加替沙星与左氧沙星治疗细菌感染的多中心随机对照临床研究  

Randomized controlled multicentre clinical trial of gatifloxacin versus levofloxacin in the treatment of acute bacterial infection

作　　者：刘又宁[1] 王睿[2] 余秉翔[1] 段蕴铀[3] 高和[4] 张洪玉[5] 孙铁英[6] 张建鹏[7] 王洪武[3] 张沂[3] 张歆刚[1] 刘庆锋[1] 樊毫军[7] 柴栋[2] 

机构地区：[1]解放军总医院呼吸科,北京100853 [2]解放军总医院临床药理研究室,北京100853 [3]海军总医院呼吸科,北京100037 [4]空军总医院呼吸科,北京100036 [5]北京朝阳医院呼吸科,北京100020 [6]北京医院呼吸科,北京100730 [7]武警总医院呼吸科,北京100039

出　　处：《中国临床药理学杂志》2004年第5期345-350,共6页The Chinese Journal of Clinical Pharmacology

摘　　要：目的　评价新药甲磺酸加替沙星注射液治疗常见致病菌引起的呼吸、泌尿系统细菌感染性疾病的疗效和安全性。方法　以盐酸左氧沙星注射液为对照药,用多中心随机双盲阳性对照平行试验设计。结果　甲磺酸加替沙星注射液组治疗呼吸道和泌尿系统感染的临床痊愈率和有效率分别为68.97%和91.95%,79.31%和93.10%;细菌阴转率为95.65%,药物不良反应发生率为5.51%。2组比较差异均无统计学意义。结论　甲磺酸加替沙星注射液治疗临床常见致病菌引起的呼吸和泌尿系统感染临床疗效较好,药物不良反应率较低,与盐酸左氧氟沙星注射液相似。Objective To compare the efficacy and safety of gatifloxacinmethanesulfonate versus levofloxacin hydrochoric in treatment of acute respiratoryand urinary system bacterial infections. Methods Levofloxacin hydrochoric wasused as control drug and a randomized controlled multicentre clinical trial wasconducted to evaluate the efficacy and safety of gatifloxacin and levofloxaxin againstacute bacterial infection. Results The cure and efficacy rate against respiratory andurinary system bacterial infections in the gatifloxacin (trial group) were 68.97%,91.95% and 79.31%, 93.10% respectively, and the bacterial clearance ratewas 95.65%, 83.33%.The bacterial clearance rate was 92.19% and the adversedrug reaction rate was 5.51%. The difference between the two groups was nostatistically significant. No serious adverse drug reaction was found during thetreatment. Conclusion Gatifloxacin methanesulfonate infusion was effective andsafe in treatment of acute respiratory and urinary system bacterial infections.

关 键 词：甲磺酸加替沙星注射液 盐酸左氧氟沙星注射液 细菌性感染 

分 类 号：R563.1[医药卫生—呼吸系统] R978.19[医药卫生—内科学]