Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
Gastroenterology. 2019 Apr;156(5):1324-1332.e3. doi: 10.1053/j.gastro.2018.12.019. Epub 2019 Jan 2.
BACKGROUND & AIMS: Fecal microbiota transplantation (FMT) is recommended for treatment of recurrent Clostridium difficile infection (rCDI). We performed a single-center randomized trial to compare the effects of FMT with those of fidaxomicin and vancomycin.
We studied consecutive adults with rCDI seen at a gastroenterology clinic in Denmark from April 5, 2016 through June 10, 2018. Patients were randomly assigned to a group that received FMT, applied by colonoscopy or nasojejunal tube, after 4-10 days of vancomycin (125 mg 4 times daily; FMTv; n = 24), 10 days of fidaxomicin (200 mg twice daily; n = 24), or 10 days of vancomycin (125 mg 4 times daily; n = 16). Patients who had rCDI after this course of treatment and patients who could not be randomly assigned to groups were offered rescue FMTv. The primary outcome was combined clinical resolution and a negative result from a polymerase chain reaction test for Clostridium difficile (CD) toxin 8 weeks after the allocated treatment. Secondary end points included clinical resolution at week 8.
All 64 patients received their assigned treatment. The combination of clinical resolution and negative results from the test for CD were observed in 17 patients given FMTv (71%), 8 patients given fidaxomicin (33%), and 3 patients given vancomycin (19%; P = .009 for FMTv vs fidaxomicin; P = .001 for FMTv vs vancomycin; P = .31 for fidaxomicin vs vancomycin). Clinical resolution was observed in 22 patients given FMTv (92%), 10 patients given fidaxomicin (42%), and 3 patients given vancomycin (19%; P = .0002; P < .0001; P = .13). Results did not differ significantly between patients who received FMTv as their initial therapy and patients who received rescue FMTv. There was 1 serious adverse event that might have been related to FMTv.
In a randomized trial of patients with rCDI, we found the FMTv combination superior to fidaxomicin or vancomycin based on end points of clinical and microbiological resolution or clinical resolution alone. ClinicalTrials.gov, number NCT02743234; EudraCT, j.no 2015-003004-24.
粪便微生物群移植（FMT）被推荐用于治疗复发性艰难梭菌感染（rCDI）。我们进行了一项单中心随机试验，比较了 FMT 与 fidaxomicin 和万古霉素的疗效。
我们研究了 2016 年 4 月 5 日至 2018 年 6 月 10 日期间在丹麦一家胃肠病诊所就诊的连续 rCDI 成年患者。患者随机分配至以下组：接受 FMT 组（FMTv），在接受万古霉素（125 mg，每日 4 次）4-10 天后，经结肠镜或鼻空肠管给药（n=24）；接受 fidaxomicin 组（10 天，200 mg，每日 2 次；n=24）；或接受万古霉素（125 mg，每日 4 次）组（n=16）。接受此疗程治疗后仍发生 rCDI 的患者和不能随机分组的患者接受挽救性 FMTv。主要结局是在接受分配治疗后 8 周时联合临床缓解和对艰难梭菌（CD）毒素的聚合酶链反应检测呈阴性。次要终点包括第 8 周的临床缓解。
所有 64 例患者均接受了其指定的治疗。FMTv 组 17 例（71%）、fidaxomicin 组 8 例（33%）和万古霉素组 3 例（19%）患者出现联合临床缓解和 CD 毒素检测阴性（P=0.009 与 fidaxomicin 相比；P=0.001 与万古霉素相比；P=0.31 与 fidaxomicin 相比）。FMTv 组 22 例（92%）、fidaxomicin 组 10 例（42%）和万古霉素组 3 例（19%）患者出现临床缓解（P=0.0002；P<0.0001；P=0.13）。接受 FMTv 作为初始治疗的患者与接受挽救性 FMTv 的患者之间的结果无显著差异。有 1 例严重不良事件可能与 FMTv 有关。
在 rCDI 患者的随机试验中，我们发现 FMTv 联合治疗在临床和微生物学缓解或临床缓解方面优于 fidaxomicin 或万古霉素。临床试验注册编号：NCT02743234；EudraCT 编号：2015-003004-24。
