Comparison of Drug Induced Hepatotoxicity Incident of Fixed-Dose Combination and Separate Formulations Regimen for Pulmonary Tuberculosis Treatment in Hospital Sukabumi

Abstract

Pulmonary Tuberculosis is still a health problem in the world, including in Indonesia. The World Health Organization reports that Indonesia ranks third the highest pulmonary tuberculosis case in the world. The regimen for treatment of pulmonary tuberculosis is isoniazid, rifampicin, pyrazinamide, and ethambutol, which has been used either as Fix-Dose Combination (FDC) or as SF (SF). These drugs induced hepatotoxicity side effect. The aims of this study was the comparison of drug induced hepatotoxcity incident of FDC and SF regimen for pulmonary tuberculosis treatment. This study was an observational with retrospective method in 130 pulmonary tuberculosis patients with category I (65 patients have used FDC and 65 patients have used SF). The result showed that based on the severity level of DIH were the following stage I as many as 36 patients for FDC and 34 patients for SF, stage II as many as 14 patients for FDC and 13 patients for SF, stage III as many as 8 patients for FDC and 8 patients for SF, stage IV as many as 7 patients for FDC and 10 patients for SF. The Mann-Whitney test show no significant differences in the severity level of DIH (P=0,253) in two group.