Baunwall Simon Mark Dahl, Lee Mads Ming, Eriksen Marcel Kjærsgaard, Mullish Benjamin H, Marchesi Julian R, Dahlerup Jens Frederik, Hvas Christian Lodberg
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 35, DK-8200 Aarhus N, Denmark.
Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, United Kingdom.
EClinicalMedicine. 2020 Nov 23;29-30:100642. doi: 10.1016/j.eclinm.2020.100642. eCollection 2020 Dec.
Faecal microbiota transplantation (FMT) is effective for recurrent infection (CDI), but inconsistent effect rates and uncertain evidence levels have warranted caution. To clarify, we aimed to establish the evidence of FMT for recurrent CDI, updated across different delivery methods, treatment regimens, and in comparison with standard antibiotics.
In this updated systematic review and meta-analysis, we searched PubMed, Scopus, Embase, Web of Science, Clinical Key, and Svemed+ for FMT literature published in English until November 11, 2019. We included observational and clinical trials with or without antibiotic comparators and excluded studies with below 8 weeks follow-up and fewer than 15 patients. The primary outcome was clinical outcome by week 8. We comprehensively extracted patient and procedural data. In a random-effects meta-analysis, we estimated the clinical effect for repeat or single FMT, different delivery methods, and versus antibiotics. We rated the evidence according to the Cochrane and GRADE methods. The PROSPERO preregistration number is CRD42020158112.
Of 1816 studies assessed, 45 studies were included. The overall clinical effect week 8 following repeat FMT (24 studies, 1855 patients) was 91% (95% CI: 89-94%, =53%) and 84% (80-88%, =86%) following single FMT (43 studies, 2937 patients). Delivery by lower gastrointestinal endoscopy was superior to all other delivery methods, and repeat FMT significantly increased the treatment effect week 8 (<0·001). Compared with vancomycin, the number needed to treat (NNT) for repeat FMT was 1·5 (1·3-1·9, <0·001) and 2.9 (1·5-37·1, =0·03) for single FMT. Repeat FMT had high quality of evidence.
High-quality evidence supports FMT is effective for recurrent CDI, but its effect varies with the delivery method and the number of administrations. The superior NNT for FMT compared with antibiotics suggests that patients may benefit from advancing FMT to all instances of recurrent CDI.
Innovation Fund Denmark (j.no. 8056-00006B).
粪便微生物群移植（FMT）对复发性艰难梭菌感染（CDI）有效，但有效率不一致且证据水平不确定，因此需谨慎对待。为了阐明这一点，我们旨在确立FMT治疗复发性CDI的证据，涵盖不同的给药方式、治疗方案，并与标准抗生素进行比较。
在这项更新的系统评价和荟萃分析中，我们检索了PubMed、Scopus、Embase、Web of Science、Clinical Key和Svemed+，以查找截至2019年11月11日发表的英文FMT文献。我们纳入了有或没有抗生素对照的观察性和临床试验，并排除了随访时间少于8周且患者少于15例的研究。主要结局是第8周时的临床结局。我们全面提取了患者和程序数据。在随机效应荟萃分析中，我们估计了重复或单次FMT、不同给药方式以及与抗生素相比的临床效果。我们根据Cochrane和GRADE方法对证据进行评级。PROSPERO预注册号为CRD42020158112。
在评估的1816项研究中，纳入了45项研究。重复FMT（24项研究，1855例患者）后第8周的总体临床有效率为91%（95%CI：89 - 94%，I² = 53%），单次FMT（43项研究，2937例患者）后为84%（80 - 88%，I² = 86%）。通过下消化道内镜给药优于所有其他给药方式，重复FMT显著提高了第8周的治疗效果（P < 0·001）。与万古霉素相比，重复FMT的治疗所需人数（NNT）为1·5（1·3 - 1·9，P < 0·001），单次FMT为2.9（1·5 - 37·1，P = 0·03）。重复FMT具有高质量的证据。
高质量证据支持FMT对复发性CDI有效，但其效果因给药方式和给药次数而异。与抗生素相比，FMT的NNT更优，这表明患者可能会从将FMT应用于所有复发性CDI病例中获益。
丹麦创新基金（项目编号8056 - 00006B）。
