加替沙星片与左氧氟沙星片随机双盲对照治疗急性细菌性感染多中心临床试验  

Randomized controlled multicenter clinical trial on gatifloxacin versus levofloxacin in the treatment of acute bacterial infections

作　　者：李家泰[1] 赵彩芸[1] 郑波[1] 薛峰[1] 赵鸣武[2] 姚婉贞[2] 张莉莎[2] 刘又宁[3] 王睿[3] 汪建新[3] 梁德荣[4] 苗佳[4] 郑莉[4] 陈楠[5] 陈晓农[5] 沈平雁[5] 邵庆翔 刘相勇 

机构地区：[1]北京大学第一医院临床药理研究所,北京100034 [2]北京大学第三医院,北京100083 [3]中国人民解放军总医院,北京100853 [4]华西医科大学附属第一医院,成都610041 [5]上海瑞金医院,上海200025 [6]浙江医学科学院药物研究所临床药理研究室,杭州310006

出　　处：《中国临床药理学杂志》2004年第1期3-7,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价加替沙星片治疗临床常见急性细菌性感染的安全性和有效性。方法本项多中心临床试验以左氧氟沙星为对照药,用随机双盲对照的试验方法。两药剂量均为200mg,每日口服2次,疗程7-14天。共入选病例280例,其中加替沙星组143例,临床疗效评价病例114例,安全性评价例数116例;左氧氟沙星组137例,临床疗效评价病例110例,安全性评价病例112例。结果两组临床总有效率分别为95.6％和91.8％,细菌清除率分别为96.1％和92.3％,药物不良反应发生率分别为10.3％与9.8％。结论加替沙星与左氧氟沙星治疗临床常见急性细菌性感染安全、有效。Objective In order to evaluate the efficacy and safety of gatifloxacin and levofloxacin in the treatment of bacterial infections. Metheds A randomized double-blind labeled controlled multicenter clinical trial was conducted for the treatment of 280 patients with respiratory tract and urinary tract infections. The dosage of both drugs was 200 mg, twice daily orally. The duration of treatment was 7-14 days in both groups. In the randomized double-blind controlled study, 143 patients were enrolled in gatifloxacin group, 116 patients were assessable for safety and 114 patients assessable for efficacy while 137 patients were enrolled in levofloxacin group, 112 patients were assessed safety and 110 patients assessed efficacy. Results The results showed that the overall efficacy rates were 95.6% for gatifloxacin group and 91.8% for levofloxacin group, the bacterial clearance rates were 96.1% and 92.3%, respectively. The incidence of adverse reaction was 10.3% and 9.8%, respectively. Conclusion Gratifloxacin and levofloxacin are both effictive and safe drugs for bacterial infections.

关 键 词：替沙星片 左氧氟沙星片 随机双盲对照 治疗 急性细菌性感染 多中心临床试验 

分 类 号：R563.1[医药卫生—呼吸系统]