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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(píng)價(jià)一個(gè)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(duì)1 例單獨(dú)服用仙靈骨葆片導(dǎo)致肝損傷的典型病例進(jìn)行臨床和實(shí)驗(yàn)室系統(tǒng)研究。 方法：研究對(duì)象為一名服用中藥復(fù)方制劑導(dǎo)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(píng)分量表（RUCAM）和《中草藥相關(guān)肝損傷臨床診療指南》（簡(jiǎn)稱(chēng)HILI指南）推薦的整合證據(jù)鏈法（iEC）對(duì)病例進(jìn)行診斷研究。 結(jié)果：利用臨床病史、生化指標(biāo)和影像學(xué)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(duì)診斷的影響。通過(guò)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(duì)診斷的影響，懷疑該患者為仙靈骨葆片導(dǎo)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(jì)算的R值為6，被診斷為可能的急性藥物性肝細(xì)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(jìn)一步采用HPLC法對(duì)患者服用的剩余藥物進(jìn)行鑒定，將患者服用的藥物與市售仙靈骨葆片進(jìn)行指紋圖譜相似度對(duì)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(kù)檢查，未發(fā)現(xiàn)化學(xué)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(guó)藥典》含量限度要求。 結(jié)論：綜上，通過(guò)更新的RUCAM和iEC評(píng)價(jià)方法，仙靈骨葆片引起的肝損傷最終診斷達(dá)到中草藥相關(guān)肝損傷的臨床診斷標(biāo)準(zhǔn)，且屬于急性、重度的肝細(xì)胞損傷型。因此，本研究為中藥復(fù)方制劑相關(guān)肝損傷的因果關(guān)系評(píng)價(jià)提供了科學(xué)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(xué)分析;中藥復(fù)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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