国产左旋氧氟沙星治疗细菌性感染的疗效评价  

Clinical evaluation of domestic levofloxacin chloride injection in the treatment of bacterial infection

作　　者：施毅[1,2] 夏锡荣[1,2] 印洁[1,2] 童茂荣[1,2] 马宏青[1,2] 朱维铭[1,2] 邵海枫[1,2] 李珍大[1,2] 

机构地区：[1]南京军区南京总医院 [2]解放军医学检验中心微生物室

出　　处：《医学研究生学报》1999年第3期5-9,共5页Journal of Medical Postgraduates

摘　　要：目的：评价国产盐酸左旋氧氟沙星注射液对呼吸、泌尿等系统急性细菌性感染的临床疗效及安全性。方法：１６２例患者随机分为左旋氧氟沙星治疗组６１例、氧氟沙星对照组６１例和开放组（左旋氧氟沙星）４０例。给药方法为左旋氧氟沙星注射液０．１～０．２ｇ，静滴，２次／ｄ；氧氟沙星注射液０．２～０．４ｇ，静滴，２次／ｄ；一个疗程为７～１４天。结果：左旋氧氟沙星治疗１０１例各种细菌性感染的有效率为９６．０％（９７／１０１），细菌清除率为９１．８％（８９／９７）。对照研究显示，左旋氧氟沙星的临床疗效与氧氟沙星相当（有效率分别为９６．７％和９３．５％，Ｐ＞０．０５），细菌清除率治疗组（８９．５％）与对照组（８９．５％）相同（Ｐ＞０．０５）。不良反应发生率治疗组（１１．５％）略低于对照组（１４．８％）（Ｐ＞０．０５）。结论：国产盐酸左旋氧氟沙星注射液对呼吸、泌尿系统等部位的急性细菌性感染有效而安全。Objectives: To evaluate the efficacy and safety of domastic levofloxacin chloride injection in the treatment of acute bacterial infections. Methods: A total of 162 patients were enrolled in the study. Sixtyone cases of respiratory and urinary tract infections treated with levofloxacin chloride were compared with 61 cases treated with ofloxacin. Forty cases of other tissue infections were treated with levofloxacin chloride. Drugs were administered intravenously twice daily for 714 days, at a daily dose of either 0.20.4 g of levofloxacin or 0.40.8 g of ofloxacin. Results: The overall clinical efficacy rate and the bacteriological clearance rate of levofloxacin was 96.0% (97/101) and 91.8%(89/97),respectively. Randomized controlled trial showed that clinical efficacy rates between levofloxacin and ofloxacin were similar (96.7% & 93.5%, P>0.05), the bacteriological clearance rate for levofloxacin (89.5%) was the same as that of ofloxacin (89.5%, P>0.05) The incidence of adverse drug reactions for levofloxacin and ofloxacin were 11.5% and 14.8%, respectively (P>0.05). Conclusions: Levofloxacin injection is an effective and safe antibiotics for the treatment of bacterial infections.

关 键 词：随机对照试验 细菌性感染 左旋氧氟沙星 氧氟沙星 

分 类 号：R978.1[医药卫生—药品]