A comparative study on the adverse effects of two anti-tuberculosis drugs regimen in initial two-month treatment period

Abstract

Tuberculosis (TB) is a leading cause of death throughout the world and Bangladesh stands 4^th among high burden countries. Treatment of TB hampered with poor patient compliance and intolerance at least partly due to the adverse drug reactions. A prospective longitudinal non-randomized case study was conducted on 64 Hospital admitted patients diagnosed as primary (category I) and resistant or treatment failure (category II) to compare adverse effects between two anti-TB drug treatment regimen based on diagnostic category. Category I received four drug (rifampicin, isoniazid, ethambutol, pyrazinamide) and category II received five drug (rifampicin, isoniazid, ethambutol, pyrazinamide, sparfloxacin) combination treatments for initial 2 months under DOTS during the period of July 2004 to July 2005. Adverse effect parameters e.g. gastrointestinal disturbances, arthralgia, hepatic dysfunction and renal impairment were estimated before, two and eight weeks after initiation of treatment. Predisposing risk factors for adverse effects e.g. age, sex, nutritional status, associated disease, habits were also analyzed. In our study, 76.47% of total patients experienced some sorts of adverse effects. In 4- and 5-drug regimen groups’ adverse reaction were observed in 50% and 95% of patients respectively. Serum bilirubin, SGPT, creatinine did not change in neither of the treated group while alkaline phosphatase tended to decrease and uric acid to increase. No disease was established to be risk factor for drug intolerance.

Key words: Bangladesh, isoniazid, pyrazinamide, rifampicin, tuberculosis

DOI: 10.3329/bjp.v1i2.488

Bangladesh J Pharmacol 2006; 1: 51-57