with mild-to-severe hypertension than it was for persons with normal BP.3 The relative risk for stroke ranged from 3.6% to 19.2. The populationattributable risk percentage for CAD varied from 2.3% to 25.6%, whereas the population-attributable risk for stroke ranged from 6.8% to 40%. Nephrosclerosis is one of the possible complications of long-standing hypertension. The risk of hypertensioninduced ESRD is higher in black patients, even when BP is under good control. Furthermore, patients with diabetic nephropathy who are hypertensive are also at high-risk for developing ESRD. The Framingham Heart Study found a 72% increase in the risk of all-cause death and a 57% increase in the risk of any cardiovascular event in patients with hypertension who were also diagnosed with diabetes mellitus.4 BP is also a powerful determinant of risk for ischemic stroke and intracranial hemorrhage; in fact, long-standing hypertension may manifest as hemorrhagic and atheroembolic stroke or encephalopathy. Both the high systolic and diastolic pressures are harmful; a diastolic pressure of >100 mmHg and a systolic pressure of >160 mmHg are associated with a significant incidence of strokes. The American Heart Association notes that individuals whose BP level is <120/80 mmHg have about 50% the lifetime stroke risk of that of hypertensive individuals. Marked and acute elevation of BP can also lead to accentuation of an underlying predisposition to any of the symptoms traditionally associated with chronic hypertension. The most common clinical presentations of hypertensive emergencies are cerebral infarction (24.5%), pulmonary edema (22.5%), hypertensive encephalopathy (16.3%) and CHF (12%). Other clinical presentations associated with hypertensive emergencies include intracranial hemorrhage, aortic dissection and eclampsia,5 as well as acute myocardial infarction. Hypertension is also one of several conditions that have been increasingly recognized as having an association with posterior reversible encephalopathy syndrome (PRES), a condition characterized by headache, altered mental status, visual disturbances and seizures.6
Indian Journal of Clinical Practice, Vol. 27, No. 5, October 2016
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EXPERT VIEW Clinical trials have demonstrated the following benefits with antihypertensive therapy.1 ÂÂ
Average 35-40% reduction in stroke incidence.
ÂÂ
Average 20-25% reduction in myocardial infarction.
ÂÂ
Average reduction in heart failure >50% in heart failure.
Moreover, it is estimated that one death is prevented per 11 patients treated for Stage 1 hypertension and other cardiovascular risk factors when a sustained reduction of 12 mmHg in systolic BP over 10 years is achieved.1 However, for the same reduction in systolic BP, it is estimated that one death is prevented per 9 patients treated when cardiovascular disease or endorgan damage is present.1 REFERENCES
High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003;42(6):1206-52. 2. Culleton BF, Larson MG, Kannel WB, Levy D. Serum uric acid and risk for cardiovascular disease and death: the Framingham Heart Study. Ann Intern Med. 1999;131(1): 7-13. 3. Mortality after 10 1/2 years for hypertensive participants in the Multiple Risk Factor Intervention Trial. Circulation. 1990;82(5):1616-28. 4. Chen G, McAlister FA, Walker RL, Hemmelgarn BR, Campbell NR. Cardiovascular outcomes in Framingham participants with diabetes: the importance of blood pressure. Hypertension 2011;57(5):891-7. 5. Zampaglione B, Pascale C, Marchisio M, Cavallo-Perin P. Hypertensive urgencies and emergencies. Prevalence and clinical presentation. Hypertension. 1996;27(1):144-7.
1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, et al. Joint National Committee on 6. Staykov D, Schwab S. Posterior reversible encephalopathy syndrome. J Intensive Care Med. 2012;27(1):11-24. Prevention, Detection, Evaluation, and Treatment of ■■■■
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MEDILAW
Death of a Patient While Undergoing Standard Treatment Protocol is Not Negligence A patient filed a complaint with the Sub-Divisional Magistrate (SDM) alleging that his wife died on the same day she was hospitalised as a result of negligence in the treatment given to her in the hospital.
The patient was brought with intrauterine fetal death, jaundice and sepsis. She was managed as per standard treatment but died within 6 hours despite treatment.
Proceed
The SDM has sought opinion if there has been a medical negligence in managing this patient, who was 30 weeks pregnant and died within 6 hours of hospital stay.
The case is dismissed.
Lesson: In the order, DMC/DC/F14/Comp.1183/2/2013, the Council gave its decision that prima facie there was no medical negligence in this case as standard protocol was followed in the management of the patient.
CASE SUMMARY Patient X was brought to Hospital Y in early morning at 5.13 am on 25th September 2011. She was a case of 39 weeks pregnancy with intrauterine fetal death with jaundice. A diagnosis of septicemic shock was made and the management was done according to the standard protocol for the condition. The patient succumbed to her illness few hours later on the same day at 11.15 am. A representation was sent by Sub-Divisional Magistrate to examine the death of Patient X to find out if there was any medical negligence in the treatment administered to the patient on the part of Hospital Y. Along with the representation, the Executive Committee of the Council also examined the medical records of Hospital Y, autopsy report and other documents placed on record.
Judgement Based on its observations, the Executive Committee found that prima facie there was no medical negligence in the line of treatment adopted on the part of Hospital Y and disposed off the complaint.
