国产福多司坦胶囊随机双盲II期多中心临床研究

A multi-center,randomized and double blind phase II clinical trial for evaluating domestic fudosteine capsule

目的：评价国产福多司坦胶囊祛痰的临床疗效和安全性。方法：采用随机、双盲双模拟、阳性平行对照的多中心研究。210例呼吸疾病患者等分为2组,试验组口服福多司坦胶囊400 mg,tid;对照组口服盐酸氨溴索片30 mg,tid,共5~7 d。记录并评价每日症状及肺部体征。主要观察痰的性状、痰量、咳痰难易程度、咳嗽、啰音。于治疗前、治疗后d 4及治疗结束后d 1进行临床疗效和安全性评价。结果：205例患者完成试验,福多司坦组101例,盐酸氨溴索组104例。福多司坦组与盐酸氨溴索组对各种呼吸系统常见病祛痰治疗的综合临床疗效相似,总有效率分别为82.00%和85.43%（P〉0.05）。福多司坦组与盐酸氨溴索组的不良反应率分别为2.97%和2.88%（P〉0.05）。结论：国产福多司坦胶囊祛痰疗效确切,安全性好。

Objective： To evaluate the efficacy and safety of domestic fudosteine capsule in treat ment of sputum clearance in respiratory system diseases. Methods： In the multi-center, randomized, double blind, double dummy, parallel controlled clinical trial, 210 patients with cough induced by re spiratory system diseases were treated with fudosteine （400 rag, tid, for 5 -7 days） and ambroxol hydrochloride （30 rag, rid, for 5 -7 days）, respectively. The respiratory symptoms and the signs were recorded daily. The main indicators were the character and volume of sputum, difficulty in expectoration, cough, and rale in the lung . The efficacy and safety were determined before treatments, on the forth day after treatments and the first day after ending the treatments. Results： In all the patients, 205 patients finished whole study （101 in fudosteine group and 104 in ambroxol hydrochloride group）. The effective rates of sputum clearance were 82.00% in fudosteine group and 85.43% in ambroxol hydrochloride group （P 〉0.05）. The adverse reaction rates were 2.97% in fudosteine group and 2.88% in ambroxol hydrochloride group （P 〉 0.05）. Conclusions： Domestic fudosteine capsule has the similar efficacy and safety as ambroxol hydrochloride in sputum clearance.