目的 探讨我国近10年中药药物警戒的研究现状与热点，为开展中药药物警戒相关研究提供参考。方法 自中国知网和万方数据库中检索中药药物警戒相关关键词，检索时限为2012年1月至2022年6月。利用R语言等多个软件对年度发文量、作者、机构以及关键词的共现、聚类和突现情况等方面进行可视化分析。结果 共纳入研究文献4632篇，作者和机构之间合作关系较为薄弱。中药注射剂、中药疗法、分析、疗效、中西医结合等关键词是中药药物警戒领域的高频词，对关键词进行归纳，该领域主要分为管理、机制及方法学3个研究方向。其中，管理研究热点包括药事管理、药房管理、风险管理、预防措施等；机制研究热点主要为毒性、配伍、辨证论治、代谢组学、炮制等；方法学研究热点包括处方分析、处方点评、报告分析、回顾性分析、调查分析等。结论 当前高校、企业、监管机构、监测机构在中药的技术交流、全产业链监督、管理、监测、风险评估、预测等方面未形成有效合作网络，各机构应通过搭建信息共享平台，促进数据、技术互联互通，增进学术交流等进一步扩大研究规模与深度，共同推动我国中药药物警戒领域的发展。

Objective To explore the current situation and hotspots on pharmacovigilance of traditional Chinese medicine (TCM) in China in recent 10 years, and provide reference for conducting relevant research on pharmacovigilance. Methods The keywords related to pharmacovigilance of TCM were retrieved from CNKI and Wanfang databases from January 2012 to June 2022. The annual number of publications, authors, institutions and co-occurrence, clustering and emergence of keywords were analyzed visually by R language and other software. Results A total of 4632 literatures were included. The cooperative relationship between authors and institutions was weak. Keywords such as TCM injection, TCM therapy, analysis, curative effect, integrated traditional Chinese and western medicine were the high-frequency words in the field of TCM pharmacovigilance. According to the summary of keywords, the field could be divided into three research directions: management, mechanism and methodology. Pharmaceutical management, pharmacy management, risk management and preventive measures were hotspots of management research; Toxicity, compatibility, syndrome differentiation and treatment, metabolomics, processing were the main hotspots of mechanism research. Prescription analysis, prescription comment, report analysis, retrospective analysis, survey analysis and so on were the main hotspots of methodological research.Conclusion The effective cooperation network in technical communication, the supervision of the whole industry chain, management, monitoring, risk assessment and prediction of TCM have not been established among universities, enterprises and regulator. The agencies should build an information sharing platform, promote data and technology interconnection, enhance academic exchanges and further expand the scale and depth of research, so as to jointly promote the development of TCM pharmacovigilance.

R288

广东省药品监督管理局2021年科技创新项目（2021TDB06，2021ZDB01）；广东省药品监督管理局2022年科技创新项目（2022TDB16）