Reference 1. DMC/DC/F.14/Comp.1183/2/2013/dated 5th December, 2013.
CIVIL OR CRIMINAL NEGLIGENCE: WHAT THE SUPREME COURT SAY ÂÂ
In Martin F. D’Souza vs Mohd. Ishfaq, 3541 of 2002, dated 17.02.2009, the Supreme Court of India held “… It has been stated that simple negligence may result only in civil liability, but gross negligence or recklessness may result in criminal liability as well.
ÂÂ
In its judgement in Dr Suresh Gupta vs. Government of N.C.T. of Delhi and another AIR 2004 SC 4091 Appeal (crl.) 778 of 2004, the Supreme Court of India said, “… the cause of death is stated to be ‘not introducing a cuffed endotracheal tube of proper size as to prevent aspiration of blood from the wound in the respiratory passage’. This act attributed to the doctor, even if accepted to be true, can be described as negligent act as there was lack of due care and precaution. For this act of negligence he may be liable in tort but his carelessness or want of due attention and skill cannot be described to be so reckless or grossly negligent as to make him criminally liable. Between civil and criminal liability of a doctor causing death of his patient the court has a difficult task of weighing the degree of carelessness and negligence alleged on the part of
Indian Journal of Clinical Practice, Vol. 27, No. 5, October 2016
487
MEDILAW the doctor. For conviction of a doctor for alleged criminal offence, the standard should be proof of recklessness and deliberate wrong doing i.e. a higher degree of morally blameworthy conduct. To convict, therefore, a doctor, the prosecution has to come out with a case of high degree of negligence on the part of the doctor. Mere lack of proper care, precaution and attention or inadvertence might create civil liability but not a criminal one. The courts have, therefore, always insisted in the case of alleged criminal offence against doctor causing death of his patient during treatment, that the act complained against the doctor must show negligence or rashness of such a higher degree as to indicate a mental state which can be described as totally apathetic towards the patient. Such gross negligence alone is punishable.” ÂÂ
In Jacob Mathew vs. State of Punjab and Anr: 5th day of August 2005: 334/2005/SCI/144-145 of 2004, the Supreme Court of India observed: “Generally speaking, it is the amount of damages incurred which is determinative of the extent of liability in tort; but in criminal law it is not the amount of damages but the amount and degree of negligence that is determinative of liability…To prosecute a medical professional for negligence under criminal law it must be shown that the accused did something or failed to do something which in the given facts and circumstances no medical professional in his ordinary senses and prudence would have done or failed to do. The hazard taken by the accused doctor should be of such a nature that the injury which resulted was most likely imminent.”
FACTORS ON WHICH PUNISHMENT SHOULD BE CONSIDERED ÂÂ ÂÂ ÂÂ ÂÂ ÂÂ ÂÂ ÂÂ
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Any contributory negligence (by the patient, relatives, previous treating doctors).
ÂÂ
Mitigating circumstances.
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Treatment received prior to the current admission.
ÂÂ
Opinion of the experts.
ÂÂ
Who was at fault (hospital, resident, nurse and paramedical staff)?
ÂÂ
Was there any deficiency of service by the hospital?
ÂÂ
Deviation from normal practice.
ÂÂ
Is it the case of a ‘never event’?
ÂÂ
Failure to maintain medical records or comply with the request for medical records by the patient/their authorised representative or tampering with medical records.
ÂÂ
Issuing false, misleading or improper certificates
ÂÂ
Informed consent not taken.
NEVER EVENTS Never events are situations where deficiency of service and/or negligence is presumed and no trial or expert evidence is necessary. In Nizam Institute of Medical Sciences Vs. Prasanth S. Dhananka and Ors, SC/4119 of 1999 and 3126 of 2000, the Supreme Court of India observed: “There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the outpatient card containing the warning.”
Doctor not registered with the council. Quackery. Hospital not registered with Directorate of Health Services. Negligence or misconduct. Degree of professional misconduct or infamous conduct. First offence or regular offender. Patient information: Age, pregnancy, income, status, dependency.
In Martin F. D’Souza vs. Mohd. Ishfaq, 3541 of 2002, dated 17.02.2009, the Supreme Court has defined some situations of negligence:
Is the doctor a junior or senior doctor, a general practitioner, a specialist or a super specialist?
ÂÂ
Degree of negligence: An element of recklessness, willful or apathetic act?
ÂÂ
Extent of damage: Death, disability (temporary/ permanent), monetary loss, mental agony.
488
ÂÂ
Indian Journal of Clinical Practice, Vol. 27, No. 5, October 2016
ÂÂ
Failing to strictly observe current practices, infrastructure, paramedical and other staff, hygiene and sterility
ÂÂ
Giving a prescription without examining the patient
ÂÂ
Giving a prescription on telephone (except in an acute emergency)
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Not investigating a patient as necessary
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Experimenting when not necessary and without written consent
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Not consulting an expert when in doubt
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Not maintaining treatment, etc.
