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目的 评价氨红那敏栓治疗支气管哮喘的有效性和安全性。方法 以氨茶碱片剂为对照 ,采用随机双盲双模拟多中心临床实验设计方法。试验药含氨红那敏栓和 2片安慰剂 ,对照药含空白基质栓剂和 2片氨茶碱片。将栓剂送入肛门用拇指按压1min ,2次 /d ,1枚 /次 ;氨茶碱片 2片 /次 ,2次 /d ,轻度支气管哮喘疗程 1周 ,中、重度哮喘 6周。结果 试验组 97例 ,对照组 94例 ,分别有 5 0例和 41例观察单剂量用药的即刻平喘疗效。实验组和对照组 1周临床有效率分别为 93 3 %和 76 9%。肺功能改善率分别为 86 7%和 73 1% ;6周临床有效率分别为 86 6%和 72 1% ,肺功能改善率分别为 90 5 %和 82 8%。即刻平喘试验表明试验组具有缓慢释放的特点。试验组和对照组患者血药谷 -峰浓度在 10～ 2 0 μg·ml-1范围分别占 91 9%和 5 6 7%。结论 近期观察氨红那敏栓是一种安全、有效的平喘药物。
Objective To evaluate the efficacy and safety of Aminophenacin in the treatment of bronchial asthma. Methods aminophylline tablets as a control, using double-blind randomized double-simulated multicenter clinical experimental design. Test drug containing ammonia red navel suppository and two placebo, control drug containing blank matrix suppository and 2 aminophylline tablets. The suppository into the anus with thumb press 1min, 2 times / d, 1 / times; aminophylline tablets 2 / times, 2 times / d, mild bronchial asthma treatment for 1 week, moderate and severe asthma for 6 weeks. Results 97 cases of the experimental group, 94 cases of the control group, respectively, 50 cases and 41 cases of single-dose observation of immediate anti-asthma efficacy. The clinical effective rates of the experimental group and the control group were 93 3% and 76 9% respectively. The lung function improvement rates were 86.7% and 73.1% respectively. The 6-week clinical efficacy rates were 86.6% and 72.1% respectively, and the lung function improvement rates were 90.5% and 82.8% respectively. Immediate anti-asthma test showed that the test group has the characteristics of slow release. In the test group and the control group, the blood serum-peak concentration was 91 9% and 57 6% respectively in the range of 10 ~ 20 μg · ml-1. Conclusion The recent observation that Aminoprazole is a safe and effective antiasthmatic drug.