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比较左氧氟沙星和环丙沙星治疗单纯性皮肤及皮肤结构感染的多中心随机研究。

Multicenter, randomized study comparing levofloxacin and ciprofloxacin for uncomplicated skin and skin structure infections.

作者信息

Nichols R L, Smith J W, Gentry L O, Gezon J, Campbell T, Sokol P, Williams R R

机构信息

Department of Surgery, Tulane University School of Medicine, New Orleans, La 70112, USA.

出版信息

South Med J. 1997 Dec;90(12):1193-200. doi: 10.1097/00007611-199712000-00006.

DOI:10.1097/00007611-199712000-00006
PMID:9404904
Abstract

BACKGROUND

The fluoroquinolone, levofloxacin, is active against most common pathogens in skin and skin structure infections.

METHODS

The efficacy, tolerability, and safety of levofloxacin and ciprofloxacin were compared in a randomized, open-label, multicenter trial of patients with uncomplicated skin and skin structure infections. Of 469 patients treated, 231 received levofloxacin (500 mg qd) and 238 were given ciprofloxacin (500 mg bid).

RESULTS

Overall clinical success rates (cured plus improved) for levofloxacin and ciprofloxacin were 98% and 94%, respectively (95% confidence interval [CI], -7.7, 0.7). Overall microbiologic eradication rates by patient were 98% in the levofloxacin group and 89% in the ciprofloxacin group (95% CI, -14.5, -2.7), whereas eradication rates by pathogen were 98% and 90%, respectively (95% CI, -12.6, -3.7). The eradication rate for Staphylococcus aureus was 100% in the levofloxacin group and 87% in the ciprofloxacin group (95% CI, -20.2, -5.1). Treatment-emergent adverse events were comparable, with drug-related adverse events reported in 6% of levofloxacin patients and 5% of ciprofloxacin patients.

CONCLUSIONS

Levofloxacin is as effective and safe as ciprofloxacin in the treatment of uncomplicated skin and skin structure infections.

摘要

背景

氟喹诺酮类药物左氧氟沙星对皮肤及皮肤结构感染的大多数常见病原体具有活性。

方法

在一项针对非复杂性皮肤及皮肤结构感染患者的随机、开放标签、多中心试验中,比较了左氧氟沙星和环丙沙星的疗效、耐受性及安全性。在469例接受治疗的患者中,231例接受左氧氟沙星(每日500毫克)治疗,238例接受环丙沙星(每日两次,每次500毫克)治疗。

结果

左氧氟沙星和环丙沙星的总体临床成功率(治愈加改善)分别为98%和94%(95%置信区间[CI],-7.7, 0.7)。按患者计算,左氧氟沙星组的总体微生物清除率为98%,环丙沙星组为89%(95% CI,-14.5, -2.7),而按病原体计算的清除率分别为98%和90%(95% CI,-12.6, -3.7)。左氧氟沙星组金黄色葡萄球菌的清除率为100%,环丙沙星组为87%(95% CI,-20.2, -5.1)。治疗中出现的不良事件相当,左氧氟沙星组6%的患者和环丙沙星组5%的患者报告了与药物相关的不良事件。

结论

在治疗非复杂性皮肤及皮肤结构感染方面,左氧氟沙星与环丙沙星同样有效且安全。

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