福多司坦治疗慢性阻塞性肺疾病稳定期的随机对照双盲试验

A randomized and double-blind clinical trial for evaluating fudosteine capsule to the stable stage of chronic obstructive pulmonary disease( COPD)

目的:研究福多司坦胶囊对慢性阻塞性肺疾病稳定期的咳嗽咳痰症状的治疗作用及安全性。方法:将70名慢性阻塞性肺疾病稳定期患者随机分为2组:福多司坦组和氨溴索组(n=35)。福多司坦组给予福多司坦胶囊与安慰剂片剂,氨溴索组给予氨溴索片与安慰剂胶囊。治疗28 do观察受试者日间咳嗽、夜间咳嗽、24 h痰量、痰液黏稠度、肺部啰音。结果:两组的日间咳嗽、夜间咳嗽24 h痰量、肺部啰音、临床综合疗效无统计学差异,痰液黏稠度积分有统计学差异(P<0.05)。两组的不良反应无统计学差异(6.25%vs 9.38%)。结论:福多司坦胶囊治疗慢性阻塞性肺疾病稳定期有良好的疗效及安全性。

AIM：To evaluate the efficacy and safety of fudosteine in the stable stage of chronic obstructive pulmonary disease（COPD）.METHODS：70 patients in stable stage of COPD were divided into fudosteine group and ambroxol group.Two groups were treated with fudosteine capsules or ambroxol hydrochloride tablets for 28 days respectively.The degree of cough,volume and thickness of sputum,difficulty in cough,rale in the lung were observed.RESULTS：There were no significant differences with respect to the degree of cough,volume of sputum,difficulty in cough,rale in the lung and clinical comprehend effect between fudosteine treatment group and that of ambroxol,however,significant difference existed between the groups with regards to sputum thickness.There was no significant difference between the adverse reaction rates among the two groups（6.25%vs 9.38%）.CONCLUSION;Fudosteine capsule was effective and safe to patients in the stage of COPD.