甲磺酸加替沙星氯化钠注射液治疗细菌感染随机双盲对照临床研究

A Randomized Double-blind Controlled Clinical Trial of Gatifloxacin Versus Levofloxacin in the Treatment of Acute Bacterial Infections

目的 对甲磺酸加替沙星氯化钠注射液治疗常见致病菌引起的呼吸系统、泌尿系统细菌感染性疾病的临床疗效和安全性进行评价。方法 采用随机双盲对照试验设计，以盐酸左氧氟沙星氯化钠注射液作为对照药。给药方法：甲磺酸加替沙星氯化钠注射液，400me／次，qd，静滴时问不少于2h。盐酸左氧氟沙星氯化钠注射液，200rag／次，每12h 1次，静滴时问不少于1h。疗程：下呼吸道感染疗程7—14d,泌尿系统感染疗程5—14d。结果 试验组、对照组各20例。试验组与对照组总有效率和痊愈率分别为85％、60％和90％、65％；细菌清除率分别为77.8％和87．5％；不良反应发生率均为5％。以上结果统计学比较均无显著性差异（P＞0.05）。结论甲磺酸加替沙星氯化钠注射液治疗临床常见致病菌引起的呼吸系统、泌尿系统感染临床疗效肯定，不良反应率较低，与盐酸左氧氟沙星氯化钠注射液作用相似。

Aim To evaluate the clinical efiqcacy and safety of gatifloxacin methanesulfonate in treatment of acute respiratory and urinary system bacterial infections. Methods A randomized double- blind controlled clinical trial was conducted of intravenous gatifloxacin in patients with respiratory tract infections or urinary system infections. Levofloxacin was used as the controlled drug. Dosage： gatifloxacin, 400rag, qd. and levofloxacin, 200mg, bid. 5 - 14 days. The duration of intravenous injection was not less than two hours for gatifloxacin and one hour for levofloxacin. Results In this trial, 20 patients were enrolled in the gatifloxacin group, 20 patients in the levofloxacin group. The overal efiqcacy rate and cure rate in the trial group and control group were 85% ,60% and 90% ,65% ; respectively. The rates of bacterial clearance was 77.8 % and 87.5 %, respectively. The rates of adverse drug reaction were 5 % in two groups. There was no statistically significant difference in the above results between the trial group and the control group （ P 〉 0.05）. Conclusion The clinical efficacy and adverse drug reaction of treatment using gatifloxacin methanesulfonate infusion in respiratory and urinary system infections were similar to those produced by Levofloxacin hydrochloride infusion.