An adverse drug reaction (ADR) as defined by World Health Organization (WHO) is a noxious, unintended effect of a drug, occurring at normal doses in humans for prophylaxis, diagnosis or therapy of disease or for the modification of physiological function. ADRs rank among the top ten leading causes of mortality. The adverse effects (AEs) of antiepileptic drugs (AEDs) are highly prevalent and can be potentially life threatening. The objective of this study is to identify the ADR by chart review method, to determine the causality of the ADR by Naranjo's algorithm, to analyze the severity of the ADR by modified Hartwig method and to motivate the health care professionals to report ADRs in Neurology ward of Gauhatu Medical College and Hospital (GMCH), Guwahati, Assam, India. Preventability of ADR is done by Schumock and Thorton preventability scale. A prospective observational and hospital based case control study (Jan 2011-Dec 2011) was carried out in the Neurology ward of GHMC, including both outpatient and in-patient departments. All the values are statistically determined and expressed as Mean ± SD Graph Pad prism-5 statistical software was used for the data analysis. Statistical significance was defined as p < 0.05. All P values were two tailed. Out of the 2880 patients treated with AEDs for various indications, 85 (2.95 %) patients were reported with an incidence of 1 or more ADRs. The most common ADR involved the CNS (44 cases). Among them ataxia was found to be the most frequently reported (15 cases), followed by nystagmus (14 cases) and somnolence (9 cases). 37 cases involved the skin and connective tissue, the most common complaint being gum hypertrophy (23 cases). GI apparatus and liver involved 41 cases, the most frequent being nausea/vomiting (21 cases) and poor appetite (12 cases). Out of the 134 ADRs recorded, most of the ADRs were of Type A (n = 80, 59.70 %), followed by Type C (n = 37, 27.61 %), Type B (n = 16, 11.94 %) and Type D (n = 1, 0.75 %). Phenytoin resulted in a total of 38 (44.7 %) ADRs when prescribed as mono therapy followed by Sodium Valproate which caused a total of 19 (22.35 %) ADRs when prescribed alone. Anti-epileptic drugs have narrow therapeutic index, physician should be encouraged to do therapeutic drug monitoring in order to ensure effective treatment and prevent adverse drug reactions.
Background : As HIV/AIDS has emerged to be the first modern pandemic with ever increasing prevalence globally, the present study was undertaken to study the renal profile in patients living with HIV/AIDS, not started on ART.Materials and Methods: This was a hospital based observational study where 277 cases were studied in details with the aims and objectives of studying the renal manifestations in ART naïve patients with HIV/AIDS and its relationship with CD4 counts. A detailed history, clinical examination and relevant investigations were done in patients above 15yrs of age who were not on ART.Results and Observations: Out of 277 seropositives, 40 had proteinuria (14.44%) on urine examination. The mean serum creatinine of the total study population was found to be 0.92±0.83 mg/dl while 14 cases (5%) had serum creatinine more than 1.5mg/dl. A decrease in eGFR (<60ml/min/1.73m 2 ) was seen in 28 (10.1%) cases. Out of 178 cases with CD4 count more than 200cells/mm 3 , renal dysfunction was found in 12 cases (6.7%), whereas the cases with CD4 count less than or equal to 200cells/mm 3 , 19 out of 99 cases (19.2%) had renal dysfunction which is statistically significant Conclusion: In the present study, which included ART naïve patients with HIV/AIDS, predominant renal involvement was in the form of proteinuria followed by raised serum creatinine levels and reduced eGFR. A negative correlation was found between renal dysfunction and CD4 counts.
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