利福昔明与环丙沙星治疗急性感染性腹泻的疗效比较：一项随机对照多中心研究。
Efficacy of rifaximin compared with ciprofloxacin for the treatment of acute infectious diarrhea: a randomized controlled multicenter study.
机构信息
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
出版信息
Gut Liver. 2010 Sep;4(3):357-62. doi: 10.5009/gnl.2010.4.3.357. Epub 2010 Sep 24.
BACKGROUND/AIMS: Ciprofloxacin has been widely prescribed for acute infectious diarrhea. However, the resistance to this drug is increasing. Rifaximin is a novel but poorly absorbed rifamycin derivative. This study evaluated and compared the efficacies of rifaximin and ciprofloxacin for the treatment of acute infectious diarrhea.
METHODS
We performed a randomized controlled multicenter study in Korea. Patients with acute diarrhea were enrolled and randomized to receive rifaximin or ciprofloxacin for 3 days. The primary efficacy endpoint was the time to last unformed stool (TLUS). Secondary endpoints were enteric wellness (reduction of at least 50% in the number of unformed stools during 24-hour postenrollment intervals), general wellness (subjective feeling of improvement), and proportion of patients with treatment failure.
RESULTS
Intent-to-treat analysis (n=143) showed no significant difference between the rifaximin and ciprofloxacin groups in the mean TLUS (36.1 hours vs 43.6 hours, p=0.163), enteric wellness (49% vs 57%, p=0.428), general wellness (67% vs 78%, p=0.189), or treatment failure rate (9% vs 12%, p=0.841). The adverse events did not differ significantly between the two groups.
CONCLUSIONS
These results suggest that rifaximin is as safe and effective as ciprofloxacin in the treatment of acute infectious diarrhea.
背景/目的：环丙沙星被广泛用于治疗急性感染性腹泻。然而，该药的耐药性正在增加。利福昔明是一种新型但吸收不良的利福霉素衍生物。本研究评估并比较了利福昔明和环丙沙星治疗急性感染性腹泻的疗效。
方法
我们在韩国进行了一项随机对照多中心研究。招募了急性腹泻患者，并随机分为利福昔明组或环丙沙星组，分别接受 3 天治疗。主要疗效终点是末次不成形粪便时间（TLUS）。次要终点包括肠道舒适度（24 小时内至少减少 50%不成形粪便次数）、整体舒适度（主观改善感）和治疗失败患者比例。
结果
意向治疗分析（n=143）显示，利福昔明组和环丙沙星组的平均 TLUS（36.1 小时 vs 43.6 小时，p=0.163）、肠道舒适度（49% vs 57%，p=0.428）、整体舒适度（67% vs 78%，p=0.189）或治疗失败率（9% vs 12%，p=0.841）均无显著差异。两组的不良反应无显著差异。
结论
这些结果表明，利福昔明治疗急性感染性腹泻的安全性和疗效与环丙沙星相当。
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