Clinical evaluation and monitoring of adverse effects for fixed multidose combination against single drug therapy in pulmonary tuberculosis patients.

To evaluate the clinical and therapeutic value of 4 and 3 drug fixed dose combinations verses single drug formulations to treat pulmonary tuberculosis patients. The occurrence of adverse effects was also monitored. A total of 293 patients having sputum positive pulmonary tuberculosis were enrolled (Male: 187 and Female: 106). Patients with renal, hepatic, diabetic, cardiac problem and pregnancy were excluded from study. Patients were randomly selected into three groups (A, B, C). Group A and B were given FDCs and group C was given single drug formulations. All patients received 4 drugs in the intensive phase and 3 drugs in the continuation phase. Group A showed the highest percentage of patients who achieved sputum conversion (98.9%). The numbers of days taken to achieve sputum conversion on average were the least for Group B (32 days). When comparing the adverse effects, the patients of Group C suffered the most, with 22 patients who vomited repeatedly, 3 complaining of itching, 2 with Jaundice and 1 dead. There was no significant difference in the efficacy among the three treatment regimens. However the side effects observed in all three groups strongly indicate that FDCs are safer for treating TB patients. There were no side effects in the continuation phase.

RCT Entities:   Population Interventions Outcomes