中国药物警戒 ›› 2021, Vol. 18 ›› Issue (7): 686-688.
DOI: 10.19803/j.1672-8629.2021.07.19

• 安全与合理用药 • 上一篇    下一篇

我国药物警戒研究的文献计量分析

郑明节1, 程蓉2, 宋海波1,*   

  1. 1国家药品监督管理局药品评价中心,北京100022;
    2贵州省药品评价中心,贵州 贵阳550081
  • 收稿日期:2020-04-14 出版日期:2021-07-15 发布日期:2021-07-23
  • 通讯作者: *宋海波,男,博士,主任药师,临床药理研究。E-mail：songhaibo@cdr-adr.org.cn
  • 作者简介:郑明节,女,硕士,副主任药师,药品不良反应监测与评价。
  • 基金资助:
    中医药行业科研专项（201507004）

Bibliometric Analysis of Pharmacovigilance Research in China

ZHENG Mingjie1, ChENG Rong2, SONG Haibo1,*   

  1. 1Center for Drug Reevaluation, NMPA, Beijing 100022, China;
    2Center for Drug Reevaluation, Guiyang Guizhou 550081, China
  • Received:2020-04-14 Online:2021-07-15 Published:2021-07-23

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摘要： 目的 分析国内药物警戒研究领域的现况及不足,为推动药物警戒研究提供参考。方法 检索PubMed和中国知网涉及药物警戒的相关文献,检索时间为建库至2020年12月31日,采用文献计量学对检索结果进行分析,比较国内外药物警戒研究的趋势,分析国内相关研究领域的现况及不足。结果 我国药物警戒的研究仍以传统的药品不良反应监测为主,偏重于药学、中药学及预防医学等学科,可能与我国药物警戒制度刚刚实施、国内高校缺乏药物警戒领域的学历教育、医疗机构及企业对药物警戒研究的参与度不高、科研管理部门对药物警戒研究的科研经费资助不足,绝大多数学术期刊未将药物警戒相关研究作为刊发的重点领域等有关。结论 需采取有效措施推动我国药物警戒的研究发展与制度落实。

关键词: 药物警戒, 文献计量学, 药品不良反应, 风险管理

Abstract: Objective To analyze the current status and shortcomings of pharmacovigilance research in China and provide references for promoting pharmacovigilance research. Methods Literatures related to pharmacovigilance and Pharmacovigilance of PubMed and CNKI from the establishment of the database to 31 December 2020 were searched and analyzed. The trends of pharmacovigilance research at home and abroad were compared. The current status and deficiencies of relevant research in China were analyzed. Results The research on pharmacovigilance in China still focuses on traditional adverse drug reaction monitoring, mainly involving pharmacy, traditional Chinese medicine and preventive medicine., which may be due to the fact that China's pharmacovigilance system has just been implemented, domestic colleges and universities lack academic education in the field of pharmacovigilance, medical institutions and enterprises are not highly involved in pharmacovigilance research, and scientific research management departments have insufficient funding for pharmacovigilance research. Most academic journals do not regard pharmacovigilance related research as a key area of publication. Conclusion Effective measures should be taken to promote the research development and system implementation of pharmacovigilance in China.

Key words: pharmacovigilance, bibliometrics, adverse drug reactions, risk management

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