Abstract: Objective To study the short-term efficacy and safety of four-drug fixed-dose combinations (FDC) in tuberculosis treatment.  Methods 540 registered smear positive pulmonary tuberculosis cases in six countiesof Zhanjiang citywere divided into 2 groups,with the case group takingFDC and control group taking the blister pack. The clinical manifestation, treatment outcome and adverse reaction were compared between two groups.   Results (1) the cure rates for FDC group and control group were 94.4% and 92.2% respectively. There was no significant difference between two groups（χ²=1.071, P=0.301）. (2) Related clinical symptoms (such as cough, chest pain, fatigue, night sweats, fever, hemoptysis) both gradually improved, no significant difference between the two groups (P>0.05); (3) The sputum conversion rates at the end of 2_nd and 3_rd month were 90.7% and 94.1% in the FDC group and 89.6% and91.9% in the control group, and no significant difference between two groups(P>0.05). Chest radiography showed that the cavity closure rate at the end of treatment in the FDC group was 78.2%, higher than that in the control group (61.2%).(4) In the FDC group and the control group, the rate of adverse reactions was 21.5% and 20.0% respectively, with no significant difference between the two groups (P>0.05). In the intensive phase, gastrointestinal adverse reactions in the control group were significantly greater than the FDC group (P<0.05). The abnormal rate of blood routine and liver function was similar in the two groups. The discontinuation rate due to adverse reactions in FDC group was higher than control group.   Conclusion Four-drug FDCs and blister pack drug have equal efficacy in TB treatment, and similar incidence of adverse reactions. FDCs showed great advantages in TB patients management. Therefore, it is recommended to apply FDCs in National TB Program.

Key words: fixed-dose combination, tuberculosis,pulmonary, antitubercular agents