药品上市后安全性主动监测文献计量学分析  

Bibliometric analysis of active surveillance of post-marketing drug safety

作　　者：王聪慧 杨子铭 王振兴 世伟 阿拉腾花 席成伟 皮松宁 袁新敏 詹思延[2,3,4,5] WANG Conghui;YANG Ziming;WANG Zhenxing;SHI Wei;ALATENG Hua;XI Chengwei;PI Songning;YUAN Xinmin;ZHAN Siyan(Inner Mongolia Pharmacovigilance Center,Hohhot 010010,China;Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing 100191,China;Key Laboratory of Epidemiology of Major Diseases(Peking University),Ministry of Education,Beijing 100191,China;Research Center of Clinical Epidemiology,Peking University Third Hospital,Beijing 100191,China;Center for Intelligent Public Health,Institute for Artificial Intelligence,Peking University,Beijing 100871,China)

机构地区：[1]内蒙古自治区药物警戒中心,呼和浩特010010 [2]北京大学公共卫生学院流行病与卫生统计学系,北京100191 [3]重大疾病流行病学教育部重点实验室(北京大学),北京100191 [4]北京大学第三医院临床流行病学研究中心,北京100191 [5]北京大学人工智能研究院智慧公众健康研究中心,北京100871

出　　处：《药物流行病学杂志》2024年第9期1054-1063,共10页Chinese Journal of Pharmacoepidemiology

基　　金：内蒙古自治区药品监督管理局药品安全监管科研项目(NMYJ-KJ-202306)。

摘　　要：目的对国内外药品上市后安全性主动监测文献进行文献计量学可视化分析,展示领域热点现状与趋势,为未来我国研究开展和主动监测管理体系的完善提供参考。方法系统检索Web of Science和CNKI数据库中药品上市后安全性主动监测的英文与中文文献,导入CiteSpace 6.3.R2软件进行发文量、作者、机构和国家合作网络分析,并进行关键词共现、聚类和突现分析。结果经筛选共纳入中文文献415篇,英文文献676篇,年发文量整体呈增加趋势。中文文献作者合作网络相对于英文文献规模较小,合作关系网络较为稀疏,无强中心性机构。中文文献中,国内药品监管机构发挥了重要作用,而药企对自身产品的监测研究仍较少。研究内容涵盖主动监测体系与技术方法研究和特定药物与疾病的药品安全性主动监测实践研究。结论药品上市后安全性主动监测被世界各国广泛关注,我国研究活动热度呈现明显增长趋势,但与国际前沿相比仍有差距,需要进一步加强合作,促进我国主动监测管理体系完善。Objective To conduct bibliometric visualization analyses of the literature domestic and overseas on active surveillance of post-marketing safety of drugs,aiming to display the current status and trend of hotspots in this field and to provide references for future research and the improvement of the Chinese management system of active surveillance.Methods The English and Chinese literature on active surveillance of post-marketing safety of drugs were searched in Web of Science and CNKI respectively and imported into CiteSpace 6.3.R2 software for the analysis of the number of publications,authors,institutions,and national cooperative networks,and the analysis of keyword co-occurrence,clustering and emergence.Results 415 Chinese and 676 English literature were included,with an overall increasing trend in annual publication volume.The author collaboration network of Chinese literature was smaller than that of English literature,and the partnership network was sparse,with no strong centralized institution.Domestic drug regulatory agencies played an important role in the field,while drug companies'monitoring research on their own products was still relatively scarce.The research topic covered active surveillance systems,technical method research,and drug safety active surveillance practice research for specific drugs and diseases.Conclusion Countries worldwide have widely considered active surveillance of post-marketing drug safety.The heat of research activities in China has shown a significant growth trend.However,there is still a significant gap compared with the international frontiers.Further cooperation needs to be strengthened to promote the improvement of the active surveillance management system in China.

关 键 词：药品上市后安全性监测 主动监测 药物警戒 文献计量学 可视化分析 

分 类 号：R95[医药卫生—药学] G353.1[文化科学—情报学]