基于FAERS的药品不良事件数据挖掘研究现状的文献计量分析
Bibliometric Analysis of Research Status on Data Mining of Drug Adverse Events Based on FAERS
DOI: 10.12677/pi.2025.145042, PDF,    科研立项经费支持
作者: 祝 赫：昆明医科大学药学院，云南 昆明；吴 凡*：云南省阜外心血管病医院药剂科，云南 昆明
关键词: 不良事件；CiteSpace；可视化分析；FAERS；数据挖掘；Adverse Events； CiteSpace； Visualization Analysis； FAERS； Data Mining
摘要: 目的：对FAERS数据库相关药品不良事件数据挖掘研究热点、发展现状、未来趋势以及可能遭遇的挑战进行研究。方法：检索2019年1月至2024年6月期间中国知网、Web of Science Core Collection、Scopus三个数据库中关于FAERS数据库研究的文章，利用CiteSpace软件对关键词、发表时间、国家分布进行分析。按时间分层抽样500篇相关文章进行深入探索。结果：纳入1494篇相关文章，发文最多的国家是中国，结果分别涉及7个、10个和10个关键词聚类，16个、25个和18个关键词突现。500篇相关文章抽样分析结果提示挖掘时间跨度的中位数为11年，平均值为11.37 ± 5.87年。研究中最为常用的挖掘工具为Open Vigil，检测方法则以ROR法为主。结论：当前FAERS挖掘研究主要聚焦于药物警戒领域，关注点主要集中在热点药物、抗肿瘤药物、与重大公共卫生事件相关的药物以及新药。此外，FAERS挖掘研究存在一定问题和局限性，在未来有进一步发展和拓展的空间。
Abstract: Objective: To investigate the research hotspots, current development status, future trends, and potential challenges in the data mining of drug adverse events related to the FAERS database. Methods: Articles on FAERS database research were retrieved from three databases—CNKI, Web of Science Core Collection, and Scopus—from January 2019 to June 2024. CiteSpace software was employed to analyze keywords, publication dates, and national distributions. A stratified time-based sampling of 500 relevant articles was conducted for in-depth exploration. Results: A total of 1,494 relevant articles were included, with China being the most prolific contributor. The results revealed 7, 10, and 10 keyword clusters, as well as 16, 25, and 18 emerging keywords, respectively. The sampling analysis of 500 relevant articles indicated that the median time span of data mining was 11 years, with an average of 11.37 ± 5.87 years. The most commonly used mining tool in the studies was Open Vigil, and the reporting odds ratio (ROR) method was the predominant detection approach. Conclusion: Current research on FAERS data mining primarily focuses on the field of pharmacovigilance, with particular attention given to hotspot drugs, antineoplastic agents, drugs related to major public health events, and new drugs. Additionally, FAERS data mining research faces certain issues and limitations, indicating potential for further development and expansion in the future.
文章引用：祝赫, 吴凡. 基于FAERS的药品不良事件数据挖掘研究现状的文献计量分析[J]. 药物资讯, 2025, 14(5): 369-378. https://doi.org/10.12677/pi.2025.145042

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