中国药物警戒 ›› 2024, Vol. 21 ›› Issue (6): 703-708.
DOI: 10.19803/j.1672-8629.20240016

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多中心真实世界数据评价药品安全性研究进展

汪春楠1, 秦诗如1△, 章萌2,3, 宋海波4, 刘俊昌5,6, 李戈7#, 孙凤2,3,5,*   

  1. 1天津中医药大学中药学院,天津 301617;
    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国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100076;
    5新疆医科大学,新疆 830017;
    6新疆维吾尔自治区中医药研究院 830000;
    7天津中医药大学公共卫生与健康科学学院,天津 301617
  • 收稿日期:2024-01-11 出版日期:2024-06-15 发布日期:2024-06-18
  • 通讯作者: *孙凤,女,博士,研究员·博导,医学统计学与循证医学。E-mail：sunfeng@bjmu.edu.cn; #为共同通信作者。
  • 作者简介:汪春楠,女,本科,临床药学。△为并列第一作者。
  • 基金资助:
    国家自然科学基金资助项目（72361127500、82360979）; 中国药品监管科学行动计划第三批重点项目（RS2024Z008）; 新疆维吾尔自治区科技创新团队项目（2022TSYCTD0008）

Evaluation of drug safety with multicenter real-world data

WANG Chunnan1, QIN Shiru1△, ZHANG Meng2,3, SONG Haibo4, LIU Junchang5,6, LI Ge7#, SUN Feng2,3,5,*   

  1. 1School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;
    2Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China;
    3Key Laboratory of Epidemiology of Major Diseases (Peking University), Beijing 100191, China;
    4Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
    5Xinjiang Medical University, Xinjiang 830017, China;
    6Xinjiang Uygur Autonomous Region Academy of Traditional Chinese Medicine, Urumqi Xinjiang 830000, China;
    7School of Public Health of TJUTCM, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
  • Received:2024-01-11 Online:2024-06-15 Published:2024-06-18

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摘要： 目的 探讨基于多中心真实世界数据开展药品安全性评价的研究进展。方法 检索并筛选有关文献,利用文献计量学工具Bibliometrix实现可视化分析,展示文献分布及关键词词频、共现、历时变化情况;提取并分析目标疾病及干预药物、真实世界数据来源、多中心数据共享情况等信息。结果 纳入405篇文献,发文量逐年增长,研究重点关注肿瘤治疗中的药物干预,如靶向药、化疗药、糖皮质激素、免疫药物等,及循环系统疾病中口服抗凝药和抗血小板药等。作者关键词共现网络中有10个聚类,最主要的2个聚类中心为安全性和心房颤动。最常见数据来源是注册登记数据（217/405,53.5%）。当前以国家内部多个研究中心共享数据为主,欧洲实现了国家间数据共享。结论 基于多中心真实世界数据评估药品安全研究热度不断增加,研究领域逐步扩大,涉及多种常见慢性病。构建国际性的多中心数据管理平台,共用真实世界多来源数据评估药品安全是未来研究和发展方向。

关键词: 药品安全, 药物警戒, 真实世界数据, 文献计量学, Bibliometrix, 多中心

Abstract: Objective To explore the progress, hot spots, and developments of research on drug safety evaluation based on multicenter real-world data. Methods PubMed, Web of Science, and Scopus were searched for literature on drug safety evaluation using multicenter real-world data. Firstly, bibliometrix was used for visual analysis of the time the included literature was published and the distribution of countries and journals. In addition, the frequency, co-occurrence, and diachronic changes of keywords were displayed. Information on the target diseases, intervention drugs, research safety outcomes, real-world data sources, multicenter data sharing was retrieved. Results A total of 405 publications in 2004-2023 were included in the analysis, and the number of publications increased year by year. Research focused on pharmacological interventions in neoplasms treatment, including targeted drugs, chemotherapeutic drugs, glucocorticoids, immunological agents, oral anticoagulants and antiplatelet drugs for circulatory disorders. The keyword co-occurrence analysis found 10 keyword clusters, the top two of which involved safety and atrial fibrillation. The most important source of data was the registry (217/405, 53.5%) in these studies. Currently, most research centers shared data within the country, so research data mostly came from more than 10 institutions (158/280, 56.4%). Data was shared across countries in Europe in this field. Conclusion There is increasing research on drug safety evaluation based on multicenter real-world data. The related research covers a wide range, such as neoplasms and circulatory system diseases. Multicenter data sharing between countries is increasing. Advances in information technology can facilitate inter-country RWD information exchange. The more commonly used real-world data is registry data and hospital database information. Building a global and multicenter data management platform and sharing real-world multi-source data will catch on.

Key words: drug safety, pharmacovigilance, real-world data, bibliometrics, Bibliometrix, multicenter

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