目的 分析寧德市近10年（2013—2023年）藥物性肝損傷（DILI）的臨床特點(diǎn)、發(fā)生規(guī)律及可能風(fēng)險(xiǎn)因素，以期為臨床合理、安全用藥提供參考。方法 從寧德市2013年1月1日—2023年12月31日期間上報(bào)至國(guó)家藥品不良反應(yīng)監(jiān)測(cè)系統(tǒng)數(shù)據(jù)庫(kù)的藥品不良反應(yīng)/事件個(gè)例報(bào)告中篩選出DILI病例報(bào)告，并對(duì)報(bào)告類型、患者性別、年齡以及DILI潛伏期、臨床表現(xiàn)、涉及的藥物類別及其分布、治療與轉(zhuǎn)歸等情況進(jìn)行回顧性分析。結(jié)果 篩選出DILI病例報(bào)告850例，均來自醫(yī)療機(jī)構(gòu)，其中嚴(yán)重報(bào)告326例（38.35%），新的病例報(bào)告63例（7.41%）；患者男女比例為1.15∶1，平均年齡為（55.14±16.56）歲，且主要集中在45歲及以上（638例，75.06%）。DILI涉及13類260種藥物，主要包括抗感染藥物、抗腫瘤藥物、心血管系統(tǒng)用藥和中樞神經(jīng)系統(tǒng)用藥，其中排名前3的依次是抗結(jié)核藥、調(diào)血脂藥及抗動(dòng)脈粥樣硬化藥和抗生素；引起DILI頻次排名前5位的藥物依次為阿托伐他汀、異煙肼、利福平、瑞舒伐他汀和吡嗪酰胺。大多數(shù)患者DILI發(fā)生于用藥后2～14 d（567例，66.71%）；716例（84.24%）患者接受預(yù)防性和/或治療性保肝用藥；598例（70.35%）患者的轉(zhuǎn)歸為好轉(zhuǎn)或痊愈。結(jié)論 臨床上使用抗結(jié)核病藥、他汀類調(diào)血脂藥、抗腫瘤藥和抗甲狀腺藥物等治療時(shí)，應(yīng)密切關(guān)注患者肝功能生化情況，科學(xué)評(píng)估動(dòng)態(tài)監(jiān)測(cè)頻次，加強(qiáng)患者的健康和合理用藥教育，及時(shí)識(shí)別疑似DILI，加強(qiáng)中重度DILI干預(yù)治療。

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