中国医药科学Issue(19)：15-17,3.
富马酸福莫特罗粉雾剂治疗支气管哮喘的随机阳性药平行对照多中心临床研究
Formoterol fumarate powder therapy in bronchial asthma patients:a multicenter randomized double-blind, positive controlled trial
朱运奎 1吴昌归 2金发光 3刘华 4刘晓菊 5王莹 6王训强7
作者信息
- 1. 兰州军区兰州总医院，甘肃兰州730050
- 2. 第四军医大学西京医院，陕西西安710032
- 3. 第四军医大学唐都医院，陕西西安710038
- 4. 甘肃省人民医院，甘肃兰州730000
- 5. 兰州大学第一医院，甘肃兰州730000
- 6. 皖南医学院弋矶山医院，安徽芜湖241001
- 7. 正大天晴药业集团股份有限公司，江苏南京210023
- 折叠
摘要
Abstract
Objective This study compared the efficacy and safety of formoterol fumarate powder for inhalation with Oxis Turbuhaler for treatment of bronchial asthma. Methods A multicenter, double-blind, positive controlled trial was conducted. Subjects (n=236) diagnosed bronchial asthma were randomized to 4 weeks of twice-daily treatment with formoterol fumarate powder for inhalation 12μg, Oxis Turbuhaler 9μg. Results At 4 weeks, the control rate of ACT of test group was 13.79%, control group 13.68%; efficiency of test group was 73.28%, control group 69.23%; Result of non-inferiority was that test group was not inferior to control group, which was consistent with analysis results. At 4 weeks, FEV1 improvement rate of test group was 49.14%, control group 44.44%, the difference was not statistically significant. The incidence of adverse events of test group was 9.48%, control group 9.40%, the difference was not statistically significant. Conclusion Formoterol fumarate powder for inhalation produced in China is same effective and safe compareded with the exported powder for treatment of bronchial asthma.关键词
支气管哮喘/福莫特罗/都保/随机对照Key words
Bronchial asthma/Formoterol/Turbuhaler/Randomized control分类
医药卫生引用本文复制引用
朱运奎,吴昌归,金发光,刘华,刘晓菊,王莹,王训强..富马酸福莫特罗粉雾剂治疗支气管哮喘的随机阳性药平行对照多中心临床研究[J].中国医药科学,2013,(19):15-17,3.
