肠道菌群移植治疗终末期肝病的临床研究操作规范专家共识(2024版)  

Expert consensus on clinical research standards of fecal microbiota transplantation for end-stage liver disease patients(2024 version)

作　　者：中华预防医学会微生态学分会 中国医师协会感染科医师分会 浙江省人工器官与计算医学重点实验室 高海女 邹鹏飞 吴仲文[4] Chinese Society of Microecology;Chinese Preventive Medicine Association;Infectious Diseases Physicians Branch;Gao Hainv(不详;Shulan International Medical College,Zhejiang Shuren University,Zhejiang Provincial Key Laboratory of Artificial Organs and Computational Medicine,Hangzhou 310003,China)

机构地区：[1]不详 [2]浙江树人学院树兰国际医学院,浙江省人工器官与计算医学重点实验室,杭州310003 [3]树兰(杭州)医院 [4]浙江大学医学院附属第一医院

出　　处：《中华临床感染病杂志》2024年第6期413-423,共11页Chinese Journal of Clinical Infectious Diseases

基　　金：国家重点研发计划(2021YFA1301104、2022YFC2304505)。

摘　　要：肠道菌群移植(fecal microbiota transplantation,FMT)是一种通过移植健康人群的肠道菌群来改善患者肠道功能的新兴生物技术。FMT在治疗终末期肝病中的潜力得到广泛关注和研究,但推广至大规模临床应用仍需谨慎,需要大样本临床研究来证实。在开展临床研究之前,要制定一套规范的流程以确保研究的合理性和可行性,同时最大程度地规避风险,保护受试者。既往的FMT临床共识和指南对实施FMT中心的基本要求、适应证、供体筛选、菌液质量控制、方法学、治疗剂量标准、联合用药标准、不良反应处理,以及档案管理等方面进行了阐述,但对于如何规范地开展临床研究还缺乏相应的共识。本共识在已有共识的基础上,重点阐述如何规范地开展FMT治疗终末期肝病,主要针对复发性肝性脑病和重症酒精性肝炎,旨在为临床试验设计提供参考和指导。Fecal microbiota transplantation(FMT)is an emerging biotechnology that improves patient intestinal function by transplanting of the gut microbiota from healthy individuals.The therapeutic potential of FMT for patients with end-stage liver disease has received widespread attention,however,its efficacy and safety need to be confirmed through large scale clinical studies before its promotion in clinical application.The previous clinical consensus and guidelines have demostrated important issues dealing with clinical application of FMT,including the basic requirements,indications,donor screening,bacterial liquid quality control,methodology,treatment dose standards,combination therapy standards,adverse reaction management,and record management for implementing FMT centers.On the basis of existing consensus and guidelines,this consensus focuses on the standardized clinical application of FMT for patients with end-stage liver disease,mainly recurrent hepatic encephalopathy and severe alcoholic hepatitis,to provide reference and guidance for future clinical trials.

关 键 词：肠道菌群移植 终末期肝病 临床研究 共识 

分 类 号：R575[医药卫生—消化系统]