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一项多中心、双盲、随机研究,比较口服左氧氟沙星与环丙沙星治疗单纯性皮肤及皮肤结构感染的疗效和安全性。

A multicentre, double-blind, randomised study comparing the efficacy and safety of oral levofloxacin versus ciprofloxacin in the treatment of uncomplicated skin and skin structure infections.

作者信息

Nicodemo A C, Robledo J A, Jasovich A, Neto W

机构信息

Hospital das Clínicas, Universidade de São Paulo, Brazil.

出版信息

Int J Clin Pract. 1998 Mar;52(2):69-74.

PMID:9624783
Abstract

A multicentre, randomised, double-blind trial in Latin America compared oral levofloxacin 500 mg once daily for 7 days with oral ciprofloxacin 500 mg twice daily for 10 days in 272 patients with uncomplicated skin and skin structure infections. Among 253 subjects evaluable for clinical efficacy (129 levofloxacin, 124 ciprofloxacin), clinical success (cure and improvement) was observed in 96.1% of levofloxacin-treated patients and in 93.5% of ciprofloxacin-treated patients. Overall, bacteriological eradication rates by pathogen were 93.2% and 91.7%, respectively. Levofloxacin eradicated 94% (66/70) of Staphylococcus aureus and 94% (17/18) of Streptococcus pyogenes isolates, compared with 93% (70/75) and 92% (12/13) for ciprofloxacin. Microbiological eradication rates by subject were approximately 93% and 90% for the levofloxacin and ciprofloxacin groups, respectively. Drug-related adverse events were reported by 8.9% of those receiving levofloxacin and 8.2% of those administered ciprofloxacin. Findings support the efficacy of oral levofloxacin for uncomplicated skin and skin structure infections due to S. aureus and S. pyogenes.

摘要

在拉丁美洲进行的一项多中心、随机、双盲试验,对272例无并发症的皮肤及皮肤结构感染患者,比较了每日口服1次500mg左氧氟沙星,疗程7天,与每日口服2次500mg环丙沙星,疗程10天的疗效。在253例可评估临床疗效的受试者中(129例接受左氧氟沙星治疗,124例接受环丙沙星治疗),左氧氟沙星治疗组临床成功率(治愈和改善)为96.1%,环丙沙星治疗组为93.5%。总体而言,按病原体计算的细菌清除率分别为93.2%和91.7%。左氧氟沙星清除了94%(66/70)的金黄色葡萄球菌分离株和94%(17/18)的化脓性链球菌分离株,而环丙沙星分别为93%(70/75)和92%(12/13)。左氧氟沙星组和环丙沙星组按受试者计算的微生物清除率分别约为93%和90%。接受左氧氟沙星治疗的患者中有8.9%报告了与药物相关的不良事件,接受环丙沙星治疗的患者中有8.2%报告了此类事件。研究结果支持口服左氧氟沙星对由金黄色葡萄球菌和化脓性链球菌引起的无并发症皮肤及皮肤结构感染的疗效。

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