粪便微生物群移植：一种受到独家商业宣称挑战的救命疗法。
Faecal microbiota transplantation: A life-saving therapy challenged by commercial claims for exclusivity.
作者信息
Hvas Christian Lodberg, Baunwall Simon Mark Dahl, Erikstrup Christian
机构信息
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, Aarhus, DK 8200, Denmark.
Department of Clinical Immunology, Aarhus University Hospital, Aarhus, Denmark.
出版信息
EClinicalMedicine. 2020 Jul 2;24:100436. doi: 10.1016/j.eclinm.2020.100436. eCollection 2020 Jul.
Faecal microbiota transplantation (FMT) is an innovative treatment which is challenged by a regulatory struggle in Europe. A recent publication in EClinicalMedicine describes the successful adaptation of FMT to a National drug legislation, but this approach fails to take into account the donor-related aspects. The European tissue and cells directive and affiliated technical guide provide extensive safety and quality standards which may readily be adopted in an FMT service to provide patients with this life-saving treatment embedded in a public blood centre.
粪便微生物群移植（FMT）是一种创新疗法，但在欧洲面临监管方面的难题。《电子临床医学》最近发表的一篇文章描述了FMT成功适应国家药品立法的情况，但这种方法没有考虑到与供体相关的方面。欧洲组织和细胞指令及附属技术指南提供了广泛的安全和质量标准，这些标准可以很容易地应用于FMT服务中，以便在公共血液中心为患者提供这种挽救生命的治疗方法。
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