中国药物警戒 ›› 2024, Vol. 21 ›› Issue (10): 1130-1136.
DOI: 10.19803/j.1672-8629.20240246

• 安全与合理用药 • 上一篇    下一篇

中药相关性肝损伤潜在可疑中药识别及临床特征分析

王恒鑫1, 顿文亮2, 胡婧文2, 李青3, 赵泽玉3, 骆天炯3,*   

  1. 1南京中医药大学中医药学院,江苏 南京 210023;
    2南京中医药大学附属南京市中医院药学部,江苏 南京 210022;
    3南京中医药大学附属南京中医院老年病科,江苏 南京 210022
  • 收稿日期:2024-04-18 出版日期:2024-10-15 发布日期:2024-10-14
  • 通讯作者: *骆天炯,女,博士,主任中医师,临床老年病。E-mail: 969914725@qq.com
  • 作者简介:王恒鑫,男,在读硕士,老年病。
  • 基金资助:
    江苏省药品监督管理局课题（2023084）

Identification and clinical characteristics of potential suspicious traditional Chinese medicines in traditional Chinese medicine-related liver injury

WANG Hengxin1, DUN Wenliang2, HU Jinwen2, LI Qing3, ZHAO Zeyu3, LUO Tianjiong3,*   

  1. 1Nanjing University of Chinese Medicine, TCM Colleges and Universities, Nanjing Jiangsu 210023, China;
    2Pharmaceutics Department, Nanjing Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing Jiangsu 210022, China;
    3Department of Geriatrics, Nanjing Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Traditional Chinese Medicine, Nanjing Jiangsu 210022, China
  • Received:2024-04-18 Online:2024-10-15 Published:2024-10-14

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摘要： 目的 探讨通过医院大数据平台发现药物性肝损伤风险信号的方式,筛选出可能会诱发肝损伤的相关中药,分析中药相关性肝损伤的易感因素。方法 收集2019年6月1日至2023年6月1日数据,对药物性肝损伤的诊断先确认存在肝损伤,其次除外其他肝病,再通过Roussel-Uclaf因果关系评估法（RUCAM）对药物与肝损伤的因果关系进行量化评估;再剔除合并用药中致药物性肝损伤使用化药（主要是A类及B类的药物）的住院患者,发现并整理出可疑中药品种,分为可能、有可能、不太可能、不可能4类。结果 共收集肝功能异常患者2 056例,筛选出可能中药相关性肝损伤患者142例,其中可能及有可能药物种类主要包括解表药、清热解毒药、活血化瘀药、祛风湿药等。结论 可疑中药种类涉及范围较广,药物性肝损伤的发生可能与人体机体状态、药物本身有关,发生药物性肝损伤的机制可能与免疫炎症促进相关。

关键词: 中草药相关肝损伤, 药物性肝损伤, 中药, 解表药, 清热解毒药, 活血化瘀药, 祛风湿药, 临床特征, 机制

Abstract: Objective To study ways to discover risk signals of drug-induced liver injury by using the big data platform of the hospital, to screen out the related traditional Chinese medicines that may induce liver injury, and to analyze the risk factors for liver injury. Methods The diagnosis of DILI started with confirmation of liver injury with the data from June 1, 2019 to June 1, 2023, followed by the exclusion of other liver diseases before the causal relationship between drugs and liver injury was quantitatively evaluated using the Roussel-Uclaf causality assessment method (RUCAM). Experienced experts were consulted to exclude inpatients who used chemical drugs (mostly class A and class B drugs) for drug-induced liver injury caused by drug combination before suspicious Chinese medicine varieties were found and sorted out, which were divided into four categories: possible, probable, unlikely and impossible. Results A total of 2 056 patients with abnormal liver function were collected, 142 of whom with possible Chinese medicine-related liver injury were screened out. The types of possible and probable drugs included antidepressants, herbal medicines for removing heat and toxins, activating blood circulation and reducing blood stasis, and for dispelling winddampness. Conclusion There is a wide range of suspected traditional Chinese medicines. The occurrence of drug-induced liver injury may be related to the state of the human body and the drug itself. The mechanism of drug-induced liver injury may be related to immune inflammation.

Key words: HILI, DILI, herb, antidepressants, purgatives to remove heat and toxins, activating blood circulation and removing blood stasis, expelling wind-dampness, clinical features, mechanism

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