Wei Zheng-Jie, Dong Hai-Bin, Ren Yu-Tang, Jiang Bo
Department of Gastroenterology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.
Ann Transl Med. 2022 Jul;10(14):802. doi: 10.21037/atm-22-3236.
Fecal microbiota transplantation (FMT) is a novel management strategy for ulcerative colitis (UC). However, its effectiveness remains controversial. This study sought to assess the effectiveness of FMT in the treatment of active UC by performing a meta-analysis of randomized controlled trials (RCTs).
We searched the Cochrane, Embase, PubMed, and Web of Science databases from their inception to December 2021. RCTs that recruited patients with active UC and treated them with FMT, a placebo or a suitable comparator were included in the meta-analysis. PICOS: Patients, active UC; Intervention, FMT; Control, placebo or a suitable comparator; Outcomes, remission rate; Studies, RCTs. The risk of bias assessment was performed with Revised Cochrane risk-of-bias tool (version 2). Meta-analyses of risk ratios (RRs) were performed to estimate the differences in remission rates and the risk of serious adverse events (SAEs) between the FMT-treated and control patients.
A total of 9 RCTs comprising 425 UC patients (213 FMT and 212 control) were included in the meta-analysis. The risk of bias was low in these RCTs. Clinical remission was observed in 86 of the 213 patients in the FMT groups and 47 of the 212 patients in the control groups [RR: 1.84; 95% confidence interval (CI): 1.37, 2.47; P<0.0001]. Clinical remission was better when the FMT delivery route was via the lower gut, the FMT dose was >300 grams, and the fecal specimen from multiple donors. Endoscopic remission (observed in 7 RCTs) was achieved in 33 of the 195 FMT-treated patients compared to 17 of the 194 control patients (RR: 1.94; 95% CI: 1.14, 3.31; P=0.01). SAEs were reported in 22 of the 213 FMT-treated patients but only 11 of the 212 control patients (RR: 2.05; 95% CI: 1.03, 4.09; P=0.04).
FMT is an effective treatment for patients with active UC. Significantly higher clinical and endoscopic remission rates are observed with FMT than with control treatments. However, FMT may cause a significantly higher incidence of SAEs than control treatments. Future studies should delineate the effects of donor selection, dosage, delivery route, and antibiotic pretreatment and should evaluate the safety profile of FMT.
粪便微生物群移植（FMT）是治疗溃疡性结肠炎（UC）的一种新型管理策略。然而，其有效性仍存在争议。本研究旨在通过对随机对照试验（RCT）进行荟萃分析，评估FMT治疗活动性UC的有效性。
我们检索了Cochrane、Embase、PubMed和Web of Science数据库，检索时间从建库至2021年12月。纳入荟萃分析的RCT研究需招募活动性UC患者，并使用FMT、安慰剂或合适的对照进行治疗。PICOS：患者，活动性UC；干预措施，FMT；对照，安慰剂或合适的对照；结局指标，缓解率；研究类型，RCT。使用修订的Cochrane偏倚风险工具（第2版）进行偏倚风险评估。对风险比（RR）进行荟萃分析，以估计FMT治疗组和对照组患者缓解率的差异以及严重不良事件（SAE）的风险。
荟萃分析共纳入9项RCT，包括425例UC患者（213例FMT组和212例对照组）。这些RCT的偏倚风险较低。FMT组213例患者中有86例实现临床缓解，对照组212例患者中有47例实现临床缓解[RR：1.84；95%置信区间（CI）：1.37，2.47；P<0.0001]。当FMT给药途径为下消化道、FMT剂量>300克且粪便样本来自多个供体时，临床缓解情况更佳。195例接受FMT治疗的患者中有33例实现内镜缓解（7项RCT中观察到），而194例对照组患者中有17例实现内镜缓解（RR：1.94；95%CI：1.14，3.31；P=0.01）。213例接受FMT治疗的患者中有22例报告发生SAE，而212例对照组患者中只有11例报告发生SAE（RR：2.05；95%CI：1.03，4.09；P=0.04）。
FMT是治疗活动性UC患者的有效方法。与对照治疗相比，FMT的临床和内镜缓解率显著更高。然而，FMT可能导致SAE的发生率显著高于对照治疗。未来的研究应明确供体选择、剂量、给药途径和抗生素预处理的影响，并应评估FMT的安全性。
