摘要
目的:初步评价苏黄止咳胶囊治疗咳嗽变异型哮喘(cough variant asthma,CVA)风邪犯肺证的有效性和安全性。方法:采用随机、双盲、多中心平行对照、非劣性试验方法,进行苏黄止咳胶囊的Ⅱ期临床试验。受试者共140例,试验组70例,对照组70例,分别应用苏黄止咳胶囊和对照胶囊0.45g/粒,3粒/次,3次/日口服,疗程14天。结果:咳嗽总疗效比较,试验组总有效率为86.2%,对照组为71.6%,两组比较差异有显著性意义(P<0.05)。中医证候综合疗效,试验组总有效率为96.9%,对照组为80.6%,两组比较差异有显著性意义(P<0.01)。治疗14天后,两组部分患者出现血、尿、便常规及肝、肾功能异常,经分析与药物无关。不良事件1例,出现在对照组。结论:苏黄止咳胶囊治疗咳嗽变异型哮喘安全有效。
Objective： To preliminary evaluate the clinical efficacy and safety of SuHuang ZhiKe capsule for the treatment of cough variant asthma. Methods： A parallel-group randomized non-inferiority and double-blind mutlicenter clinical trial with positive control was carried out in phase Ⅱ with 140 cases. The treatment group including 70 cases received capsule SuHuang ZhiKe in a dosage of 0.45g × 3 tid. by oral. The control group including 70 cases took another capsule in the same way. The course of treatment was 14 days. Results： The total cough efficacy rates were 86.2% in treatment group and 71.6% in control group （P 〈 0.05）. The total TCM syndrome efficacy rates were 96.9 % in treatment group and 80.6 % in control group （ P 〈 0.01 ）. After 14-day treatment, the results of the safety evaluation showed that some patients were abnormal in blood test, urine test, stool test, liver function test and kidney function test. Meanwhile, adverse events occurred in 1 case which belonged to the control group. Conclusion： Capsule SuHuang ZhiKe is effective and safe for the treatment of CVA with syndrome of wind evil invading lungs.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2007年第11期773-776,共4页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
国家中医药管理局新药开发专项课题(No.DIX066B)
关键词
咳嗽变异型哮喘
苏黄止咳胶囊
Ⅱ期临床试验
风邪犯肺
Cough variant asthma
SuHuang ZhiKe capsule
Phase Ⅱclinical trail
Wind evil invading lungs
