人乳头瘤病毒疫苗应用真实世界研究长三角地区专家建议

Expert recommendation for real-world study on the application of human papillomavirus vaccine in the Yangtze River Delta region

子宫颈癌已成为严重威胁女性健康的全球公共卫生问题,接种人乳头瘤病毒(HPV)疫苗是预防子宫颈癌的重要一级预防措施。随着中国HPV疫苗应用的加快,开展HPV疫苗应用的真实世界研究(RWS)能够指导疫苗的合理应用,对于中国加速消除子宫颈癌的策略和实践具有重要的意义。长三角宫颈癌及女性下生殖道感染防控联盟和长三角免疫规划一体化项目组组织专家制定了《人乳头瘤病毒疫苗应用真实世界研究长三角地区专家建议》。本文基于中国医疗信息化和HPV疫苗接种现况,结合国内外研究的文献和案例,阐述了HPV疫苗接种和评价的数据链,介绍了RWS的研究设计、研究方向、数据库建设、数据治理和统计分析,对开展HPV疫苗RWS实践中的问题提出了专家建议,旨在指导HPV疫苗应用的RWS,促进中国真实世界证据的产生。

Cervical cancer has become a global public health problem that poses a serious threat to women′s health.Human papillomavirus(HPV)vaccination is an important primary preventive measure for cervical cancer.With the accelerated application of the HPV vaccine in China,conducting real-world studies(RWS)on the application of HPV vaccines can guide the rational use of the vaccine,which is of great significance for the strategy and practice of accelerating the elimination of cervical cancer in China.The Yangtze River Delta Cervical Cancer and Female Lower Genital Tract Infection Prevention and Control Alliance and Yangtze River Delta Immunization Integration Working Group organized an expert group to develop the"Expert recommendation for real-world study on the application of HPV vaccine in the Yangtze River Delta region".Based on the current situation of medical informatization and HPV vaccination administration in China,as well as literature and cases from domestic and international studies,this study describes the data chain of HPV vaccination and evaluation,introduces the study design,study direction,database construction,data governance and statistical analysis of RWS,and provides expert recommendation on the problems in carrying out the practice of HPV vaccine RWS,aiming to guide the RWS of HPV vaccine application and promote the generation of real-world evidence(RWE)in China.