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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 被引量:10

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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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。 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.
出处 《中国抗生素杂志》 CAS CSCD 北大核心 2009年第5期316-318,I0002,共4页 Chinese Journal of Antibiotics
关键词 盐酸安妥沙星片剂 盐酸左氧氟沙星片剂 急性呼吸道感染 随机对照试验 双盲法 双模拟临床试验 Antofloxacin hydrochloride Levofloxacin hydrochloride Acute respiratory infection Randomized controlled Double-blind Double-simulation clinical trial
作者简介 杨春,女,生于1974年,讲师,医学硕士。主要从事抗感染药物的临床研究。E-mail:chunyang678@163.com
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