基于毒害成分的中药临床安全性评价与思考

doi:10.19803/j.1672-8629.2021.06.06

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (6): 520-524.
DOI: 10.19803/j.1672-8629.2021.06.06

• 中药药物警戒实践创新专栏 • 上一篇下一篇

基于毒害成分的中药临床安全性评价与思考

李耀磊^1,2, 张冰^1,2,*, 张晓朦^1,2, 林志健^1,2

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:2020-03-09 出版日期:2021-06-15 发布日期:2021-07-02
通讯作者: ^*张冰,女,博士,教授·博导,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:李耀磊,男,在读博士,中药药物警戒与合理用药研究、中药防治代谢性疾病研究。
基金资助:
国家自然科学基金资助项目(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

Evaluation and Consideration of Clinical Safety of Traditional Chinese Medicine Based on Toxic Components

LI Yaolei^1,2, ZHANG Bing^1,2,*, ZHANG Xiaomeng^1,2, LIN Zhijian^1,2

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:2020-03-09 Online:2021-06-15 Published:2021-07-02

摘要/Abstract

摘要： 目的针对含有毒害成分的中药,综合其临床应用中的多种因素,分析其临床安全性,探讨含毒害成分中药的安全风险评价模式,为其临床合理用药提供技术支撑。方法在系统梳理中药外源性有害物质和内源性毒性成分的毒性特征基础上,引入膳食风险评价方法,综合药物、机体和临床用药等多因素,赋予风险因素适宜权重,建立体现临床用药特点的风险评价模式。结果通过对含毒害成分中药尝试应用该模式进行安全性分析,得到初步的验证,为其后续临床安全用药奠定基础。结论对含有毒害成分的中药,在控制用药频率、疗程和剂量等用药因素下,可实现含毒害成分中药在临床安全合理的使用。

关键词: 中药, 毒害成分, 临床安全性, 风险评估, 合理用药

Abstract: Objective Based on many factors in clinical application, this article aimed to analysis the clinical safety of traditional Chinese medicine (TCM), which contained toxic ingredients. And discussed the safety risk assessment model to provide technical support for clinical rational use of TCM. Methods This study described the toxicity characteristics of exogenous harmful substances and endogenous toxic ingredients in TCM, it is based on dietary risk assessment methods after combined multiple factors such as drugs, organism, and clinical medication, and assigned appropriate weights to risk factors. We established a risk evaluation model that reflected the characteristics of clinical medication. Results We tried to apply the model to analysis the safety of TCM which contained toxic and harmful ingredients. The preliminary verification had been obtained, and the foundation had been laid for the safe clinical use of drugs in the future. Conclusion This study believed that only under the control of medication frequency, course of treatment, dosage and other medication factors, can TCM contained toxic ingredients be used safely and reasonably in clinical practice.

Key words: traditional Chinese medicine, toxic components, clinical safety, risk assessment, rational use of drug

中图分类号:

R994.11

李耀磊, 张冰, 张晓朦, 林志健. 基于毒害成分的中药临床安全性评价与思考[J]. 中国药物警戒, 2021, 18(6): 520-524.

LI Yaolei, ZHANG Bing, ZHANG Xiaomeng, LIN Zhijian. Evaluation and Consideration of Clinical Safety of Traditional Chinese Medicine Based on Toxic Components[J]. Chinese Journal of Pharmacovigilance, 2021, 18(6): 520-524.

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基于毒害成分的中药临床安全性评价与思考

Evaluation and Consideration of Clinical Safety of Traditional Chinese Medicine Based on Toxic Components

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