噬菌体治疗临床应用管理专家共识(2024版)  

Expert consensus on management of clinical application of phage therapy(2024 version)

作　　者：中国噬菌体研究联盟 中国生物工程学会噬菌体技术专业委员会 中国微生物学会医学微生物学与免疫学专业委员会 胡必杰 李娜[3] 吴楠楠 陈婷婷 乐率 Chinese Phage Research Alliance;Phage Technology Committee of Chinese Society of Biotechnology;Medical Microbiology and Immunology Committee of Chinese Society for Microbiology;Hu Bijie(不详;Department of Infectious Diseases,Zhongshan Hospital,Fudan University,Shanghai 200032,China)

机构地区：[1]不详 [2]复旦大学附属中山医院感染病科,上海200032 [3]复旦大学附属中山医院,上海200032 [4]上海市公共卫生临床中心 [5]陆军军医大学

出　　处：《中华临床感染病杂志》2024年第6期424-430,共7页Chinese Journal of Clinical Infectious Diseases

基　　金：国家自然科学基金(82072325);国家重点研发计划(2021YFA0911200);上海申康医院发展中心重大临床研究项目(SHDC2020CR2031B);上海市科委基金项目(21MC1930400)。

摘　　要：噬菌体治疗是利用烈性噬菌体治疗细菌病原体引起的感染性疾病的疗法。近年来,噬菌体治疗在细菌感染性疾病治疗中取得了突破性进展,为阻击全球细菌耐药危机提供了新方案。现阶段,噬菌体治疗仍未广泛应用于临床,在国内外缺乏统一的临床管理规范。为此,在上海市卫生健康委员会和上海市医学会的指导下,噬菌体治疗临床管理相关领域的专家在充分检索国内外相关文献、行业政策,以及总结国内多家医疗机构开展噬菌体治疗经验的基础上,参照医疗技术管理规范,编写了适用于医疗机构常规开展噬菌体治疗工作的临床管理专家共识,以期进一步加强我国噬菌体规范化临床应用及管理,提高噬菌体治疗的安全性和有效性。Phage therapy,the use of lytic bacteriophages to treat bacterial infections,has emerged as a promising approach to combat the global crisis of antimicrobial resistance(AMR).Despite recent breakthroughs in its application for infectious diseases,its clinical implementation remains limited,largely due to the absence of standardized guidelines,both domestically and internationally.To address this gap,under the guidance of the Shanghai Municipal Health Commission and the Shanghai Medical Association,a panel of experts have developed a consensus on the management of clinical application of phage therapy in China based on current research progress,relevant policies,and practical experiences from multiple medical institutions,and in accordance with medical technology management standards.This expert consensus aims to enhance the management of standardized clinical use of phage therapy to improve its safety and efficacy.

关 键 词：噬菌体治疗 细菌耐药 医疗技术 临床管理规范 

分 类 号：R446[医药卫生—诊断学] R446.5[医药卫生—临床医学]