Stuntz Mark, des Vignes Franka
Deerfield Institute, New York, NY, United States.
Contemp Clin Trials Commun. 2015 Dec 1;1:39-41. doi: 10.1016/j.conctc.2015.11.001. eCollection 2015 Oct 30.
Fecal microbiota transplantation (FMT) has emerged as a highly effective treatment for infection (CDI), the most frequent cause of hospital-acquired infectious diarrhea in developed countries and the cause of nearly 30,000 annual deaths in the US. FMT is proving to be more effective at treating CDI than traditional antibacterial therapy, and reduces the exposure of valuable antibiotics to potential resistance. A systematic review to assess the efficacy of FMT for CDI treatment showed that across all studies for recurrent CDI, symptom resolution was observed in 85% of patients. The United States Food and Drug Administration currently classifies FMT as an investigational drug, which imparts overly restrictive regulations that are impossible to apply to FMT in the same manner as conventional drugs. Reclassification of FMT to a human cell, tissue, and cellular and tissue-based product could potentially expand access to this important treatment while maintaining rigorous safety standards.
粪便微生物群移植（FMT）已成为治疗艰难梭菌感染（CDI）的一种高效疗法。在美国，CDI是发达国家医院获得性感染性腹泻的最常见病因，每年导致近30000人死亡。事实证明，FMT在治疗CDI方面比传统抗菌疗法更有效，并且减少了珍贵抗生素暴露于潜在耐药性的情况。一项评估FMT治疗CDI疗效的系统评价表明，在所有复发性CDI的研究中，85%的患者症状得到缓解。美国食品药品监督管理局目前将FMT归类为研究性药物，这赋予了过度严格的规定，而这些规定无法以与传统药物相同的方式应用于FMT。将FMT重新分类为人类细胞、组织和基于细胞及组织的产品，可能会在维持严格安全标准的同时，扩大获得这种重要治疗方法的机会。
