中国药物警戒 ›› 2024, Vol. 21 ›› Issue (1): 15-19.
DOI: 10.19803/j.1672-8629.20230779

• 药品安全风险防控新策略与新方法专栏 • 上一篇    下一篇

基于不良反应监测大数据的中药药源性肝损伤风险信号新发现及易感因素初探

郭龙鑫1,2, 高云娟1, 吴承钊1, 龙敏娟1, 祝胜凯1, 宋海波3, 赵旭1,*, 肖小河1#   

  1. 1解放军总医院第五医学中心,全军中医药研究所,北京 100039;
    2大理大学药学院,云南 大理 671000;
    3国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100076
  • 收稿日期:2023-12-14 出版日期:2024-01-15 发布日期:2024-01-18
  • 通讯作者: *赵旭,男,助理研究员,中药安全性与合理用药。E-mail: xuzhao080@Outlook.com; #为共同通信作者。
  • 作者简介:郭龙鑫,男,在读硕士,药学。
  • 基金资助:
    国家自然科学基金资助项目( 82230118 ); 国家中医药管理局项目（ZYYCXTD-C-202005）

Exploring new risk signals and susceptibility factors of traditional Chinese medicine-induced hepatotoxicity based on big data from adverse reaction monitoring

GUO Longxin1,2, GAO Yunjuan1, WU Chengzhao1, LONG Minjuan1, ZHU Shengkai1, SONG Haibo3, ZHAO Xu1,*, XIAO Xiaohe1#   

  1. 1China Military Institute of Chinese Materia, the Fifth Medical Centre, Chinese PLA General Hospital, Beijing 100039, China;
    2College of Pharmacy, Dali University, Dali Yunnan 671000, China;
    3Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China
  • Received:2023-12-14 Online:2024-01-15 Published:2024-01-18

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摘要： 目的 探索基于国家不良反应监测大数据发现中药肝损伤风险信号的方式,初步筛选风险品种,并基于“三因致毒”理论分析其肝损伤的易感因素。方法 对2012年1月1日至2016年12月31日收集的中药相关药物性肝损伤（DILI）的药品不良反应（ADR）报告进行回顾性分析,发现相关可疑中药品种,并预测可疑中药品种的肝损伤易感因素。结果 共收集中药导致DILI的ADR报告1 901份（1 719例患者）,新发现可疑中药品种237种,用于抗肿瘤的中药DILI发生率最高。给药途径以口服给药占比最大（71.70%）,DILI的潜伏期的中位数为13.00 d,潜伏期以0~7 d（34.46%）最多。依据“三因致毒”理论分析发现可疑中药品种导致DILI与机体状态、药物本身和用药环境有关。结论 发现系列中药风险信号,需要进一步对风险的确证和成因机制解析。

关键词: 中药, 药品不良反应, 三因致毒, 肝损伤, 抗肿瘤, 风险信号

Abstract: Objective To explore the method of discovering signals of hepatotoxicity risk in traditional Chinese medicine (TCM) based on national adverse reaction monitoring big data, preliminarily screen risky varieties, and analyze the susceptible factors of liver damage based on the “ Trielement Injury Hypothesis ” theory. Methods Retrospective analysis of adverse drug reaction (ADR) reports related to TCM-induced drug-induced liver injury (DILI) collected between 2012 and 2016. Identify suspicious TCM varieties and predict the susceptible factors for liver damage in these varieties. Results A total of 1 901 ADR reports（1 719 patients) of TCM-induced DILI were collected, and 237 suspicious TCM varieties were newly discovered. Traditional Chinese medicine used for anti-tumor purposes had the highest incidence of DILI. The oral route of administration accounted for the largest proportion (71.70%), with a median latency period of 13.00 days, and the majority of cases had a latency period of 0 to 7 days (34.46%). Analysis based on the “ Trielement Injury Hypothesis ”theory revealed that the TCM varieties suspected of causing DILI were related to the body’s state, the drugs themselves, and the medication environment. Conclusion Discovery of a series of TCM risk signals requires further confirmation of the risk and analysis of the causal mechanisms.

Key words: traditional Chinese medicine, adverse drug reactions, Trielement Injury Hypothesis, liver injury, anti-tumor, risk signals

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