抗菌新药研发立题的新思考  

New considerations on the research and development of antimicrobial novel drugs

作　　者：康悦[1] 赵明[2] 张菁[1] 

机构地区：[1]复旦大学附属华山医院抗生素研究所卫计委抗生素临床药理重点实验室,上海200040 [2]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国抗生素杂志》2017年第3期169-175,共7页Chinese Journal of Antibiotics

摘　　要：在细菌耐药性日益严重的今天,大力研发针对未满足的以控制耐药菌感染为主要目标的新结构、新靶点和新机制的新型抗菌药物和合理使用抗菌药物是关注的核心。新抗菌药物也同样体现了从研发到撤出市场的药品全生命周期,但对于一个新研发项目的启动,其立题合理性无疑是研发中最关键的一环。唯有适应临床治疗需要的创新,才具有开发的意义和价值。本文从多国发布与抗菌药物研发有关的指导原则出发,综述了抗菌药物研发的原则、依据和评价,通过介绍国外刚上市的新药研发的案例,探讨研发过程中把握一些关键节点对于研发的意义和价值。Nowadays, with the increasingly resistance of bacteria, research and development （R＆D） of novel antibiotics with new structure, target and mechanism of action for the unmet needs to control the infections caused by resistant bacteria is the core of attention. New antibiotics have lifecycle from R＆D to withdrawal like all the drugs. However, the rationale for a new R＆D project is undoubtedly to the key part. Only the novel antibiotics which can meet the requirement of clinical have the meaning and value for further development. This article reviews the principals, basis and evaluation of novel antibiotics R＆D based on the guidance released by governments and discusses the meaning and value of some key points for R＆D.

关 键 词：抗菌药物 耐药性 药物临床评价评价 微生物学评价 

分 类 号：R978.1[医药卫生—药品]