马兜铃酸致肝癌的客观性研究与思考

doi:10.19803/j.1672-8629.20230785

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (1): 20-24.
DOI: 10.19803/j.1672-8629.20230785

• 药品安全风险防控新策略与新方法专栏 • 上一篇下一篇

马兜铃酸致肝癌的客观性研究与思考

方志娥^1,2, 李承贤^1,3, 柏兆方¹, 赵旭¹, 王伽伯⁴, 肖小河^1,*

¹解放军总医院第五医学中心,全军中医药研究院,北京 100039;
²重庆市中医院药剂科,重庆 400021;
³北京中医药大学中药学院,北京 100102;
⁴首都医科大学中医药学院,北京 100069

收稿日期:2023-12-15 出版日期:2024-01-15 发布日期:2024-01-18
通讯作者: ^*肖小河,男,博士,研究员·博导,临床中药学与安全用药研究。E-mail: pharmacy302xxh@126.com
作者简介:方志娥,女,博士,临床中药学。
基金资助:
国家自然科学基金资助项目(81930110、82230118); 国家中医药管理局医药创新团队及人才支持计划项目（ZYYCXTD-C-20225）; 重庆市教委科学技术研究项目(KJQ N202215119)

Investigation of objectivity in the relationship between aristolochic acid and hepatocellular carcinoma

FANG Zhie^1,2, LI Chengxian^1,3, BAI Zhaofang¹, ZHAO Xu¹, WANG Jiabo⁴, XIAO Xiaohe^1,*

¹China Military Institute of Chinese Materia, the Fifth Medical Centre, Chinese PLA General Hospital, Beijing 100039, China;
²Department of Pharmacy, Chongqing Hospital of Traditional Chinese of Medicine, Chongqing 400021, China;
³Beijing University of Traditional Chinese Medicine, Beijing 100102, China;
⁴School of Traditional Chinese Medicine, Capital Medical University, Beijing 100069, China

Received:2023-12-15 Online:2024-01-15 Published:2024-01-18

摘要/Abstract

摘要： 目的通过梳理马兜铃酸致肝癌的客观性研究,提出风险防控策略。方法简述马兜铃酸致肝癌的研究进展,阐明马兜铃酸与肝癌相关性再研究的科学意义,梳理本课题组关于马兜铃酸致肝癌的客观性、真实性、系统性研究内容,提出含马兜铃酸中药的防控策略。结果与结论 马兜铃酸与肝癌发生缺乏相关性;提出含马兜铃酸中药及制剂安全用药的风险防控策略：明确风险获益比,综合分析药品研究数据做出监管决策;针对不同风险水平患者采取分级管理措施;建立科学认知和精准评价使用中药的新方法,健全安全性质量控制制度。

关键词: 马兜铃酸, 肝癌, 中药安全性, 风险防控, 质量控制

Abstract: Objective To propose risk prevention and control strategies by sorting out Objective studies on hepatocellular carcinoma caused by aristolochic acid (AA). Methods The research progress of hepatocellular carcinoma caused by AA was briefly described. The scientific significance of the re-study of the correlation between AA and hepatocellular carcinoma was elucidated. The objectivity, authenticity, and systematic research content of the study on hepatocellular carcinoma caused by AA by our group were sorted out, and the prevention and control strategies of traditional Chinese medicines containing AA were proposed. Results and Conclusion The result clarified a lack of a correlation between AA and hepatocellular carcinoma. Risk prevention and control strategies for safe use of traditional Chinese medicines and preparations containing aristolochic acid were proposed including clarification of risk-benefit ratios, comprehensive analysis of pharmaceutical research data for regulatory decision-making; adoption of graded management measures for patients with different levels of risk; establishment of quality-control methods for safety and standards for limitations; and establishment of a new method for the scientific cognition and precise evaluation of the use of traditional Chinese medicines.

Key words: aristolochic acid, hepatocellular carcinoma, safety evaluation, risk prevention and control, quality control

中图分类号:

方志娥, 李承贤, 柏兆方, 赵旭, 王伽伯, 肖小河. 马兜铃酸致肝癌的客观性研究与思考[J]. 中国药物警戒, 2024, 21(1): 20-24.

FANG Zhie, LI Chengxian, BAI Zhaofang, ZHAO Xu, WANG Jiabo, XIAO Xiaohe. Investigation of objectivity in the relationship between aristolochic acid and hepatocellular carcinoma[J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 20-24.

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马兜铃酸致肝癌的客观性研究与思考

Investigation of objectivity in the relationship between aristolochic acid and hepatocellular carcinoma

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