113例抗肿瘤药物相关肝损伤的临床特点及危险因素分析  

Clinical characteristics and risk factors of 113 cases of anti-neoplastic drug-induced liver injury

作　　者：李容容 李盟 苟悦 罗琼 吕桦[2] 孙鑫 刘成海 LI Rongrong;LI Meng;GOU Yue;LUO Qiong;LYU Hua;SUN Xin;LIU Chenghai(Institute of Liver Diseases,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Medical Quality Monitoring Center of TCM Hospital,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai Key Laboratory of Traditional Chinese Clinical Medicine,Shanghai 201203,China;Key Laboratory of Liver and Kidney Diseases,Ministry of Education,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属曙光医院肝病研究所,上海201203 [2]上海中医药大学附属曙光医院中医医院医疗质量监测中心,上海201203 [3]上海市中医临床重点实验室,上海201203 [4]肝肾疾病病证教育部重点实验室,上海201203

出　　处：《中国药物警戒》2023年第5期505-510,共6页Chinese Journal of Pharmacovigilance

基　　金：上海市中医药事业发展三年行动计划[ZY(2018-2020)-CCCX-5001];上海市科学技术委员会科技计划项目(20Z21900100);上海市临床重点专科建设项目(shslczdzk 01201)。

摘　　要：目的分析抗肿瘤药物所致药物性肝损伤(DILI)的临床特点及危险因素。方法回顾性分析上海中医药大学附属曙光医院2021年1月1日至2022年6月30日接受抗肿瘤药物治疗致DILI的113例患者临床资料,包括性别、年龄、个人史、原发肿瘤部位、抗肿瘤治疗方案、血常规、肝肾功能、肿瘤指标等。采用χ^(2)检验、t检验和非参数检验(两独立样本检验)进行分析。结果113例抗肿瘤药物致DILI患者中,男女比例1.13∶1,55岁以上老年患者居多。在肿瘤原发部位方面,结肠癌(25.7%)、肺癌(13.3%)、胃癌(12.4%)患者抗肿瘤治疗中发生DILI较多。抗肿瘤治疗方案中以化学治疗及靶向联合化疗的治疗方案导致DILI最多见。DILI的临床分型中胆汁淤积型患者比例最高(107例,94.7%),混合型次之(6例,5.3%);在肝损伤程度方面以轻度肝损伤为主(107例,94.7%)。Logistic回归分析显示,饮酒(OR 4.336,P=0.042)是抗肿瘤药物诱导DILI发生的独立危险因素。结论抗肿瘤药物致DILI多发生于老年患者,以化疗及靶向联合化疗方案最常见,临床表现以胆汁淤积型为主,肝损伤程度较轻,饮酒史是重要风险因素。Objective To analyze the clinical characteristics of anti-neoplastic drug induced liver injury(DILI).Methods The clinical data of 113 patients with DILI during anti-neoplastic therapy in Shuguang Hospital Affiliated to Shanghai University of TCM from January 1,2021 to June 30,2022 was retrospectively analyzed,including gender,age,disease history,primary tumor sites,anti-neoplastic therapy regimens,blood routine,liver and kidney function and tumor indicators.Chi-square test,t test and nonparametric test were used for analysis.Results Among the 113 patients with antitumor DILI,the ratio of males to females was 1.13∶1,and most of them were over 55 years old.In terms of primary tumor sites,the incidence of DILI was higher in patients with colon cancer(25.7%),lung cancer(13.3%),and gastric cancer(12.4%).Among antitumor therapy regimens,chemotherapy and targeted combined chemotherapy were most likely to cause DILI.As for the clinical classification of DILI,the proportion of patients with cholestasis was the highest(107 cases,94.7%),followed by the mixed type(6 cases,5.3%).The degree of liver injury was mostly mild(107 cases,94.7%).Logistic regression analysis showed that alcohol consumption(OR 4.336,P=0.042)was an independent risk factor for antitumor DILI.Conclusion DILI caused by anti-neoplastic drugs mostly occur in elderly patients,and chemotherapy and targeted combination chemotherapy are the most common.Cholestasis is the dominating type.The degree of liver injury is relatively mild,and a previous history of alcohol consumption increases the risk of anti-neoplastic DILI.

关 键 词：肿瘤 抗肿瘤药物 药物性肝损伤 胆汁淤积型 化疗 靶向联合化疗 临床特点 危险因素 饮酒 

分 类 号：R979.1[医药卫生—药品] R994.11[医药卫生—药学]