依诺肝素钠导致肝功能异常的表现及其危险因素的Logistic回归分析  

Abnormal Manifestations of Liver Function Induced by Enoxaparin Sodium and Logistic Regression Analysis of Risk Factors

作　　者：于鹏飞[1,2] 赵莉 YU Pengfei;ZHAO Li(Dept.of Pharmacy,Affiliated Hospital of Binzhou Medical University,Shandong Binzhou 256600,China;Dept.of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China)

机构地区：[1]滨州医学院附属医院药学部,山东滨州256600 [2]中日友好医院药学部,北京100029

出　　处：《中国医院用药评价与分析》2023年第12期1524-1527,1531,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：首都卫生发展科研专项项目(No.首发2020-1-2031)。

摘　　要：目的:探讨依诺肝素钠导致肝功能异常的表现及影响因素。方法:通过医院信息系统,收集2021—2022年中日友好医院呼吸病区住院期间使用依诺肝素钠的患者病历资料,根据Roussel Uclaf因果关系评估法2015版,筛选出评价结果为“高度可能”“可能性大”和“可能”的患者,并进行分析。结果:入组患者506例,其中男性292例,女性214例;依诺肝素钠高剂量(100 AXaIU/kg,每12 h给药1次)217例,低剂量(2000/4000 AXaIU,1日1次)289例。其中38例患者(占7.5%)发生依诺肝素钠相关性肝功能指标异常(因果关系评价结果均为“可能性大”以及以上),主要表现为氨基转移酶升高,胆红素水平正常。二元Logistic回归分析显示,高剂量组患者(31例)的肝功能异常发生率高于低剂量组(7例),差异有统计学意义(P<0.001);男性患者(29例)的肝功能异常发生率高于女性(9例),差异有统计学意义(P=0.023);年龄、吸烟史、饮酒史、用药时长各组间的差异均无统计学意义(P>0.05)。停用、更换非肝素类抗凝血药可以获得良好的转归。结论:依诺肝素钠导致的肝功能异常是一类可逆、初始症状缓和的不良反应,主要表现为氨基转移酶升高,更换非肝素类药物后能转归。高剂量依诺肝素钠及男性患者是发生肝功能异常的高危因素,临床使用依诺肝素钠过程中需加强对该类患者的用药监护。OBJECTIVE:To probe into the abnormal manifestations of liver function induced by enoxaparin sodium and its influencing factors.METHODS:Medical records of patients who used enoxaparin sodium in the respiratory ward of China-Japan Friendship Hospital from 2021 to 2022 were collected through the hospital information system.According to Roussel Uclaf causality evaluation method 2015 edition,patients whose evaluation results were“extremely likely”,“highly likely”and“likely”were selected for analysis.RESULTS:A total of 506 patients were enrolled,including 292 males and 214 females.There were 217 cases of high dose(100 AXaIU/kg,q12 h)enoxaparin sodium and 289 cases of low dose(2000/4000 AXaIU,qd).Totally 38 patients(7.5%)developed abnormal liver indexes induced by enoxaparin sodium(the results of causality evaluation were“highly likely”and above),the clinical manifestations were mainly elevated transaminase,with normal bilirubin.Binary logistic regression analysis showed that the incidence of abnormal liver function in the high dose group(31 cases)was higher than that in the low dose group(7 cases),the difference was statistically significant(P<0.001).The incidence of abnormal liver function in males(29 cases)was higher than that in females(9 cases),the difference was statistically significant(P=0.023).There was no significant difference in age,smoking history,drinking history and duration of drug use(P>0.05).Good outcomes can be obtained by discontinuation and replacement of non-heparin anticoagulants.CONCLUSIONS:Abnormal liver function induced by enoxaparin sodium is a reversible adverse reaction with initial remission of symptoms,mainly manifested by elevated aminotransferase,which can be cured after replacement of non-heparin drugs.High dose enoxaparin and male patients are high risk factors for abnormal liver function,and it is necessary to strengthen the drug monitoring of during clinical use of enoxaparin.

关 键 词：依诺肝素钠 肝功能 氨基转移酶 胆红素 

分 类 号：R973.2[医药卫生—药品]