Abstract:
From its origins as a left-field, experimental, and even \"maverick\" intervention, faecal microbiota transplantation (FMT) is now a well-recognised, accepted, and potentially life-saving therapeutic strategy, for the management of recurrent Clostridiodes difficile infection (rCDI). It is being investigated as a treatment for a growing number of diseases including hepatic encephalopathy and eradication of antimicrobial resistant organisms, and the list of indications will likely expand in the future. There is no universally accepted definition of what FMT is, and its mechanism of action remains incompletely understood; this has likely contributed to the breadth of approaches to regulation depending on interpretation. In the UK FMT is considered a medicinal product, in North America, a biological product, whereas in parts of Europe, it is considered a human cell/tissue product. Regulation seeks to improve quality and safety, however, lack of standardisation creates confusion, and overly restrictive regulation may hamper widespread access and discourage research using FMT. FMT is generally considered safe, especially if rigorous donor screening and testing is conducted. Most short-term risks are associated with the delivery method (e.g. colonoscopy). Longer term risks are less well described but longitudinal follow-up of treated cohorts is in place to assess for this, and no signal towards harm has been found to date. Rarely it has been associated with adverse outcomes including the transmission of antibiotic resistant bacteria, and even death. It is vital patients undergoing FMT are well informed to the currently appreciated risks and benefits before proceeding.
摘要:
从它的起源作为一个左场,实验性的,甚至“特立独行”的干预,粪便微生物移植(FMT)现在是一个公认的,接受,和潜在的挽救生命的治疗策略,用于治疗复发性艰难梭菌感染(rCDI)。它正在研究作为治疗越来越多的疾病,包括肝性脑病和根除抗微生物药物抗性生物,和适应症列表可能会在未来扩大。FMT是什么没有普遍接受的定义,并且其作用机制仍未完全了解;这可能有助于根据解释进行监管的方法的广度。在英国,FMT被认为是一种药用产品,在北美,一种生物制品,而在欧洲部分地区,它被认为是人类细胞/组织产品。法规旨在提高质量和安全性,然而,缺乏标准化会造成混乱,过度限制的监管可能会阻碍广泛的获取,并阻碍使用FMT进行研究。FMT通常被认为是安全的,特别是如果进行严格的供体筛选和测试。大多数短期风险与分娩方法(例如结肠镜检查)有关。较长期的风险描述较少,但治疗队列的纵向随访已到位,以评估这一点,到目前为止还没有发现伤害的信号。它很少与包括抗生素抗性细菌传播在内的不良后果有关。甚至死亡。至关重要的是,接受FMT的患者在继续进行之前要充分了解目前认识到的风险和收益。