51 research outputs found

    Analysis of individual case safety reports of spontaneous reporting in adverse drug reaction monitoring centre at a tertiary care hospital

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    Background: In developing countries like India, the increased economic burden in healthcare system is due to adverse drug reactions (ADRs) related hospitalizations which in turn are related to polypharmacy associated with increased potential of ADRs. World Health Organization (WHO) started the program for international drug monitoring (WHO PIDM) in the year 1968. India is one of the member countries under WHO PIDM using the Vigibase for analysis of individual case safety reports (ICSRs). Aim of the study was to analyse the ICSRs by spontaneous reporting at ADR monitoring centre.Methods: The present study was focused on analyzing the ICSRs of spontaneous reporting using Vigiflow data from the ADR monitoring centre (AMC), Madras Medical College, Chennai.Results: A total of 541 ICSRs from the period between July 2017 and June 2018 were analysed. Among 541 ICSRs, 814 ADRs were analysed and found that the majority of the ADRs belonged to SOC of gastrointestinal disorders and the most of the ADRs were implicated by antimicrobial agents followed by non-steroidal anti-inflammatory drugs (NSAIDs). Among all the ICSRs, majority of the ADRs occurred in males (n=292) and the maximum number of ADRs were in the age group of 45-60 years (n=197). Of the 541 ICSRs, 313 were found to be of “serious” category and majority of the ICSRs outcome was found to be “recovered” (n=262). The causality assessment of the ICSRs were anlysed and found that the maximum number of ICSRs were under “probable” category as per WHO-UMC scale.Conclusions: Robust pharmacovigilance activities plays important role in minimizing the ADRs for better patient safety

    Litsea Deccanensis Ameliorates Myocardial Infarction in Wistar Rats: Evidence from Biochemical and Histological Studies

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    The present study was designed to evaluate the cardioprotective effects of methanolic extract of Litsea deccanensis (MELD) against isoproterenol-induced myocardial infarction in rats by studying cardiac markers, lipid peroxidation, lipid profile, and histological changes. Male Wistar rats were treated orally with MELD (100 and 200 mg/kg) daily for a period of 21 days. After 21 days of pretreatment, isoproterenol (100 mg/kg) was injected subcutaneously to rats at an interval of 24 h for 2 days to induce myocardial infarction. Isoproterenol-induced rats showed significant (P < 0.05) increase in the levels of serum creatine kinase, lactate dehydrogenase, thiobarbituric acid reactive substances, and lipid hydro peroxides. The serum lipid levels were altered in the isoproterenol-induced myocardial infarcted rats. The histopathological findings of the myocardial tissue evidenced myocardial damage in isoproterenol-induced rats. The oral pretreatment with MELD restored the pathological alterations in the isoproterenol-induced myocardial infarcted rats. The MELD pretreatment significantly reduced the levels of biochemical markers, lipid peroxidation and regulated the lipid profile of the antioxidant system in the isoproterenol-induced rats. An inhibited myocardial necrosis was evidenced by the histopathological findings in MELD pretreated isoproterenol-induced rats. Our study shows that oral pretreatment with MELD prevents isoproterenol-induced oxidative stress in myocardial infarction. The presence of phenolic acid and flavonoid contents were confirmed by preliminary phytochemical tests. The reducing power and free radical scavenging activities of the MELD may be the possible reason for it pharmacological actions
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