莫西沙星治疗皮肤细菌感染随机双盲对照临床研究

A Randomized Double-blind Control Clinical Study on Moxifloxacin for Treatment of Bacterial Skin Infections

目的:比较每日po 1次莫西沙星400 mg与每日po 2次左旋氧氟沙星200 mg,治疗轻中度急性无合并症皮肤细菌感染(包括蜂窝织炎、脓疱病、疖、单纯脓肿和伤口感染)的安全性和有效性。方法:用随机、双盲、平行研究,共入选88例患者,试验组和对照组各44例。疗程7～14天,主要疗效参数为治疗结束后第1,第7天的临床疗效。结果:在治疗结束后第1天,莫西沙星组与左旋氧氟沙星组临床有效率分别为84.6％(33/39),85.0％(34/40);细菌学清除率分别为93.8％(30/32),93.9％(31/33)。在治疗结束后第7天莫西沙星组与左旋氧氟沙星组临床有效率分别为85.3％(29/34),90.0％(36/40);细菌学清除率分别为92.9％(26/28),93.9％(31/33)。莫西沙星组药物不良反应发生率为27.3％(12/44),左旋氧氟沙星组为11.4％(5/44)。两组差异均无统计学意义。结论:莫西沙星治疗轻中度急性无合并症皮肤细菌感染有效安全。

OBJECTIVE: To evaluate the efficacy and safety of moxifloxacin in comparison with the levofloxacin in the treatment of patients with acute uncomplicated bacterial skin infections( including cellulitis, erysipelas, impetigo, furuncles, simple abscesses, wound infection).METHODS: A randomized, double-blind, parallel study was conducted. Treatment will be given for 7 to 14 days. The primary efficacy variable will be the clinical response 1 day and 7 days after end of treatment. RESULTS: Eighty-eight subjects were included, 44 subjects in the trial group (moxifloxacin) and 44 in the control group(levofloxacin). The clinical efficacy rates in the trial group at 1 day after end of treatment was 84.6%(33/39), the bacterial clearance rate was 93.8%(30/32), while in the control group were 85.0%(34/40) and 93.9%(31/33),respectively. The clinical efficacy rates in the trial group at 7 days after end of treatment was 85.3%(29/34). The bacterial clearance rate was 92.9%(26/ 28), while in the control group were 90.0%(36/40) and 93.9%(31/33),respectively. The adverse reaction rate in the trial group was 27.3%( 12/44), while in the control group was 11.4%(5/44). The difference between the two groups were no statistically significant. CONCLUSION: It suggested that moxifloxacin is an effective and safe drug for acute uncomplicated bacterial skin infections.