摘要
目的:评价复方薤白胶囊治疗痰热郁肺型慢性支气管炎急性发作期的有效性和安全性。方法:采用随机、双盲双模拟、阳性药平行对照临床试验设计。480例慢性支气管炎急性发作患者按3:1随机进入复方薤白胶囊组(试验组,n=360)和芩暴红止咳胶囊组(对照组,n=120),疗程10d。以慢性支气管炎急性发作期疗效、中医证候疗效、气喘起效时间和控制时间评价有效性,以不良反应、实验室检查和心电图评价安全性。结果:试验组慢支炎急性发作期疗效、中医证候疗效非劣于对照组;治疗5d的中医症状,治疗10d的气喘起效时间和控制时间、肺部罗音的改善均优于对照组(P<0.05)。两组不良反应发生率分别为1.40%和1.69%,差异无统计学意义(P=1.00)。结论:复方薤白胶囊治疗慢性支气管炎急性发作期痰热郁肺证安全有效。
Objective： To evaluate the efficacy and safety of compound Xiebai capsule （CXC） in the treatment of acute exacerbation of chronic bronchitis （AECB） with Lung Syndrome of Phlegm-Heat Stagnating. Methods： A randomized, double-blind and double-dummy, parallel positive drug-controlled trial was conducted in 474 AECB patients. They were randomly assigned in a 3：1 ratio to receive either compound Xiebai capsule （n = 360） and Qinbaohong capsule （control, n = 120） for 10 days. The improvements of chronic bronchitis, TCM syndrome, asthma onset time and controlled time were employed to assess the efficacies. Adverse events and laboratory exami- nation indexes were employed to assess the safety. Results： The efficacy of CXC on AECB and TCM syndrome was not inferior to that of control capsule. The improvement of TCM syndrome after 5-day treatment, asthma onset time,controlled time and the pulmonary rales in CXC group were superior to those in control group （P 〈 0.05）. The adverse reactions were not significantly different between two groups （1.40% vs 1.69% , P = 1.00）. Conclusion： Compound Xiebai capsule is effective and safe in the treatment of AECB with Lung Syndrome of Phlegm-Heat Stagnating.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2010年第15期1333-1336,1354,共5页
Chinese Journal of New Drugs
关键词
慢性支气管炎急性发作期
痰热郁肺证
随机对照试验
临床试验
acute exacerbation of chronic bronchitis
Lung Syndrome of Phlegm-Heat Stagnating
randomized and controlled trial
clinical trial
