中国药物警戒 ›› 2021, Vol. 18 ›› Issue (6): 532-536.
DOI: 10.19803/j.1672-8629.2021.06.08

• 中药药物警戒实践创新专栏 • 上一篇    下一篇

蒽醌类中药的安全问题分析及合理应用思考

黄政凯1, 张冰1,2,*, 林志健1#, 张晓朦1,2, 张丹1, 殷玉玲1   

  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:2020-03-09 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;＃为共同通信作者。
  • 作者简介:黄政凯,男,在读硕士,中药药物警戒与合理用药研究。
  • 基金资助:
    国家中医药领军人才支持计划“岐黄学者”项目; 国家自然科学基金资助项目（81874349）; 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; 中国毒理学会临床毒理专项（2020年度）（CST2020CT101）

The Analysis and Thought of Safety Problem and Rational Application of Anthraquinones-Containing Traditional Chinese Medicine

HUANG Zhengkai1, ZHANG Bing1,2,*, LIN Zhijian1,2#, ZHANG Xiaomeng1,2, ZHANG Dan1, YIN Yuling1   

  1. 1School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China;
    2Center for Pharma-covigilance 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

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摘要： 目的 梳理蒽醌类中药的应用情况及不良反应特征,挖掘相关用药风险因素,为蒽醌类中药的合理使用提供参考。方法 采用问卷调研与文献研究结合的方法,一方面对公众开展蒽醌类保健食品应用情况及安全风险问卷调研;另一方面系统检索国内文献数据库,包括中国知网、万方数据、维普网,收集自建库至2021年2月28日蒽醌类中药饮片及其中成药致药品不良反应/事件（adverse drug reaction/adverse event, ADR/AE）的案例报道，采用回顾性研究及数据挖掘等方法对该类中药饮片及中成药的ADR/AE进行分析。结果 调研问卷发放6 000份，回收有效问卷5 491份。其中，1 140份问卷反馈服用蒽醌类保健食品后出现不适症状，主要表现为皮肤及附件损害、消化系统损害、泌尿系统异常等。文献检索蒽醌类中药饮片及中成药致ADR/AE报道234篇，涉及276个案例，多表现为消化系统、皮肤及附件、神经系统等多系统-器官损害。数据挖掘结果提示蒽醌类中药致ADR的因素主要包括特殊人群用药、不合理用药等。结论 蒽醌类中药存在潜在的安全风险，需充分认识到其在日常保健、临床用药中的影响因素，以保障大众在保健及临床治疗过程中的安全。

关键词: 蒽醌类, 中药, 安全问题, 合理应用, 药品不良反应/事件

Abstract: Objective This paper aims to find out the risk-related factors and provide references for the rational use of the Chinese traditional medicine containing anthraquinones by reviewing the application situation and the characteristics of the adverse reactions. Methods This study used the methods of questionnaire survey and literature research. We conducted the questionnaire survey on the application and risk problems of anthraquinones-containing functional food in the public. On the other hand, we searched the domestic literature systematically such as CNKI, Wan Fang and VIP and collected the ADR /AE case reports caused by anthraquinones-containing traditional Chinese medicine and Chinese patent medicine comprehensively from the establishment to February 28, 2021. Then, we analyzed the adverse reactions from retrospective study and data mining. Results Total 6000 questionnaires were distributed and 5491 valid questionnaires were collected. 1140 questionnaires contained with the reports of discomfort symptoms, such as astrointestinal damage, skin and accessories damage, and urinary system dysfunction, after using the anthraquinones-containing functional food. And 234 papers contained the reports of ADR/AE induced by the anthraquinones-containing Chinese traditional medicine and Chinese patent drug, involving 276 cases, which showed damages to skin and appendages, digestive system, and other organs and systems. This research shown the influencing factors of ADR/AE were the special population and irrational drug use. Conclusion The anthraquinones-containing traditional Chinese medicine has potential risks, so it is necessary to recognize the risk factors in daily healthcare and clinical applications. This paper might ensure the safe use of the anthraquinones-containing Chinese medicine.

Key words: anthraquinones, traditional Chinese medicine, risk problems, rational application, adverse drug reaction/adverse event

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