中草药肝损伤的临床诊断

doi:10.19803/j.1672-8629.20230021

摘要/Abstract

摘要： 目的为中草药肝损伤（HILI）的临床诊断提供基于模块化证据链的路线图。方法分析中草药应用与肝损伤发生的时序关系、中草药自身相关肝毒性信息、合并用药情况的评估及非药物性肝损伤因素的排查等4大模块信息,并进行证据链的逻辑组合。结果及结论 HILI的临床诊断原则与现代药（化学药和生物医药）相似,但具有自身的特点和难点。在阐述中草药与肝损伤时序关系多样性的基础上,对中草药相关肝毒性、合并用药肝毒性及其他肝损伤病因的存在情况进行了多维评估,构建了基于完整证据链的HILI临床诊断路线图。罗素优克福因果关系评估法（RUCAM）量表对HILI的诊断有参考价值,改良电子化因果关系评估法（RECAM）量表对HILI的诊断价值有待在真实世界临床进一步论证,必要时可借助结构化专家观点程序（SEOP）确认诊断;肝活检病理组织学的某些病变特点有助于明确HILI的诊断;HILI相关生物标志物有待深入探索。

关键词: 中草药, 肝损伤, 临床诊断, 证据链, 路线图

Abstract: Objective To provide a roadmap based on modular evidence chains for the clinical diagnosis of herbal induced liver injury (HILI). Methods Four modules of information were investigated, including the temporal relationship between the application of Chinese herbal medicine and the occurrence of liver injury, the related liver toxicity information of the herbals itself, the possibility of drug combination as the cause of liver injury, and the potential non-drug factors of liver injury. All these information were incorporated to form an logistically structured chain of evidence for the diagnosis of HILI. Results and Conclusion The clinical diagnostic principle of HILI is similar to that of liver injury caused by modern drugs (including chemical drugs and biomedicine), but it has its own characteristics and difficulties. After analyzing the variability of temporal relationship between Chinese herbal medicine and liver injury, the following information were detailedly evaluated in multiple dimensions, including the liver toxicity information related to Chinese herbal medicine itself, the corresponding information of concomitant drugs, and the existent status of liver injury caused by other pathogens. Then a revised roadmap based on the evidence chain was proposed. Rousse Uclaf Causality Assessment Method (RUCAM) scale is advisable in the diagnosis of HILI, yet the diagnostic value of Revised Electronic Causality Assessment Method (RECAM) scale for HILI needs to be further investigated in real world clinic. If necessary, the diagnosis of HILI should be further confirmed with the Structured Expert Opinion Progress (SEOP). Some pathological features of liver biopsy may be helpful for the confirmation of HILI, and specific biomarkers of HILI need to be further explored.

Key words: Chinese herbal medicine, liver injury, clinical diagnosis, evidence chain, roadmap

中图分类号:

R961
R994.11

于乐成, 郝坤艳, 范晔. 中草药肝损伤的临床诊断[J]. 中国药物警戒, 2023, 20(5): 481-488.

YU Lecheng, HAO Kunyan, FAN Ye. Clinical diagnosis of Chinese-herbal-induced liver injury[J]. Chinese Journal of Pharmacovigilance, 2023, 20(5): 481-488.

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