甲磺酸帕珠沙星治疗呼吸道和泌尿道细菌性感染的多中心双盲随机对照临床研究

目的 评价国产注射用甲磺酸帕珠沙星治疗呼吸道和泌尿道细菌感染的临床疗效和安全性。方法 采用多中心双盲随机对照试验设计，以注射用盐酸左氧氟沙星为对照药，试验组用甲磺酸帕珠沙星注射剂每次0．5g．每日2次，静脉滴注；对照组用盐酸左氧氟沙星注射剂每次0．3g，每天2次，静脉滴注．疗程7～14d。结果 本研究共人选病例252例．脱落4例．剔除8例，可评价病例240例．试验组120例，对照组120例。试验组与对照组的痊愈率分别为77．50％和74．17％，总有效率分别为98．33％和96．67％，细菌清除率分别为96．97％和95．70％，不良反应率分别为4．03％和2．42％。结论 国产注射用甲磺酸帕珠沙星治疗呼吸道和泌尿道细菌性感染疗效确切．安全性好。

Clinical randomized controlled trials of pazufloxacin for injection in the treatment of respiratory tract and urinary tract bacterial infections

Objective To evaluate the efficacy and safety of pazufloxacin for injection in the treatment of respiratory tract and urinary tract bacterial infections.Methods A multicenter double-blind randomized controlled clinical study was conducted to compare the efficacy and safety with that of levofloxacin.Pazufloxacin and levofloxacin were administered intravenously at a dosage of 500mg and 200mg respectively twice daily for 7~14 days.Results Two hundred and fifty-two patients were enrolled in the study,but 12 cases were excluded.Two hundred and fourty patients were divided into pazufloxacin and levofloxacin groups.The cure rates and overall clinical efficacious rates were 77.50% and 98.33% in the pazufloxacin group,and 74.17% and 96.67% in the levofloxacin group respectively.The bacterial clearance rates of the two groups were 96.97% and 95.70% respectively.The incidence of adverse drug reactions of pazufloxacin was 4.03% while that of levofloxacin was 2.42%.Conclusion Domestic pazufloxacin for injection is effective and safe for the treatment of acute respiratory tract and urinary tract infections.