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Drug adverse effects in HIV-infected patients receiving antiretroviral therapy-a pharmacovigilence approachGaula, M. D. January 2011 (has links)
Thesis (M Med Pharmacy)--University of Limpopo, 2011 / Most pharmaceutical agents can result in side effects and toxicities that in some
instances may be life threatening, especially if there is delay in their recognition. For
various reasons it is therefore imperative to study adverse events associated with
antiretroviral agents (ARVs). The aim of this study was to study the adverse events in
adult HIV-infected patients receiving antiretroviral therapy at a public health treatment
site, and to quantify the frequency of adverse events in different population
subgroups. A retrospective cohort study was conducted in a sample of 99 patients
(i.e. 70% females and 30% males) from a public health clinic providing antiretroviral
drugs to more than 1500 patients. The reported adverse events were neurological
disorders (33%), rash (17%), gastrointestinal toxicity (16%), lactic acidosis (14%),
hepatitis (7%), lipodystrophy (7%), pancreatitis (5%), IRIS (3%), anaemia (1%), and
gynaecomastia (1%). Based on the analysis of the presented data in this report, age,
weight, gender, and pCD4 count are not the predictors for the development of lactic
acidosis, pancreatitis, and peripheral neuropathy. The duration of treatment was
found to be the predictor for the development of lactic acidosis, pancreatitis, and
peripheral neuropathy in this study sample. More frequent and closer monitoring of
the reported adverse events will be necessary for patients treated longer on ART.
Information bias is possible as case data for all reported adverse effects were
collected retrospectively from hand-written patient records which were not consistent
and standardised.
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