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In This Issue
Asian Journal of Diabetology
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Emerging role of Cardiac MRI in Ischemic and Non-ischemic Cardiomyopathy
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Acute Renal Failure and Silent Myocardial Infarction Following Multiple Honey Bee Stings
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Superficial Brachial Artery: Its Embryological and Clinical Significance
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Glucose Tolerance in Nondiabetic Patients after First Attack of Acute Myocardial Infarction and its Outcome
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A Case of Left Atrial Myxoma Presenting as Severe Pulmonary Hypertension
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Double-Chambered Right Ventricle with Transient 2:1 Atrioventricular Block: A Rare Presentation
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Cornary Artery Air Embolism
Volume 17, Number 5
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January-March 2015
Volume 1, Number 1
Asian Journal of OBS & Gynae Practice Asian Journal of Paediatric Practice
Volume 18, Number 3
Dr Swati Y Bhave
Dr KK Aggarwal
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AROUND THE GLOBE
News and Views 71st UN General Assembly, New President Pledges to ‘Turn the Wheels’ on Implementing 17 Global Goals The United Nations General Assembly opened its 71st session, with an emphasis on ensuring that implementation of the new global development goals, adopted by its 193 Member States last year, is well underway. “The 70th Session launched the SDGs (Sustainable Development Goals), and for integrity’s sake the 71st must be the year we witness the wheels turning on the implementation of all 17 SDGs,” the President of the General Assembly, Peter Thomson, said as he opened the new session and took an oath of office. Mr Thomson, who had been serving as the Permanent Representative of Fiji to the United Nations until his appointment, said that the theme of the 71st session is “The Sustainable Development Goals: A Universal Push to Transform our World”. On 1st January 2016, the 17 SDGs of the 2030 Agenda for Sustainable Development— adopted by world leaders in September last year– officially came into force … (UN, September 13, 2016)
Shutdown of Reactor Endangers Global Supply of Technetium-99m Canada’s Chalk River reactor, which makes large amounts of technetium-99m, will end production next month, as reported by Jeff Tollefson in Nature on September 12, 2016. A report from the US National Academies of Sciences, Engineering and Medicine has cautioned that any unplanned outages at the remaining production sites in the world could lead to severe shortages of the radioactive tracer technetium-99m until new facilities come online in 2017 and 2018. Chalk River reactor produces about 20% of the world’s supply of technetium; the rest comes from 6 other aging reactors in Europe, Australia and South Africa... (Nature │News)
New PAHO Publication Brings Together Strategies for Suicide Prevention in the Americas The Pan American Health Organization (PAHO) has launched a new publication that brings together strategies for suicide prevention in the Americas, which has been prepared together with the Ramón de la Fuente Muñiz National Institute of Psychiatry, a WHO Collaborating Center in Mexico. The publication
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“provides essential information aimed at a better understanding of suicidal behavior and the principal strategies for addressing it––from the time it is reported until the corresponding interventions are assessed––in light of experiences currently underway in the Region,” said Dévora Kestel, head of PAHO’s Mental Health and Substance Use Unit.
Cardiac Event Recurrence High in Familial Hypercholesterolemia Post-ACS Patients with heterozygous familial hypercholesterolemia and acute coronary syndrome (ACS) have a >2-fold adjusted risk of coronary event recurrence within the first year after discharge than patients without familial hypercholesterolemia despite the widespread use of high-intensity statins, suggests a study published online September 6, 2016 in the journal Circulation.
Laser Pointers may Cause Irreversible Vision Loss in Children A case report published in Pediatrics September 1, 2016 has described 4 male children, aged between 9 and 16 years, who had laser-related retinal injury to the macula of 1 eye or both eyes due to the mishandling of the laser pointer devices at a single vitreoretinal clinical practice. Their presenting symptoms included central vision loss, central scotoma and metamorphopsia. And, 3 patients had potential irreversible vision loss. The authors discourage the use of laser pointers in children due to danger of harming their vision.
Comorbidities Increase in Patients with Rheumatoid Arthritis Comorbidities as well as age at onset have considerably increased in patients newly diagnosed with rheumatoid arthritis (RA), suggests a new study published August 26, 2016 in Arthritis Care & Research. The study also highlights the need for more screening of these patients when deciding on treatment approach. The major conditions reported in the study included noncardiac vascular (mainly hypertension), followed by endocrine disease (mainly thyroid problems), cardiovascular (mainly ischemic heart disease) and respiratory disease. These findings were based on analysis of 2,701 participants in the Early RA Study (ERAS) and the Early RA Network (ERAN), who were recruited from several centers within 3 years of symptom onset and majority
AROUND THE GLOBE had not yet started disease-modifying antirheumatic drug (DMARD) therapy.
Study Recommends Bone Marrow for Unrelated Donor Hematopoietic Stem Cell Transplants Long-term follow-up results of a study published online August 11, 2016 in JAMA Oncology suggest that bone marrow should be the preferred source of hematopoietic stem cell transplants from unrelated donors. The study also found that recipients of unrelated donor bone marrow had better psychological wellbeing, less burdensome chronic graft-vs-host disease symptoms, and were more likely to return to work than recipients of peripheral blood at 5 years after transplantation.
