替加环素肝功能异常风险的回顾性观察研究  

Risk of liver function abnormalities with tigecycline:a retrospective observational study

作　　者：左成淳 许青 李晓宇 吕迁洲 石晓萍 ZUO Chengchun;XU Qing;LI Xiaoyu;LYU Qianzhou;SHI Xiaoping(Department of Pharmacy,Affiliated Zhongshan Hospital of Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属中山医院药剂科,上海200032

出　　处：《中国医院药学杂志》2024年第18期2146-2153,共8页Chinese Journal of Hospital Pharmacy

摘　　要：目的:阐明患者使用替加环素后出现肝功能异常的特征和预后,尤其是达到药物性肝损伤诊断标准前的肝功能异常的变化趋势。方法:通过电子病历收集2018年1月1日至2020年1月1日期间在复旦大学附属中山医院接受替加环素治疗满72 h、信息完整、已排除其他原因导致肝功能异常的585名成年住院患者资料进行回顾性研究,分析的肝功能指标包括丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)和总胆红素(TB)。分别评估各项指标异常的发生率和严重程度分级的动态变化过程。采用二分类logistic回归分析法确定与肝功能指标异常相关的独立风险因素。结果:与基线值相比,肝功能各项指标的首次异常值和异常峰值均明显上升。性别是导致ALT(OR=0.507,P=0.001)和AST(OR=0.657,P=0.034)异常的独立危险因素。高维持剂量(100 mg,每日2次)和长疗程(>14 d)是导致ALT、AST和ALP异常的独立危险因素(所有指标P<0.01)。此外,长疗程(>14 d)(OR=1.699,P=0.017)、手术(OR=1.819,P=0.001)和TB基线值超过正常范围上限(OR=4.079,P<0.01)是TB异常的独立危险因素。结论:使用替加环素后应当密切监测肝功能,重视肝功能异常指标,有利于发现肝损伤趋势,避免患者肝功能恶化。OBJECTIVE To elucidate the characteristics and outcomes of liver function abnormalities in patients taking tigecycline and detect the trends in liver function abnormalities before reaching the diagnostic criteria for drug-induced liver injury(DILI)METHODS For this retrospective study,the relevant clinical data of 585 adult inpatients were collected through an electronic medical record system.Tigecycline was dosed for 72 h or more between January 1,2018 and January 1,2020,medical data were complete and other causes of hepatic function abnormality excluded.The liver function parameters of alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(ALP) and total bilirubin(TB) were analyzed.The dynamic changes in the incidence and severity grading of abnormalities of each parameter was assessed.Binary Logistic regression analysis was employed for determining independent risk factors associated with liver function abnormalities.RESULTS As compared with baseline values,initial and peak abnormalities values of various liver function parameters spiked markedly.Gender was identified as an independent risk factor for abnormal ALT(OR=0.507,P=0.001) or AST(OR=0.657,P=0.034).High maintenance dose(100 mg bid) and prolonged duration(>14 days) were independent risk factors for abnormal ALT/AST/ALP(P<0.01 for all parameters).Furthermore,prolonged duration( >14 days)(OR=1.699,P=0.017),surgery(OR=1.819,P=0.001) and baseline TB value beyond upper limit of normal(OR=4.079,P<0.001) were independent risk factors for abnormal TB.CONCLUSION Clinicians should closely monitor liver function and pay greater attention to abnormal parameters of liver function after tigecycline therapy.This approach is conducive to detecting trends of liver injury and preventing further deterioration of liver function.

关 键 词：替加环素 肝功能异常 不良反应 风险因素 

分 类 号：R969.3[医药卫生—药理学]