益肺止咳胶囊临床安全性的观察

Evaluation of the clinical safety of Yifeizhike capsule

目的评价益肺止咳胶囊的临床安全性。方法对250例新肺结核病例随机分配到观察组(125例)和对照组(125例),观察组接受化疗加益肺止咳胶囊,对照组仅应用相同的化疗方案。观察8周内2组药物不良反应及血、尿和肝、肾功能的异常发生情况。结果血液白细胞、红细胞、血小板及转氨酶、尿素氮、尿酸异常发生率两组无差别;胃肠道、过敏反应、神经系统和关节痛的不良反应率2组无差别;因不良反应而停药两组各6例,在12例中11例由抗结核药引起,1例由益肺止咳胶囊所致皮疹。结论益肺止咳胶囊临床应用是安全的,个别可能引起皮疹应注意观察。

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 eases） 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 oeeuring of allergic skin. Conclusion Yifeizhike capsule is safe in clinical use, and the problem of allergic skin should be paid more attention.