Objective: To explore the drugs and clinical characteristics causing drug-induced liver injury (DILI) in recent years, as well as identify drug-induced liver failure, and chronic DILI risk factors, in order to better manage them timely. Methods: A retrospective investigation and analysis was conducted on 224 cases diagnosed with DILI and followed up for at least six months between January 2018 and December 2020. Univariate and multivariate logistic regression analyses were used to identify risk factors for drug-induced liver failure and chronic DILI. Results: Traditional Chinese medicine (accounting for 62.5%), herbal medicine (accounting for 84.3% of traditional Chinese medicine), and some Chinese patent medicines were the main causes of DILI found in this study. Severe and chronic DILI was associated with cholestatic type. Preexisting gallbladder disease, initial total bilirubin, initial prothrombin time, and initial antinuclear antibody titer were independent risk factors for DILI. Prolonged time interval between alkaline phosphatase (ALP) and alanine aminotransferase (ALT) falling from the peak to half of the peak (T(0.5ALP) and T(0.5ALT)) was an independent risk factor for chronic DILI [area under the receiver operating characteristic curve (AUC) = 0.787, 95%CI: 0.697~0.878, P < 0.001], with cutoff values of 12.5d and 9.5d, respectively. Conclusion: Traditional Chinese medicine is the main contributing cause of DILI. The occurrence risk of severe DILI is related to preexisting gallbladder disease, initial total bilirubin, prothrombin time, and antinuclear antibodies. T(0.5ALP) and T(0.5ALT) can be used as indicators to predict chronic DILI.
目的： 旨在探讨近年引起药物性肝损伤(DILI)的药物和临床特征，识别药物性肝功能衰竭和慢性DILI的危险因素，以便于早期识别和更好地管理。 方法： 对2018年1月至2020年12月期间诊断为DILI并随访至少6个月的224例患者进行回顾性调查和分析。采用单因素和多因素logistic回归分析识别药物性肝功能衰竭和慢性DILI的危险因素。 结果： 中药（占62.5%）包括草药（占中药的84.3%）和一些中成药是研究中发现引起DILI的主要原因。胆汁淤积型与严重和慢性DILI更相关。已存在胆囊疾病、初始总胆红素、初始凝血酶原时间、初始抗核抗体滴度是药物性肝功能衰竭的独立危险因素。碱性磷酸酶（ALP）、丙氨酸转氨酶（ALT）从峰值下降到峰值的50%的时间间隔(T(0.5ALP)和T(0.5ALT))延长为慢性DILI的独立危险因素（受试者操作特征曲线下面积=0.787，95%置信区间：0.697～0.878，P < 0.001），临界值分别为12.5 d和9.5 d。 结论： 中药是导致DILI的主要原因，发生严重DILI的风险与已存在胆囊疾病、初始总胆红素、凝血酶原时间和抗核抗体相关。T(0.5ALP)和T(0.5ALT)可作为预测慢性DILI的指标。.
Keywords: Chinese medicine; Chronicity; Drug-induced liver injury; Liver failure; Risk factor.