高剂量左氧氟沙星静脉制剂治疗呼吸道感染的临床研究

Clinical study on high dosage levofloxacin veno-preparation for the treatment of respiratory tract infections

目的在中国人群验证左氧氟沙星500mg静脉制剂治疗呼吸道感染的安全性和有效性。方法前瞻性、多中心临床研究。结果研究共纳入49所医院的1746例下呼吸道感染的患者,左氧氟沙星的用法用量为500mgIVOD,平均疗程8.9天。左氧氟沙星500mg每日一次给药治疗常见下呼吸道感染的临床有效率为91.55%,细菌清除率为72.28%,临床不良反应发生率为7.67%,主要为轻度胃肠道反应和中枢神经系统反应,3.78%的患者出现实验室检查异常,主要为白细胞一过性减少和肝功能一过性异常。结论左氧氟沙星500mg/d能有效地治疗下呼吸道感染,患者耐受性好、安全性高。

Objective To evaluate the efficacy and safety of levofloxacin （LVFX） 500mg veno-preparation （IV） for treatment of respiratory tract infections （RTI） in Chinese population. Methods A prospective, multiple centers, open trial was conducted. Results Forty-nine hospitals joined this study and 1746 patients with RTI were enrolled. Average course of treatment with LVFX （500mg IV OD） was 8.94 days. The results showed that LVFX （500mg IV OD） could reach the total clinical efficacy of 91.55% and the bacterium eradication rate of 72.28%. Safety assessment showed that clinical adverse reaction rate were 7.67%, such as lightly gastrointestinal reactions and central nervous system reactions. Besides, 3.78% patients were reported to have lab abnormal, such as temporary white blood cell decrease and hepatic dysfunction. Adverse drug reactions reported in this study were identical with many international reports. Conclusions LVFX 500mg OD administration was effective in the treatment of RTI with high tolerance and safety.