中国药物警戒 ›› 2022, Vol. 19 ›› Issue (12): 1352-1357.
DOI: 10.19803/j.1672-8629.20220209

• 安全与合理用药 • 上一篇    下一篇

中药药源性肝损伤文献个案报道数据元素分析

朱兰1, 朱彦2, 姚克宇2, 陈超2, 刘丽红2,*   

  1. 1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;
    2中国中医科学院中医药信息研究所,北京 100700
  • 收稿日期:2022-04-29 出版日期:2022-12-15 发布日期:2022-12-21
  • 通讯作者: *刘丽红,女,硕士,副研究员,中药数据标准化。E-mail：llhong_2008@163.com
  • 作者简介:朱兰,女,硕士,主管药师,药品不良反应监测与评价。
  • 基金资助:
    国家重点研发计划（2018YFC1707409）; 国家自然科学基金资助项目（82274684）; 中国中医科学院科技创新工程（CI2021A05409）; 中央级公益性科研院所基本科研业务费专项资金（ZZ13-YQ-126、2213-YQ-128）; 中国中医科学院基本科研业务费自主选题（ZZ150316、ZZ150314、ZZ160311）

Analysis of data elements in case reports of traditional Chinese medicine drug-induced liver injury

ZHU Lan1, ZHU Yan2, YAO Keyu2, CHEN Chao2, LIU Lihong2,*   

  1. 1Center for Drug Reevaluation, NMPA/ NMPA Key Latorarorg for Research and Evaluation of Pharmacovigilance, Beijing 100022, China;
    2Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • Received:2022-04-29 Online:2022-12-15 Published:2022-12-21

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摘要： 目的 评估国内报告的中药药源性肝损伤（DILI）个案报道文献,为中药DILI文献肝损伤个案报道规范化提供参考。方法 收集中国知网、万方数据以及中国生物医学文服务系统3个数据库从建库至2021年5月31日的中药DILI个案报道文献,设定中药DILI文献报道基本数据元素,对国内已发表中药DILI文献个案报道逐一进行评估。结果 设定了43个中药DILI文献报道数据元素,纳入了451篇文献,涉及549个病例,对数据元素进行信息抽取,其中16个数据元素报告率低于50%;与Roussel Uclaf评分法（RUCAM）相关的数据元素报告率低,且存在一些元素报告模糊、数值数据描述不连续等问题。结论 中药DILI文献中一些重要信息缺失,导致难以支持中药DILI因果关系评估,建议通过研制中药DILI文献个案报道基本数据集,建立统一标准,提高中药DILI文献个案报道质量,促进文献深入分析与利用。

关键词: 文献个案报道, 中药, 药源性肝损伤, 数据元素, 数据分析

Abstract: Objective To evaluate the reported cases of traditional Chinese medicine (TCM) drug-induced liver injury(DILI) in China and provide reference for the standardization of TCM DILI. Methods Comprehensive collection of the 3 databases of CNKI, Wanfang Data and China Biomedical Text Service System from the establishment of the database to May 31, 2021, set the basic data elements of TCM DILI literature reports and evaluate the reported cases of TCM DILI in China. Results 43 data elements of TCM DILI literature reports were set, and 451 literatures involving 549 cases were included. The information of data elements was extracted, of which the reporting rate of 16 data elements was less than 50%.The reporting rate of data elements related to Roussel Uclaf scoring method (RUCAM) was low, and there were some problems such as fuzzy element reporting and discontinuous description of numerical data. Conclusion Some important information was missing in the literature of TCM DILI, and it is difficult to support the diagnosis and cality evaluation of TCM DILI. It is suggested that a unified standard should be established by developing the basic data set of TCM DILI literature case reports, to improve the quality of case report and promote the in-depth analysis and utilization of literature.

Key words: literature case report, TCM, drug-induced liver injury, data element, data analysis

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