中国药物警戒 ›› 2022, Vol. 19 ›› Issue (6): 600-604.
DOI: 10.19803/j.1672-8629.2022.06.04

• 特殊人群的中药药物警戒与药学服务专栏 • 上一篇    下一篇

中药肝损伤风险分析与肝功能不全人群用药警戒思考

章之琪1,2, 张晓朦1,2, 张冰1,2,*, 吕锦涛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:2022-02-09 出版日期:2022-06-15 发布日期:2022-06-13
  • 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:章之琪,女,在读硕士,中药药物警戒与合理用药。
  • 基金资助:
    国家中医药管理局-国家中医药领军人才支持计划“岐黄学者”项目; 中国毒理学会临床毒理专项课题（CST2020CT501）; 国家自然科学基金项目资助（81874349）

Risk factors of liver injury in traditional Chinese medicine and TCM pharmacovigilance for medications against hepatic insufficiency

ZHANG Zhiqi1,2, ZHANG Xiaomeng1,2, ZHANG Bing1,2,*, LYU Jingtao1,2   

  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:2022-02-09 Online:2022-06-15 Published:2022-06-13

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摘要： 目的 系统梳理中药导致肝损伤风险影响因素,并针对不同程度的肝功能不全人群提出中药用药警戒措施。方法 收集中国知网、万方数据、维普网等数据库从建库开始截至2021年12月31日的口服中药导致肝损伤的个案报道,采用Apriori算法、贝叶斯网络分析中药致肝损伤的影响因素,及与肝损伤严重程度之间的关联度。结果 纳入因果关系确切的中药致肝损伤个案报道88例,涉及24味中药,患者年龄46~64岁范围占比最高。在能够判断肝损伤严重程度的个案中,中重度最多,主要表现为黄疸、恶心、呕吐、厌油、食欲不振、意识障碍等。肝损伤的发生与药物因素、患者机体、临床用药诸多方面都有关联,且随疗程延长肝损伤的严重程度增加。结论 肝功能不全人群可根据严重程度不同在选药用药、用药监护等方面开展针对性措施,降低中药应用过程中的肝损伤风险。

关键词: 中草药, 药源性肝损伤, 肝功能不全, 药物警戒, 安全用药

Abstract: Objective To identify the risk factors for liver injury caused by traditional Chinese medicine, and to recommend measures of pharmacovigilance for medications against liver insufficiency of different degrees. Methods Adverse drug reactions of liver injury caused by traditional Chinese medicine as of the end of 2021 were collected from different databases, while possible influencing factors and their correlations with the severity of liver injury were analyzed using Apriori and the Bayesian network. Results A total of 88 cases of liver injury caused by traditional Chinese medicine with exact causality were included, involving 24 types of Chinese herbal medicines. The percentage of patients ages 46 to 64 was the highest. Of the 69 cases whose severity of liver injury could be determined, the majority were mild and severe ones, and the main symptoms ranged from jaundice, nausea, vomiting through aversion to oil, loss of appetite to impaired consciousness. The occurrence of liver injury was associated with drugs, the physique of patients, and medications, and liver injury became severe along with the duration of treatment. Conclusion Targeted measures should be taken among patients with hepatic insufficiency, such as the selection of herbal medicines and medication monitoring according to the degrees of severity, which can effectively reduce the risk of liver injury during the application of traditional Chinese medicine.

Key words: traditional Chinese medicine, drug-induced liver injury, hepatic insufficiency, pharmacovigilance, medication safety

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