中国药物警戒 ›› 2021, Vol. 18 ›› Issue (5): 411-415.
DOI: 10.19803/j.1672-8629.2021.05.03

• 中药药物警戒研究与实践专栏 • 上一篇    下一篇

基于“药性”的中药“毒-效”认知与药物警戒思考

张冰1,2, 吕锦涛1,2, 张晓朦1,2, 林志健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
  • 作者简介: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
  • 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;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

Traditional Chinese Medicine Property-Based Understanding of Toxicity, Efficacy and Pharmaco-vigilance

ZHANG Bing1,2, LYU Jintao1,2, ZHANG Xiaomeng1,2, LIN Zhijian1,2   

  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 围绕“药性”探讨中药“毒-效”认知与药物警戒,为中药药物警戒的理论研究与实践提供借鉴。方法 以药性理论为基础,结合临床用药实际情况与实验研究,分析和提炼临床有效性与安全性影响因素,探讨论证“性”“毒”“效”关系,构建以“药性”为核心的中药药物警戒模式。结果 “效”“毒”分别是“药性”的正、负向表达,可相互转化。中药药物警戒可从“药性”出发,认识药物特点、促进“毒”转为“效”、防范“效”转为“毒”、解除药物毒性,根据药物自身因素、患者机体因素与临床用药因素,通过源头质量把控、终端信号监测、过程控制预警,实现中药全程警戒。结论 “药性”是中药的临床特色,中药药物警戒应考虑“药性”认知,体现中药“毒-效”应用特点,构建中药特色的药物警戒模式,促使药性理论更好地为临床合理用药服务,为中药药物警戒实践的开展提供新思路。

关键词: 药性, 中药, 毒, 效, 药物警戒

Abstract: Objective To explore toxicity, efficacy and pharmacovigilance of traditional Chinese medicine (TCM) based on the property of TCM so as to provide reference for research on and implementation of Chinese medicine pharmacovigilance. Methods Based on related theories, actual clinical medication and experimental research, the factors that influenced the effectiveness and safety of TCM were analyzed, and the relationship between the property, toxicity and efficacy was studied. Meanwhile, a TCM property-based pharmacovigilance model was established. Results Efficacy and toxicity were positive and negative expressions of TCM property, and one could be transformed into the other. Pharmacovigilance of TCM was supposed to start with the property of TCM, which involved advancing our understanding of properties of TCM, facilitating "toxicity to efficacy" transformation, preventing "efficacy to toxicity" transformation and detoxification. Factors including drugs, patients and medication had to be taken into consideration in the whole process of pharmacovigilance by means of quality control, terminal signal monitoring and process warning. Conclusion The medicinal property is the clinical feature of TCM. Pharmacovigilance of TCM calls for keen insights into the property of TCM while giving weight to toxicity and efficacy so as to establish a model of pharmacovigilance that could provide new ideas and guide rational use of TCM.

Key words: traditional Chinese medicine property, traditional Chinese medicine, toxicity, efficacy, pharmacovigilance

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