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目的 :评价复方曲尼司特胶囊 (舒尔泰 )对轻、中度支气管哮喘的平喘效果和不良反应。方法 :采用多中心、随机平行对照、双盲试验方法 ,2 0 9例轻、中度支气管哮喘患者被分成试验组 10 3例和对照组 10 6例 ,分别服用复方曲尼司特胶囊 1粒和硫酸沙丁胺醇片剂 1片 ,q8h ,疗程 2 8d。结果 :试验组和对照组总有效率分别为 84 .5 %(P <0 .0 5 )和 71.7% ;肺功能FEV1有效率分别为 6 8.0 % (P <0 .0 1)和 4 4 .2 % ;不良反应发生率分别为 11.7%(P >0 .0 5 )和 12 .3%。结论 :复方曲尼司特胶囊是一种安全有效的平喘药。
OBJECTIVE: To evaluate the antiasthmatic efficacy and adverse reactions of compound tranilast (SC) capsules in mild and moderate bronchial asthma. Methods: A multicenter, randomized, parallel-controlled, double-blind trial was performed. A total of 209 patients with mild to moderate bronchial asthma were divided into two groups: trial group (103) and control group (106) And salbutamol sulfate tablets 1, q8h, treatment 2 8d. Results: The total effective rates of the experimental group and the control group were 84.5% (P <0.05) and 71.7% respectively. The effective rates of pulmonary function FEV1 were respectively 6 8.0% (P <0.01) and 4 4. The incidence of adverse reactions were 11.7% (P> 0.05) and 12.3% respectively. Conclusion: The compound tranilast is a safe and effective antiasthmatic agent.