呼吸道病毒感染预防药物临床试验设计的考虑  

Considerations on the clinical trial design of prophylactic drugs for respiratory viral infections

作　　者：何春俐 赵建中 HE Chun-li;ZHAO Jian-zhong(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》2024年第17期1761-1766,共6页Chinese Journal of New Drugs

摘　　要：呼吸道病毒感染对人类健康造成了极大危害,常见的呼吸道病毒包括流感病毒、副流感病毒、呼吸道合胞病毒、人类偏肺病毒、鼻病毒、新型冠状病毒等。有效的疫苗接种是控制呼吸道病毒感染传播的关键,药物预防是其有效补充。本文通过综述流感病毒、呼吸道合胞病毒和新型冠状病毒感染预防药物的研发进展和临床试验情况,探讨呼吸道病毒感染药物预防临床试验的关注点,包括研究设计、研究人群、疗效评价指标等,以期对此类药物的研发提供参考。Respiratory viral infections cause great harm to public health.Common respiratory viruses include influenza virus,parainfluenza virus,respiratory syncytial virus,human metapheumovirus,rhinovirus,and novel coronavirus,etc.The essential key to controlling the spread is effective vaccination,to which are a beneficial supplement.This article reviews the development and clinical trials of the prophylactic drugs of the influenza virus,respiratory syncytial virus and novel coronavirus infection.The key points of prophylactic clinical trials involved in respiratory viral infections are also discussed,including study design,study population and efficacy endpoints,etc.,hoping to provide references for the drug research and development.

关 键 词：流感病毒 呼吸道合胞病毒 新型冠状病毒 预防药物 临床试验 

分 类 号：R95[医药卫生—药学]