国内外药物警戒研究现状与热点的文献计量学分析

目的探讨国内外药物警戒的研究现状与热点前沿,为科学评价药品安全性提供参考。方法在Web of Science和中国知网数据库中检索药物警戒相关文献,检索时限均为建库起至2021年3月31日。采用Excel 2019软件、CiteSpace 5.7R2软件对年度发文量、研究者、国家/地区、机构以及关键词的共现、聚类和突现情况进行可视化处理并分析。结果与结论共纳入国外文献5422篇、国内文献966篇,国内外发文量均呈逐年增加趋势。国外研究者之间的合作较为紧密,而国内研究者合作较少。各国之间构建了密切的合作网络,主要集中在欧美等国。我国在该研究领域虽起步较晚,但自2018年起呈现较为迅猛的发展态势且持续至今。国内文献中,发文量较高的主要为国家药品监督管理机构、研究所及高校,但各机构合作关系较为薄弱。药品不良反应、安全性及相关高危因素是目前国外药物警戒的研究热点,前沿主要为针对疫苗、药物及治疗方法的药物警戒研究;国内药物警戒目前的研究热点为药品不良反应,且特别关注中药的安全性,建立“药品上市许可持有人”药物警戒体系是研究前沿。在药品安全性评价过程中不可仅局限于药品不良反应监测和报告,更应重视药物警戒的多环节、多维度研究证据的评价和应用,以有效促进安全合理用药。

Bibliometric analysis of status quo and hot spots of domestic and foreign pharmacovigilance research

OBJECTIVE To investigate the status quo and hot spots of domestic and foreign pharmacovigilance research,so as to provide reference for scientific evaluation of drug safety.METHODS Relevant literature were searched from Web of Science and CNKI during the inception to Mar.31st,2021.Excel 2019 software and CiteSpace 5.7R2 software were used to visualize and analyze the co-occurrence,clustering and burst of annual document volume,researchers,countries/regions,institutions and keywords.RESULTS&CONCLUSIONS A total of 5422 foreign literature and 966 domestic literature were included,with an increasing trend year by year.The cooperation between foreign researchers was relatively close,while the cooperation between domestic researchers was less.A close network of cooperation was set up,mainly in Europe and the United States.China although the late start,but since 2018,there was a relatively rapid development trend and has continued so far.In domestic literature,the organizations with a large number of published literature were mainly national medicine regulatory authorities,research institute,colleges and universities,the cooperation of them was relatively weak.ADR,drug safety and relevant risk factors are the research hotspots of pharmacovigilance abroad;the frontier mainly focuses on pharmacovigilance research for vaccines,drugs and therapeutic methods.The current research hotspot in China is ADR,and special attention is paid to the safety of traditional Chinese medicine.The establishment of pharmacovigilance system of“Drug Marketing Authorization Holders”is the research frontier.In the process of drug safety evaluation,attention should be paid not only to the monitoring and reporting of ADR,but also to the evaluation and application of multi-link and multi-dimensional research evidence of pharmacovigilance,so as to effectively promote safe and rational drug use.