摘要
抗生素的广泛使用使得耐药和泛耐药病原菌不断涌现,对全球公共卫生造成了巨大威胁。目前,噬菌体治疗已成为抗击多重耐药菌的重要手段之一,在欧美国家和中国已经进行了临床应用。然而,中国目前尚未形成针对噬菌体治疗的专项监管法规,研究者发起的临床研究成为我国开展噬菌体治疗的主要形式,这制约了我国噬菌体治疗的进一步发展和广泛应用,亟需在当前的药品监管框架下,制定适当的噬菌体监管法规。因此,本文回顾了格鲁吉亚、美国、英国、比利时和中国的噬菌体治疗现状和监管法规框架,旨在为噬菌体临床治疗的监管提供参考。完善的噬菌体临床应用监管法规将极大促进噬菌体治疗在中国的推广和应用,也必将有效地遏制细菌耐药危机,更好地维护人民群众的生命健康安全。
With the widespread use of antibiotics,more and more drug-resistant pathogens are constantly emerging,posing a huge threat to global public health security.Currently,bacteriophage(phage)therapy has become one of the most important approaches to combating multi-drug resistant bacteria and has been clinically applied in countries of Europe and America,and China.However,there is no special regulation for phage therapy in China,so the investigator-initiated trial has become the main form of phage therapy in China,which restricts the further development and widespread application of phage therapy.Establishing appropriate phage therapy regulations under the current drug regulatory framework is urgent.Therefore,this article first reviews the current situation and regulatory framework of bacteriophage therapy in Georgia,the United States,the United Kingdom,Belgium,and China,aiming to provide a reference for regulating bacteriophage clinical treatment.This article also proposes effective ways to develop bacteriophage therapy in China.Improvement of regulations for bacteriophage clinical application will greatly promote the application of phage therapy in China,effectively curb the crisis of bacterial resistance and better safeguard the health of the people.
作者
姜昕宇
吴楠楠
卢曙光
朱同玉
乐率
Jiang Xinyu;Wu Nannan;Lu Shuguang;Zhu Tongyu;Le Shuai(Department of Microbiology,College of Basic Medical Sciences,Key Laboratory of Microbial Engineering Under the Educational Committee in Chongqing,Army Medical University,Chongqing 400038;CreatiPhage Biotechnology Co.,Ltd,Shanghai 201100;Shanghai Public Health Clinical Center,Shanghai Institute of Phage,Fudan University,Shanghai 201508;Shanghai Key Laboratory of Organ Transplantation,Zhongshan Hospital Fudan University,Shanghai 200030)
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2024年第1期26-34,共9页
Chinese Journal of Antibiotics
基金
国家重点研发计划(No.2021YFA0911200)。
关键词
噬菌体治疗
药品立法监管
新药申报
限制类医疗技术
噬菌体制剂生产
Phage therapy
Drug legislation and supervision
Register of new medicine
Restrictive medical techniques
Production of phage preparations
