药品风险分析评估系统的开发及在71例碘造影剂不良反应信号挖掘中的应用  

Development of Drug Risk Analysis and Evaluation System and its Application in Mining Adverse Reaction Signals of 71 Iodinated Contrast Media

作　　者：李继腾 Jiteng Li(Zhangqiu District People's Hospital,Jinan,Shandong 250219)

机构地区：[1]章丘区人民医院,山东济南250219

出　　处：《医学研究前沿》2024年第8期7-11,共5页Frontiers of Medical Research

摘　　要：目的目的通过开发药品风险分析评估系统,对某院碘造影剂药品不良反应数据进行信号挖掘,为临床合理用药提供参考依据。方法方法应用Java语言开发了药品风险分析评估系统,其信号检测方法采用贝叶斯判别可信区间递进神经网络模型(BCPNN)、比例报告比法(PRR)、综合标准法(MHRA),方法间的比较以BCPNN方法为参考,比较阳性预测值、阴性预测值、灵敏度、特异度和约登指数等检测指标。对某院2007年7月~2021年11月所报告的数据进行ADR信号挖掘。结果结果提取数据库中2670份ADR报告信息,其中以碘造影剂类药物为怀疑药物的ADR报告71份。71份报告中共有ADR 126例次(1份患者报告中可能含有多个ADR),PRR法检测到8个信号,ROR法检测到8个信号,MHRA法检测到6个信号,BCPNN法检测到5个弱信号。经检测,碘克沙醇面部水肿、眼睑水肿信号突出。3种检测方法与BCPNN比较,灵敏度一致,而MHRA法具有更好的特异度。结论结论药品风险分析评估系统的开发使用有助于医疗机构对系统中自发呈报数据库进行ADR信号的分析和检测,提升用药安全。碘克沙醇皮肤水肿损害值得重点关注。Objective To explore the data of adverse reactions of iodinated contrast media in hospital by developing drug risk analysis and evaluation system,and to provide reference for rational clinical drug use.Method The drug risk analysis and evaluation system was devel-oped by Java language.The signal detection methods were proportional reporting ratio method(PRR),reporting ratio method(ROR),Bayes-ian discriminant trusted interval progressive neural network model(BCPNN),comprehensive standard method(MHRA).BCPNN method was used as the reference standard to compare the detection methods through sensitivity,specificity,positive predictive value,negative predic-tive value and Jorden index.ADR signal mining was performed on the data reported from the hospital from July 1,2007 to November 30,2021.Result 2670 ADR reports were extracted from the database,of which 71 were suspected iodinated contrast media.There were 126 CASES of ADR in 71 reports(one patient report may contain multiple ADRs),8 signals were detected by PRR method,8 signals by ROR method,6 signals by MHRA method,and 5 weak signals by BCPNN method.After detection,iodixanol have high risk signals of facial edema and eyelid edema.The sensitivity of the three methods was consistent with that of BCPNN,while MHRA method had better specific-ity.Conclusion The development and use of drug risk analysis and evaluation system is helpful for our hospital and other medical institu-tions to detect and analyze ADR signals in the database of self-reporting system,and improve drug safety.Skin edema damage caused by iodoxanol is worthy of attention,which provides reference for clinical application of drugs.

关 键 词：药品不良反应 药品风险分析评估系统 碘造影剂 信号检测 水肿 

分 类 号：R969.3[医药卫生—药理学]