盐酸马布特罗片与盐酸丙卡特罗片比较治疗支气管哮喘随机对照多中心临床试验

Multicenter randomized controlled clinical trial of mabuterol hydrochloride tablets versus procaterol hydrochloride in the treatment of bronchial asthma

目的评价盐酸马布特罗片(平喘药)的临床疗效和安全性。方法通过与盐酸丙卡特罗片比较,用随机、双盲、双模拟、平行多中心对照临床试验设计;240例病人分为2组:试验组120例,对照组120例;所有病人连续给药7 d,观察临床疗效、肺功能疗效和药物不良反应。结果脱落21例(8.75%),符合方案219例,其中试验组107例,对照组112例。连续给药7 d后,试验组和对照组的症状、体征评分及肺功能指标(FEV1,PEF)与治疗前相比均有显著改善(P<0.05)。盐酸马步特罗片的症状体征综合疗效的有效率为86.67%(91/105);而盐酸丙卡特罗片为82.73%(91/110)(P>0.05)。肺功能(FEV1)有效率,盐酸马步特罗片为20.51%(24/117);而盐酸丙卡特罗片为18.48%(22/119)(P>0.05)。盐酸马步特罗片与盐酸丙卡特罗片的不良反应发生率分别为18.80%,11.76%(P>0.05)。结论盐酸马布特罗片治疗支气管哮喘与盐酸丙卡特罗片一样是安全有效的药物。

Objective To evaluate the efficacy and safety of mahuterol compared with procaterol in the treatment of mild and moderate bronchial asthma. Methods This study was designed as a prospective and parallel randomized controlled clinical trial. There were 120 and 120 patients in trial group and controlled group, respectively. All the randomized were administered for 7 days and evaluated the efficacy and safety. Results Comparison with pre - treatment, the symptom score and sign score, the forced expiratory volumn in 1 second （FEVI ） and the peak expiratory flow （PEF） were obviously improved in both trial group and control group （ P 〈 0. 05 ）. The clinical and lung function （ FEV1 ） efficacy of 7 days duration were 86. 67% and 20. 51% respectively which were compared with those of procaterol （82. 73% and 18.48% ,P 〉 0. 05）. The adverse drug reaction rate of mabuterol was 18.80% and that of the controlled was 11.76% （P 〉 0. 05 ）. Conclusion Mabuterol was effective and safe in the treatment of mild and moderate bronchial asthma.