Objective To evaluate the efficacy and safety of Bufei Huoxue Capsule（ 补肺活血胶囊） combined with chemotherapy for new patients with initial pulmonary tuberculosis（ TB）. Methods A total of 180 new cases with pulmonary tuberculosis were randomized divided into treatment group（ 90 cases） and control group（ 90 cases）.Standard chemotherapy（ 2 HREZ/4 HR） combined with Bufei Huoxue Capsule was used in treatment group

and standard chemotherapy（ 2 HREZ/4 HR） only was used in control group

both for continuously 6 months. Index of efficacy for symptoms improvement of both groups were calculated in the end of 3 rd and 6 th month after the treatment. Rates of negative conversion of bacteria

efficacy of X-rays of both groups after 6 months treatment

and the adverse reaction were recorded. Results A total of 82 cases in treatment group and 85 cases in control group finally completed the treatment. The therapeutic index in the treatment group was higher than those of the control group after 3 and 6 months of the treatment（ P < 0. 01）. The difference of negative conversion rate of bacteria（ including sputum smear and sputum culture） between both groups after 6 months of treatment has no statistical significance（ P > 0. 05）.There were 7 cases of obvious absorption

43 cases of absorption

16 cases without obvious changes

16 cases of deterioration and 61. 0% of total absorptance in treatment group

corresponding as 6 cases

28 cases

30 cases

21 cases and 40. 0% in control group. The results in the treatment group were better than those of control group（ P < 0. 05）.However

differences of the changes of conversion-ray closure and closure rate between 2 groups were not statistically significant（ P > 0. 05）. There was no adverse reaction in both groups. Conclusion Bufei Huoxue Capsule can effectively and safely alleviate the symptoms of TB patients

and also can improve the rate of focus absorption.