苏黄止咳胶囊治疗咳嗽变异型哮喘140例临床研究  

Clinical study on SuHuang ZhiKe capsule in treating 140 cases of cough variant asthma

作　　者：张燕萍[1] 赵丹 林琳 魏葆琳[4] 李素云[5] 徐艳玲[6] 晁恩祥[7] 

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]北京东方运嘉医药科技开发有限公司,北京100027 [3]广州中医药大学第二附属医院,广州510120 [4]天津中医药大学第二附属医院,天津300150 [5]河南中医学院第一附属医院,郑州450000 [6]辽宁中医药大学附属医院,沈阳110032 [7]中日友好医院,北京100029

出　　处：《中华中医药杂志》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)

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.

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 

分 类 号：R256.1[医药卫生—中医内科学]