中国药物警戒 ›› 2018, Vol. 15 ›› Issue (5): 268-275.

• 法规与管理研究 • 上一篇    下一篇

近五年药物警戒国际领域研究态势分析及对我国的启示

黄桂华1,杜化荣2,宫丽 1   

  1. 1中国科学院上海药物研究所药物安全评价中心，上海201203;
    2上海中医药大学图书馆，上海201203
  • 收稿日期:2018-04-26 修回日期:2018-06-21 出版日期:2018-05-20 发布日期:2018-06-21
  • 作者简介:黄桂华，女，实验师，药理毒理学。
  • 基金资助:
    中国科学院战略性先导科技专项（XDA12050300）：《个性化药物核心资源系统与可持续应用研究》。

Analysis on Global Research Trends of Pharmacovigilance in Recent Five Years and Its Implications for China

HUANG Gui-hua1,DU Hua-rong2,GONG Li-kun1   

  1. 1Center for Drug Safety Evaluation and Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201023, China;
    2Library of Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
  • Received:2018-04-26 Revised:2018-06-21 Online:2018-05-20 Published:2018-06-21
  • Contact: 宫丽,女,博士,研究员·博导,药理毒理学。E-mail：lkgong@cdser.simm.ac.cn

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摘要： 目的 利用情报学分析方法分析药物警戒国际领域的研究态势，探讨对我国药物警戒研究的启示。方法 以Web of Science核心集为数据源，主要运用文献计量分析、社会网络分析、共词聚类法对药物警戒国际领域的研究趋势、研究主体、资助来源、核心期刊和研究热点进行分析。结果 药物警戒研究的特点有：分阶段式增长；研究主体以高校、医院、职能机构和药企为主，且群体合作密切；资助来源多样化，包括制药企业、研究院所、职能机构和重大研究项目；Drug Safety等14个外文核心期刊和国际药物警戒协会年会是主要交流载体和途径；研究热点有7个，主要集中在基于大数据、人工智能算法的药物警戒信号管理和药物警戒数据库的数据挖掘，儿童、孕妇特殊人群、疫苗的用药安全和生物制剂、生物仿制药的药物警戒研究，以及社会媒体在药品不良反应事件监测中的应用3个方向。结论 加大政策引导力度，鼓励机构合作和国际交流，引导多元化资助、加强研发投入，健全数据体系、发掘中医药特色研究，将有力提升我国药物警戒研究水平。

关键词: 药物警戒, 国际领域, 研究态势, 文献计量, 研究热点

Abstract: Objective To analyze the global research trends of pharmacovigilance by using an intelligence analysis method, so as to explore the implications for pharmacovigilance research in China.Methods Data derived from core set of Web of Science. Bibliometrics, social network analysis and co-word clustering analysis were used to analyze institutions, foundations, core journals and research hot spots in terms of global pharmacovigilance research trends.Results Staged growth and main institutions are universities, hospitals, academic institutions and pharmaceutical enterprises, and collaborations between institutions were tight. The funding sources were diverse, including pharmaceutical enterprises, institutions, academic institutions and key projects. Fourteen core journals, such as Drug Safety, and the annual meeting of the international society of pharmacovigilance were the main communication carriers and approaches. There were seven hot spots which focused on three directions. a) The pharmacovigilance signal management and pharmacovigilance database data mining based on big data and artificial intelligence algorithm. b) The safety of vaccines and special populations, such as children and the pregnant, and pharmacovigilance studies about biological agents and biosimilars. c) The application of social media in the monitoring of adverse drug events. All above are the global research trends of pharmacovigilance.Conclusion a) To increase the intensity of government policies'guidance; b) To encourage inter-agency collaborations and seek international collaborations; c) to strengthen R&D investment by engaging diverse funds; d) To improve the pharmacovigilance data system and explore research activities with characteristics of TCM. These will promote research studies on pharmacovigilance in China.

Key words: pharmacovigilance, global, research trend, bibliometrics, research hot spots

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