替加环素药源性肝损伤与胰腺炎的主动监测研究  

Automatic monitoring research on drug induced liver injury and pancreatitis of tigecycline

作　　者：朱曼[1] 田小燕[2] 郭代红[1] 王啸宇[1] ZHU Man TIAN Xiao-yan GUO Dai-hong WANG Xiao-yu(PLA General Hospital, Beijing 100853, China)

机构地区：[1]解放军总医院药品供应中心,北京100853 [2]重庆医科大学药学院,重庆401331

出　　处：《中华医院感染学杂志》2017年第20期4581-4583,4603,共4页Chinese Journal of Nosocomiology

基　　金：2014年全军后勤科研重点基金资助项目(BWS14R039)

摘　　要：目的探讨住院患者应用注射用替加环素相关的药源性肝损伤和药源性胰腺炎的发生情况。方法采用回顾性研究方法、借助"医疗机构药品不良事件(ADE)主动监测与智能评估警示系统"监测医院信息系统(HIS)历史库中,选择2012年3月-2017年3月期间使用过注射用替加环素的所有住院患者499例,并人工逐一甄别系统报警的疑似药源性肝损伤和药源性胰腺炎病例。结果药源性肝损伤(DILI)和药源性胰腺炎(DIP)的实际筛查病例分别为487例占97.60%和424例占84.97%。经人工评价具关联性的药源性肝损伤阳性病例为8例占1.60%,未发现药源性胰腺炎阳性病例。8例药源性肝损伤患者平均(69.75±20.49)岁,平均发生时间为用药后(5.25±4.06)天,轻度和重度肝损伤各4例;肝细胞损伤型为3例占37.50%,胆汁淤积型为5例占62.50%;采取停药及对症治疗后治愈3例、好转2例、持续3例。结论 499例替加环素住院患者中药源性肝损伤较为常见,略高于说明书,药源性胰腺炎0例,有待后续扩大监测样本。利用专项软件实施自动监测,能高效快捷的获取优质的真实世界用药风险数据,协助临床及时识别并规避用药风险。OBJECTIVE To investigate incidences of liver injury and pancreatitis induced by tigecycline in hospitalized patients.METHODS Retrospectively automatic monitoring method and active monitor and assessment system on adverse drug events（ADE）of medical institution were implemented for 499 inpatients who received tigecycline in hospital information system（HIS）from Mar.2012 to Mar.2017.The suspected cases of drug induced liver injury and acute pancreatitis warned by system were manually reviewed.RESULTS The actual screening cases of drug induced liver injury（DILI）and pancreatitis（DIP）of 499 patients were 487 cases（97.60%）and 424 cases（84.97%）.After the manual re-evaluation,there were 8 actual positive cases of drug induced liver injury and the incidence was 1.60%.No pancreatitis induced by tigecycline was found.The mean age of 8 patients with drug induced liver injury was（69.75±20.49）years old,and the mean occurrence time was（5.25±4.06）days after medication.Mild and severe liver injury were both 4 cases.There were 3 cases of hepatocellular damage（37.50%） and 5 case of cholestasis（62.50%）respectively.Totally 3 cases were cured,2 cases were improved,and 3 cases were continued after drug withdrawal and symptomatic treatment.CONCLUSION The incidence of liver injury induced by tigecycline is common in 499 cases of hospitalized patients which is higher than that in instruction.In consideration of limited number of cases and no pancreatitis case is found,which needs aubsequent monitoring samples.Using special software to implement automatic monitoring can efficiently and quickly obtain highquality real world drug risk data,and assist timely identification and avoid the risk of medication in clinic.

关 键 词：替加环素 药品不良反应 自动监测 药源性肝损伤 药源性胰腺炎 

分 类 号：R193.2[医药卫生—卫生事业管理]