400例药物性肝损伤特征与危险因素分析

doi:10.19803/j.1672-8629.20250464

摘要/Abstract

摘要： 目的分析药物性肝损伤（DILI）现状及危险因素,并进一步探索是否服用抗结核药物（ATB）危险因素谱之间的差异。方法汇总云南省昆明市第三人民医院2024年1月1日至2024年12月31日诊断为DILI的400例患者病历信息。分为DILI组（n=400）为病例组,肝生化异常组（n=500）为对照组,采用多因素Logistic回归模型筛选DILI的潜在危险因素。在此基础上,根据是否服用ATB将DILI病例划分为非ATB-DILI与ATB-DILI,并分别将肝生化异常组及其相应亚组（非ATB-肝生化异常组和ATB-肝生化异常组）作为对照组进行比较,以探讨两类DILI在危险因素谱上的差异性。结果在可疑致DILI药物中,ATB占比最高（64.54%）,其次为抗感染药物（23.52%）和传统中药/膳食补充剂（TCM/TDS）（4.12%）。DILI及其亚组（非ATB-DILI和ATB-DILI）的临床分型均以肝细胞损伤型为主,严重程度则主要集中于1级。多因素Logistic分析显示：女性、肝脏疾病、HIV感染和凝血功能异常均可能为DILI发生的潜在危险因素,且这些危险因素在非ATB-DILI与ATB-DILI间的差异具有统计学意义。非ATB-DILI的危险因素涵盖女性、肝脏疾病、HIV感染和凝血功能异常,而ATB-DILI则仅将凝血功能异常视为危险因素,此外,凝血功能异常患者发生非ATB-DILI的可能性更高（OR值：2.595>1.847）。结论女性、肝脏疾病、HIV感染及凝血功能异常均可能是DILI的潜在危险因素,且非ATB-DILI与ATB-DILI之间的危险因素谱存在的差异具有统计学意义。因此,在临床实践中应针对不同类型患者制定差异化的风险评估和监测策略,以实现对高危人群的早期识别和精准干预,从而降低DILI发生风险。

关键词: 药物性肝损伤, 抗结核药物, 抗感染药物, 传统中药/膳食补充剂, 危险因素, 女性, 肝脏疾病, HIV感染, 凝血功能异常

Abstract: Objective To analyze the current incidence of and risk factors for drug-induced liver injury (DILI), and to investigate the differences in risk factor profiles between non-ATB-DILI and ATB-DILI. Methods A retrospective study was conducted to collect medical records of patients diagnosed with drug-induced liver injury (DILI) in 2024 at the Third People's Hospital of Kunming. Patients in the DILI group (n=400) were assigned to the case group while those in the abnormal liver biochemistry group (n=500) served as controls. A multivariate logistic regression model was used to identify potential risk factors associated with DILI. Based on the suspected causative agents, DILI cases were subsequently classified into non-ATB-DILI and ATB-DILI subgroups that were then compared with the overall abnormal liver biochemistry group as well as their corresponding subgroups (non-ATB abnormal liver biochemistry and ATB abnormal liver biochemistry) in order to explore differences in risk factor profiles between the two types of DILI. Results Among the suspected drugs causing DILI, anti-tuberculosis agents accounted for the highest proportion (64.54%), followed by anti-infective agents (23.52%) and traditional Chinese medicines/dietary supplements (TCM/DS) (4.12%). DILI and its subgroups (non-ATB-DILI and ATB-DILI) were mostly hepatocellular in type, with most cases classified as mild (Grade 1). Multivariate logistic regression analysis indicated that female sex, liver disease, HIV infection, and coagulation dysfunction might be potential risk factors for DILI, with notable differences between non-ATB-DILI and ATB-DILI. For non-ATB-DILI, risk factors included female sex, liver disease, HIV infection, and coagulation dysfunction, whereas for ATB-DILI, only coagulation dysfunction was identified as a risk factor. In addition, patients with coagulation dysfunction were more vulnerable to non-ATB-DILI (OR=2.595>1.847). Conclusion Female sex, liver disease, HIV infection, and coagulation dysfunction are identified as potential risk factors for DILI. Differences in risk factor profiles between non-ATB-DILI and ATB-DILI are of statistically significant. Therefore, differentiated risk assessment and monitoring strategies should be implemented in clinical practice according to the types of patients in order to enable early identification and precise interventions among high-risk populations, thereby reducing the risk of DILI.

Key words: Drug-Induced Liver Injury, Anti-Tuberculosis Drugs, Anti-Infective Agents, Traditional Chinese Medicine(TCM)/Herbal and Dietary Supplements(HDS), Risk Factors, Female, Liver Diseases, HIV Infection, Abnormal Coagulation Function

中图分类号:

R994.11

杨闯, 周莹, 朱翔, 李娜, 全明霞, 万江桔, 申洪, 陈洁. 400例药物性肝损伤特征与危险因素分析[J]. 中国药物警戒, 2025, 22(12): 1404-1409.

YANG Chuang, ZHOU Ying, ZHU Xiang, LI Na, QUAN Mingxia, WAN Jiangju, SHEN Hong, CHEN Jie. Clinical Profiles and Risk Factors of 400 Cases of Drug-Induced Liver Injury[J]. Chinese Journal of Pharmacovigilance, 2025, 22(12): 1404-1409.

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