目的 分析宁德市近10年（2013—2023年）药物性肝损伤（DILI）的临床特点、发生规律及可能风险因素，以期为临床合理、安全用药提供参考。方法 从宁德市2013年1月1日—2023年12月31日期间上报至国家药品不良反应监测系统数据库的药品不良反应/事件个例报告中筛选出DILI病例报告，并对报告类型、患者性别、年龄以及DILI潜伏期、临床表现、涉及的药物类别及其分布、治疗与转归等情况进行回顾性分析。结果 筛选出DILI病例报告850例，均来自医疗机构，其中严重报告326例（38.35%），新的病例报告63例（7.41%）；患者男女比例为1.15∶1，平均年龄为（55.14±16.56）岁，且主要集中在45岁及以上（638例，75.06%）。DILI涉及13类260种药物，主要包括抗感染药物、抗肿瘤药物、心血管系统用药和中枢神经系统用药，其中排名前3的依次是抗结核药、调血脂药及抗动脉粥样硬化药和抗生素；引起DILI频次排名前5位的药物依次为阿托伐他汀、异烟肼、利福平、瑞舒伐他汀和吡嗪酰胺。大多数患者DILI发生于用药后2～14 d（567例，66.71%）；716例（84.24%）患者接受预防性和/或治疗性保肝用药；598例（70.35%）患者的转归为好转或痊愈。结论 临床上使用抗结核病药、他汀类调血脂药、抗肿瘤药和抗甲状腺药物等治疗时，应密切关注患者肝功能生化情况，科学评估动态监测频次，加强患者的健康和合理用药教育，及时识别疑似DILI，加强中重度DILI干预治疗。

Objective To analyze clinical characteristics, occurrence patterns, and possible risk factors of drug-induced liver injury (DILI) in Ningde City over the past 10 years (2013—2023), in order to provide reference for rational and safe drug use in clinical practice. Methods Cases of DILI were screened from the database of the National Adverse Drug Reaction Surveillance System in Ningde between January 1, 2013 and December 31, 2023, and the report type, gender, age, incubation period, clinical manifestations, distribution of drug classes involved, treatment and outcome were retrospectively analyzed. Results A total of 850 DILI cases were reported, all of which were from medical institutions, of which 326 (38.35%) were severely reported and 63 (7.41%) were newly reported. The male-to-female ratio was 1.15∶1, and the average age was (55.14 ±16.56) years, and the patients were mainly 45 years old and above (638 cases, 75.06%). DILI involves 260 drugs in 13 categories, mainly including anti-infective drugs, antitumor drugs and drugs for cardiovascular system and central nervous system, of which the top three are anti-tuberculosis drugs, lipidregulating and anti-atherosclerotic drugs and antibiotics. The top five drugs that cause DILI frequency are atorvastatin, isoniazid, rifampicin, rosuvastatin, and pyrazinamide. DILI occurred in most patients on the 2—14 d after treatment (567 cases, 66.71%) and 716 patients (84.24%) received prophylactic and/or therapeutic hepatoprotective drugs. A total of 598 patients (70.35%) improved or recovered after treatment. Conclusion When using anti-tuberculosis drugs, statins, antineoplastic drugs and antithyroid drugs in clinical treatment, it is necessary to pay close attention to the biochemical status of patients' liver function, scientifically evaluate the frequency of dynamic monitoring, strengthen the health and rational drug use education of patients, identify suspected DILI in a timely manner, and strengthen the intervention and treatment of moderate to severe DILI.

R965.3