Jigaranu Anca Olivia, Nedelciuc Otilia, Blaj Andreea, Badea Mircea, Mihai Catalina, Diculescu Mircea, Cijevschi-Prelipcean Cristina
Institute of Gastroenterology and Hepatology, Iași, Romania.
Dig Dis. 2014;32(4):378-83. doi: 10.1159/000358141. Epub 2014 Jun 23.
Recent studies indicate that persistent intestinal inflammation in patients with Crohn's disease (CD) might be caused by abnormal intestinal microbiota. This hypothesis may suggest a beneficial effect of antibiotics in CD therapy. So far, guidelines do not recommend antibiotics except in the treatment of complicated CD, and there are few studies on the effects of rifaximin in these patients.
Between December 2011 and December 2012, we performed a blinded randomized trial in 168 patients with a previous history of moderately active CD concerning the efficacy of rifaximin. All the patients had previously achieved remission with standard therapy (prednisone/budesonide). Data from patients receiving 800 mg of rifaximin (83 patients) twice a day for 12 weeks were compared with those from patients who received placebo (83 patients). The primary endpoint was maintaining remission during the follow-up.
All the patients (100%; 83/83) on 800 mg of rifaximin were in remission after 12 weeks of treatment in comparison with 84% (70/83) of the placebo group. This significant difference was also persistent at the 24-week follow-up [78% (65/83) vs. 41% (34/83), respectively]. The last evaluation performed at 48 weeks revealed disease activity in 45% (38/83) of the patients of the rifaximin group, i.e. a significant decrease compared with the placebo group [75% (63 of 83)].
Remission previously obtained with standard treatment can be sustained in patients with moderately active CD after the administration of 800 mg of rifaximin.
近期研究表明，克罗恩病（CD）患者持续的肠道炎症可能由肠道微生物群异常引起。这一假说提示抗生素在CD治疗中可能具有有益作用。到目前为止，除了用于治疗复杂性CD外，指南并不推荐使用抗生素，而且关于利福昔明对这些患者疗效的研究很少。
在2011年12月至2012年12月期间，我们对168例有中度活动期CD病史的患者进行了一项关于利福昔明疗效的双盲随机试验。所有患者此前均通过标准治疗（泼尼松/布地奈德）实现了缓解。将每天两次接受800mg利福昔明治疗12周的患者（83例）的数据与接受安慰剂治疗的患者（83例）的数据进行比较。主要终点是随访期间维持缓解状态。
接受800mg利福昔明治疗的所有患者（100%；83/83）在治疗12周后均处于缓解状态，而安慰剂组为84%（70/83）。在24周随访时，这一显著差异依然存在[分别为78%（65/83）和41%（34/83）]。在48周时进行的最后评估显示，利福昔明组45%（38/83）的患者出现疾病活动，即与安慰剂组相比显著降低[75%（83例中的63例）]。
对于中度活动期CD患者，在给予800mg利福昔明后，先前通过标准治疗获得的缓解状态可以得以维持。
