人呼吸道合胞病毒疫苗的临床安全性研究与思考  

Clinical safety research and considerations of human respiratory syncytial virus vaccine

作　　者：刘琳玉 鲁爽 LIU Lin-yu;LU Shuang(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国新药杂志》2025年第7期693-698,共6页Chinese Journal of New Drugs

摘　　要：人呼吸道合胞病毒(respiratory syncytial virus,RSV)是导致下呼吸道感染的常见病原体。目前针对RSV感染以对症支持治疗为主,接种疫苗仍是预防RSV感染的有效手段之一。婴幼儿、老年人及其他免疫功能低下者等人群为RSV感染的高风险人群,在相应目标人群的RSV疫苗临床研发中需重点关注安全性评价。本文将结合境外已上市RSV疫苗的临床安全性研究,对RSV疫苗的安全性评价进行探讨。Human respiratory syncytial virus(RSV) is a common pathogen that causes lower respiratory tract infections.At present,symptomatic and supportive treatment remains the main treatment for RSV infections,while vaccination is one of the effective means to prevent such infections.Infants,the elderly and other immunocompromised people are at high risk of RSV infection.Therefore,it is important to pay attention to the safety evaluation of RSV vaccine in clinical research.This paper will discuss the safety evaluation of RSV vaccines alongside the clinical safety researches of RSV vaccines approved abroad.

关 键 词：人呼吸道合胞病毒 疫苗 安全性研究 安全性评价 

分 类 号：R95[医药卫生—药学]