Childs S J
Brookwood Medical Center, Birmingham, Alabama 35209.
Am J Med. 1993 Mar 22;94(3A):105S-107S.
Fleroxacin, 400 mg once daily, and norfloxacin, 400 mg twice daily, both administered orally, were compared for the treatment of serious urinary tract infections (UTIs). In total, 301 patients from multiple centers who had serious UTIs were randomized to receive fleroxacin or norfloxacin in a double-blind study. The demographic parameters of the two groups were similar. A total of 190 patients were evaluable for efficacy, 94 in the fleroxacin group and 96 in the norfloxacin group. The reasons for exclusion from the efficacy analysis were not significantly different in the two groups, but more patients receiving fleroxacin were prematurely withdrawn from the study. The majority (134) of the diagnoses were complicated UTI, and the pathogens were primarily Enterobacteriaceae. The clinical responses were cure or improvement in 98% of the fleroxacin group and 92% of the norfloxacin group and failure in 2% of the fleroxacin group and 7% of the norfloxacin group. The bacteriologic results by infection were cure in 98% of the fleroxacin group and 89% of the norfloxacin group (including cure with superinfection in 4% of the fleroxacin group and 5% of the norfloxacin group) and failure in 2% of the fleroxacin group and 11% of the norfloxacin group. Adverse events were more common in the fleroxacin group and were mostly nausea, insomnia, and headache. Fleroxacin, 400 mg once daily, was as effective as norfloxacin, 400 mg twice daily, in eradicating UTIs but was associated with more adverse events.
对氟罗沙星（每日一次，每次400毫克）和诺氟沙星（每日两次，每次400毫克）口服治疗严重尿路感染（UTI）的效果进行了比较。在一项双盲研究中，来自多个中心的301例患有严重UTI的患者被随机分配接受氟罗沙星或诺氟沙星治疗。两组的人口统计学参数相似。共有190例患者可进行疗效评估，氟罗沙星组94例，诺氟沙星组96例。两组中被排除在疗效分析之外的原因无显著差异，但接受氟罗沙星治疗的患者中有更多人提前退出研究。大多数（134例）诊断为复杂性UTI，病原体主要为肠杆菌科细菌。氟罗沙星组98%、诺氟沙星组92%的临床反应为治愈或改善，氟罗沙星组2%、诺氟沙星组7%的临床反应为失败。按感染情况的细菌学结果显示，氟罗沙星组98%、诺氟沙星组89%治愈（氟罗沙星组4%、诺氟沙星组5%包括重叠感染治愈），氟罗沙星组2%、诺氟沙星组11%治疗失败。氟罗沙星组的不良事件更为常见，主要是恶心、失眠和头痛。每日一次服用400毫克氟罗沙星在根除UTI方面与每日两次服用400毫克诺氟沙星效果相当，但不良事件更多。