New Cluster Headache Guidelines from the American Headache Society The American Headache Society has released new evidence-based guidelines for the treatment of cluster headaches. Sumatriptan, subcutaneous zolmitriptan (Zomig) nasal spray and high flow oxygen continue to have Level A recommendation as acute treatment. Sphenopalatine ganglion stimulation has been administered a Level B recommendation for acute treatment. The guidelines are published online in the July/August 2016 issue of Headache, the Journal of Head and Face Pain.
Skin Autofluorescence may Predict Risk of Cardiac Events in Patients with Type 1 Diabetes According to a study published September 1, 2016 in the journal Cardiovascular Diabetology, skin autofluorescence predicts macrovascular events in patients with type 1 diabetes, adjusted for cardiovascular risk factors. A history of macrovascular events; however, remains the most powerful predictive factor. Skin autofluorescence also predicts estimated glomerular filtration rate (eGFR) impairment, adjusted for initial urinary albumin excretion rate and renal function.
Arunachal Pradesh’s First Pradhan Mantri Jan Aushadhi Store Inaugurated The first Pradhan Mantri Jan Aushadhi Store in Arunachal Pradesh was inaugurated by Shri Mansukh Mandaviya, Minister of State for Chemicals and Fertilizers at Naharlagun, Itanagar. A MoU was signed between Health & Family Welfare Dept. of Arunachal Pradesh and Bureau of Pharma PSUs of India (BPPI), an agency under Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers on the occasion. As per
the MoU, 84 Jan Aushadhi Stores will be opened in Arunachal Pradesh … (PIB, Ministry of Chemicals and Fertilizers, 13th September, 2016)
DoP Directs NPPA to Re-fix Ceiling Price of ‘Coagulation Factor VIII’ The Dept. of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, Govt. of India has directed the NPPA to re-fix the ceiling price of “Coagulation Factor VIII” vide order No. 31015/26/2016-PI.I after taking into consideration all data, furnished by the petitioner company and available from other sources, on merit within a period of 1 month from the date of issue of the Order of Reviewing Authority. This order was issued after reviewing the application of M/s Baxter (India) Pvt. Ltd. against price fixation of Coagulation Factor VIII vide NPPA order No. S.O. 1405(E), dated 12.4.2016 issued under Drugs (Prices Control) Order, 2013.
Adjunctive Everolimus for Treatment-resistant Seizures in Patients with Tuberous Sclerosis Adjunctive everolimus treatment significantly reduced seizure frequency with a tolerable safety profile compared with placebo in patients with tuberous sclerosis complex and treatment-resistant seizures according to the results of the EXIST-3 trial reported in The Lancet, September 6, 2016. The response rate was 15.1% with placebo versus 28.2% for low-exposure everolimus versus 40.0% for high-exposure everolimus.
Low Knee Extensor Strength Linked to Functional Decline in Knee Osteoarthritis According to a systematic review and meta-analysis of 15 studies involving more than 8,000 patients evaluating low knee extensor strength published online in Arthritis Care & Research, low knee extensor muscle strength was associated with an increased risk of systematic and functional deterioration in patients with knee osteoarthritis. But, no increase in risk of radiographic tibiofemoral joint space narrowing was found.
Prolonged Seizures in Super-refractory Status Epilepticus Linked to Brain Atrophy Patients with very prolonged seizures in super-refractory status epilepticus (SRSE) develop brain atrophy, despite administration of agents for seizure control, suggests a new retrospective study published online August 15, 2016 in JAMA Neurology. And, the degree of atrophy was found to be related to the duration of SRSE. Prolonged seizures in SRSE are seizures that continue or recur for at least 24 hours after initiation of general anesthetic therapy.
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AROUND THE GLOBE Low FT4 Levels, a Risk Factor for Gestational Diabetes A new study published online September 2, 2016 in the Journal of Clinical Endocrinology & Metabolism has suggested that low free thyroid hormone levels in early pregnancy are a risk factor for gestational diabetes mellitus (GDM). Increasing FT4 levels were associated with a protective effect against GDM in that the incidence of GDM decreased as the level of FT4 increased. In the study, GDM was also found to increase with age, pre-pregnancy body mass index and a family history of diabetes.
Complementary Health Approaches may Help in Pain Management Data from a review of 105 US-based randomizedcontrolled trials published in the September 2016 issue of Mayo Clinic Proceedings suggest that some of the most popular complementary health approaches such as yoga, tai chi and acupuncture appear to be effective tools for helping to manage common pain conditions. The review from the National Institutes of Health (NIH) examined seven approaches - acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi and yoga used for one or more of five painful conditions namely, back pain, osteoarthritis, neck pain, fibromyalgia and severe headaches and migraine. Gadolinium MRI should be Avoided During Pregnancy A study reported in the September 6, 2016 issue of JAMA says that exposure to MRI during the first trimester of pregnancy compared with nonexposure was not associated with increased risk of harm to the fetus or in early childhood. However, undergoing a gadolinium MRI at any time during pregnancy was associated with an increased risk for a broad set of rheumatological, inflammatory or infiltrative skin conditions in children and for stillbirth or neonatal death.
