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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。
In this study, theophylline sustained-release tablets as a control, randomized double-blind double-simulations multi-center clinical trial design, evaluate the efficacy and safety of compound tea ketone sustained-release tablets in the treatment of bronchial asthma. Randomized controlled trials of drugs were prepared according to double-blind double-dummy requirements, two groups of patients taking three test drugs, each containing theophylline compound theophylline 200mg, ketotifen 1mg; control theophylline sustained-release tablets per tablet Containing theophylline 100mg (two hundred pairs of simulations a sophomore small), q12h, mild patient 1 week, moderate patient 6 weeks. The experimental group of 103 cases, control group of 100 cases, respectively, 50 cases and 41 cases observed single-dose Dayton instant immediate asthma efficacy. The clinical effective rates of the experimental group and the control group were 90.9% and 75.7%, respectively, and the improvement rates of pulmonary function were 87.9% and 72.4% respectively. The clinical effective rates of the 6 weeks and the control group were 82.9% and 74.6%, pulmonary function improvement rates were 90.8% and 82.1%. Immediate anti-asthma test showed that both groups have a slow release characteristics. Adverse drug reactions in both groups were 7.7% and 9.0%, respectively. Conclusions for the compound tea ketone sustained-release tablets is an effective and safe antiasthmatic drugs.