Abstract: Objective To evaluate the clinical safety of Yifeizhike capsule in treatment of tuberculosis. Methods Two hundred and fifty new patients with pulmonary tuberculosis were randomly divided into observation group(125 cases) and control group(125 cases).The observation group received chemical therapy and Yifeizhike capsule, while the control group only received the same chemical therapy.Evaluate the adverse drug reaction and the abnormity of blood,urine and the function of liver and kidney within 8 weeks. Results There was no significant difference between the two groups in white blood cell(WBC),red blood cell(RBC),platelet(PLT),glutamic pyruvic transaminase(ALT),glutamic oxalacetic transaminase(AST),blood urine nitrogen(BUN) and uric acid(UA);and there was no significant difference between the two groups in digestive system,allergic reaction,nervous system and arthralgia either.6 cases stopped using drugs because of the adverse drug reaction in each group respectively,11 cases were due to using the anti-TB drugs and 1 case was due to using Yifeizhike capsule with the occuring of allergic skin. Conclusion Yifeizhike capsule is safe in clinical use,and the problem of allergic skin should be paid more attention.

Key words: Safety, Yifeizhike capsule