India Declares Itself Free From Bird Flu India has declared itself free from the highly contagious avian influenza (H5N1) or bird flu even as it stressed the need for continued surveillance. “India has declared itself free from avian influenza (H5N1) from September 5, 2016 and notified the same to the World Organization for Animal Health (OIE),” the Dept. of Animal Husbandry under the Agriculture Ministry said
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in a statement. In a letter to Chief Secretaries of states, the Center has emphasized the need for “continued surveillance especially in the vulnerable areas bordering infected countries and in areas visited by migratory birds”. India had notified outbreak of avian influenza on May 9, 2016 at Humnabad, Bidar district, Karnataka. In areas on the one-kilometer radius of the outbreak location, the government took measures, including culling, disinfection and clean-up, to contain the spread of avian influenza. “Post the surveillance, the state has shown no evidence of presence of the disease... There has been no further outbreak reported in the country thereafter,” the ministry said. Bird flu affects mainly the domestic poultry. The disease spreads from infected birds to other winged creatures through contact with nasal and respiratory secretions and also due to contamination of feed and water. (PTI, September 14, 2016)
Landmark ABCD Study Starts Recruitment The ABCD or Adolescent Brain Cognitive Development study, the largest long-term study of brain development and child health in the United States has begun recruitment of participants. The landmark study by the National Institutes of Health (NIH) will follow the biological and behavioral development of more than 10,000 children beginning at ages 9-10 through adolescence into early adulthood. Recruitment will be done over a 2-year period through partnerships with public and private schools near research sites across the country as well as through twin registries. During the course of the next decade, scientists will use advanced brain imaging, interviews, and behavioral testing to determine how childhood experiences interact with each other and with a child’s changing biology to affect brain development and ultimately social, behavioral, academic, health and other outcomes… (NIH, September 13, 2016)
Study Identifies Risk Factors for Post-TAVR Endocarditis According to a retrospective study, younger age, male sex, history of diabetes mellitus and moderate-to-severe residual aortic regurgitation were significantly associated with an increased risk of infective endocarditis in patients undergoing transcatheter aortic valve replacement (TAVR). Patients who developed endocarditis had high rates of in-hospital mortality and 2-year mortality. The study is published online September 13, 2016 in the Journal of the American Medical Association.
AROUND THE GLOBE Anti-VEGF Treatment for Diabetic Macular Edema Analysis of the DRCR.net Protocol I data presented September 10, 2016 at the European Society of Retina Specialists 16th EURETINA Congress in Copenhagen, Denmark suggests that visual acuity at 1 and 3 years is better in patients with diabetic macular edema, if the central retinal thickness has reduced by at least 20% after three monthly injections of ranibizumab, an antivascular endothelial growth factor (VEGF).
CKD Common in Children After Cardiac Surgery Results of the prospective multicenter cohort TRIBEAKI Study published online September 12, 2016 in JAMA Pediatrics show that chronic kidney disease and hypertension are common 5 years after pediatric cardiac surgery. Perioperative acute kidney injury (AKI) was not associated with these complications. At follow-up, 22 of the 131 children had hypertension, while 9, 13 and one had microalbuminuria, an eGFR <90 mL/min/1.73 m2 and an eGFR <60 mL/min/1.73 m2, respectively.
Study Supports Triple Therapy in Patients with Newly Diagnosed Diabetes Treating newly diagnosed diabetes patients upfront with metformin/pioglitazone/exenatide therapy appeared to lower blood glucose and reduce hypoglycemic events better than standard sequential therapy. At 3-year follow-up, patients who received the triple therapy had a A1c of 5.8% versus A1c of 6.71% if they were treated with metformin, had a sulfonylurea added on and then had basal insulin added. These findings from a 3-year follow-up of patients in the EDICT trial were presented at the European Association for the Study of Diabetes 2016 meeting.
Many Patients with Acute Ischemic Stroke do not Receive IV tPA A new analysis from a national registry in the US suggests that overall, about one-quarter of eligible patients with acute ischemic stroke presenting within 2 hours of onset of stroke failed to receive intravenous (IV) tissue plasminogen activator (tPA) treatment. The study also identified factors associated with failure to treat: Older age, female sex, nonwhite race, diabetes mellitus, prior stroke, atrial fibrillation, prosthetic heart valve, NIH Stroke Scale score <5, arrival off-hours and not via emergency medical services, longer onset-to-arrival and door-to-CT times, earlier calendar year, and arrival at rural, nonteaching, nonstroke center hospitals. These findings are published online September 14, 2016 in Neurology.
Use of Sunscreen with SPF ≥15 can Reduce Risk of Melanoma Use of sunscreens with SPF ≥15 rather than SPF <15 significantly decreases risk of melanoma in women at average risk, says a population-based cohort study reported online September 12, 2016 in the Journal of Clinical Oncology. The study, which analyzed data from the Norwegian Women and Cancer Study also observed that use of SPF ≥15 sunscreen by all women aged 40-75 years could potentially reduce their risk of melanoma by 18%.
