莫西沙星注射液与左氧氟沙星注射液随机对照治疗社区获得性肺炎临床研究  

Randomized controlled clinical trial of moxifloxacin versus levofloxacin injection in the treatment of community acquired pneumonia

作　　者：赵彩芸[1] 李家泰[1] 高磊[1] 王进[1] 郝凤兰[1] 

机构地区：[1]北京大学第一医院临床药理研究所,北京100034

出　　处：《中国临床药理学杂志》2008年第2期99-103,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价莫西沙星注射液与左氧氟沙星注射液(均为氟喹诺酮类抗生素)治疗社区获得性肺炎的安全性和有效性。方法采用区组随机、开放、平行对照设计,试验组静脉点滴莫西沙星注射液,每次400mg,每日1次;对照组静脉点滴左氧氟沙星注射液,每次200mg,每日2次,疗程均为7～14天。入选病例进入ITT分析92例,试验组46例,对照组46例;73例进入PP分析,试验组37例,对照组36例。73例进入ITT/MBE分析,试验组和对照组分别为34、39例;62例进入PP/MBE分析,试验组和对照组均为31例。结果治疗结束后第7天,ITT分析人群:试验组与对照组临床有效率均为76.1%;PP分析人群:试验组与对照组的临床有效率分别为89.2%和88.9%;ITT/MBE人群:2组细菌清除率分别为88.2%与82.1%;PP/MBE人群:2组细菌清除率分别为90.3%和90.6%。92例进入安全性分析,2组药物不良反应发生率分别为10.9%和8.7%,上述结果差异均无显著性。结论莫西沙星注射液与左氧氟沙星注射液治疗社区获得性肺炎均安全、有效。Objective To evaluate the efficacy and safety of moxifloxacin for the treatment on the patients with community acquired pneumonia. Methods A randomized controlled, parallel, block, open clinical trial was conducted. Patients were randomized into each group in the study. Trial group patients received moxifloxacin 400 mg once daily, and control group patients received levofloxacin 200 mg twice daily by intravenous infusion. The duration was 7 - 14 days in both groups. Ninety - two cases in the ITT analysis, 46 patients in trial group received moxifloxacin treatment, and 46 in control group received levofloxacin treatment; 73 cases in the PP analysis, 37 patients in moxifloxacin group, and 66 patients in levofloxacin group; 73 cases in PP/MBE, 34 patients in moxifloxacin group and 39 patients in levofloxacin group; 62 cases in the PP/MBE, 31 patients in each group. The overall efficacy rates of each group in ITT were 76.1%. Results The overall efficacy rates in PP were 89.2% and 88.9% , respectively. The bacterial eradication rates of each group in ITT/MBE were 88.2% and 82.1% , and in PP/MBE were 90.3% and 90.6% , respectively. The adverse drug reaction was evaluated in 92 cases. The adverse drug reaction rates, which related to study drug of each group were 10.3% and 8.7% , respectively. The results showed that there were no statistical differences between these two groups （P 〉 0.05 ）. Conclusion Moxifloxacin was effective and safe as levofloxacin in the treatment of community acquired pneumonia.

关 键 词：莫西沙星 左氧氟沙星 社区获得性肺炎 

分 类 号：R978.19[医药卫生—药品] R563.1[医药卫生—药学]