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

作　　者：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 

机构地区：[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

出　　处：《中国医药科学》2013年第19期15-17,共3页China Medicine And Pharmacy

摘　　要：目的以奥克斯TM都保作为对照,评价国产富马酸福莫特罗粉雾剂治疗支气管哮喘的有效性和安全性。方法确诊的支气管哮喘患者236例,按随机双盲阳性药平行对照设计,分为两组,福莫特罗粉雾剂组,专用吸入器,12μg bid;奥克斯TM都保组,9μg bid,疗程4周。结果治疗4周后哮喘控制测评(ACT)的控制率试验组为13.79%,对照组为13.68%;有效率试验组为73.28%,对照组为69.23%,非劣效性检验,试验组非劣于对照组。4周FEV1好转率试验组为49.14%,对照组为44.44%,差异无统计学意义(P>0.05)。不良事件发生率试验组为9.48%,对照组为9.40%,差异均无统计学意义(P>0.05)。结论国产富马酸福莫特罗粉雾剂与进口福莫特罗粉雾剂在治疗支气管哮喘的有效性和安全性差异无统计学意义(P>0.05)。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 12 μg, Oxis Turbuhaler 9 μg. 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 

分 类 号：R562.25[医药卫生—呼吸系统]