FAO Launches Action Plan on Antimicrobial Resistance The Food and Agricultural Organization (FAO) has pledged to help countries develop strategies for tackling the spread of antimicrobial resistance in their food supply chains, as governments prepare to debate the emerging challenge posed by medicine-resistant “superbugs” next week at the UN General Assembly. The significant risk to human health posed by “antimicrobial resistance” (AMR) and its connection to and impact on agriculture will be discussed at a high-level UN event on September 21st in New York. According to FAO’s Action Plan on Antimicrobial Resistance: “Antimicrobial medicines play a critical role in the treatment of diseases of farm animals and plants. Their use is essential to food security, to our well-being, and to animal welfare. However, the misuse of these drugs, associated with the emergence and spread of antimicrobial-resistant micro-organisms, places everyone at great risk.” FAO’s plan highlights four key areas for action in the food and agriculture sphere: ÂÂ
Improving awareness of AMR issues among farmers and producers, veterinary professionals and authorities, policymakers and food consumers
ÂÂ
Building national capacities for surveillance and monitoring of AMR and antimicrobial use (AMU) in food and agriculture
ÂÂ
Strengthening governance related to AMU and AMR in food and agriculture
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Promoting good practices in food and agricultural systems and the prudent use of antimicrobials. (FAO, September 14, 2016)
FDA Issues First Warning Letters to Retailers of Newly Regulated Tobacco Products The US Food and Drug Administration (FDA) has announced that it has taken action against 55 tobacco
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AROUND THE GLOBE retailers by issuing the first warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids and cigars, to minors. These actions come about a month after the FDA began enforcing new federal regulations making it illegal nationwide to sell e-cigarettes, cigars, hookah tobacco and other newly regulated tobacco products to anyone under age 18 in person and online, and requiring retailers to check photo ID of anyone under age 27, among other restrictions … (FDA, September 15, 2016)
to a study presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016 in London, UK. Children with demyelinating diseases had a significantly higher risk for being hospitalized for psychotic disorders (such as bipolar and schizophrenia), anxiety, intellectual disability, stress-related and somatoform disorders and behavioral disorders. The reverse was also true i.e. children who first had psychiatric disorders had higher chances of developing demyelinating diseases.
FDA Approves Subcutaneous Immunoglobulin for Primary Immunodeficiency
A New Combination Drug to Reduce Stomach Ulcers in Heart Patients
The US Food and Drug Administration (FDA) has approved immune globulin subcutaneous (human) 20% solution (Cuvitru, Shire) for the treatment of primary immunodeficiency in adults and children aged 2 years and older. Cuvitru is to be administered only via subcutaneous route. The label carries a boxed warning stating that thrombosis may occur with immunoglobulin products, including Cuvitru.
Collaborative Care Reduces Post-concussive Symptoms in Adolescents According to a study “Collaborative care for adolescents with persistent post-concussive symptoms: a randomized trial” published in the October 2016 issue of Pediatrics, adolescents with persistent post-concussive symptoms who received collaborative care - cognitive-behavioral therapy, care management and psychopharmacological consultation—had fewer post-concussive symptoms and co-occurring psychological symptoms along with improved quality-of-life.
Study Finds Strong Association of Pediatriconset MS with Psychiatric Disorders Pediatric-onset multiple sclerosis (MS) patients are at a higher risk of comorbid psychiatric disorders, according
Yosprala, an oral fixed-dose delayed-release combination of aspirin (81 mg or 325 mg) and omeprazole (40 mg) has been approved by the US FDA. Yosprala is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. It is to be administered once daily. According to the FDA, Yosprala cannot be replaced with aspirin or omeprazole individually.
Semaglutide Reduces Cardiovascular Events in Patients with Type 2 Diabetes Type 2 diabetes patients at high cardiovascular risk had significantly fewer adverse cardiac events in the form of nonfatal myocardial infarction, or nonfatal stroke or cardiovascular death with once-weekly subcutaneous semaglutide treatment (0.5 or 1.0 mg) compared to placebo. Semaglutide is a glucagon-like peptide 1 analog with an extended half-life of about 1 week. The findings of the Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN-6) were published in the New England Journal of Medicine online September 16, 2016.
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INSPIRATIONAL STORY
A Story for Passover
A
good Passover story should always involve cakes. Austrian baker Manfred Klaschka is the subject of this year’s story. He was in the news because of his most recent catalogue of cake designs, Klaschka is a pastry specialist. Of course, Austrian pastries are famous the world over. Now, pastry baker Manfred Klaschka’s most recent catalogue of such tasty delights was in the news this week because it included cakes decorated with swastikas as well as one with a baby raising its right arm in a Nazi salute. Herr Klaschka insists he is not a Nazi. After the news story broke, he even met with a Holocaust awareness group, and apologized for what he had done and he then baked a cake to say he was sorry, a cake with Jewish and Christian symbols. The point of the story – the bit I found interesting is Herr Klaschka’s explanation for what he did. “I see it was a mistake, anyone who knows me knows what kind of person I am. I am no Nazi”, said Klaschka, who had earlier said he was just a pastry maker fulfilling his customers wishes. Fulfilling his customers wishes? There is a market in Austria in 2011 for cakes with babies raising their arms in Nazi salutes, cakes with swastikas on them? There are parties where people serve such cakes? May be birthday parties for babies? Of course there are such people, and there are such parties, and because of that, there is a market, there is consumer demand for swastika cakes, which is why Herr Klaschka was happy to bake them and not only in Austria. You may remember the case of the Campbell family from New Jersey. When Kurt Waldheim was exposed as a war criminal his popularity rose. The neo-Nazi Freedom Party headed by the late Jorg Haider, won 27% of the vote in the 2000 elections and became part of the coalition government the first time since 1945 that Nazis had sat in a European government.
