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。
Bibliometric analysis of active surveillance of post-marketing drug safety
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.
Surveillance of post-marketing safety of drugsActive surveillancePharmacovigilanceBibliometricsVisualization analysis
万方数据
维普
