Chen Sheng-Sen, Yu Kang-Kang, Huang Chong, Li Ning, Zheng Jian-Ming, Bao Su-Xia, Chen Ming-Quan, Zhang Wen-Hong
Department of Infectious Diseases and Hepatology, Huashan Hospital, Fudan University, Shanghai, China.
Medicine (Baltimore). 2016 Aug;95(34):e4683. doi: 10.1097/MD.0000000000004683.
The aim of this cohort study was to determine the characteristics and clinical outcome of 287 patients with drug-induced liver injury (DILI) in a Chinese hospital.Between January 2008 and January 2013, individuals who were diagnosed with DILI were selected. The complete medical records of each case were reviewed, and factors for the outcome of patients with DILI were extracted and analyzed using univariate and multivariate analysis.Two hundred eighty-seven cases identified as DILI were included in the study. A total of 105 different drugs were considered to be related to the hepatotoxicity. The main causative group of drugs was Chinese herb (n = 111). Liver failure developed in 9 (3.1%) patients, and 2 died (0.7%). Overall, complete recovery occurred in 92 (32.1%) patients. Univariate analysis and binary logistic regression analysis identified the digestive symptoms, jaundice, total bilirubin (TBIL), and direct bilirubin (DBIL) as independent factors for the non-recovery of DILI. Then the prediction model, including digestive symptoms, jaundice, TBIL, and DBIL, was built by using binary logistic regression analysis again. Receiver operating characteristic curve validated the strong power (area under the curve (AUC) = 0.907) of prediction model for predicting the DILI non-recovery.DILI is an important cause of liver test abnormalities, and Chinese herb represented the most common drug group. The factors such as digestive symptoms, jaundice, TBIL, and DBIL have effect on DILI outcomes. The prediction model, including digestive symptoms, jaundice, TBIL, and DBIL, established in this study is really an excellent predictive tool for non-recovery of DILI patients.
这项队列研究的目的是确定一家中国医院中287例药物性肝损伤(DILI)患者的特征和临床结局。在2008年1月至2013年1月期间,选取被诊断为DILI的患者。查阅了每例患者的完整病历,提取了DILI患者结局的相关因素,并采用单因素和多因素分析进行分析。本研究纳入了287例确诊为DILI的病例。共有105种不同药物被认为与肝毒性有关。主要的致伤药物类别为中草药(n = 111)。9例(3.1%)患者发生肝衰竭,2例死亡(0.7%)。总体而言,92例(32.1%)患者完全康复。单因素分析和二元逻辑回归分析确定消化症状、黄疸、总胆红素(TBIL)和直接胆红素(DBIL)是DILI未康复的独立因素。然后再次使用二元逻辑回归分析构建了包括消化症状、黄疸、TBIL和DBIL的预测模型。受试者工作特征曲线验证了该预测模型对预测DILI未康复具有强大的预测能力(曲线下面积(AUC)= 0.907)。DILI是肝功能检查异常的重要原因,中草药是最常见的致伤药物类别。消化症状、黄疸、TBIL和DBIL等因素对DILI结局有影响。本研究建立的包括消化症状、黄疸、TBIL和DBIL的预测模型确实是预测DILI患者未康复的优秀预测工具。