But this never happened in New Jersey, which is why I want to talk about the Campbell family. The Campbell family in New Jersey made the news back in 2008 when they tried to get a birthday cake made for their son—they have a son and two daughters—at the local Shop Rite in Holland Township. The store refused their request. And the reason was that Mr Campbell wanted the cake to read “Happy birthday Adolf Hitler”. Because, you see, his son’s name was Adolf Hitler Campbell. One of the daughters is named is named Joyce Lynn Aryan Nation Campbell. Well, you get the point. When I read about the Austrian baker Manfred Klaschka, I thought here was a marketing opportunity for him. He would have happily baked a cake for the Campbell family. So, what does all this have to do with Passover? This week, when we are forbidden to eat Sachertore or Linzer tort or even the delightfully named Punschkrapfen, we might want to pause and think about something we say every year at the Passover seder: “In every generation it is the duty of man to consider himself as if he had come forth from Egypt”. Because in this generation, as in all others, there are those who order custom-made swastika cakes. There are those who name their children after Adolf Hitler. And there are others who fire anti-tank missiles at school busses with Jewish children in them. Because there are those who are building nuclear weapons, having told the world that their intention is to wipe the Jewish state off the face of the earth. Because people like that make Pharaoh look like a nice guy. Because getting out of the house of bondage, out of slavery in Egypt, was not the end of the story for the Jewish people, but was the beginning. It is a story of a never-ending struggle for freedom, for dignity, for respect, for human rights, that has universal resonance and meaning—for all people, everywhere, always.
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LIGHTER READING
different models of bar stools on display. Next to them there was a sign that read: “All models in stock now!”
TRAFFIC COURT A New York man was forced to take a day off from work to appear for a minor traffic summons. He grew increasingly restless as he waited hour after endless hour for his case to be heard. When his name was called late in the afternoon, he stood before the judge, only to hear that court would be adjourned for the next day and he would have to return the next day. “What for?” he snapped at the judge. His honor, equally irked by a tedious day and sharp query roared, “Twenty dollars contempt of court. That’s why!” Then, noticing the man checking his wallet, the judge relented. “That’s all right. You don’t have to pay now.” The young man replied, “I’m just seeing if I have enough for two more words.” WILL I LIVE LONGER?
So I paused next to the display and said, “Do you know what these are?” “What?” she asked. I said, “Stool samples.”
QUOTES
HUMOR
Lighter Side of Medicine
“We should not give up and we should not allow the problem to defeat us.” —APJ Abdul Kalam “You can’t cross the sea merely by standing and staring at the water.” —Rabindranath Tagore “Whatever the mind of man can conceive and believe, it can achieve.” —Napoleon Hill “Strive not to be a success, but rather to be of value.” —Albert Einstein
Patient: Doctor, if I give up wine, women, and song, will I live longer? Doctor: Not really, it will just seem longer. WHOEVER TELLS THE BIGGEST LIE
Dr. Good and Dr. Bad SITUATION: A patient came with tubercular pericarditis.
Two boys were arguing when the teacher entered the room. The teacher says, “Why are you arguing?” One boy answers, “We found a 10 dollar bill and decided to give it to whoever tells the biggest lie.”
No steroids are needed
Start steroids
© IJCP Academy
“You should be ashamed of yourselves,” said the teacher, “When I was your age I didn’t even know what a lie was.” The boys gave the 10 dollars to the teacher. MODEL STOOLS I was in Target the other day, shopping with a young lady friend. We were walking past the furniture section where there were several
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LESSON: The current recommendation is to use corticosteroids for patients with constrictive tuberculous pericarditis and for those at high risk of developing the condition e.g. large effusion, high level of pericardial fluid inflammatory cells, or early signs of constriction.
Information for Authors Manuscripts should be prepared in accordance with the ‘Uniform requirements for manuscripts submitted to biomedical journals’ compiled by the International Committee of Medical Journal Editors (Ann. Intern. Med. 1992;96: 766-767). Indian Journal of Clinical Practice strongly disapproves of the submission of the same articles simultaneously to different journals for consideration as well as duplicate publication and will decline to accept fresh manuscripts submitted by authors who have done so. The boxed checklist will help authors in preparing their manuscript according to our requirements. Improperly prepared manuscripts may be returned to the author without review. The checklist should accompany each manuscript. Authors may provide on the checklist, the names and addresses of experts from Asia and from other parts of the World who, in the authors’ opinion, are best qualified to review the paper. Covering letter –
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The manuscript should be arranged as follow: Covering letter, Checklist, Title page, Abstract, Keywords (for indexing, if required), Introduction, Methods, Results, Discussion, References, Tables, Legends to Figures and Figures.
