左氧氟沙星750mg注射液5日短程疗法治疗社区获得性肺炎的多中心临床研究

目的：比较左氧氟沙星750 mg注射液5 d短程疗法与500 mg注射液7-14 d常规疗法治疗社区获得性肺炎（CAP）疗效和安全性差异。方法本临床试验为随机对照、开放、非劣效性多中心临床试验。CAP患者被随机分配到左氧氟沙星750 mg组治疗5 d或500 mg组治疗7-14 d ，两组均接受静脉给药治疗，观察其临床表现、实验室检查、影像学改变及微生物学检查等，比较两组安全性和疗效差异。结果10个研究中心共入选病例241例。其中全分析集（FAS ）223例，包括750 mg组111例，500 mg组112例。符合方案分析集（PPS）211例，包括750 mg组107例，500 mg组104例。安全性分析集（SS）241例，包括750 mg组121例，500 mg组120例。FAS 750 mg组疗程中位数为5．0 d ，500 mg组疗程中位数为9．0 d。750 mg组总剂量中位数为3750 mg ，500 mg组总剂量中位数为4500 mg。FAS第4次随访750 mg组有效率为86．2％，500 mg组有效率为84．7％，两组综合疗效评价相比为非劣效。FAS 750 mg组可进行微生物疗效评价者共40例，获病原菌41株，500 mg组可行微生物疗效评价者共49例，获病原菌51株，两组细菌清除率均为100％。另外，750 mg组和500 mg组的非典型病原体的临床有效率均为100％。对750 mg组安全性观察结果显示，临床不良反应最常见为注射部位瘙痒、疼痛和充血等，其次为失眠、恶心、皮疹等。较常见的实验室指标异常为中性粒细胞比率降低、白细胞总数降低、ALT升高、AST升高等。以上不良反应多属轻微，患者可耐受，与500 mg组相比，因药物中止试验和不良反应发生率差异无统计学意义，提示两组安全性相仿。结论左氧氟沙星750 mg注射液5 d短程疗法治疗CAP与左氧氟沙星500 mg注射液7-14 d常规疗程相比，其临床和微生物疗效相仿，不良反应发生率相仿，均较轻微，患者耐受性好。

A multi-center clinical trial of levofloxacin 750 mg intravenous infusion for 5 days short-course treatment of community-acquired pneumonia

Objective To compare the efficacy and safety of levofloxacin 750 mg for 5 days versus 500 mg for 7‐14 days intravenous （IV ） infusion in the treatment of community‐acquired pneumonia （CAP ） . Methods This study was a multi‐center , randomized , open‐label , non‐inferiority , controlled clinical trial .The CAP patients were randomized to receive levofloxacin 750 mg IV daily for 5 days or levofloxacin 500 mg IV daily for 7‐14 days .The clinical symptoms , laboratory tests , imaging results and microbiology data were collected and compared between the two treatment groups in terms of efficacy and safety .Results A total of 241 patients were enrolled in this clinical trial from 10 study centers .Among these patients ,223 were eligible for full analysis set （FAS） analysis ,including 111 in 750 mg group and 112 in 500 mg group .Of the 223 patients in FAS ,211 were eligible for per‐protocol set （PPS） analysis ,including 107 in 750 mg group and 104 in 500 mg group .Two hundred and forty‐one patients were included in safety set （SS） ,including 121 patients in 750 mg group and 120 in 500 mg group .The median treatment duration was 5 .0 days in 750 mg and 9 .0 days in 500 mg group .The median total dose was 3 750 mg in 750 mg group and 4 500 mg in 500 mg group .The overall efficacy rate was 86 .2% in 750 mg group and 84 .7% in 500 mg group in terms of FAS at visit 4 ,which suggested that the efficacy of 750 mg group was non‐inferior to 500 mg group .Of the 111 FAS patients in 750 mg group ,40 were bacteriological evaluable ,and 41 strains of pathogens were isolated .Forty‐nine of the 112 FAS patients in 500 mg group were bacteriological evaluable ,and 51 bacterial strains were obtained .The bacterial eradication rate was 100% in both groups .The clinical treatment efficacy rate for atypical pathogens was 100% in both groups .In 750 mg group ,the most common clinical adverse drug reactions （ADRs） were injection site adverse reactions including injection site pruritus ,pain and hype