国产氟罗沙星注射液治疗细菌性感染的临床研究

Clinical evaluation of domestic fleroxacin injection in the treatment of bacterial infection

目的：评价氟罗沙星注射液治疗呼吸系统、泌尿系统、皮肤软组织、胆道及肠道等急性细菌性感染中的临床疗效及安全性。方法：共入选病例１６２例，其中试验组（氟罗沙星）６１例、对照组（乳酸环丙沙星）６１例、开放组（氟罗沙星）４０例。给药方法为氟罗沙星注射液每次０．２～０．４ｇ，每天１次静滴，疗程为７～１４天。结果：１０１例患者应用氟罗沙星注射液治疗的痊愈率为７６．２％，有效率为９３．１％。对照试验显示，氟罗沙星注射液治疗的临床疗效与乳酸环丙沙星注射液相当（有效率分别为９１．８％和８２．０％）；但试验组的细菌清除率（９３．８％）和细菌转阴率（９５．１％）高于对照组的细菌清除率（８５．５％）和细菌转阴率（８３．６％），不良反应发生率试验组（５．９％）略低于对照组（８．２％）。结论：氟罗沙星注射液对呼吸系统、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 fleroxacin injection compared with ciprofloxacin injection in the treatment of acute bacterial infections. Methods:A total of 162 patients enrolled in the sutdy.One hundred and one patients were evaluated for efficacy and safety of fleroxacin.Drugs were administered once a day for 7-14 days,at a daily dose of 0.2-0.4 g. Results:The overall clinical efficacy rates of fleroxacin was 93.1%(94/101).Sixty one cases of respiratory and urinary tract infections treated with fleroxacin were compared with 61 cases treated with ciprofloxacin.The clinical efficacy rates between fleroxacin and ciprofloxacin were similar(91.8% & 82.0%, P >0.05),but the bacterialogical clearance rate for fleroxacin(93.8%) was higher than that for ciprofloxacin(85.5%, P <0.05).The incidence of adverse drug reactions for fleroxacin and ciprofloxacin were 5.9% and 8.2 %,respectively. Conclusions:Fleroxacin infection is an effective and safe antibiotic for treatment of bacterial infection.