中国药物警戒 ›› 2021, Vol. 18 ›› Issue (5): 416-421.
DOI: 10.19803/j.1672-8629.2021.05.04

• 中药药物警戒研究与实践专栏 • 上一篇    下一篇

中药药物警戒“四维联动”研究平台的构建与应用

张丹1,2, 吕锦涛1,2, 张冰1,2,*, 林志健1,2, 吴焕章1, 张晓朦1,2   

  1. 1北京中医药大学中药学院,北京 102488;
    2北京中医药大学中药药物警戒与合理用药研究中心,北京 102488
  • 收稿日期:2020-02-26 出版日期:2021-05-15 发布日期:2021-05-12
  • 通讯作者: *张冰,女,博士,教授,主任医师,中药药物警戒与合理用药研究、中药药性理论与名老中医传承研究、中药防治代谢性疾病研究。E-mail:zhangbing6@263.net
  • 作者简介:张丹,女,在读博士,中药药物警戒与合理用药研究。
  • 基金资助:
    国家自然科学基金项目（81874349）;国家中医药领军人才支持计划“岐黄学者”项目;中国毒理学会临床毒理专项课题(CST2020CT501);第三批国家高层次人才特殊支持计划（万人计划）教学名师项目

Construction and Application of Four-Dimensional and Chained Research Platform for Pharmacovigilance of Traditional Chinese Medicine

ZHANG Dan1,2, LYU Jintao1,2, ZHANG Bing1,2,*, LIN Zhijian1,2, WU Huanzhang1, ZHANG Xiaomeng1,2   

  1. 1School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China;
    2Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, China
  • Received:2020-02-26 Online:2021-05-15 Published:2021-05-12

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摘要： 目的 针对中药临床安全应用的复杂性,构建中药药物警戒“四维联动”研究平台,期望既能体现中医药特色又能发挥全面评价优势,为加强中药安全性研究提供思路借鉴与实际操作指导。方法 通过中药药物警戒“四维联动”研究平台探索中药药物警戒的关键环节,构建风险信号发掘、隐患证据强化、风险-效益评价、中药风险沟通4个维度的中药安全性研究模型,以全面、系统、量化、精准地发现、理解、评估和防范中药临床用药的安全问题。结果 本研究平台已集成风险信号发掘模型、隐患证据强化模型、风险-效益评价模型、中药风险沟通模型,并已在中药药物警戒研究领域展开应用。结论 本课题组构建的中药药物警戒“四维联动”研究平台可用于全面、客观地阐释中药临床安全性的复杂问题,科学、系统地解析中药传统安全用药的思想实质,促进中药药物警戒思想与理论的落地与发展。

关键词: 中药, 药物警戒, 四维联动, 研究平台, 研究模型

Abstract: Objective To construct a four-dimensional and chained research platform for pharmacovigilance of TCM given the complexity of safe clinical use of traditional Chinese medicine (TCM) in order to provide reference and guidance for research on the safety of TCM. Methods By exploring the critical elements of pharmacovigilance of TCM, the core models of risk signal discovery, risk evidence enhancement, risk-benefit assessment and drug risk communication were utilized by the platform, which could comprehensively, systematically, quantitatively and accurately discover, determine, assess and prevent problems with safety of clinical medication of TCM. Results This research platform was not only able to integrate the models of risk signal mining, risk evidence enhancement, risk benefit evaluation and drug risk communication, but used for pharmacovigilance research of TCM. Conclusion The four-dimensional and chained research platform of TCM pharmacovigilance can be used to comprehensively and Objectively account for the complex problems with the safety of TCM, properly and systematically clarify the essence of traditional ideas about safe application of TCM, and promote the implementation and development of TCM pharmacovigilance.

Key words: traditional Chinese medicine (TCM), pharmacovigilance, four-dimensional and chained, research platform, research model

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