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Note: Please keep a copy of your manuscript as we are not responsible for its loss in the mail. Manuscripts will not be returned to authors. Title page Should contain the title, short title, names of all the authors (without degrees or diplomas), names and full location of the departments and institutions where the work was performed,
name of the corresponding authors, acknowledgment of financial support and abbreviations used. – The title should be of no more than 80 characters and should represent the major theme of the manuscript. A subtitle can be added if necessary. – A short title of not more than 50 characters (including inter-word spaces) for use as a running head should be included. – The name, telephone and fax numbers, e-mail and postal addresses of the author to whom communications are to be sent should be typed in the lower right corner of the title page. – A list of abbreviations used in the paper should be included. In general, the use of abbreviations is discouraged unless they are essential for improving the readability of the text. Summary – The summary of not more than 200 words. It must convey the essential features of the paper. – It should not contain abbreviations, footnotes or references. Introduction – The introduction should state why the study was carried out and what were its specific aims/objectives. Methods – These should be described in sufficient detail to permit evaluation and duplication of the work by others. – Ethical guidelines followed by the investigations should be described. Statistics The following information should be given: – The statistical universe i.e., the population from which the sample for the study is selected. – Method of selecting the sample (cases, subjects, etc. from the statistical universe). – Method of allocating the subjects into different groups. – Statistical methods used for presentation and analysis of data i.e., in terms of mean and standard deviation values or percentages and statistical tests such as Student’s ‘t’ test, Chi-square test and analysis of variance or non-parametric tests and multivariate techniques. –
Confidence intervals for the measurements should be provided wherever appropriate.
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Discussion –
This should consist of a review of the literature and relate the major findings of the article to other publications on the subject. The particular relevance of the results to healthcare in India should be stressed, e.g., practicality and cost.
References These should conform to the Vancouver style. References should be numbered in the order in which they appear in the texts and these numbers should be inserted above the lines on each occasion the author is cited (Sinha12 confirmed other reports13,14...). References cited only in tables or in legends to figures should be numbered in the text of the particular table or illustration. Include among the references papers accepted but not yet published; designate the journal and add ‘in press’ (in parentheses). Information from manuscripts submitted but not yet accepted should be cited in the text as ‘unpublished observations’ (in parentheses). At the end of the article the full list of references should include the names of all authors if there are fewer than seven or if there are more, the first six followed by et al., the full title of the journal article or book chapters; the title of journals abbreviated according to the style of the Index Medicus and the first and final page numbers of the article or chapter. The authors should check that the references are accurate. If they are not this may result in the rejection of an otherwise adequate contribution. Examples of common forms of references are: Articles Paintal AS. Impulses in vagal afferent fibres from specific pulmonary deflation receptors. The response of those receptors to phenylguanide, potato S-hydroxytryptamine and their role in respiratory and cardiovascular reflexes. Q. J. Expt. Physiol. 1955;40:89-111.
Figures – Two complete sets of glossy prints of high quality should be submitted. The labelling must be clear and neat. – All photomicrographs should indicate the magnification of the print. – Special features should be indicated by arrows or letters which contrast with the background. – The back of each illustration should bear the first author’s last name, figure number and an arrow indicating the top. This should be written lightly in pencil only. Please do not use a hard pencil, ball point or felt pen. – Color illustrations will be accepted if they make a contribution to the understanding of the article. –
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Illustrations must be drawn neatly by an artist and photographs must be sent on glossy paper. No captions should be written directly on the photographs or illustration. Legends to all photographs and illustrations should be typed on a separate sheet of paper. All illustrations and figures must be referred to in the text and abbreviated as “Fig.”.
Please complete the following checklist and attach to the manuscript: 1. Classification (e.g. original article, review, selected summary, etc.)_______________________________ 2. Total number of pages ________________________ 3. Number of tables ____________________________ 4. Number of figures ___________________________
Books
5. Special requests _____________________________
Stansfield AG. Lymph Node Biopsy Interpretation Churchill Livingstone, New York 1985.
6. Suggestions for reviewers (name and postal address)
Articles in Books
2.____________ 2.________________
Strong MS. Recurrent respiratory papillomatosis. In: Scott Brown’s Otolaryngology. Paediatric Otolaryngology Evans JNG (Ed.), Butterworths, London 1987;6:466-470.
3.____________ 3.________________
4.____________ 4.________________
Tables –
These should be typed double spaced on separate sheets with the table number (in Roman Arabic numerals) and title above the table and explanatory notes below the table.
Legends – These should be typed double spaces on a separate sheet and figure numbers (in Arabic numerals) corresponding with the order in which the figures are presented in the text. –
498
The legend must include enough information to permit interpretation of the figure without reference to the text.
Indian Journal of Clinical Practice, Vol. 27, No. 5, October 2016
Indian 1.____________Foreign 1.________________
7. All authors’ signatures________________________ 8. Corresponding author’s name, current postal and e-mail address and telephone and fax numbers __________________________________________
Online Submission Also e-Issue @ www.ijcpgroup.com For Editorial Correspondence
Dr KK Aggarwal
Group Editor-in-Chief Indian Journal of Clinical Practice E-219, Greater Kailash Part-1 New Delhi - 110 048. Tel: 40587513 E-mail: editorial@ijcp.com Website: www.ijcpgroup.com
R.N.I. No. 50798/1990 Date of Publication 13th of Same Month Date of Posting 13-14 Same Month
POSTAL REGISTRATION NO. DL (S)-01/3200/2015-2017 Posted in N.D. PSO New Delhi