Fecal microbiota transplantation: Uses, questions, and ethics.
Fecal microbiota transplantation: Uses, questions, and ethics.
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DOI：
10.1016/j.medmic.2020.100027
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发表时间：
2020-12-01
影响因子：
--
通讯作者：
Bateman-House, Alison
中科院分区：
文献类型：
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作者：
Grigoryan, Zoya;Shen, Michael J;Bateman-House, Alison
粪便微生物区系移植(FMT)作为一种治疗复发和难治性艰难梭菌感染(CDI)以及无数其他适应症的方法，在世界范围内迅速声名狼藉和流行，有不同程度的证据证明其使用是合理的。目前，FMT在美国的使用尚未获得美国食品和药物管理局(FDA)的上市批准，但根据“执行裁量权”，CDI对标准治疗无效是允许的。与此同时，主流媒体对肠道微生物群的兴趣日益高涨，为“自己动手”(DIY)改编这一程序铺平了道路。这种获取和不受监管的使用，通常在任何临床监督之外，已经迅速超过了医学界的研究和监管努力。虽然一些研究已经能够证明FMT在治疗CDI以外的疾病方面取得了成功--关于溃疡性结肠炎的研究特别有希望--但对这种疗法的作用机制或长期副作用仍知之甚少。同样，就方案标准化而言，捐赠者粪便的筛查还处于早期阶段。在这篇文章中，我们探讨了由于需要在获得一种新的但有希望的创新治疗与研究其有效性、风险概况和长期影响之间取得平衡而引起的监管和伦理问题。
Fecal microbiota transplantation (FMT) has rapidly grown in notoriety and popularity worldwide as a treatment for both recurrent and refractory C. difficile infection (CDI), as well as for a myriad of other indications, with varying levels of evidence to justify its use. At present, FMT use in the U.S. has not received marketing approval from the U.S. Food and Drug Administration (FDA), but is permitted under "enforcement discretion" for CDI not responding to standard therapy. Meanwhile, the rising interest in the gut microbiome throughout mainstream media has paved the way for "do-it-yourself" (DIY) adaptations of the procedure. This access and unregulated use, often outside any clinical supervision, has quickly outpaced the medical community's research and regulatory efforts. While some studies have been able to demonstrate the success of FMT in treating conditions other than CDI-studies on ulcerative colitis have been particularly promising-little is still known about the treatmen's mechanism of action or long-term side effects. Likewise, screening of donor stool is in its early stages in terms of protocol standardization. In this paper, we explore the regulatory and ethical concerns that arise from the need to balance access to a nascent but promising innovative treatment with the need for research into its efficacy, risk profile, and long-term impact.