目的探讨固定剂量复合剂异福酰胺胶囊和异福胶囊抗结核疗效及安全性。方法将187例初治痰涂片阳性肺结核患者,双盲随机分为治疗组93例和对照组94例进行短程化疗。结果治疗组和对照组2个月末痰菌阴转率分别达85.4%(76例)和83.9%(73例);满疗程痰菌阴转率分别为97.8%(87例)和97.7%(85例);胸部X线病灶,治疗组显效率62.9%(56例),对照组62.1%(54例);治疗组有效率98.9%(88例),对照组97.7%(85例);疗程结束时治疗组空洞闭合率为92.9%(26/28),对照组空洞闭合率为92%(23/25);不良反应发生率分别为治疗组11.8%(11/93)、对照组14.9%(14/94)。结论抗结核固定剂量复合剂异福酰胺胶囊和异福胶囊是一种疗效高、安全、方便、能减少耐药性发生的抗结核制剂。 Objective To investigate the efficacy and safety of fixed-dose combination of Isoflurane and Yi-fu capsule against tuberculosis. Methods A total of 187 patients with newly diagnosed sputum smear-positive pulmonary tuberculosis were randomly divided into treatment group (n = 93) and control group (n = 94) for short-term chemotherapy. Results The sputum negative conversion rates of the treatment group and the control group were 85.4% (76 cases) and 83.9% (73 cases) respectively at the end of 2 months. The sputum negative conversion rates were 97.8% (87 cases) and 97.7% (85 cases) The effective rate was 98.9% (88 cases) in the treatment group and 97.7% (85 cases) in the control group, and the treatment group ended with 62.9% (56 cases) in the treatment group and 62.1% (54 cases) in the control group The cavity closure rate was 92.9% (26/28) in the treatment group and 92% (23/25) in the control group. The adverse reaction rates were 11.8% (11/93) in the treatment group and 14.9% (14.9%) in the control group 14/94). Conclusion The anti-tuberculosis fixed-dose combination of Isoflurane and Yi-fu capsule is an anti-TB agent with high curative effect, safety and convenience and can reduce the occurrence of drug resistance.