哮喘联盟

   摘要
   目的：本研究的目的是测定盐酸川丁特罗片在治疗支气管哮喘中的疗效和安全性。
   方法：本项多中心、随机、双盲临床研究开始于2009年3月，结束于2010年6月，由中国的6个中心完成。一项针对日本大冢制药有限公司生产的盐酸丙卡特罗片的随机试验已进行过了。 本研究经由中国医科大学附属第一医院的医学伦理委员会批准。临床试验注册号为2007L04263。
   结果：本研究共纳入223例患者，其中试验组112例，对照组111例。两组治疗后的肺功能均显著增加 (P < 0.05)；然而，两组之间并没有显著性统计学差异(P> 0.05)。对照组不同程度的相关不良事件的发生率高于试验组。
   启示：使用盐酸川丁特罗片治疗支气管哮喘是安全有效的。
 

（苏欣 审校）
ClinTher. 2015Apr7.pii:S0149-2918(15)00150-2.doi:10.1016/j.clinthera.2015.03.013. [Epub ahead of print]
 

Randomized, Multicenter Clinical Study of Tratinterol Hydrochloride Tablets for the Treatment of Bronchial Asthma.
 

Kong L1, Liu J1, Gu G2, Huo J3, Ma Z4, Shao Y5, Sun S6, Yuan Y1, Zhu S7, Yao C7, Du G8, Cheng M9, Kang J10.

Author information
 

Abstract
PURPOSE:The aim of this study was to determine the efficacy and safety profile of tratinterol hydrochloride tablets in the treatment of bronchial asthma.
METHODS:This multicenter, randomized, double-blind clinical research study was completed at 6 centers in the People's Republic of China from March 2009 to June 2010, and a randomized trial of procaterol hydrochloride tablets produced by Otsuka Pharmaceutical Co Ltd was conducted. The study was approved by the Medical Ethics Committee of the First Hospital of China Medical University. The clinical trial registration number is 2007L04263.
FINDINGS:A total of 223 patients were selected for this study, with 112 patients in the treatment group and 111 in the control group. The lung function of the 2 groups after treatment significantly increased in all (P < 0.05); however, there was no significant difference in the changes between the 2 groups (P > 0.05). The occurrence of related adverse events at varying degrees in the control group was higher than in the treatment group.
IMPLICATIONS:It is safe and effective to use tratinterol hydrochloride tablets to treat bronchial asthma.
 

ClinTher. 2015Apr7.pii:S0149-2918(15)00150-2.doi:10.1016/j.clinthera.2015.03.013. [Epub ahead of print]