ABSTRACT
Background: Tuberculosis (TB) continues to remain one of the most pressing health problems in India with highest TB burden country in the world. Anti-tubercular therapy (ATT) induced organ toxicities are potentially serious ADRs of first line ATT regimen. The underlying mechanism of ATT-induced ADRs especially hepatotoxicity and the factors predisposing to its incidence which is significantly high in Indians are not clearly understood. It's vital to emphasize on ATT induced ADRs as it has direct influence on therapeutic outcome; result in high dropout rate and potential to develop MDR/XDR cases. ADR monitoring help us to revise the treatment protocol thereby improve treatment adherence and therapeutic outcome. Objective of this study is therefore designed to explore and monitor ADRs of first line anti-TB drugs.Methods: In this prospective observational study 60 TB patients (18-70 yrs) of either sex, newly sputum positive with normal parameters were included. Patients were followed up for six months aiming primarily to assess rate of ADRs and to identify preventable and potentially serious ADRs of anti-TB drugs. The ADRs of ATT on various organ systems (heart, kidney and liver), biochemical and haematological parameters were assessed and compared after 2 and 6 months; gender and age specific adverse events were also studied. Data obtained was analysed using student’s t-test of OpenEpi statistical software.Results: Study clearly revealed that ATT exhibit significant increase in toxicity markers viz. liver enzymes (p<0.01), urea and creatinine (p<0.01), ESR (p<0.05) and PTINR (p<0.01), wherein decrease in Hb% (p<0.01) when compared to baseline.Conclusions: ATT related ADRs is the major cause of dropouts and development of MDR/XDR cases. It's crucial to develop strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely. The data obtained from present study may be helpful in developing these effective strategies.
ABSTRACT
Background: Low therapeutic index of established antiepileptic drugs (AEDs) coupled with better understanding of the pathophysiology of seizure has encouraged the development of several novel AEDs. The conventional antiepileptics like phenytoin, phenobarbitone, valproate and carbamazepine and newer antiepileptics like levetiracetam, lamotrigine and topiramate etc. are used for epilepsy. AEDs induce potentially toxic effects over a period of time which remains undetermined over very long time. Earlier studies in this regard, states uneven results about biochemical (i.e. blood sugar level, lipid profile) and hematological (Hb%, blood cell count etc.) toxicity of AEDs. Aims: To unveil the toxic effects of AEDs when given singly or as combinations. Methods: Adult epileptics of either sex taking antiepileptic monotherapy or combination therapy for ≥ six months were enrolled. Biochemical and hematological parameters studied were compared with their age and sex matched controls, baseline and amongst groups. Statistical Analysis Used: Student’s ‘t’-test & One way ANOVA followed by posthoc Tukey HSD test for pair wise comparison; p<0.05 was considered significant. Results: Conventional antiepileptic combination therapy was found more toxic; p<0.01 for lipid profile. Combination groups showed significant reduction in Hb% (p<0.05) with no significant difference among them (p>0.05). Monotherapy and conventional combination therapy caused significant reduction in platelet count (p<0.01), but conventional combination therapy was found more toxic in this regard (p<0.05). Conclusions: Monotherapy found less toxic with no significant effects on lipid profile, Hb%, RBC count and O2 carrying capacity and less impact on platelets while combination therapy did not show any advantage over monotherapy and its use must be reserved only for refractory cases.