Objective: We aimed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for the treatment of ulcerative colitis (UC) in this Meta-analysis. Methods: Literature related to FMT for the treatment of UC from PubMed, Embase, Cochrane databases, CNKI, VIP and Wanfang Data were searched and screened with update study in May 2018. Two independent investigators extracted information according to inclusion and exclusion criteria. The Meta-analysis was conducted by Stata 12.0 software. Results: A total of 4 randomized controlled trials (RCTs) and 19 non-randomized controlled trials (non-RCTs) including 536 participants met the inclusion criteria. Meta-analysis of RCTs showed that FMT significantly increased the clinical remission rate (OR=2.47, 95%CI 1.40-4.33, P=0.02) and clinical response rate (OR=1.86, 95%CI 1.15-3.02, P=0.01) in UC patients without increasing the incidence of severe adverse effects (OR=1.40, 95%CI 0.51-3.79, P=0.51). The results from 19 non-RCTs showed that clinical remission rate in UC patients with FMT treatment was 20%(95%CI 13%-28%) and the clinical response rate was 50%(95%CI 36%-65%). All adverse events were graded as mild and self-resolving. No FMT-related severe adverse effects were reported. Conclusions: Our analysis suggests that FMT is a safe and effective method for the treatment of UC. Considering several limitations of this Meta-analysis and previous clinical trials, further large-scale multicenter RCTs are still required to further verify the conclusion.
目的： 采用Meta分析方法系统评价粪微生态移植（FMT）治疗溃疡性结肠炎（UC）的疗效和安全性。 方法： 在PubMed、Cochrane Library、Embase、中国知网（CNKI）、维普、万方数据库检索关于FMT治疗UC的临床研究，检索时限为从建库到2018年5月。由2名评价者按纳入与排除标准进行文献筛选和数据提取后，采用Stata12.0软件进行Meta分析。 结果： 共纳入23个研究，包括4个随机对照试验（RCT）和19个非随机对照试验（non-RCT），共536例UC患者。RCT的Meta分析结果显示FMT能显著提高UC的临床缓解率（OR=2.47，95%CI 1.40~4.33，P=0.02）及有效率（OR=1.86，95%CI 1.15~3.02，P=0.01），且不增加严重不良反应发生率（OR=1.40，95%CI 0.51~3.79，P=0.51）。non-RCT的Meta分析结果示FMT治疗UC的临床缓解率为20%（95%CI 13%~28%），有效率为50%（95%CI 36%~65%），发生不良反应多为轻度及自限性，未记录到FMT相关严重不良反应。 结论： FMT治疗UC安全且有效，但仍需开展大规模、多中心RCT研究来验证。.
Keywords: Colitis, ulcerative; Fecal microbiota transplantation; Meta-analysis.