三唑类抗真菌药物的药源性肝损伤主动监测研究  

The active surveillance of triazole antifungal agents-induced liver injury

作　　者：朱曼[1] 郭茂文[1,2] 郭代红[1] 吴旭[1,3] 马亮[1] 赵鹏芝[1] 赵靓[1] ZHU Man;GUO Mao-wen;GUO Dai-hong;WU Xu;MA Liang;ZHAO Peng-zhi;ZHAO Liang(Department of Clinical Pharmacy, PLA General Hospital, Beijing 100853, China;Capital Institute of Pediatrics, Beijing 100020, China;College of Pharmacy, Chongqing Medical University, Chongqing 401331, China)

机构地区：[1]解放军总医院药学部临床药学中心,北京100853 [2]首都儿科研究所附属儿童医院,北京100020 [3]重庆医科大学药学院,重庆401331

出　　处：《中国药物应用与监测》2017年第1期45-47,68,共4页Chinese Journal of Drug Application and Monitoring

基　　金：2014全军后勤科研重点项目(BWS14R039)

摘　　要：目的:研究应用计算机辅助系统主动监测住院患者3种三唑类抗真菌药物致药源性肝损伤的可行性和关键要素。方法:利用住院患者药品不良事件主动监测与评估警示系统,通过团队论证的方式优化住院患者三唑类抗真菌药物致药源性肝损伤主动监测的事件配置器。回顾性调取2015年1月1日–2015年11月30日我院经静脉途径应用氟康唑氯化钠注射液、注射用伏立康唑、伊曲康唑注射液的住院患者,对系统提示的阳性预警病例进行人工再评价。结果:计划3参数为最优的事件配置器参数,分别筛查氟康唑组、注射用伏立康唑组和伊曲康唑组病例840例、211例和81例。其中氟康唑组系统阳性预警病例377例,人工再评价实际阳性病例为42例,人工阳性预警率为5.00%;注射用伏立康唑组系统阳性预警病例94例,人工再评价实际阳性病例为15例,人工阳性预警率为7.11%;伊曲康唑注射液组系统阳性预警病例28例,人工再评价实际阳性病例为4例,人工阳性预警率为4.94%。结论:本研究中设置的肝损伤事件配置器结合了多种标准参数,可操作性好,弹性空间大,阳性病例丢失率低。采用该系统进行主动监测研究时,事件配置器的参数设置为关键要素,应基于不同目标药物和药品不良事件特点进行个体化设置。Objective:To study the feasibility and key elements of active surveillance of inpatient's drug-induced liver injury onthree kinds of triazole antifungal agents based on computer-aided system.Methods:Based on inpatient's active monitor and assessmentsystem of adverse drug events and team work,the event configurator of drug-induced liver injury on triazole antifungal agents wasoptimized.Retrospective method was used for evaluating the inpatients in PLA general hospital from January1,2015to November30,2015who intravenously used the fluconazole and sodium chloride injection,voriconazole for injection and itraconazole injection.The positivewarning cases were re-evaluated manually.Results:The event monitor configurator parameters of plan three were the most reasonable.The screening cases about fluconazole,voriconazole and itraconazole were840,211and81cases,respectively.A total of377warning casesof fluconazole were screened by the system,and after the manual re-evaluation,the actual positive cases and warning rate were42casesand5.00%.94warning cases about voriconazole were screened by the system,while the actual positive cases and warning rate were15cases and7.11%.28warning cases about itraconazole were screened by the system,and the actual positive cases and warning rate were4cases and4.94%.Conclusion:In this study,we considered diverse criteria to set the parameters of hypohepatia event configurator,whichwas proved excellent maneuverability and elasticity.The loss rate of positive cases was low.Setting parameters of adverse drug eventsconfigurator was the key point and should be based on different target drugs as well as the characteristics of different adverse drug events.

关 键 词：三唑类抗真菌药物 药源性肝损伤 主动监测 氟康唑 伏立康唑 伊曲康唑 

分 类 号：R575[医药卫生—消化系统]