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盐酸安妥沙星片剂与盐酸左氧氟沙星片剂随机、双盲、双模拟治疗急性呼吸道感染的Ⅲ期临床研究

A randomized controlled,double-blind and double-simulation clinical trial of antofloxacin hydrochloride versus levofloxacin hydrochloridefor the treatment of acute respiratory infection

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【作者】 杨春袁哲黄文祥刘成伟

【Author】 Yang Chun,Yuan Zhe,Huang Wen-xiang and Liu Cheng-Wei(Key Laboratory of Chongqing Infection Disease and Parasitic Disease,The First Affiliated Hospital,Chongqing Medical University,Chongqing 400016)

【机构】 重庆医科大学附属第一医院重庆市传染病寄生虫病学重点实验室

【摘要】 目的评价盐酸安妥沙星片剂治疗急性呼吸道感染的安全性和有效性。方法采用随机对照、双盲双模拟、平行对照的试验设计。选用40例急性呼吸道感染病人,随机分为2组,每组20例,试验组予盐酸安妥沙星片剂和安慰剂,对照组予左氧氟沙星片剂和安慰剂,每日服药2次,每次间隔12h,疗程均为7~14d。结果盐酸安妥沙星片剂与盐酸左氧氟沙星片剂相比,具有相似的临床疗效、细菌学疗效和不良反应发生率,经统计学比较两组间无显著差别。结论盐酸安妥沙星片剂治疗呼吸道感染疗效确切,安全性好。

【Abstract】 Objective To evaluate the efficacy and safety of antofloxacin hydrochloride and levofloxacin hydrochloride,a randomized controlled clinical trial was conducted for the treatment on the patients with acute respiratory infection.Methods A randomized controlled,double-blind and double-simulationn clinical trial was conducted.Forty patients with acute respiratory infection were selectesd and divided into two groups randomly(n=20).The patients in trial group were treated with antofloxacin and placebo and the other in control group were treated with levofloxacin and placebo,q12h po.The course of treatment was 7-14 days on average.Results The results showed that there were no statistical differences between these two groups(P>0.05) in the efficay,safety and adverse reaction.Conclusions Antofloxacin hydrochloride was effective and safe for the treatment of acute respiratory infection.

  • 【文献出处】 中国抗生素杂志 ,Chinese Journal of Antibiotics , 编辑部邮箱 ,2009年05期
  • 【分类号】R56
  • 【被引频次】9
  • 【下载频次】225
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