摘要
目的:了解国内外疫苗上市后主动药物警戒领域的现状、研究热点和发展趋势,为我国疫苗上市后安全性评价的建设与发展提供理论参考.方法:检索Web of Science数据库和中国知网数据库2013-2023年收录的疫苗上市后主动药物警戒相关文献,采用CiteSpace软件对筛选后的文献进行年发文量、作者机构合作、关键词共现、聚类、突发性探测等方面的可视化分析和比较分析.结果:共纳入中文文献1 151篇、英文文献1 120篇,国内作者及其团体/机构多独立研究,国际合作缺乏,英文作者间形成的合作团体更多且交流密切;国内外研究共同关注疫苗上市后的安全性监管,国外探索用主动监测数据库进行大数据信号挖掘,国内侧重在被动数据中发现风险信号,主动监测研究多处于理论分析层面,尚未建立一套通用的主动监测模式与机制.结论:国内外对疫苗上市后主动药物警戒都十分重视,安全性信号检测仍是热点,新疫苗、新型疫苗的上市后主动药物警戒是未来发展趋势,我国亟需与国际发展接轨,应对疫苗安全性监测的新需求与挑战.
Abstract
OBJECTIVE To understand the current situation,research hotspots and development trends in the field of active pharmacovigilance of vaccines after marketing at home and abroad and provide theoretical references for conducting vaccine safety evaluations after marketing in China.METHODS From 2013 to 2023,the relevant literature items on active pharmacovigilance after vaccine marketing were retrieved from the databases of Web of Science and CNKI.And CiteSpace was utilized for conduct-ing visual and comparative analyses of annual publication volume,institution/author cooperation,keyword co-occurrence,cluster ing and keyword burst detection.RESULTS The study included 1 151 Chinese literatures and 1 120 English literatures.Chinese authors and their groups/institutions performed more independent researches and lacked international cooperation while English authors formed more cooperative groups and enjoyed closer communications.Domestic and foreign researches focused on the safety supervision of vaccines after marketin,and some foreign countries explored big data signal mining through active monitoring databases.Domestic researches were apt to discover risk signals in passive data while researches on active monitoring stayed largely at the level of theoretical analysis level.And universal active monitoring mode and mechanism is yet to be established.CONCLUSION Both at home and abroad,clinicians should attach great importance to active pharmacovigilance after vaccine marketing.Safety signal detection remains a hot spot.And post-marketing active pharmacovigilance of new vaccines and novel vaccines is a future trend.China urgently needs to align with international developments and address the new needs and emerging challenges of vaccine safety monitoring.
基金项目
药物制剂质量研究与控制重点实验室开放基金(YWZJZD-202202)
湖北省药品监督管理局药品安全监管科研项目(20220112)
NETL
NSTL
万方数据