Incidence of hepatotoxicity in Indian patients receiving standard multidrug antitubercular therapy without risk factors

Abstract

Background: Antituberculosis drug-induced hepatotoxicity (ATDH) causes substantial morbidity and mortality and diminishes treatment effectiveness. The incidence of ATDH during standard multidrug TB treatment has been variably reported as between 2% and 28%. This rate depends on the investigators' definition of hepatotoxicity, population studied, risk factors and regional characteristics. Objective: to find out the incidence of hepatotoxicity without risk factors in patients receiving standard antitubercular multidrug therapy. Design: This was prospective, two centered, clinical study. Setting: This current study is conducted at outpatient department of pulmonary medicine at KEM Mumbai and King George Medical college, Lucknow. Method: Total 616 patients were screened and 182 patients were enrolled in the study. Patients were excluded if they had history of jaundice in the past 6 months or received any drug from the non allopathic systems of medicine in the past 3 months. Patients with severe hepatic, renal or cardiac disease or history of consuming alcohol daily were also excluded. Pregnant and lactating women were not allowed in the study. The development of hepatotoxicity was assessed based on clinical and biochemical examination. Drug induced injury was assessed according to the Councils for International Organizations of Medical Sciences (CIOMS) based criteria. Results & Conclusion Total 12 patients developed drug induced liver injury. The incidence of antitubercular drug induced hepatotoxicity was found to be 6.6% in this study