目的：分析药物性肝损伤(drug?induced liver injury，DILI)的临床特征及预后，提高DILI的早期诊断率和治疗效果。 方法：收集2017年1月—2020年12月南京医科大学第一附属医院416例药物性肝损伤患者的临床资料，回顾性分析其临床特征及预后情况。结果：药物性肝损伤患者中女性较多(61.30%)，40~59岁年龄段占比最大(46.39%)，≥60岁次之(31.50%)。临床表现主要为乏力、纳差、尿黄、皮肤巩膜黄染、上腹不适等。临床分型中肝细胞型占比最大(52.64%)，其余依次为混合型 (23.80%)、胆汁淤积型(23.56%)。引起药物性肝损伤的可疑药物以中草药、中成药类占首位(56.25%)。肝细胞型患者的总体预后最佳，治愈率和好转率分别为10.05%、88.58%，无效率为1.37%。结论：引起药物性肝损伤的药物种类繁杂，临床表现无特异性。大多患者经积极治疗后预后较好，但仍有部分患者病情进展或死亡，需引起临床重视。
Objective：To analyze the clinical features and prognosis of patients with drug ?induced liver injury(DILI)，so as to provide basis for its prevention and treatment. Methods：The clinical materials of 416 patients with DILI in the First Affiliated Hospital of Nanjing Medical University between January 2017 to December 2020 were reviewed. The demographic data，suspicious drugs， clinical characteristics，laboratory examination results and prognosis were retrospectively analyzed. Results：Among 416 DILI patients， there were 161 males(38.70%)and 255 females(61.30%)，and their ages mainly distributed between 40~59 years old(46.39%)， followed by ≥60 years old(31.50%). The main clinical manifestations included fatigue，darker urine，yellow skin and sclera，and gastrointestinal symptoms. The main type of injuries was hepatocellular injury(52.64%)，followed by mixed type(23.80%)and cholestatic type(23.56%). The most common drug causing DILI was Chinese herbal and patent medicine(56.25%). Patients with hepatocellular type had the best overall prognosis，with cure and improvement rates of 10.05% and 88.58% respectively，and a failure rate of 1.37%. Conclusion：A number of drugs may cause DILI，and the clinical manifestations were nonspecific. Most patients have a good prognosis after active treatment，but some patients still progress or die，which needs more clinical attention.