克咳片治疗慢性支气管炎的多中心随机对照临床研究

Keke Tablets in the treatment of chronic bronchitis: a multicenter randomized controlled clinical trial

目的:评价克咳片治疗风寒证或风寒兼痰湿证慢性支气管炎的临床疗效和安全性。方法:采用多中心、分层区组随机、双盲双模拟、阳性药平行对照的临床试验设计方法,将240例慢性支气管炎患者以3∶1的比例随机分为克咳组和对照组,克咳组口服克咳片及通宣理肺片模拟剂,对照组口服通宣理肺片及克咳片模拟剂,疗程7d。观察两组治疗前后咳嗽症状计分、视觉模拟评分(VAS)、中医证候疗效、咳嗽缓解/复发情况及安全性评价。结果:合格病例共225例,其中克咳组169例,对照组56例。治疗后,两组的咳嗽症状计分、VAS评分均较治疗前改善(P<0.01),但组间比较无显著性差异。克咳组中医证候疗效的总有效率为94.67%,平均咳嗽缓解时间为(4.03±2.14)d,咳嗽缓解率为72.19%,咳嗽复发率为3.55%,与对照组比较无显著性差异。两组均未发现不良反应。结论:克咳片治疗慢性支气管炎风寒证或风寒兼痰湿证具有较好的临床疗效和较高的安全性。

Objective： To investigate the therapeutic effect and safety of Keke Tablets for chronic bronchitis with windcold syndrome or wind-cold complicated with phlegm-dampness. Methods： A multicenter trial of stratified block randomization, double-blind, double-mimic, positive-medicine parallel-control was carried out in chronic bronchitis patients. A total of 240 patients were randomized into an observation group and a control group in the proportion of 3∶1. The observation group was given Keke Tablets and sham Tongxuan Lifei Tablets, while the control group was given Tongxuan Lifei Tablets and sham keke tablets orally, lasting for 7 days. The scores of cough, visual analogue scale（VAS） and traditional Chinese medical syndrome were compared before and after treatment. The relief and recurrence of cough were observed, and the safety was also monitored during the treatment. Results： A total of 225 qualified patients were enrolled, 169 cases were in the observation group and 56 cases in the control group. After treatment, the scores of cough and VAS were improved in both groups（P〈0.01）, compared with those before treatment）, but the differences between the two groups were insignificant. The total effective rate of efficacy of traditional Chinese medical syndrome was 94.67%, the average time for cough relief was（4.03±2.14）d, the remission rate of cough was 72.19%, and recurrence rate of cough was 3.55% in the observation group. Compared with the control group, the difference was insignificant. No adverse reaction occurred in the observation group or the control group. Conclusion： Keke Tablets showed certain clinical efficacy and safety for treatment of chronic bronchitis with wind-cold syndrome or wind-cold complicated with phlegm-dampness.