Background:Epidemiological data is limited for cutaneous adverse drug reactions (CADRs) in India. Most of the Indian studies have small sample size and are of limited duration.Aims:The aim of this study is to analyze CADRs with reference to the causative drugs and their clinical characteristics in Indian population.Materials and Methods:As per selection criteria, electronic databases were searched for publications describing CADRs from January-1995 to April-2013 by two independent investigators. Data of the causative drugs and clinical characteristics were extracted and summarized by absolute numbers, percentages, ranges, and means as presented by the authors. The subgroup analysis of causative drugs was performed for causality assessment, severe or nonsevere reactions and occurrence of common CADRs. Studies showing “definite” and “probable” categories of causality analysis were labeled as “definite and probable causality (DPC) studies”. The other included studies were labeled as “non-DPC studies”.Results:Of 8337 retrieved references, 18 prospective studies were selected for analysis. The pooled incidence was 9.22/1000 total among outpatient and inpatient cases. Commonly observed reactions were maculopapular rash (32.39%), fixed drug eruptions (FDEs) (20.13%), urticaria (17.49%) and Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (6.84%). The major causative drug groups were antimicrobials (45.46%), nonsteroidal anti-inflammatory drugs (NSAIDs) (20.87%) and anti-epileptic drugs (14.57%). Commonly implicated drugs were sulfa (13.32%), β-lactams (8.96%) and carbamazepine (6.65%). High frequency of CADRs is observed with anti-epileptic drugs in DPC studies only. Carbamazepine, phenytoin and fluoroquinolones had higher severe to nonsevere cutaneous reaction ratio than other drugs. Antimicrobials were the main causative drugs for maculopapular rash, FDEs and SJS/TEN, and NSAIDs for the urticaria. The mortality for overall CADRs, SJS/TEN, and exfoliative dermatitis were 1.71%, 16.39%, and 3.57%, respectively. “Definitely preventable”, “probably preventable” and “not preventable” categories CADRs were 15.64%, 63.14%, and 34.64%, respectively.Conclusion:Antimicrobials, NSAIDs and antiepileptic are common causative agents of CADRs in India. Antiepileptic agents show high rates of severe cutaneous reactions.

Introduction:Early diagnosis and early adequate drug treatment is very important aspect to reduce the load in cases of leprosy. So, correct labeling of paucibacillary and multibacillary cases is a prerequisite for the adequate treatment. Confirmation of diagnosis is an important indication for histopathological examination in doubtful cases.Objectives:The present study was carried out to know the clinical profile of leprosy patients, concordance between clinical and histopathological diagnosis in cases of leprosy, and to assess the therapeutic efficacy of antileprosy therapy.Study Design:Two hundred and fifty clinically diagnosed leprosy patients attending skin outdoor patient department (OPD) were included in the study. Slit skin smear was performed in all the cases. In that case concordance between clinical and histology can be determined only in 30 cases. All the patients were treated with MDT (multidrug therapy) as per WHO guideline.Results:A total of 250 patients attended the clinic with male to female ratio of 1.7:1. The highest incidence was noted in 17-40 years of age group. In the clinical disease spectrum, 40% patients were in the borderline spectrum followed by tuberculoid leprosy (TT) (29.2%), lepromatous leprosy (LL) (26.8%), and 3.9% of indeterminate leprosy (IL). A total of 18% of patients were of primary neuritic leprosy. A total of 8.3% patients had definite history of contact in the family or neighborhood. Clinicopathological correlation was noted in 60% of patients with maximum disparity (52.9%) in the borderline group of patients. A total of 52.8% were MB (Multibacillary) and 47.2% were PB (Paucibacillary) cases. Morphological index became negative after 6 months in all patients. Mean fall of bacteriological index after 6 months was 0.19, while after 1 year, it was 1.05.Conclusion:Timely diagnosis and adequate treatment of cases with MDT is most effective. Histopathological examination is must in doubtful cases of leprosy.

We describe two fatal cases of low dose methotrexate (MTX) toxicity in patients with psoriasis, emphasizing the factors that exacerbate MTX toxicity. The first patient was a 50-year-old male of psoriasis on intermittent treatment with MTX. After a treatment-free period of six months, he had self-medication of MTX along with analgesic for joint pain for one week which followed ulceration of the lesions, bone marrow suppression, and eventually death. The second patient was a 37-year-old male of psoriasis, who has taken MTX one week earlier without prior investigations. He had painful ulcerated skin lesions and bone marrow suppression. On investigations, he showed high creatinine level and atrophied, nonfunctioning right kidney on ultrasonography. In spite of dialysis, he succumbed to death. MTX is safe and effective if monitored properly, but inadvertent use may lead to even death also. Prior workup and proper counseling regarding the drug interactions as well as self-medication should be enforced.

