Medical Center of Digestive Disease, the Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Key Lab of Holistic Integrative Enterology, Nanjing Medical University, Nanjing, China.
Aliment Pharmacol Ther. 2021 Jan;53(1):33-42. doi: 10.1111/apt.16148. Epub 2020 Nov 7.
Faecal microbiota transplantation (FMT) is an effective treatment in C. difficile infection (CDI) and is currently being investigated in other diseases. There is concern around the safety of FMT and that side effects or complications may be under-reported in the medical literature.
To evaluate the safety of FMT by summarising the overall reported Adverse Events (AEs) over a 20-year period METHODS: We searched EMBASE, MEDLINE, and Cochrane Library databases, and CNKI and Wanfang Data from January 2000 to April 2020. All original studies reporting FMT-related AEs were considered for inclusion. FMT-related AEs were further classified as delivery-related or microbiota-related.
Based on the inclusion criteria, 129 studies, which included 4241 patients (5688 FMT courses), were finally eligible. The most common indication for FMT was CDI. Overall, FMT-related AEs were observed in 19% of FMT procedures. The most frequently reported FMT-related AEs were diarrhoea (10%) and abdominal discomfort/pain/cramping (7%). FMT-related serious adverse events (SAEs), including infections and deaths, have been reported in 1.4% of patients who underwent FMT (0.99% microbiota-related SAEs). Four of five FMT-related deaths were reported in patients receiving FMT via the upper gastrointestinal route. Importantly, all reported FMT-related SAEs were in patients with mucosal barrier injury.
Most FMT-related AEs were mild or moderate and self-limiting. Although FMT appears to be highly safe, its methodology should be improved to reduce both delivery-related AEs and, microbiota-related AEs.
粪便微生物群移植（FMT）是治疗艰难梭菌感染（CDI）的有效方法，目前正在其他疾病中进行研究。人们对 FMT 的安全性表示担忧，担心其副作用或并发症在医学文献中可能报告不足。
通过总结 20 年来报告的所有不良事件（AE）来评估 FMT 的安全性。
我们检索了 EMBASE、MEDLINE 和 Cochrane 图书馆数据库，以及 2000 年 1 月至 2020 年 4 月期间的 CNKI 和万方数据。纳入所有报告 FMT 相关 AE 的原始研究。将 FMT 相关 AE 进一步分为与输送相关或与微生物群相关。
根据纳入标准，最终有 129 项研究（包括 4241 名患者（5688 次 FMT 疗程））符合纳入条件。FMT 的最常见适应证是 CDI。总体而言，19%的 FMT 手术观察到 FMT 相关 AE。报告最频繁的 FMT 相关 AE 是腹泻（10%）和腹部不适/疼痛/痉挛（7%）。接受 FMT 的患者报告了 1.4%（0.99%与微生物群相关的 SAE）的 FMT 相关严重不良事件（SAE），包括感染和死亡。接受 FMT 经上消化道途径的患者中报告了 4/5 例 FMT 相关死亡。重要的是，所有报告的 FMT 相关 SAE 均发生在有黏膜屏障损伤的患者中。
大多数 FMT 相关 AE 为轻度或中度且自限性。尽管 FMT 似乎非常安全，但应改进其方法，以减少输送相关 AE 和与微生物群相关的 AE。
