丙卡特罗气雾剂与喘乐宁气雾剂治疗支气管哮喘随机对照多中心临床试验  

A Multicenter Randomized Controlled Clinical Trial of Procaterol Aerosol Inhaler Versus Salbutamol Aerosol Inhaler in Asthma Treatment

作　　者：徐志豪[1] 刘富光[1] 陈光谨[2] 杜文彬[3] 

机构地区：[1]浙江大学医学院附属第二医院,杭州310009 [2]天津医科大学总医院,天津300193 [3]天津市第一中心医院,天津300190

出　　处：《中国临床药理学杂志》2002年第4期268-271,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的:评价国产丙卡特罗气雾剂（procaterol）与沙丁胺醇气雾剂随机对照治疗轻中度哮喘的疗效和安全性。方法:采用前瞻性、开放式随机平行对照临床试验设计。121例病人分为两组,试验组61例,对照组60例,其中分别有42例和39例观察即刻平喘作用,所有病人连续给药7d,观察临床疗效、肺功能疗效和药物不良反应。结果:丙卡特罗气雾剂在5min起效,15min以后作用开始增强,并在30min～2h达高峰,8h时仍有一定的作用,1～4h试验组作用优于对照组（P<0.05）;连续给药7d,丙卡特罗气雾剂的临床疗效为88.5％,肺功能疗效为77.0％,均优于对照药（P<0.05）;丙卡特罗气雾剂的不良反应发生率为9.9％,对照药为11.7％（P>0.05）。结论:丙卡特罗气雾剂治疗轻中度支气管哮喘是有效而且安全的。OBJECTIVE: To evaluate the efficacy and safety of procaterol aerosol inhaler compared with salbutamol aerosol inhaler in mild and moderate bronchial asthma treatment. METHODS: This study was designed as a prospective and parallel randomized controlled clinical trial. There were 61 and 60 patients in study group and controlled group respectively. 42 and 39 cases were evaluated the efficacy after single dose administration. All the randomized were administered for 7 days and evaluated the efficacy and safety. RESULTS: Procaterol was effective after 5min of single dose administration. The effect was strengthened after 15min, reached the peak at 30min-2h and prolonged 8h after administration. The clinical and lung function efficacy of 7 days duration were 88.5% and 77.0% respectively which were superior compared with those of salbutamol (P<0.05). The adverse drug reaction rate of procaterol was 9.9% and that of the controlled was 11.7%( P>0.05). CONCL USION: Procaterol aerosol inhaler was effective and safe in mild and moderate bronchial asthma treatment.

关 键 词：喘乐宁 随机对照多中心临床试验 丙卡特罗 沙丁胺醇 气雾剂 支气管哮喘 疗效 安全性 

分 类 号：R562.25[医药卫生—呼吸系统] R969.4[医药卫生—内科学]