302例药物性肝损伤患者的临床特征及其预后分析

肝脏 ›› 2026, Vol. 31 ›› Issue (3): 405-411.

302例药物性肝损伤患者的临床特征及其预后分析

孙双双, 金银鹏, 李莉, 傅青春

201508 上海上海市公共卫生临床中心肝病诊疗中心

收稿日期:2025-12-20 出版日期:2026-03-31 发布日期:2026-05-19
通讯作者: 李莉,Email:lilyshz@163.com;傅青春,Email:qcfu85@163.com
基金资助:
上海市公共卫生临床中心院级课题(KY-GW-2019-14)

Analysis of the clinical characteristics and prognosis of 302 patients with drug-induced liver injury

SUN Shuang-shuang, JIN Yin-peng, LI Li, FU Qing-chun

Department of Clinical Research Center for Liver Diseases, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China

Received:2025-12-20 Online:2026-03-31 Published:2026-05-19
Contact: LI Li, Email: lilyshz@163.com;FU Qing-chun, Email: qcfu85@163.com

摘要/Abstract

摘要： 目的分析药物性肝损伤(DILI)患者的临床特征及相关影响因素。方法收集2020年1月~2025年1月在上海市公共卫生临床中心确诊的DILI患者302例,收集所有患者的病史、临床表现与分型、实验室检查指标、疾病严重程度及病死率等数据。采用t检验、单因素方差分析(one-way ANOVA)、Mann-Whitney U检验、Kruskal-Wallis H秩和检验、logistic回归模型进行统计学分析。结果多数患者为中老年(72%),女性患者多见。导致DILI的药物中,中药占128例(42.38%),以何首乌、土三七等中草药为主;西药所致DILI为174例(57.6%),以抗结核药物(30.79%)为主。其中中药和西药对比,临床表现上,中药组出现皮肤黄染、食欲减退、尿黄的占比较西药组高(分别为P<0.001,P<0.004,P<0.001),而出现皮疹的占比较西药组低(P<0.004)。中药组患者的血清 ALT、AST、ALP、TBil、DBil 峰值水平明显高于西药组(分别为P<0.001,P<0.001,P<0.015,P<0.001,P<0.001),西药组嗜酸性粒细胞百分比峰值水平明显高于中药组。98.7%的DILI患者治愈或者好转,1.3%的患者未治愈。结论导致DILI的可疑用药以草药、抗结核药物等为主,中老年女性、肝细胞损伤型多见,绝大多数DILI患者停药后预后良好。

关键词: 药物性肝损伤, 中药, 西药, 临床特征, 预后

Abstract: Objective To analyze the clinical characteristics and related influencing factors of drug-induced liver injury (DILI). Methods A total of 302 patients diagnosed with DILI at Shanghai Public Health Clinical Center from January 2020 to January 2025 were enrolled. Data including medical history, clinical manifestations and classification, laboratory test indicators, disease severity and mortality were collected. Statistical analyses were performed using t-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis H test and logistic regression model. Results Most patients were middle-aged and elderly (72%), with a female predominance. Among the drugs causing DILI, traditional Chinese medicine (TCM) accounted for 128 cases (42.38%), mainly including polygonum multiflorum and gynura segetum; western medicine accounted for 174 cases (57.6%), mainly anti-tuberculosis drugs (30.79%).Compared with the western medicine group, the TCM group had significantly higher rates of skin jaundice, anorexia and dark urine (all P<0.001, P<0.004, P<0.001, respectively), but a lower rate of rash (P<0.004).Peak serum levels of ALT, AST, ALP, TBil and DBil were significantly higher in the TCM group (all P<0.001, P<0.001, P<0.015, P<0.001, P<0.001, respectively), while the peak percentage of eosinophils was significantly higher in the western medicine group.In total, 98.7% of DILI patients were cured or improved, and 1.3% had no recovery. Conclusion Herbal medicines and anti-tuberculosis drugs are the main suspicious agents causing DILI. DILI is more common in middle-aged and elderly women, mostly presenting as hepatocellular injury. The prognosis of most DILI patients is favorable after drug withdrawal.

Key words: Drug-induced liver injury, Traditional Chinese medicine, Western medicine, Clinical features, Prognosis

孙双双, 金银鹏, 李莉, 傅青春. 302例药物性肝损伤患者的临床特征及其预后分析[J]. 肝脏, 2026, 31(3): 405-411.

SUN Shuang-shuang, JIN Yin-peng, LI Li, FU Qing-chun. Analysis of the clinical characteristics and prognosis of 302 patients with drug-induced liver injury[J]. Chinese Hepatolgy, 2026, 31(3): 405-411.

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