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目的评价莫西沙星注射液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。对照组予左氧氟沙星注射液,每次200mg,静脉滴注,每日2次;试验组予莫西沙星注射液,每次400mg,静脉滴注,每日1次。结果入选病例进入ITT分析92例,试验组和对照组各46例;进入PP分析,试验组37例,对照组36例。根据PP分析,试验组与对照组临床有效率分别为89%和89%,2组临床疗效无显著差异(P>0.05),2组细菌清除率分别为90%和91%(P>0.05)。92例进入安全性分析,2组不良反应发生率分别为11%和9%(P>0.05),均未见严重不良反应发生。结论莫西沙星注射液治疗社区获得性肺炎安全、有效。
Objective To evaluate the safety and efficacy of moxifloxacin injection in the treatment of community-acquired pneumonia. Methods Block randomized, open, parallel control design. Control group to levofloxacin injection, each 200mg, intravenous infusion, 2 times a day; test group to moxifloxacin injection, each 400mg, intravenous infusion, once daily. Results The selected cases entered the ITT analysis of 92 cases, the experimental group and the control group of 46 cases; into the PP analysis, the experimental group of 37 cases, control group of 36 cases. According to PP analysis, the clinical efficacies of the experimental group and the control group were 89% and 89% respectively, with no significant difference in the clinical efficacy between the two groups (P> 0.05). The bacterial clearance rates in the two groups were 90% and 91%, respectively (P> 0.05) . 92 patients entered the safety analysis, two groups of adverse reactions were 11% and 9% (P> 0.05), no serious adverse reactions occurred. Conclusion Moxifloxacin injection is safe and effective for community-acquired pneumonia.