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口服粪便微生物群胶囊治疗复发性艰难梭菌感染安全有效:系统评价和荟萃分析。

Oral Fecal Microbiota Transplant Capsules Are Safe and Effective for Recurrent Clostridioides difficile Infection: A Systematic Review and Meta-Analysis.

机构信息

Department of Medicine.

Levy Library, The Icahn School of Medicine at Mount Sinai, One Gustave Levy Place.

出版信息

J Clin Gastroenterol. 2021 Apr 1;55(4):300-308. doi: 10.1097/MCG.0000000000001495.

DOI:10.1097/MCG.0000000000001495
PMID:33471490
Abstract

GOALS

We performed a systematic review with meta-analysis to examine the efficacy and safety of oral fecal microbiota transplantation (FMT) capsules for recurrent Clostridioides difficile infection (rCDI).

BACKGROUND

FMT through colonoscopy is established as effective and safe in treating multiple recurrences of CDI, but consensus has not been established on delivery through oral capsules.

STUDY

A systematic literature search was performed with multiple databases including MEDLINE and EMBASE to identify original studies including at least 10 patients that investigated the role of oral FMT capsules to treat rCDI. Cure rates were pooled by a random effects model and publication bias was assessed with the Egger test. Secondary analyses assessed for differences between capsule preparation (frozen vs. lyophilized stool) and delivery modality (capsule vs. colonoscopy).

RESULTS

Fifteen studies (12 case series and 3 randomized controlled trials) encompassing 763 patients were identified for inclusion. Significant variability existed in baseline patient characteristics and protocols. Meta-analysis of proportions showed efficacy of oral FMT capsules to be 0.821 (95% confidence interval: 0.762-0.874). No evidence for publication bias was found (P=0.51). Secondary analyses did not find significant differences in efficacy. Fourteen adverse events leading to death or hospitalization were noted, none of which were attributed to FMT.

CONCLUSIONS

Oral FMT capsules for rCDI are promising because of ease of administration and noninvasive delivery. We found an overall efficacy of 82.1% with a low rate of serious adverse events. Further studies are needed to optimize protocols and outcomes.

摘要

目的

我们进行了系统评价和荟萃分析,以评估口服粪便微生物群移植(FMT)胶囊治疗复发性艰难梭菌感染(rCDI)的疗效和安全性。

背景

通过结肠镜进行 FMT 已被证实对治疗 CDI 的多次复发是有效且安全的,但对于通过口服胶囊进行 FMT 的共识尚未达成。

研究

我们通过多个数据库(包括 MEDLINE 和 EMBASE)进行了系统文献检索,以确定至少纳入 10 名患者的原始研究,这些研究调查了口服 FMT 胶囊治疗 rCDI 的作用。采用随机效应模型汇总治愈率,并采用 Egger 检验评估发表偏倚。二次分析评估了胶囊制备(冷冻 vs. 冻干粪便)和输送方式(胶囊 vs. 结肠镜)之间的差异。

结果

共确定了 15 项研究(12 项病例系列研究和 3 项随机对照试验),共纳入了 763 名患者。基线患者特征和方案存在显著差异。比例的荟萃分析显示,口服 FMT 胶囊的疗效为 0.821(95%置信区间:0.762-0.874)。未发现发表偏倚的证据(P=0.51)。二次分析未发现疗效的显著差异。有 14 例不良事件导致死亡或住院,没有一例归因于 FMT。

结论

口服 FMT 胶囊治疗 rCDI 具有很大的前景,因为它易于管理且具有非侵入性的输送方式。我们发现总体有效率为 82.1%,严重不良事件发生率低。需要进一步的研究来优化方案和结果。

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