苏黄止咳胶囊治疗咳嗽变异性哮喘的随机对照多中心临床研究  

A Multi-Centered,Randomized-Controlled Clinical Study on Suhuang Zhike Capsule for Cough Variant Asthma

作　　者：张燕萍[1] 苗青[1] 晁燕 赵丹 林琳[3] 孙增涛[4] 李素云[5] 徐艳玲[6] 沈霖[7] 黄继汉[8] 张旭丽[1] 晁恩祥(指导)[9] 

机构地区：[1]中国中医科学院西苑医院呼吸科,北京市100091 [2]北京东方运嘉科技发展有限公司 [3]广州中医药大学附属医院 [4]天津中医药大学附属第二医院 [5]河南中医学院第一附属医院 [6]辽宁中医药大学附属医院 [7]华中科技大学同济医学院附属协和医院 [8]安徽省药物临床评价中心 [9]卫生部中日友好医院

出　　处：《中医杂志》2008年第6期504-506,共3页Journal of Traditional Chinese Medicine

基　　金：首都医学科技发展基金项目(2005-8F--029);国家中医药管理局新药开发专项课题(DIX066B)

摘　　要：目的观察苏黄止咳胶囊治疗咳嗽变异性哮喘(CVA)的临床有效性及安全性。方法以止咳宁嗽胶囊为阳性对照,采用随机、双盲、多中心平行对照临床试验。选择符合研究标准的CVA患者279例,苏黄止咳胶囊组(治疗组)209例,完成196例;止咳宁嗽胶囊组(对照组)70例,完成69例。疗程2周,观察两组患者中医症状、治疗前后肺功能和激发试验情况。结果咳嗽总疗效:治疗组愈显率61.22%,总有效率90.31%;对照组分别为36.23%及72.46%,治疗组优于对照组(P<0.05)。中医证候综合疗效:治疗组愈显率62.76%,总有效率91.84%;对照组分别为27.54%及81.16%,治疗组优于对照组(P<0.05)。支气管激发试验治疗前后比较,治疗组部分患者复查激发试验转为阴性,与对照组比较差异有统计学意义(P<0.05)。结论苏黄止咳胶囊治疗CVA疗效显著,能够降低气道高反应性。Objective To observe the effect and safety of Suhuang Zhike Capsule on cough variant asthma（CVA）.Methods In the multi-centered randomized controlled double-blinded clinical study,279 CVA cases were divided into the treatment group treated by Suhuang Zhike Capsule（196 of 209 cases completed the treatment）,and the control group treated by Zhike Ningsou Capsule（69 of 70 cases completed the treatment）.The treatment course was 2 weeks.The improvement in TCM symptoms,lung function and bronchial challenge test were observed.Results On the total effect,in the treatment group,the total effective rate was 90.31 % and the curative rate 61.22%;in the control group,the total effective rate was 72.46 % and the curative rate 36.23%.The former was superior to the latter（P〈0.05）.On the comprehensive effect of TCM symptoms,in the treatment group,the total effective rate was 91.84 % and the curative rate 62.76%;in the control group,the total effective rate was 81.16 % and the curative rate 27.54%.The former was superior to the latter（P〈0.05）.After treatment,the bronchial challenge test in some cases of the treatment group changed to negative,showing a significant difference from the control group（P〈0.05）.Conclusion Suhuang Zhike Capsule has an obvious therapeutic effect on CVA by reducing the bronchial reaction of patient.

关 键 词：苏黄止咳胶囊 咳嗽变异性哮喘 中医药疗法 随机 双盲 多中心 

分 类 号：R256.1[医药卫生—中医内科学]