Background:The epidemiological data based on intensive monitoring studies are limited for the cutaneous adverse drug reactions (CADRs) in terms of incidence. Most of earlier Indian studies focused only on types and causative drugs of CADRs.Aim:The aim of this study is to analyze the CADRs with reference to the incidence, its subgroup analysis, causative drugs, and other clinical characteristics in Indian population.Methodology:Intensive monitoring study was carried out over a period of 3 years in the dermatology outpatient and inpatient department. CADRs due to only systematically administered drugs were considered. The WHO definition for CADR, the WHO causality definitions, modified Schumock and Thornton's criteria for preventability, and International Conference on Harmonisation E2A guidelines for seriousness were considered. Incidence was expressed in percentage and its 95% confidence interval. The incidence was analyzed on basis of characteristics of study population and CADRs.Results:A total of 171 CADRs were observed from 37,623 patients. The CADR incidence was 0.45% (95% CI: 0.39–0.53). The incidence did not significantly differ in different age groups and gender. Commonly observed CADRs were maculopapular rash (23.98%), urticaria (21.64%), and fixed drug eruptions (FDEs) (18.13%). Antimicrobials (35.18%) and nonsteroidal anti-inflammatory drugs (NSAIDs) were suspected in all common CADRs. Anti-infective and NSAIDs were most commonly suspected drugs in overall CADRs, maculopapular rash, urticaria, FDEs, and erythema multiforme. The exact nature of drugs remained inaccessible in one-fourth cases due to use of the over-the-counter self-medications. The incidence of preventable and serious and fatal CADRs was 0.08% (95% CI: 0.05–0.11), 0.04% (95% CI: 0.02–0.06), and 0.003% (95% CI: 0.000–0.001), respectively.Conclusion:Ethnic characteristics should be considered while interpreting incidence from the international studies. The demographic characteristics of study population do not affect the incidence of CADRs. Indian patients should be sensitized about hazards of self-medications.

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Background: Limited evidence is available about effectiveness and choice of immunomodulating treatment modalities for toxic epidermal necrolysis (TEN). Aims: To compare the effectiveness of interventions to reduce mortality in patients of toxic epidermal necrolysis through network meta-analysis. Methods: Studies were retrieved using PubMed, Google Scholar and Cochrane Database of Systematic Reviews from inception to September 18, 2018. Only English language articles were considered. Observational and randomized controlled studies having ≥ 5 TEN patients in each intervention arm were included. Two investigators independently extracted study characteristics, intervention details and mortality data. Bayesian network meta-analysis was performed using the Markov chain Monte Carlo (MCMC) approach through the random effect model. The ranking analysis was done to provide a hierarchy of interventions. The consistency between direct and indirect evidence was assessed through node spit analysis. The primary outcome was to compare the mortality [Odds ratio OR (95% credibility interval CrI)] among all treatment modalities of TEN. Results: Twenty-four studies satisfying the selection criteria were included. The network analysis showed improved survival with cyclosporine as compared to supportive care [OR- 0.19 (95% CrI: 0.05, 0.59)] and intravenous immunoglobulin [OR- 0.21 (95% CrI: 0.05, 0.76)]. The hierarchy of treatments based on “surface under the cumulative ranking curves” (SUCRA) value were cyclosporine (0.93), steroid+intravenous immunoglobulin (0.76), etanercept (0.59), steroids (0.46), intravenous immunoglobulin (0.40), supportive care (0.34) and thalidomide (0.02). No inconsistencies between direct and indirect estimates were observed for any of the treatment pairs. Limitations: Evidence is mainly based on retrospective studies. Conclusion: The use of cyclosporine can reduce mortality in TEN patients. Other promising immunomodulators could be steroid+intravenous immunoglobulin combination and etanercept.

Aims:This study compares the clinical and laboratory diagnosis of vaginal discharge syndrome.Settings and Design:This cross-sectional study was carried out at the gynaecology outpatient department of a tertiary care hospital in Gujarat, India.Material and Methods:Total of 180 females diagnosed as vaginal discharge or cervicitis based on syndromic approach and were recruited for the study. Their clinical profile was noted and they were investigated for bacterial vaginosis, trichomoniasis, candidiasis, gonorrhoea and chlamydia infection.Results:Lower abdominal pain (35%) followed by burning micturition (23.9%) were the common associated complaints. Bacterial vaginosis was the most common clinical diagnosis, while trichomoniasis was least common. Upon laboratory investigation, 35.6% of cases of vaginal discharge and 12% of cases of cervicitis tested positive. Percentage of cases confirmed by laboratory investigation was 50, 27.8 and 41.7 for bacterial vaginosis, trichomoniasis and candidiasis respectively.Conclusion:Among all the females diagnosed as vaginal discharge syndrome, a very small percentage actually turned out to be positive upon laboratory testing.

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