粪便微生物群对移植的调节:政策和公共卫生的国际视角

Carolyn Edelstein, Z. Kassam, J. Daw, Mark B. Smith, C. Kelly
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引用次数: 17

摘要

艰难梭菌(Clostridium difficile)是美国最常见的医院获得性病原体,复发性艰难梭菌感染(CDI)是一个重大的公共卫生问题。20%的CDI患者会经历复发,并且随着每次临床治疗失败,他们的复发风险会增加。粪便微生物群移植(FMT)是治疗复发性CDI非常有效的方法。然而,国家卫生机构正在努力寻找适用于这种创新治疗的适当监管范例。目前美国、加拿大、西欧、澳大利亚和中国的FMT法规处于不同程度的变化中,尽管许多监管机构选择应用药物和生物框架。随着研究的继续,FMT法规应允许复发性CDI患者安全获得这种治疗。虽然从法律角度来看,将FMT作为一种药物或生物制剂进行监管是最方便的,但它过度限制了获取,而对粪便筛选、处理、储存和使用的方法监管不足。人体组织和基于组织的产品法规可以达到所需的水平和监督类型,但用于移植的粪便微生物群未能满足适用的法定定义。定制监管解决方案更为合适,但监管机构为实现这一目标可能采取的许多途径需要卫生机构开发时间和资源。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The regulation of fecal microbiota for transplantation: An international perspective for policy and public health
Abstract Clostridium difficile is the most common hospital-acquired pathogen in the US, and recurrent C. difficile infection (CDI) is a major public health issue. Twenty per cent of CDI patients experience recurrence, and their risk of recurrence rises with each failure to achieve clinical resolution. Fecal microbiota transplantation (FMT) is a remarkably efficacious treatment for recurrent CDI. However, national health agencies are grappling with the appropriate regulatory paradigm to apply to this innovative treatment. Current FMT regulations in the US, Canada, Western Europe, Australia, and China are in varying degrees of flux, although many regulators are choosing to apply the drug and biologic framework. FMT regulations should allow recurrent CDI patients safe access to this treatment as research continues. Regulating FMT like a drug or biologic, although most convenient from a legal perspective, overly restricts access while under-regulating the methods by which the stool is screened, processed, stored, and used. Human tissue and tissue-based products regulations could achieve the desired level and kind of oversight, but fecal microbiota for transplantation fail to meet applicable statutory definitions. A custom regulatory solution would be more appropriate, but many pathways that regulators may take to achieve this goal require time and resources for health agencies to develop.
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