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Archive > Volume 16 Issue 3 > 2024,16(3):301-309. DOI:https://doi.org/10.1016/j.chmed.2023.10.005 Prev Next

仙靈骨葆膠囊引起的肝損傷：使用更新的RUCAM和整合證據(jù)鏈評價一個病例的因果關(guān)系

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Herb induced liver injury by Xianling Gubao Tablets: A case assessed for causality using updated RUCAM and integrated evidence chain

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    摘要:
    目的：該文對1 例單獨服用仙靈骨葆片導致肝損傷的典型病例進行臨床和實驗室系統(tǒng)研究。 方法：研究對象為一名服用中藥復方制劑導致肝損傷的患者，發(fā)病前有服用仙靈骨葆片的病史，根據(jù)最新魯塞爾因果相關(guān)性評分量表（RUCAM）和《中草藥相關(guān)肝損傷臨床診療指南》（簡稱HILI指南）推薦的整合證據(jù)鏈法（iEC）對病例進行診斷研究。 結(jié)果：利用臨床病史、生化指標和影像學等檢查，排除基礎(chǔ)疾病以及病毒性、酒精性、自身免疫性等易混淆肝病對診斷的影響。通過服藥史調(diào)查，發(fā)現(xiàn)該患者僅服用仙靈骨葆片，可以排除其他藥物對診斷的影響，懷疑該患者為仙靈骨葆片導致的肝損傷。這名患者的丙氨酸氨基轉(zhuǎn)移酶（ALT）≥3×正常值上限（ULN），計算的R值為6，被診斷為可能的急性藥物性肝細胞型損傷。根據(jù) 2016 年更新的 RUCAM，這種關(guān)系被視為 "高度可能"（9 分）。進一步采用HPLC法對患者服用的剩余藥物進行鑒定，將患者服用的藥物與市售仙靈骨葆片進行指紋圖譜相似度對比分析，結(jié)果顯示其相似度為0.99，提示該患者服用的為仙靈骨葆片，而不是其它藥品；采用Agilent 6550 iFunnel Q-TOF LC-MS 技術(shù)和Agilent Fake TCM-Drugs數(shù)據(jù)庫檢查，未發(fā)現(xiàn)化學藥物添加；藥物的農(nóng)殘、重金屬以及黃曲霉毒素等外源性物質(zhì)檢查均符合《中國藥典》含量限度要求。 結(jié)論：綜上，通過更新的RUCAM和iEC評價方法，仙靈骨葆片引起的肝損傷最終診斷達到中草藥相關(guān)肝損傷的臨床診斷標準，且屬于急性、重度的肝細胞損傷型。因此，本研究為中藥復方制劑相關(guān)肝損傷的因果關(guān)系評價提供了科學證據(jù)。

    Abstract:
    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.

    關(guān)鍵詞:
    化學分析;中藥復方制劑;整合證據(jù)鏈;肝損傷;RUCAM;仙靈骨葆片

    Keywords:


    Project Supported:
    This research is supported by the National Natural Science Foundation of China (No. 82174071).

    Clc Number:

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