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PubMed | ESI PGIMSR MGM Hospital, King College, University of Delhi and Fiji National University
Type: Journal Article | Journal: Indian journal of pharmacology | Year: 2016

Cytochrome P4502E1 (CYP2E1) is involved in the metabolism of isoniazid and the mediation of its hepatotoxicity. It exhibits genetic polymorphism in humans. This study evaluated the polymorphism of CYP2E1 in adult healthy Western Indians and patients on antituberculous drugs by phenotyping and genotyping.A 500 mg single dose of chlorzoxazone (CZX) was administered to 136 healthy adult Western Indian participants. Venous blood samples 2 h postdose were analyzed for the levels of CZX and 6-hydroxy CZX, and the metabolic ratio (MR) was calculated to determine the extent of rapid and poor metabolizers using probit plot analysis. Patients on antituberculous drugs who had raised the liver enzymes or clinical symptoms of hepatotoxicity were also recruited. Genotyping for CYP2E1 * 5B allele was performed by polymerase chain reaction - rapid fragment length polymorphism technique.A total of 139 healthy participants were enrolled, of which the final analysis consisted of data from 136 participants for genotyping and 137 for phenotyping. Only 1 participant had reported mild drowsiness 2 h postdose, and no other adverse events were observed. The median (range) MR of population was 0.2 (0.1-4.0), and no polymorphisms were detected using phenotype data. A total of 134/136 (98.5%) had c1/c1 genotype and 1/136 each (0.75%) had c1/c2 and c2/c2 genotypes, respectively. Of the 2/136 participants harboring c2 allele, one had MR of 0.1 (c1/c2) and another had 0.5 (c2/c2). A total of 25 cases of antituberculous drug-induced hepatotoxicity and 50 control patients were recruited, of which finally 22 cases and 49 controls were available for evaluation. All the cases had c1/c1 genotype while 42/49 (85.7%) controls had c1/c1, 6/49 (12.2%) had c1/c2, and 1/49 (2.1%) had c2/c2 genotype and the crude odds ratio was 7.9 (0.4, 145.6).A background prevalence of CYP2E1*B polymorphism and their activity in Western Indian population was observed. The study suggests no association between the CYP2E1 genotyping with antituberculous drug-induced hepatotoxicity.


Kshirsagar N.A.,ESI PGIMSR MGM Hospital | Bachhav S.S.,Indian Council of Medical Research ICMR
International Journal of Risk and Safety in Medicine | Year: 2013

BACKGROUND: Regulatory decision for withdrawal of a drug from market in European Union (EU) or other developed countries poses a challenge to authorities in developing countries specially when decision varies from different countries, such as for nimesulide. OBJECTIVES: To compare and evaluate, benefit and risk data for regulatory action, of nimesulide in India and EU. METHODS: Data on Nimesulide from EU available from Report on EMA website and Indian data from published literature (SCOPUS data base), WHO Vigibase and International Medicines Statistics (IMS) was compared. RESULTS: Publications from India on Adverse drug reactions (ADRs) are case reports (10) and case series (14). Drug Utilization Research (DUR) studies (17) are mostly from tertiary centres. Data in the WHO Vigibase is meagre, data from IMS is not easily available and there is regional variation in prescriptions. Thus incidence of ADRs per sale, prescription or defined daily does (DDD) cannot be calculated, as has been done for EU. CONCLUSION: Limited and varying data in post marketing studies on ADRs and drug utilization for nimesulide from India made regulatory decision difficult. India and other similar countries could contribute to post marketing data for local and global regulatory decisions by systematically planned studies and networking within country and across countries in region. © 2013-IOS Press.


Rajput D.,ESI PGIMSR MGM Hospital | Gedam J.,ESI PGIMSR MGM Hospital | Bhalerao M.,ESI PGIMSR MGM Hospital | Nadar P.A.,ESI PGIMSR MGM Hospital
Journal of Clinical and Diagnostic Research | Year: 2014

Cystic abdominal lesions are extremely common in adolescent girls and are now diagnosed more frequently due to the availability of better imaging modalities. Presentations as huge cysts have become rare as most of them are diagnosed and treated early. Adolescent girls presenting with huge benign abdominal cysts is not uncommon, most of them due to serious cystadenomas of the ovary, but large follicular cysts are rare. We present a 13-year-old girl who presented with a large abdominal mass which was subsequently diagnosed as juvenile follicular cyst of the ovary.


More P.G.,ESI PGIMSR MGM Hospital | Durve S.R.,Kj Somaiya Medical College And Research Center
Journal of Clinical and Diagnostic Research | Year: 2015

Acute pulmonary oedema has been described in relation to perioperative period. The aetiology may be multifactorial and its management poses a challenge to the anaesthesiologist. Its occurrence in a normal healthy person with no other medical history makes the diagnosis difficult. The causes of pulmonary oedema are cardiac failure, fluid overload, airway obstruction, acid aspiration, gas embolism, anaesthetic drugs, sepsis, anaphylactic reaction and reaction to blood & blood products. Early detection, prompt management by an anaesthesiologist will help to prevent further postoperative complications. We report a case of 9-year-old male child, posted for tonsillectomy under general anaesthesia, who developed acute pulmonary oedema following extubation after reversal with neostigmine and how we managed it successfully. © 2015, Journal of Clinical and Diagnostic Research. All rights reserved.


