Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (5): 416-421.
DOI: 10.19803/j.1672-8629.2021.05.04

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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

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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