苏黄止咳胶囊治疗感冒后咳嗽的随机对照研究  

Randomized Controlled Study on Suhuang Zhike Capsule for Treatment of Post-cold Cough

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

机构地区：[1]中国中医科学院西苑医院呼吸科,北京100091 [2]北京东方运嘉科技发展有限公司 [3]广东中医药大学第二附属医院 [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]辽宁中医学院附属医院 [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：《中国中西医结合杂志》2008年第8期698-701,共4页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家中医药管理局新药开发专项课题(No.DIX066B)

摘　　要：目的观察苏黄止咳胶囊治疗感冒后咳嗽的临床有效性及安全性。方法以止咳宁嗽胶囊为阳性对照药,采用随机、双盲、多中心、阳性药平行对照临床试验。选择符合研究标准的感冒后咳嗽患者280例,治疗组210例(剔除2例),服用苏黄止咳胶囊3粒/次,3次/天;对照组70例(剔除1例),服用止咳宁嗽胶囊3粒/次,3次/天;7天为1个疗程。观察患者咳嗽次数、咳嗽程度、咽痒程度、咯痰情况。结果治疗组完成204例,对照组完成67例。咳嗽症状疗效PP分析:治疗组愈显率58.82%,总有效率87.75%;对照组愈显率34.33%,总有效率76.12%;治疗组优于对照组(P<0.05)。全分析集(ITT分析):治疗组愈显率57.42%,总有效率87.02%;对照组愈显率35.71%,总有效率75.36%,治疗组优于对照组(P<0.05)。总疗效符合方案集(PP分析):治疗组愈显率60.29%,总有效率92.16%;对照组愈显率31.34%,总有效率86.57%,愈显率治疗组优于对照组(P<0.05),总有效率两组差异无统计学意义(P>0.05)。ITT分析:治疗组愈显率59.62%,总有效率91.35%;对照组愈显率30.43%,总有效率85.51%,愈显率治疗组优于对照组(P<0.05),总有效率两组差异无统计学意义(P>0.05)。结论苏黄止咳胶囊治疗感冒后咳嗽安全、有效。Objective To observe the effect and safety of Suhuang Zhike Capsule （SZC） on post-cold cough. Methods The multi-centered randomized double-blinded clinical trial was adopted, and Zhike Ningsuo Capsule （ZNC） as the positive control drug, 280 patients were enrolled and assigned to two groups, the 210 patients （2 dropped out） in the treatment group were treated with SZC, and the 70 （1 dropped out） in the control group trea- ted with ZNC, both at the daily dose of 3 capsules for three times, and the course for all patients was 7 days. The frequency, degree of cough as well as the condition of throat itching and expectoration were observed. Results The program was completed in 204 patients of the treatment group and 67 in the control group, per-proto- col （PP） analysis on cough showed the total effective rate and the cured-effective rate was 87.75 % and 58.82% in the treatment group respectively, which was superior to that in the control group, 76. 12% and 34. 33%, respec- tively （P 〈0. 05）. intention-to-treat （ITT） analysis on cough also showed the similar results 87.02 % vs 75.36% for total effective rate, 57.42% vs 35.71% for the cured-effective rate （P 〈0.05 ）. The two indexes of effective- ness on disease analyzed by PP were 92. 16 % and 60.29% in the treatment group, and 86. 57% and 31.34% in the control group respectively （P 〈 0. 05） , and by ITT were 91.35 % and 59.62% , 85.51% and 30. 43%, re- spectively （P 〈 0. 05 ）, both showed significant difference between groups only in cured-effective rate but not in the total effective rate （P 〉 0. 05 ）. Conclusion SZC is effective and safe in treating post-cold cough.

关 键 词：苏黄止咳胶囊 感冒后咳嗽 随机 双盲 多中心 

分 类 号：R254[医药卫生—中医内科学]