中国药物警戒 ›› 2025, Vol. 22 ›› Issue (4): 410-414.
DOI: 10.19803/j.1672-8629.20240870

• 基础与临床研究 • 上一篇    下一篇

非典型抗精神病药物致肝损伤的临床特征及危险因素分析

陈欢1,2,3,4, 梁俊1,2,3,4, 赵伟1,2,3,4, 夏清荣1,2,3,4,*   

  1. 1安徽医科大学附属心理医院药剂科,安徽 合肥 230022;
    2合肥市第四人民医院药剂科,安徽 合肥 230022;
    3安徽省精神卫生中心精神药理研究室,安徽 合肥 230022;
    4安徽省精神心理疾病临床医学研究中心,安徽 合肥 230022
  • 收稿日期:2024-11-08 发布日期:2025-04-17
  • 通讯作者: *夏清荣,男,硕士,主任药师,医院药学。E-mail: 1356835730@qq.com
  • 作者简介:陈欢,男,本科,主管药师,医院药学。
  • 基金资助:
    国家临床重点专科经费资助; 合肥市第七周期临床重点(培育)专科资助

Clinical Features and Risk Factors of Liver Injury Induced by Atypical Antipsychotic Drugs

CHEN Huan1,2,3,4, LIANG Jun1,2,3,4, ZHAO Wei1,2,3,4, XIA Qingrong1,2,3,4,*   

  1. 1Department of Pharmacy, Affiliated Psychological Hospital of Anhui Medical University, Hefei Anhui 230022, China;
    2Department of Pharmacy, Hefei Fourth People’s Hospital, Hefei Anhui 230022, China;
    3Department of Mental Pharmacology, Anhui Mental Health Center, Hefei Anhui 230022, China;
    4Clinical Medical Research Center of Mental and Psychological Diseases in Anhui Province, Hefei Anhui 230022, China
  • Received:2024-11-08 Published:2025-04-17

摘要: 目的 探讨本院非典型抗精神病药物(AAPs)致药物性肝损伤(DILI)的临床特点及危险因素,为临床安全用药提供参考。方法 回顾性分析合肥市第四人民医院2020年1月1日至2023年12月31日接受AAPs治疗致DILI的122例患者病历资料,包括性别、年龄、疾病史、用药史、血常规、血糖、肝肾功能、初次用药和联合用药指标等。按1∶1随机匹配对照组,采用Logistic回归分析研究肝损伤的危险因素。结合Logistic回归分析结果,绘制受试者工作曲线(ROC),分析危险因素对DILI的预测能力。结果 122例AAPs致DILI的患者中,男女比例1∶1.22,平均年龄(32.98±14.04)岁。奥氮平在治疗中发生DILI最多(52例,42.62%),DILI的临床分型中肝细胞损伤型比例最高(87例,71.31%)。肝损伤的程度以轻度肝损伤为主(121例,99.18%),多数患者在对症处理后好转(62例,50.82%)或肝功能恢复正常(43例,35.25%)。Logistic回归分析显示,总胆红素(TBIL)、药物剂量、脂肪肝和联合用药是AAPs导致肝损伤的危险因素(P<0.05)。上述危险因素联合应用的ROC曲线AUC值为0.809,灵敏度75.40%,特异度76.00%,提示对APPs引起DILI有较好的预测效果。结论 APPs致DILI多发生于成年患者,以奥氮平最为常见,临床表现以肝细胞损害型为主,肝损伤程度较轻,及时干预后大多预后良好,但仍需警惕向严重肝损伤发展的可能。总胆红素、药物剂量、脂肪肝和联合用药是重要的风险因素,临床应加强用药风险评估,密切监测肝功能,减少药品不良反应的发生。

关键词: 非典型抗精神病药物, 奥氮平, 药物性肝损伤, 回顾性分析, 临床特点, 危险因素, 临床转归

Abstract: Objective To investigate the clinical characteristics and risk factors of drug-induced liver injury (DILI) induced by atypical antipsychotic drugs (AAPs) in our hospital in order to provide a reference for safe drug use. Methods The medical records of 122 patients who had received AAPs treatment for DILI at Hefei Fourth People’s Hospital between 2020 to and 2023 were retrospectively analyzed, including gender, age, disease history, medication history, blood routine, blood glucose, liver and kidney function, initial medication and indexes of combined medications. The control group was randomly matched at a ratio of 1∶1, and the risk factors for liver injury were studied logistic regression analysis. Based on the results of analysis, the receiver operating curve (ROC) was drawn to analyze the ability of risk factors to predict DILI. Results Among the 122 patients with AAPs induced DILI, the male to female ratio was 1∶1.22, and the average age was (32.98 ± 14.04) years. Olanzapine caused the largest number of cases of DILI during treatment (52 cases, 42.62%), and the proportion of hepatocyte injury in the clinical classification of DILI was the highest (87 cases, 71.31%). The degree of liver injury was mostly mild (121 cases, 99.18%), and most of the patients improved after symptomatic treatment (62 cases, 50.82%) or liver function returned to normal (43 cases, 35.25%). Logistic regression analysis showed that total bilirubin (TBIL), drug dose, fatty liver and combination of drugs were risk factors for liver injury caused by AAPs (P<0.05). The AUC value of the ROC curve for the combined application of the above risk factors was 0.809, with a sensitivity of 75.40% and a specificity of 76.00%, suggesting good predictability. Conclusion DILI caused by APPs occurs mostly in adult patients, and olanzapine is the biggest contributor. The clinical manifestations are primarily hepatocyte damage. Total bilirubin, drug dose, fatty liver and drug combination are important risk factors. The risk assessment of drug use should be assessed, liver function closely monitored, and adverse drug reactions reduced.

Key words: Atypical Antipsychotic Drugs, Olanzapine, Drug-Induced Liver Injury, Retrospective Analysis, Clinical Characteristics, Risk Factors, Clinical Outcome

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