Isaacs Kim L, Sandler Robert S, Abreu Maria, Picco Michael F, Hanauer Stephen B, Bickston Stephen J, Present Daniel, Farraye Francis A, Wolf Douglas, Sandborn William J
University of North Carolina, Chapel Hill, North Carolina 27599-7032, USA.
Inflamm Bowel Dis. 2007 Oct;13(10):1250-5. doi: 10.1002/ibd.20187.
The efficacy of the nonabsorbable antibiotic rifaximin in patients with active acute or chronic pouchitis is unknown.
We performed a placebo-controlled pilot trial to evaluate the efficacy and safety of rifaximin in patients with active pouchitis. Eighteen patients with active pouchitis were randomized to receive oral rifaximin 400 mg or placebo 3 times daily for 4 weeks. Active pouchitis was defined as a total Pouchitis Disease Activity Index (PDAI) score = 7 points. Clinical remission was defined as a PDAI score <7 points and a decrease in the baseline PDAI score = 3 points. The primary analysis was clinical remission at week 4.
Eight patients were randomized to rifaximin and 10 patients were randomized to placebo. One patient in the placebo group did not have a post-baseline efficacy evaluation and was excluded from the efficacy analysis. Two of 8 patients (25%) treated with rifaximin were in clinical remission at week 4 compared to 0 of 9 patients (0%) treated with placebo (P = 0.2059). None of 8 patients in the rifaximin group withdrew from the trial prior to week 4. Two of 9 patients in the placebo group withdrew prior to week 4 due to lack of efficacy and were categorized as treatment failures.
Clinical remission occurred more frequently in patients treated with rifaximin 400 mg 3 times daily but the difference was not significant in this pilot study. A larger trial would be required to determine if rifaximin is effective for the treatment of active pouchitis. Rifaximin was well tolerated.
不可吸收抗生素利福昔明对活动性急性或慢性袋炎患者的疗效尚不清楚。
我们进行了一项安慰剂对照的试验，以评估利福昔明对活动性袋炎患者的疗效和安全性。18例活动性袋炎患者被随机分为每日3次口服400mg利福昔明或安慰剂，疗程4周。活动性袋炎定义为袋炎疾病活动指数（PDAI）总分≥7分。临床缓解定义为PDAI评分<7分且基线PDAI评分下降≥3分。主要分析为第4周时的临床缓解情况。
8例患者被随机分入利福昔明组，10例患者被随机分入安慰剂组。安慰剂组有1例患者未进行基线后疗效评估，被排除在疗效分析之外。第4周时，利福昔明治疗的8例患者中有2例（25%）达到临床缓解，而安慰剂治疗的9例患者中无1例（0%）达到临床缓解（P = 0.2059）。利福昔明组的8例患者在第4周前均未退出试验。安慰剂组的9例患者中有2例因疗效不佳在第4周前退出，被归类为治疗失败。
每日3次服用400mg利福昔明的患者临床缓解更为常见，但在这项初步研究中差异不显著。需要进行更大规模的试验来确定利福昔明是否对治疗活动性袋炎有效。利福昔明耐受性良好。
