Taylor David N, Bourgeois A Louis, Ericsson Charles D, Steffen Robert, Jiang Zhi-Dong, Halpern Jane, Haake Robert, Dupont Herbert L
Salix Pharmaceuticals, Inc., Morrisville, North Carolina, USA.
Am J Trop Med Hyg. 2006 Jun;74(6):1060-6.
Rifaximin was compared with placebo and ciprofloxacin for treatment of travelers' diarrhea in a randomized, double-blind clinical trial. Adult travelers (N = 399) consulting travel clinics in Mexico, Guatemala, and India were randomized to receive rifaximin 200 mg three times a day, ciprofloxacin (500 mg two times a day and placebo once a day), or placebo three times a day for 3 days. Patients recorded in daily diaries the time and consistency of each stool and documented symptoms for 5 days after treatment. Stool samples were collected for microbiologic evaluations before and after treatment. The median time to last unformed stool (TLUS) in the rifaximin group (32.0 hours) was less than one half that in the placebo group (65.5 hours; P = 0.001; risk ratio 1.6; 95% confidence interval 1.2, 2.2; primary efficacy endpoint). The median TLUS in the ciprofloxacin group was 28.8 hours (P = 0.0003 versus placebo; P = 0.35 versus rifaximin). Rifaximin was less effective than ciprofloxacin for invasive intestinal bacterial pathogens. Oral rifaximin is a safe and effective treatment of travelers' diarrhea caused by noninvasive pathogens.
在一项随机双盲临床试验中，将利福昔明与安慰剂和环丙沙星用于治疗旅行者腹泻进行了比较。在墨西哥、危地马拉和印度的旅行诊所咨询的成年旅行者（N = 399）被随机分为三组，分别接受每日三次、每次200 mg的利福昔明，环丙沙星（每日两次、每次500 mg和每日一次安慰剂），或每日三次的安慰剂，疗程均为3天。患者在每日日记中记录每次粪便的时间和性状，并记录治疗后5天的症状。在治疗前后收集粪便样本进行微生物学评估。利福昔明组最后一次不成形粪便的中位时间（TLUS）为32.0小时，不到安慰剂组（65.5小时；P = 0.001；风险比1.6；95%置信区间1.2, 2.2；主要疗效终点）的一半。环丙沙星组的中位TLUS为28.8小时（与安慰剂相比，P = 0.0003；与利福昔明相比，P = 0.35）。对于侵袭性肠道细菌病原体，利福昔明的疗效不如环丙沙星。口服利福昔明是治疗由非侵袭性病原体引起的旅行者腹泻的一种安全有效的方法。
