背景:粪便微生物移植(FMT)是治疗活动性溃疡性结肠炎(UC)的一种有前途的新方法,但是关于静态UC的FMT的知识很少。
目的:探讨FMT对UC患者维持缓解的作用。
方法:48例UC患者随机接受单剂量FMT或通过结肠镜进行自体移植。主要终点是维持缓解,粪便钙卫蛋白水平低于200μg/g,在整个12个月的随访中,临床Mayo评分低于3分。作为次要终点,我们记录了病人的生活质量,粪便钙卫蛋白,血液化学,和12个月的内窥镜检查结果。
结果:FMT组24名患者中的13名(54%)和安慰剂组24名患者中的10名(41%)达到了主要终点(对数秩检验,P=0.660)。FMT之后四个月,与安慰剂组相比,FMT组的生活质量评分下降(P=0.017).此外,在同一时间点,安慰剂组的疾病特异性生活质量指标高于FMT组(P=0.003).血液化学没有差异,粪便钙卫蛋白,或12个月时研究组的内镜检查结果。不良事件很少发生,温和,并在群体之间平均分配。
结论:在12个月的随访中,研究组之间的复发次数没有差异。因此,我们的结果不支持使用单剂量FMT维持UC缓解.
BACKGROUND: Fecal microbial transplantation (FMT) is a promising new method for treating active ulcerative colitis (UC), but knowledge regarding FMT for quiescent UC is scarce.
OBJECTIVE: To investigate FMT for the maintenance of remission in UC patients.
METHODS: Forty-eight UC patients were randomized to receive a single-dose FMT or autologous transplant via colonoscopy. The primary endpoint was set to the maintenance of remission, a fecal calprotectin level below 200 μg/g, and a clinical Mayo score below three throughout the 12-mo follow-up. As secondary endpoints, we recorded the patient\'s quality of life, fecal calprotectin, blood chemistry, and endoscopic findings at 12 mo.
RESULTS: The main endpoint was achieved by 13 out of 24 (54%) patients in the FMT group and by 10 out of 24 (41%) patients in the placebo group (log-rank test, P = 0.660). Four months after FMT, the quality-of-life scores decreased in the FMT group compared to the placebo group (P = 0.017). In addition, the disease-specific quality of life measure was higher in the placebo group than in the FMT group at the same time point (P = 0.003). There were no differences in blood chemistry, fecal calprotectin, or endoscopic findings among the study groups at 12 mo. The adverse events were infrequent, mild, and distributed equally between the groups.
CONCLUSIONS: There were no differences in the number of relapses between the study groups at the 12-mo follow-up. Thus, our results do not support the use of a single-dose FMT for the maintenance of remission in UC.