Rifaximin Therapy for Patients with Irritable Bowel Syndrome without Constipation.
Rifaximin Therapy for Patients with Irritable Bowel Syndrome without Constipation.
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DOI：
10.1056/nejmoa1004409
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发表时间：
2011-01-06
影响因子：
158.5
通讯作者：
Forbes, William P.
中科院分区：
文献类型：
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作者：
Pimentel, Mark;Lembo, Anthony;Forbes, William P.
背景：有证据表明肠道菌群可能在肠易激综合征（IBS）的病理生理学中起重要作用。我们评估了利福昔明（一种吸收极少的抗生素）对IBS的治疗效果。
方法：在两项设计相同的3期双盲安慰剂对照试验（TARGET 1和TARGET 2）中，无便秘的IBS患者被随机分配接受550mg利福昔明或安慰剂治疗，每日3次，持续2周，并继续随访10周。主要终点（IBS总体症状充分缓解的患者比例）和关键次要终点（IBS相关腹胀充分缓解的患者比例）每周进行评估。充分缓解定义为在治疗后的前4周内至少有2周自我报告症状缓解。其他次要终点包括在治疗后的4周内以及整个3个月研究期间，通过每日对IBS总体症状以及腹胀、腹痛和粪便性状等个体症状的自我评估所确定的对治疗有反应的患者百分比。
结果：在治疗后的前4周内，利福昔明组IBS总体症状充分缓解的患者比例显著高于安慰剂组（TARGET 1中为40.8%对31.2%，P = 0.01；TARGET 2中为40.6%对32.2%，P = 0.03；综合为40.7%对31.7%，P……（此处原文似乎不完整）
Background: Evidence suggests that gut flora may play an important role in the pathophysiology of the irritable bowel syndrome (IBS). We evaluated rifaximin, a minimally absorbed antibiotic, as treatment for IBS.Methods: In two identically designed, phase 3, double-blind, placebo-controlled trials (TARGET 1 and TARGET 2), patients who had IBS without constipation were randomly assigned to either rifaximin at a dose of 550 mg or placebo, three times daily for 2 weeks, and were followed for an additional 10 weeks. The primary end point, the proportion of patients who had adequate relief of global IBS symptoms, and the key secondary end point, the proportion of patients who had adequate relief of IBS-related bloating, were assessed weekly. Adequate relief was defined as self-reported relief of symptoms for at least 2 of the first 4 weeks after treatment. Other secondary end points included the percentage of patients who had a response to treatment as assessed by daily self-ratings of global IBS symptoms and individual symptoms of bloating, abdominal pain, and stool consistency during the 4 weeks after treatment and during the entire 3 months of the study.Results: Significantly more patients in the rifaximin group than in the placebo group had adequate relief of global IBS symptoms during the first 4 weeks after treatment (40.8% vs. 31.2%, P=0.01, in TARGET 1; 40.6% vs. 32.2%, P=0.03, in TARGET 2; 40.7% vs. 31.7%, P