中药制剂、膳食补充剂引起的药物性肝损伤临床病理特征

摘要/Abstract

摘要： 目的分析中药制剂、膳食补充剂引起的药物性肝损伤(DILI)患者临床病理特征,并与非中药制剂、膳食补充剂(HDS)DILI比较,提高DILI的诊治。方法 2017年7月—2022年8月上海中医药大学附属曙光医院消化内科或肝病科收治入院的DILI病例214例,其中男性115例、女性99例,年龄(58.4±9.2)岁。诊断符合中华医学会肝病学分会药物性肝病学组发布的排他性DILI标准。分析DILI患者主要用药情况,并根据致病原因分为中药制剂组、膳食补充剂组,比较两组临床病例特征。结果 214例DILI主要用药包括抗结核药61例(28.5%)、中药制剂 49例(22.9%)、膳食补充剂36例(16.8%)、非甾体抗炎药物20例(9.3%)、抗菌类药物12例(5.6%)、抗精神药物12例(5.6%)、降糖药10例(4.7%)及其他4例(1.9%)。中药制剂、膳食补充剂以及非HDS组DILI患者药物潜伏时间,用药持续时间,初诊ALT、ALP,峰值ALP、TBil,MELD评分,黄疸及急性肝衰竭等差异具有统计学意义(P<0.05)。11例中药制剂DILI患者和27例膳食补充剂DILI患者接受了超声引导下肝组织活检,DILI组织病理学特征包括门静脉炎症17例、小叶炎症13例、界面性肝炎16例、局灶性坏死9例、桥接坏死7例、肝纤维化9例、肝硬化2例、胆汁淤积7例、脂肪变性5例、气球样变7例、嗜酸性粒细胞浸润5例及自身免疫性肝炎样特征7例。中药制剂、膳食补充剂DILI组织病理学特征比较差异无统计学意义(P>0.05)。结论与非HDS DILI相比,HDS DILI在肝功能指标、并发症等表现较差,其中中药制剂DILI更为严重。提高公众对中药制剂和膳食补充剂的认识并减少摄取有助于预防DILI发生并减轻病情。

关键词: 药物性肝损伤, 中药制剂、膳食补充剂, 肝功能

Abstract: Objective To investigate the clinicopathological features of patients suffering from drug-induced liver injury (DILI) triggered by herbal and dietary supplements(HDS), with a view to enhance diagnostic accuracy and treatment efficacy.Methods Between July 2017 and August 2022, a total of 214 patients were admitted to the Department of Gastroenterology and Hepatology at our institution with a confirmed diagnosis of DILI. The patient demographic consisted of 115 males and 99 females, aged (58.4±9.2) years. Diagnoses adhered to the exclusionary criteria for DILI set forth by drug-induced liver disease study group of Hepatology Branch of Chinese Medical Association. Patients were stratified into two cohorts based on the causative agents: those who had taken TCM preparations and those who had consumed dietary supplements. The clinicopathological features of both groups were then comparatively analyzed. Results Of the 214 DILI cases studied,, the primary causaitve agents were anti-tuberculosis drugs(28.5%, n=61), traditional Chinese medicine preparation(22.9%, n=49), dietary supplements(16.8%, n=36), non-steroidal anti-inflammatory drugs(9.3%, n=20), antibacterial drugs(5.6%, n=12), and antipsychotics(5.6%, n=12). Upon comparative analysis of patients affected by DILI from traditional Chinese medicine, dietary supplements, and other categories(non-TCM and non-dietary supplements) we found statistically significant differences in drug latency, duration of medication, initial ALT, ALP levels, peak ALP, TBil, MELD score, occurrences of jaundice, and acute liver failure (P<0.05). Ultraspund-guided liver biopsy were performed on 11 patients from the TCM group and 27 from the dietary supplement groups Histopathological features included portal vein inflammation(n=17), lobular inflammation(n=13), interfacial hepatitis(n=16), focal necrosis(n=9), bridging necrosis(n=7), hepatic fibrosis(n=9), liver cirrhosis(n=2), cholestasis(n=7), fatty degeneration(n=5), balloon-like degeneration(n=7), eosinophil infiltration(n=5), and autoimmune hepatitis-like features(n=7). No statistically significant difference was observed in histopathological characteristics between the TCM and dietary supplement-induced DILI groups(P>0.05). Conclusion Compared with non-HDS-induced DILI, HDS-associated DILI exhibits more detrimental effects on liver function indexes and is asscociated with a higher incidence of complications. Notably, the severity of DILI is especially pronounced when triggered by TCM preparations. Enhancing public awareness about the potential risks associated with TCM preparations and dietary supplements, as well as minimizing their consumption, can serve as effective strategies ofr both the prevention and mitigation of DILI.

Key words: Drug-induced liver injury, Herbal and dietary supplements, Liver function

刘华清, 谢雅革, 徐荫荫. 中药制剂、膳食补充剂引起的药物性肝损伤临床病理特征[J]. 肝脏, 2023, 28(9): 1097-1100.

LIU Hua-qing, XIE Ya-ge, XU Yin-yin. Clinicopathophysiological characteristics of drug-induced liver injury caused by herbal and dietary supplements[J]. Chinese Hepatolgy, 2023, 28(9): 1097-1100.

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