粪菌移植治疗活动期溃疡性结肠炎的长期安全性和有效性。
Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis.
机构信息
Medical Center for Digestive Diseases, The Second Affiliated Hospital, Nanjing Medical University, 121 Jiang Jia Yuan, Nanjing, 210011, China.
Department of Geriatrics, Sir Run Run Hospital, Nanjing Medical University, 109 Longmian Ave, Nanjing, 211166, China.
出版信息
Drug Saf. 2019 Jul;42(7):869-880. doi: 10.1007/s40264-019-00809-2.
INTRODUCTION AND OBJECTIVE
The therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis.
METHODS
Two clinical trials (NCT01790061, NCT02560727) for moderate-to-severe ulcerative colitis (Mayo score range 6-12) were performed from November 2012 to July 2017. Both studies were pooled for analysis on the safety and efficacy of fecal microbiota transplantation in patients with ulcerative colitis over a 1-year follow-up. The step-up fecal microbiota transplantation strategy included step 1: single fecal microbiota transplantation; step 2: two or more fecal microbiota transplantations; and step 3: fecal microbiota transplantations followed by immunosuppressants. Long-term clinical efficacy and adverse events were assessed, and multiple factors related to fecal microbiota transplantation were evaluated.
RESULTS
Of 134 eligible patients in this real-word study, 81.3% (109/134) were included for analysis. The follow-up ranged from 1 to 5 years. Fecal microbiota transplantation-related adverse events were observed in 17.4% (43/247) of fecal microbiota transplantation procedures including one serious adverse event (myasthenia gravis) and 56 non-serious adverse events. Multivariable logistic regression analysis showed that both the method of preparation of microbiota from stool using the automatic system and the delivery method of colonic transendoscopic enteral tubing were associated with a lower rate of fecal microbiota transplantation-related adverse events (p = 0.023, p = 0.017, respectively). In total, 74.3% (81/109) and 51.4% (56/109) of patients achieved clinical response at 1 month and 3 months after step-up fecal microbiota transplantation, respectively.
CONCLUSIONS
Fecal microbiota transplantation should be a safe and promising therapy for ulcerative colitis. The improved fecal microbiota preparation and colonic transendoscopic enteral tubing might reduce the rate of adverse events in ulcerative colitis.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01790061, NCT02560727.
介绍和目的
粪便微生物群移植在溃疡性结肠炎中的治疗作用因不同报告而异。本研究旨在评估一种称为逐步升级粪便微生物群移植的策略治疗溃疡性结肠炎的长期安全性和疗效。
方法
2012 年 11 月至 2017 年 7 月进行了两项中度至重度溃疡性结肠炎（Mayo 评分范围 6-12）的临床试验（NCT01790061，NCT02560727）。对这两项研究进行了汇总分析，以评估溃疡性结肠炎患者在 1 年随访期间粪便微生物群移植的安全性和疗效。逐步升级粪便微生物群移植策略包括第 1 步：单次粪便微生物群移植；第 2 步：两次或更多次粪便微生物群移植；第 3 步：粪便微生物群移植后使用免疫抑制剂。评估了长期临床疗效和不良事件，并评估了与粪便微生物群移植相关的多个因素。
结果
在这项真实世界的研究中，共有 134 名符合条件的患者，其中 81.3%（109/134）纳入分析。随访时间为 1 至 5 年。粪便微生物群移植相关不良事件发生率为 17.4%（43/247），包括 1 例严重不良事件（重症肌无力）和 56 例非严重不良事件。多变量逻辑回归分析显示，使用自动系统从粪便中制备微生物群的方法和经结肠镜肠内管输送的方法与粪便微生物群移植相关不良事件发生率较低相关（p=0.023，p=0.017）。总的来说，74.3%（81/109）和 51.4%（56/109）的患者在逐步升级粪便微生物群移植后 1 个月和 3 个月分别达到临床缓解。
结论
粪便微生物群移植应该是溃疡性结肠炎的一种安全且有前途的治疗方法。改进的粪便微生物群制备和经结肠镜肠内管可能会降低溃疡性结肠炎不良事件的发生率。
试验注册
ClinicalTrials.gov NCT01790061，NCT02560727。
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