Abstract: Objective To study the efficacy and adverse reaction of Mycobacterium Vaccae vaccine in treating new smear positive tuberculosis(TB). Method 109 new smear positive pulmonary TB patients were randomly allocated into treatment group which received 2 M.Vaccae vaccine +HRZE(S)/4 M.Vaccae vaccine +HR (58cases)and control group which received 2HRZE(S)/4HR(51 cases). Result The sputum negative conversion rate at the second week,the first and second month were 44.8% 62.0%,89.7% in the treatment group and 25.5%,41.2%,76% in the control group respectively;at the second month chest radiography showed the resolution of pulmonary lesions in the treatment group and the control group were 37.9% and 19.6% respectively;with cavity closure rate of 65.5% in the treatment group and 38.7% in the control group;at the 2~(nd) week,the clinical symptoms such as cough,fever,fatigue disappeared at the level of 48.3%,71.4%,59.3% in the treatment group and of 25.5%,50.0%,40.0% in the control group(P＜0.05)respectively;there were no drug adverse reaction in the treatment group;there were no significant difference on the sputum positive conversion rates at the 6^th,12^th and 24^th month after treatment between the treatment group and the control(P＞0.05). Conclusion M.Vaccae vaccine combining chemotherapy shortens the time of sputum negative conversion,the resolution of pulmonary lesions and the improvement of clinic symptoms.The drug adverse reaction is slight.It is a fairly good immune drug for TB treatment and is worth to be recommended.

Key words: Tuberculosis Pulmonary/drug therapy, Mycobacterium Vaccae vaccine