Abstract:  Objective To compare the efficacy of fixed-dose combination (FDC) with assembled drugs in patients with new smear positive pulmonary tuberculosis. Methods Patients were assigned to a FDC group (FG) or a control group (CG) by random digits table, while 269 cases in FG and 265 cases in CG. Patients were managed according to the Directly-Observed Treatment Strategy, and the efficacy of the two therapies was compared. Firstly traditional significance test was used, then superiority test was used if the difference between two groups was significant, or non inferiority test used if not, and set α=0.05. Results  Non-inferiority test indicated that the negative conversion rates of sputum at the 2nd month, the cure rates and the absorption rates of infection focus in FG were not inferior to those in CG. The negative conversion rates of sputum at the 2nd month in FG and CG was 95.54% (257/269) and 92.83% (246/265) respectively (u=3.809, P<0.001), the cure rates were 96.28% (259/269) and 93.21% (247/265) respectively (u=4.187, P<0.001) and the absorption rates of infection focus were 86.62% (233/269) and 83.40% (221/265) respectively (u=2.662, P<0.01). Superiority test showed that the cavity closure rates in FG (87.27%, 48/55) was superior to CG (63.64%, 28/44) (u=2.770, P<0.01).  Conclusion  The efficacy of FDC in new smear-positive pulmonary tuberculosis was equal to assembled drugs.

Key words: Tuberculosis,pulmonary/drug therapy, Antitubercular agents, Drug therapy,combination, Treatment outcome