中国药物警戒 ›› 2023, Vol. 20 ›› Issue (4): 449-453.
DOI: 10.19803/j.1672-8629.20220167

• 安全与合理用药 • 上一篇    下一篇

文献来源的补骨脂及其制剂引起药物性肝损伤特点探析

陈超1, 朱兰2, 刘丽红1, 韩佳寅3, 朱彦1,*   

  1. 1中国中医科学院中医药信息研究所,北京 100700;
    2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 100022;
    3中国中医科学院中药研究所,北京 100700
  • 收稿日期:2022-04-14 出版日期:2023-04-15 发布日期:2023-04-20
  • 通讯作者: *朱彦,男,博士,副研究员,中医药信息标准化。E-mail:zhuyan166@126.com
  • 作者简介:陈超,女,硕士,助理研究员,中药相关信息标准化。
  • 基金资助:
    北京市自然科学基金资助项目（7214291）; 国家自然科学基金资助项目（82192913、82104519、82174534）; 中国中医科学院科技创新工程（CI2021A04803）; 中国中医科学院基本科研业务费自主选题项目（ZZ150314）

Characteristics of Psoralea corylifolia induced liver injury

CHEN Chao1, ZHU Lan2, LIU Lihong1, HAN Jiayin3, ZHU Yan1,*   

  1. 1Institute of Information on Tradition Chinese Medicine, Beijing 100700, China;
    2Center for Drug Reevaluation, NMPA/ NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China;
    3Institute of Chinese Materia, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • Received:2022-04-14 Online:2023-04-15 Published:2023-04-20

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摘要： 目的 系统分析补骨脂及其制剂导致药物性肝损伤的患者特征、临床特点、可能的危险因素、预后和转归,为临床合理用药提供依据。方法 检索中国知网、万方数据、维普网和PubMed,收集怀疑药品涉及补骨脂及其制剂的肝损伤个案报道,检索时限为1962年1月1日至2021年12月31日。对文献进行筛选、提取相关数据、统计、分析。结果 共纳入文献47篇,涉及55例患者;发病患者以女性居多,男女比例将近1 ∶2,年龄主要在21~60岁多因使用未经炮制过的补骨脂出现肝损伤;临床用药时间多在30 d以上;既往有肝病史、与有肝损伤药品联合用药时,易出现重度、致命性肝损伤;补骨脂所导致的肝损伤以肝细胞损伤型最为显著,占比近90%,且多为急性肝损伤,停药后积极治疗大多可好转。结论 女性、高龄、再激发现象、超剂量、用药时间长、使用未经炮制补骨脂者,均易出现药物性肝损伤,在临床应用时应注意随时监测肝功能,发现异常时及时停药。

关键词: 补骨脂, 药物性肝损伤, 文献分析, 特点探析, RUCAM评分

Abstract: Objective To analyze the characteristics, risk factors and prognosis of liver injury caused by Psoralea corylifolia so as to provide data for rational drug use. Methods The literature about liver injury caused by Psoralea corylifolia or its related preparations that was published between 1962 and 2021 was searched for. The literature was screened before the related data was statistically analyzed. Results A total of 47 articles were retrieved from the databases, involving 55 cases. The incidence of the disease was higher among females, and most of the patients raged from 21 to 60 in age, mainly due to unprocessed Psoralea corylifolia. Clinical medications lasted more than 30 days. Patients who had a previous history of liver disease or used drugs that caused liver injury were more vulnerable to severe and fatal liver injury. Liver injury caused by Psoraleae corylifolia was dominated by liver cell injury, accounting for nearly 90%, and most of the cases were acute liver injury. Symptoms were likely to improve via active treatment after drug withdrawal, and the prognosis was good. Conclusion Women, elders and patients with liver disease history and previous liver injury induced by Psoraleae corylifolia should not take any Psoraleae corylifolia or its preparations in order to prevent fatal reactivation. Liver function should be monitored during clinical use of Psoralea corylifolia. Drugs should be withdrawn in case of abnormality.

Key words: Psoralea corylifolia, drug-induced liver injury, literature analysis, characteristics analysis, RUCAM analysis

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