粪便微生物群移植对多次复发性艰难梭菌感染复发的影响：一项随机试验
Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent Clostridium difficile Infection: A Randomized Trial.
作者信息
Kelly Colleen R, Khoruts Alexander, Staley Christopher, Sadowsky Michael J, Abd Mortadha, Alani Mustafa, Bakow Brianna, Curran Patrizia, McKenney Joyce, Tisch Allison, Reinert Steven E, Machan Jason T, Brandt Lawrence J
机构信息
From Warren Alpert Medical School of Brown University, Miriam Hospital, and Lifespan Hospital System, Providence, Rhode Island; University of Minnesota, Minneapolis/St. Paul, Minnesota; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York; and University of Rhode Island, Kingston, Rhode Island.
出版信息
Ann Intern Med. 2016 Nov 1;165(9):609-616. doi: 10.7326/M16-0271. Epub 2016 Aug 23.
BACKGROUND
To date, evidence for the efficacy of fecal microbiota transplantation (FMT) in recurrent Clostridium difficile infection (CDI) has been limited to case series and open-label clinical trials.
OBJECTIVE
To determine the efficacy and safety of FMT for treatment of recurrent CDI.
DESIGN
Randomized, controlled, double-blind clinical trial. (ClinicalTrials.gov: NCT01703494).
SETTING
Two academic medical centers.
PATIENTS
46 patients who had 3 or more recurrences of CDI and received a full course of vancomycin for their most recent acute episode.
INTERVENTION
Fecal microbiota transplantation with donor stool (heterologous) or patient's own stool (autologous) administered by colonoscopy.
MEASUREMENTS
The primary end point was resolution of diarrhea without the need for further anti-CDI therapy during the 8-week follow-up. Safety data were compared between treatment groups via review of adverse events (AEs), serious AEs (SAEs), and new medical conditions for 6 months after FMT. Fecal microbiota analyses were performed on patients' stool before and after FMT and also on donors' stool.
RESULTS
In the intention-to-treat analysis, 20 of 22 patients (90.9%) in the donor FMT group achieved clinical cure compared with 15 of 24 (62.5%) in the autologous FMT group (P = 0.042). Resolution after autologous FMT differed by site (9 of 10 vs. 6 of 14 [P = 0.033]). All 9 patients who developed recurrent CDI after autologous FMT were free of further CDI after subsequent donor FMT. There were no SAEs related to FMT. Donor FMT restored gut bacterial community diversity and composition to resemble that of healthy donors.
LIMITATION
The study included only patients who had 3 or more recurrences and excluded those who were immunocompromised and aged 75 years or older.
CONCLUSION
Donor stool administered via colonoscopy seemed safe and was more efficacious than autologous FMT in preventing further CDI episodes.
PRIMARY FUNDING SOURCE
National Institute of Diabetes and Digestive and Kidney Diseases.
背景
迄今为止，粪便微生物群移植（FMT）治疗复发性艰难梭菌感染（CDI）疗效的证据仅限于病例系列研究和开放标签临床试验。
目的
确定FMT治疗复发性CDI的疗效和安全性。
设计
随机、对照、双盲临床试验。（ClinicalTrials.gov：NCT01703494）。
地点
两个学术医疗中心。
患者
46例CDI复发3次或以上且在最近一次急性发作时接受了全程万古霉素治疗的患者。
干预措施
通过结肠镜检查进行粪便微生物群移植，使用供体粪便（异源）或患者自身粪便（自体）。
测量指标
主要终点是在8周随访期间腹泻缓解且无需进一步抗CDI治疗。通过审查不良事件（AE）、严重不良事件（SAE）以及FMT后6个月内的新发病情况，比较各治疗组的安全性数据。对患者FMT前后的粪便以及供体粪便进行粪便微生物群分析。
结果
在意向性分析中，供体FMT组22例患者中有20例（90.9%）实现临床治愈，而自体FMT组24例中有15例（62.5%）（P = 0.042）。自体FMT后的缓解情况因地点而异（10例中的9例对14例中的6例[P = 0.033]）。自体FMT后发生复发性CDI的所有9例患者在随后的供体FMT后均未再发生CDI。没有与FMT相关的严重不良事件。供体FMT恢复了肠道细菌群落的多样性和组成，使其类似于健康供体。
局限性
该研究仅纳入了复发3次或以上的患者，排除了免疫功能低下以及75岁及以上的患者。
结论
通过结肠镜检查给予供体粪便似乎安全，且在预防进一步的CDI发作方面比自体FMT更有效。
主要资金来源
美国国立糖尿病、消化和肾脏疾病研究所。
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