复方茶酮缓释片与茶碱缓释片双盲双模拟随机对照治疗支气管哮喘多中心临床试验

A Double-Blind Double-Dummy Randomized Controlled Multicenter Clinical Trial on Theophylline-Ketotifen Sustained-Releasing Compound Tablets Versus Theophyllie Sustained- Releasing Tablets in the Treatment of Asthma

本研究以茶碱缓释片为对照，采用随机双盲双模拟多中心临床试验设计，评价复方茶酮缓释片治疗支气管哮喘的有效性和安全性。随机对照试验的药品按双盲双模拟要求制备，两组病人均服用３片试验药，复方茶碱缓释片每片含茶碱 ２００ｍｇ，酮替芬１ｍｇ；对照药茶碱缓释片每片含茶碱 １００ｍｇ（双百双模拟片一大二小），ｑ１２ｈ，轻度病人１周，中度病人６周。试验组１０３例，对照组１００例，分别有５０例和４１例观察单剂量顿服的即刻平喘疗效。试验组和对照组１周临床有效率分别为 ９０．９％和 ７５．７％，肺功能改善率分别为 ８７．９％和 ７２．４％； ６周临床有效率分别为８２．９％和７４．６％，肺功能改善率分别为９０．８％和８２．１％。即刻平喘试验表明两组均具有缓慢释放的特点。两组药物不良反应发生率分别为７．７％和９．０％。结论为复方茶酮缓释片是一有效而且安全的平喘药物。

This study was designed as double-blind double-dummy randomized controlled multicenter clinical trial to evaluate the efficacy and safety of theophyiline-kelotifen sustained-releasing compound tablets in the treatment of asthma compared with theophylline sustained-releasing tablets. In the randomized groups, the study drugs were enveloped in double-blind double-dummy manner. The subjects with mild asthma took 3 pills (1 big pill and 2 small pills),q 12h for I week and those with moderate asthma for 6 weeks. The efficacy was investigated on nearly half of the subjects in each group after one-dose administration. The clinical efficacy of the tested group after 1-week duration was similar to that of the control group, and so as the results of lung function efficacy. After 6-week treatment, the clinical efficacy rate was 82.9% which was better than that of the control group; and the lung function efficacy rates were 90.8% and 82. 1 % respectively in the two groups. The investigation on one-dose administration suggested the study drugs had the characteristics of sustained releasing. The rate of adverse drug reactions of theophylline-ketotifen compound tablets was 7.7%.