仙灵葛宝片引起的中草药肝损伤:使用更新的 RUCAM 和综合证据链评估一个病例的因果关系

IF 4.7 4区 医学 Q1 CHEMISTRY, MEDICINAL Chinese Herbal Medicines Pub Date : 2024-04-01 DOI:10.1016/j.chmed.2023.10.005
Chunyu Li , Yingying Li , Zhaofang Bai , Jiabo Wang , Guohui Li , Xiaohe Xiao
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引用次数: 0

摘要

目的 在临床和实验室系统研究一例典型的仙灵葛片诱发肝损伤病例。方法 以中草药肝损伤(HILI)患者为研究对象,根据《中草药肝损伤诊断和治疗指南》(HILI指南)推荐的最新Roussel Uclaf因果关系评估法(RUCAM)和综合证据链法(iEC)对病例进行诊断。结果通过临床病史、生化指标和影像学检查,排除了病毒性、酒精性和自身免疫性肝病等基础疾病和易混淆肝病对诊断的影响。根据对患者用药史的调查,由于患者仅口服 XLGB 片制剂,排除了其他药物对诊断的影响,因此怀疑其为 XLGB 片引起的 HILI。该患者的丙氨酸氨基转移酶(ALT)≥ 3 倍正常值上限(ULN),计算的 R 值为 6,因此被诊断为可能是急性药物性肝细胞损伤。根据 2016 年更新的 RUCAM,这种关系被视为 "高度可能"(9 分)。此外,患者服用的制剂与市售制剂之间的指纹相似度为 0.99,表明患者服用的是 XLGB 片而不是其他药物。利用 LC-MS 技术和 Agilent Fake TCM-Drugs 数据库对该药物进行了调查,未发现任何化学添加物。结论综上所述,XLGB 引起的肝损伤的最终诊断符合 HILI 的临床诊断,根据最新的 RUCAM 和 iEC,诊断为急性重症肝细胞损伤型。因此,本研究为中药复方制剂诱发肝损伤的因果关系评价提供了科学依据。
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Herb induced liver injury by Xianling Gubao Tablets: A case assessed for causality using updated RUCAM and integrated evidence chain

Objective

A typical case of Xianling Gubao (XLGB) Tablets-induced liver injury was systematically studied in the clinic and the laboratory.

Methods

A patient with herb-induced liver injury (HILI) and a history of taking XLGB Tablets before disease onset was engaged as the study subject, and the case was diagnosed according to the updated Roussel Uclaf Causality Assessment Method (RUCAM) and the integrated evidence chain (iEC) method recommended by the Guidelines for Diagnosis and Treatment of Herb-induced Liver Injury (HILI Guidelines).

Results

Clinical history, biochemical indexes and imaging tests were used to exclude the influence of fundamental diseases and confusing liver diseases such as viral, alcoholic and autoimmune liver diseases on the diagnosis. Based on an investigation of the patient’s medication history, she was suspected to have HILI caused by XLGB Tablets, as the patient was only taking an oral preparation of XLGB Tablets, and the influence of other drugs on the diagnosis was excluded. This patient with alanine aminotransferase (ALT) ≥ 3 × upper limit of normal (ULN) and a calculated R of 6 was diagnosed with possible acute drug-induced hepatocellular injury. The relationship was considered “highly probable” (score of 9) using the updated RUCAM of 2016. Moreover, the fingerprint similarity between the preparation taken by the patient and a commercially available preparation was 0.99, suggesting that the patient was consuming XLGB Tablets rather than another drug. LC-MS technology and the Agilent Fake TCM-Drugs database were used to investigate the drug, and no chemical additions were found. Examination of the drug for pesticide residues, heavy metals, aflatoxins and other exogenous substances indicated compliance with the content limits of the Chinese Pharmacopoeia.

Conclusion

In summary, the final diagnosis of XLGB-induced liver injury reached the clinical diagnosis of HILI and was acute severe hepatocellular injury type by the updated RUCAM and iEC. Therefore, this study provides scientific evidence regarding the causality evaluation of compound preparations of traditional Chinese medicines-induced liver injury.

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来源期刊
Chinese Herbal Medicines
Chinese Herbal Medicines CHEMISTRY, MEDICINAL-
CiteScore
4.40
自引率
5.30%
发文量
629
审稿时长
10 weeks
期刊介绍: Chinese Herbal Medicines is intended to disseminate the latest developments and research progress in traditional and herbal medical sciences to researchers, practitioners, academics and administrators worldwide in the field of traditional and herbal medicines. The journal's international coverage ensures that research and progress from all regions of the world are widely included. CHM is a core journal of Chinese science and technology. The journal entered into the ESCI database in 2017, and then was included in PMC, Scopus and other important international search systems. In 2019, CHM was successfully selected for the “China Science and Technology Journal Excellence Action Plan” project, which has markedly improved its international influence and industry popularity. CHM obtained the first impact factor of 3.8 in Journal Citation Reports (JCR) in 2023.
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