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

Lingfei Kong, Jiaming Liu, Guozhong Gu, Jianmin Huo, Zhongsen Ma, Yuxia Shao, Shenghua Sun, Yuan Yuan, Sainan Zhu, Chen Yao, Guijie Du, Maosheng Cheng, Jian Kang

文献索引：Clin. Ther. 37 , 1248-58, (2015)

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摘要

The aim of this study was to determine the efficacy and safety profile of tratinterol hydrochloride tablets in the treatment of bronchial asthma.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.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.It is safe and effective to use tratinterol hydrochloride tablets to treat bronchial asthma.Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.