Gastroenterology Unit, San Camillo Forlanini Hospital, Rome, Italy.
Gastroenterology. 2012 Mar;142(3):473-481.e4. doi: 10.1053/j.gastro.2011.11.032. Epub 2011 Dec 6.
BACKGROUND & AIMS: Bacteria might be involved in the development and persistence of inflammation in patients with Crohn's disease (CD), and antibiotics could be used in therapy. We performed a clinical phase 2 trial to determine whether a gastroresistant formulation of rifaximin (extended intestinal release [EIR]) induced remission in patients with moderately active CD.
We performed a multicenter, randomized, double-blind trial of the efficacy and safety of 400, 800, and 1200 mg rifaximin-EIR, given twice daily to 402 patients with moderately active CD for 12 weeks. Data from patients given rifaximin-EIR were compared with those from individuals given placebo, and collected during a 12-week follow-up period. The primary end point was remission (Crohn's Disease Activity Index <150) at the end of the treatment period.
At the end of the 12-week treatment period, 62% of patients who received the 800-mg dosage of rifaximin-EIR (61 of 98) were in remission, compared with 43% of patients who received placebo (43 of 101) (P = .005). A difference was maintained throughout the 12-week follow-up period (45% [40 of 89] vs 29% [28 of 98]; P = .02). Remission was achieved by 54% (56 of 104) and 47% (47 of 99) of the patients given the 400-mg and 1200-mg dosages of rifaximin-EIR, respectively; these rates did not differ from those of placebo. Patients given the 400-mg and 800-mg dosages of rifaximin-EIR had low rates of withdrawal from the study because of adverse events; rates were significantly higher among patients given the 1200-mg dosage (16% [16 of 99]).
Administration of 800 mg rifaximin-EIR twice daily for 12 weeks induced remission with few adverse events in patients with moderately active CD.
细菌可能参与了克罗恩病（CD）患者炎症的发生和持续，抗生素可用于治疗。我们进行了一项临床 2 期试验，以确定利福昔明（延长肠释放[EIR]）的胃耐制剂是否能诱导中度活跃 CD 患者缓解。
我们进行了一项多中心、随机、双盲试验，评估 400、800 和 1200 mg 利福昔明-EIR 的疗效和安全性，将其每日两次给予 402 例中度活跃 CD 患者，治疗 12 周。接受利福昔明-EIR 治疗的数据与接受安慰剂的患者进行比较，并在 12 周的随访期间收集。主要终点是治疗期末的缓解（克罗恩病活动指数<150）。
在 12 周的治疗期末，接受 800 mg 利福昔明-EIR 治疗的患者中有 62%（98 例中的 61 例）处于缓解状态，而接受安慰剂的患者中有 43%（101 例中的 43 例）（P=0.005）。在整个 12 周的随访期间，这种差异一直存在（45%[89 例中的 40 例]与 29%[98 例中的 28 例]；P=0.02）。接受 400 mg 和 1200 mg 利福昔明-EIR 治疗的患者缓解率分别为 54%（104 例中的 56 例）和 47%（99 例中的 47 例）；这些比率与安慰剂组无差异。接受 400 mg 和 800 mg 利福昔明-EIR 治疗的患者因不良反应退出研究的比例较低；接受 1200 mg 利福昔明-EIR 治疗的患者退出研究的比例显著更高（16%[99 例中的 16 例]）。
每日两次给予 800 mg 利福昔明-EIR 治疗 12 周可诱导中度活跃 CD 患者缓解，且不良反应少。
