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利福昔明 550 毫克预防干燥季节墨西哥旅行者腹泻的随机、双盲、初步研究。

A randomized, double-blind, pilot study of rifaximin 550 mg versus placebo in the prevention of travelers' diarrhea in Mexico during the dry season.

机构信息

Center for Infectious Diseases, School of Public Health, The University of Texas Health Science Center at Houston, TX, USA.

出版信息

J Travel Med. 2011 Sep-Oct;18(5):333-6. doi: 10.1111/j.1708-8305.2011.00549.x. Epub 2011 Aug 1.

DOI:10.1111/j.1708-8305.2011.00549.x
PMID:21896097
Abstract

BACKGROUND

Rifaximin has been shown to be effective in treating and preventing travelers' diarrhea (TD) during the summer season.

METHODS

The goal of this double-blinded multicenter trial was to assess the efficacy and safety of rifaximin 550 mg administered once daily for 14 days compared with placebo in the prevention of TD during the dry season in Mexico.

RESULTS

There were 101 participants randomized. Overall, 25 participants developed TD during the 3 weeks of the study: 22% from the rifaximin group and 29% from the placebo group (p = 0.4). Mild diarrhea (defined as only one or two unformed stools during a 24-h period plus at least one abdominal symptoms) developed in only 3 (6%) participants taking rifaximin compared with 10 (21%) taking placebo during the first week of study (p = 0.03). No clinically significant or serious adverse events were reported.

CONCLUSIONS

Antibiotic prophylaxis of TD in Mexico during the dry season needs to be further studied and its benefits weighed against the benefits of self-treatment.

摘要

背景

利福昔明已被证明可有效治疗和预防夏季旅行者腹泻(TD)。

方法

本双盲多中心试验的目的是评估利福昔明 550mg 每日一次给药 14 天与安慰剂在预防墨西哥旱季 TD 中的疗效和安全性。

结果

共有 101 名参与者被随机分配。总体而言,在研究的 3 周内,有 25 名参与者出现 TD:利福昔明组 22%,安慰剂组 29%(p=0.4)。仅在研究的第一周,服用利福昔明的 3 名(6%)参与者出现轻度腹泻(定义为 24 小时内只有一到两次不成形的粪便,加上至少一种腹部症状),而服用安慰剂的 10 名(21%)参与者出现轻度腹泻(p=0.03)。未报告临床显著或严重不良事件。

结论

需要进一步研究在墨西哥旱季使用抗生素预防 TD,并权衡其益处与自我治疗的益处。

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