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一项评估利福昔明预防派往土耳其因吉尔利克空军基地的美国军人旅行者腹泻的疗效和安全性的随机、双盲、安慰剂对照研究。

A randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of rifaximin for the prevention of travelers' diarrhea in US military personnel deployed to Incirlik Air Base, Incirlik, Turkey.

机构信息

Naval Medical Research Unit No. 3, Cairo, Egypt.

出版信息

J Travel Med. 2010 Nov-Dec;17(6):392-4. doi: 10.1111/j.1708-8305.2010.00462.x.

DOI:10.1111/j.1708-8305.2010.00462.x
PMID:21050319
Abstract

BACKGROUND

Infectious diarrhea is an important problem among travelers and deployed US military overseas causing substantial morbidity due to acute illness and may result in burdensome postinfectious sequelae.

METHODS

The nonsystemic antibiotic rifaximin was evaluated for prevention of travelers' diarrhea (TD) in a US military and civilian adult beneficiary population in a randomized, double-blind, placebo-controlled clinical trial. In all, 100 volunteers deployed to Incirlik Air Base, Turkey, received rifaximin 1,100 mg once daily or placebo for 2 weeks, and participants were followed daily for 2 weeks.

RESULTS

In an intention to treat analysis (n = 95), TD (based on subjects meeting case definition or early treatment) developed in 6.3% (3 of 48) of the rifaximin group compared with 19.2% (9 of 47) in the placebo group (Fisher's exact test p = 0.07). Rifaximin provided 67% (95% confidence interval, -13% to 91%, p = 0.07) protection against TD. Rifaximin 1,100 mg once daily was well tolerated with no observed differences in adverse events, whether solicited or unsolicited among the two treatment groups.

CONCLUSIONS

Rifaximin may represent an option among military personnel on deployment for prevention of TD with supportive future studies that consider deployment length, settings, and operational situations where widespread use of chemoprophylaxis may increase force health protection without undue risk during critical deployments.

摘要

背景

感染性腹泻是旅行者和海外部署的美国军人的一个重要问题,由于急性疾病导致发病率较高,并可能导致令人烦恼的感染后后遗症。

方法

非系统性抗生素利福昔明在一项针对美国军人和文职成年受益人的随机、双盲、安慰剂对照临床试验中,被评估用于预防旅行者腹泻(TD)。共有 100 名志愿者部署到土耳其因吉尔利克空军基地,接受利福昔明 1100mg 每日 1 次或安慰剂治疗 2 周,参与者在接下来的 2 周内每日随访。

结果

在意向治疗分析(n=95)中,利福昔明组(根据符合病例定义或早期治疗的受试者)TD(腹泻)发生率为 6.3%(48 人中 3 例),安慰剂组为 19.2%(47 人中 9 例)(Fisher 精确检验,p=0.07)。利福昔明对 TD 的保护率为 67%(95%置信区间,-13%至 91%,p=0.07)。利福昔明 1100mg 每日 1 次治疗耐受性良好,两组之间无论是否有症状,不良事件均无明显差异。

结论

利福昔明可能是部署军人预防 TD 的选择之一,未来的研究需要考虑部署时间、环境以及可能增加部队卫生保护的化学预防措施广泛使用的情况,同时在关键部署期间不会带来不必要的风险。

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