Kshirsagar N.A.,ESI PGIMSR MGM Hospital | Bachhav S.S.,Indian Council of Medical Research ICMR
International Journal of Risk and Safety in Medicine | Year: 2013

BACKGROUND: With globalization and signing of WTO GATT treaty, the market in India has expanded. This has necessitated important regulatory decisions. OBJECTIVE: This study aims to determine the gap in introduction and withdrawal of drugs in India and EU. METHODS: For drugs prohibited for manufacture and sale(withdrawn) in India during 1983-1998 and 1999-2012 periods, data on year of introduction and withdrawal in India and EU/internationally was extracted from Central Drugs Standard Control Organization (CDSCO), European Medical Agency (EMA) websites and Google search engine and compared. RESULTS: The gap in introduction of drug in India compared to EU/internationally during 1999-2012 period is shorter than 1983-1998 period, while the gap in withdrawal has not changed much. CONCLUSION: Regulatory authority in India has approved drugs in recent year more quickly than the past but gap in withdrawal has not shortened, indicating need for strengthening postmarketing studies and review process. © 2013-IOS Press.


PubMed | ESI PGIMSR MGM Hospital
Type: Journal Article | Journal: Journal of clinical and diagnostic research : JCDR | Year: 2014

Cystic abdominal lesions are extremely common in adolescent girls and are now diagnosed more frequently due to the availability of better imaging modalities. Presentations as huge cysts have become rare as most of them are diagnosed and treated early. Adolescent girls presenting with huge benign abdominal cysts is not uncommon, most of them due to serious cystadenomas of the ovary, but large follicular cysts are rare. We present a 13-year-old girl who presented with a large abdominal mass which was subsequently diagnosed as juvenile follicular cyst of the ovary.


PubMed | ESI PGIMSR MGM Hospital
Type: Comparative Study | Journal: The International journal of risk & safety in medicine | Year: 2013

With globalization and signing of WTO GATT treaty, the market in India has expanded. This has necessitated important regulatory decisions.This study aims to determine the gap in introduction and withdrawal of drugs in India and EU.For drugs prohibited for manufacture and sale(withdrawn) in India during 1983-1998 and 1999-2012 periods, data on year of introduction and withdrawal in India and EU/internationally was extracted from Central Drugs Standard Control Organization (CDSCO), European Medical Agency (EMA) websites and Google search engine and compared.The gap in introduction of drug in India compared to EU/internationally during 1999-2012 period is shorter than 1983-1998 period, while the gap in withdrawal has not changed much.Regulatory authority in India has approved drugs in recent year more quickly than the past but gap in withdrawal has not shortened, indicating need for strengthening postmarketing studies and review process.


PubMed | ESI PGIMSR MGM Hospital
Type: Comparative Study | Journal: The International journal of risk & safety in medicine | Year: 2013

Regulatory decision for withdrawal of a drug from market in European Union (EU) or other developed countries poses a challenge to authorities in developing countries specially when decision varies from different countries, such as for nimesulide.To compare and evaluate, benefit and risk data for regulatory action, of nimesulide in India and EU.Data on Nimesulide from EU available from Report on EMA website and Indian data from published literature (SCOPUS data base), WHO Vigibase and International Medicines Statistics (IMS) was compared.Publications from India on Adverse drug reactions (ADRs) are case reports (10) and case series (14). Drug Utilization Research (DUR) studies (17) are mostly from tertiary centres. Data in the WHO Vigibase is meagre, data from IMS is not easily available and there is regional variation in prescriptions. Thus incidence of ADRs per sale, prescription or defined daily does (DDD) cannot be calculated, as has been done for EU.Limited and varying data in post marketing studies on ADRs and drug utilization for nimesulide from India made regulatory decision difficult. India and other similar countries could contribute to post marketing data for local and global regulatory decisions by systematically planned studies and networking within country and across countries in region.


PubMed | National Health Research Institute, Surat Municipal Institute of Medical science & Research SMIMER, Government Medical College and Hospital, ESI PGIMSR & MGM Hospital and GMERS Medical College
Type: | Journal: Malaria research and treatment | Year: 2014

This was a retrospective study done on 110 patients hospitalized with P. vivax malaria in three medical college hospitals, one in the union territory of Chandigarh and the other two in Gujarat, that is, Ahmedabad and Surat. The clinical presentation, treatment, and outcome were recorded. As per WHO criteria for severity, 19 of 110 patients had severe disease-six patients had clinical jaundice with hepatic dysfunction, three patients had severe anemia, three had spontaneous bleeding, two had acute respiratory distress syndrome, and one had cerebral malaria, hyperparasitemia, renal failure, circulatory collapse, and metabolic acidosis. All patients with severe P. vivax malaria survived, but one child with cerebral malaria had neurological sequelae. There was wide variation in the antimalarial treatment received at the three centres. Plasmodium vivax malaria can no longer be considered a benign condition. WHO guidelines for treatment of P. vivax malaria need to be reinforced.


PubMed | ESI PGIMSR MGM Hospital and Kjsomaiya Medical College And Research Center
Type: Journal Article | Journal: Journal of clinical and diagnostic research : JCDR | Year: 2015

Acute pulmonary oedema has been described in relation to perioperative period. The aetiology may be multifactorial and its management poses a challenge to the anaesthesiologist. Its occurrence in a normal healthy person with no other medical history makes the diagnosis difficult. The causes of pulmonary oedema are cardiac failure, fluid overload, airway obstruction, acid aspiration, gas embolism, anaesthetic drugs, sepsis, anaphylactic reaction and reaction to blood & blood products. Early detection, prompt management by an anaesthesiologist will help to prevent further postoperative complications. We report a case of 9-year-old male child, posted for tonsillectomy under general anaesthesia, who developed acute pulmonary oedema following extubation after reversal with neostigmine and how we managed it successfully.

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