药物性肝损伤自动监测与评估系统的研发与应用  

Development and application of drug-induced liver injury surveillance and assessment system

作　　者：艾超 冀召帅 张雅鑫 刘岸 周学思[2] 陈忠昊 吴及[2] AI Chao;JI Zhaoshuai;ZHANG Yaxin;LIU An;ZHOU Xuesi;CHEN Zhonghao;WU Ji(Dept.of Pharmacy,Beijing Tsinghua Changgung Hospital(BTCH)Affiliated to Tsinghua University/School of Clinical Medicine,Tsinghua University,Beijing 102218,China;Dept.of Electronic Engineering,Tsinghua University,Beijing 100084,China)

机构地区：[1]清华大学附属北京清华长庚医院/清华大学临床医学院药学部,北京102218 [2]清华大学电子工程系,北京100084

出　　处：《中国药房》2023年第19期2409-2413,共5页China Pharmacy

基　　金：中国工程院研究课题(No.12019C9001)。

摘　　要：目的建立药物性肝损伤(DILI)自动监测与评估系统(DILI-SAS),提升临床DILI的诊断效率。方法利用自然语言处理技术对全部住院病历数据进行挖掘和利用,并结合Roussel Uclaf因果关系评价法(RUCAM)构建DILI-SAS。对2022年8月-2023年1月期间在清华大学附属北京清华长庚医院住院的19445例患者病历进行检测,验证系统性能并人工分析DILI患者基本资料及第一怀疑药物分布情况。结果DILI-SAS整体准确率为91.95%,召回率为93.20%;共监测出75例DILI病例,DILI发生率为385.70/10万人;通过人机耦合的方式开展DILI监测效率比人工独立监测约提高了60倍;75例DILI中主要以男性(61.33%)、60岁以上(56.00%)患者为主,肝损伤临床分型主要是肝细胞损伤型(69.33%),潜伏期主要集中在用药后5~90d(62.67%),RUCAM评分在3~5分之间最多(66.67%);第一怀疑药物的药理分布主要为二氢吡啶类、羟甲基戊二酸单酰辅酶A还原酶抑制剂、质子泵抑制剂等,具体药物有阿托伐他汀、奥美拉唑、头孢曲松、甲硝唑等。结论建立的DILI-SAS在保障系统准确度的基础上,能提升DILI评价时效性,可为临床DILI的早期识别、诊断、评价提供解决方案。OBJECTIVE To establish the drug-induced liver injury(DILI)surveillance and assessment system(DILI-SAS),and to improve the diagnostic efficiency of clinical DILI.METHODS The DILI-SAS was constructed by using natural language processing technology to mine and utilize all inpatient medical record data,and combined with Roussel Uclaf causality assessment method(RUCAM).The medical records of 19445 hospitalized patients from August 2022 to January 2023 were detected to verify the performance of the system and manually analyze the basic data of patients with DILI and the distribution of the first suspected drugs.RESULTS The overall accuracy rate of the DILI-SAS system was 91.95%,and the recall rate was 93.20%.Seventy-five DILI cases were detected,and the DILI incidence rate was 385.70/100000 people.The efficiency of DILI monitoring by human-computer coupling was increased by about 60 times of manual monitoring;males(61.33%)and patients over 60 years old(56.00%)were the most common in the 75 cases of DILI.The clinical type of liver injury was hepatocyte injury(69.33%),the incubation period was mainly 5-90 days after treatment(62.67%),and the RUCAM score between 3 and 5 was the most common(66.67%);pharmacological distribution of the first suspected drugs was mainly dihydropyridines,HMG CoA reductase inhibitors,proton pump inhibitors,etc.The specific drugs were atorvastatin,omeprazole,ceftriaxone,metronidazole and other drugs.CONCLUSIONS The establishment of DILI-SAS can improve the evaluation efficiency on the basis of ensuring the accuracy degree,and provide a solution for the early identification,diagnosis and evaluation of clinical DILI.

关 键 词：药物性肝损伤 自然语言处理技术 自动监测与评估系统 不良反应 因果关系评价 

分 类 号：R975.5[医药卫生—药品]