上海市药品不良反应自发呈报数据库定量信号检测系统的建立与应用

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1、PartI：EstablishmentofquantitativesignaldetectionsystemonADRSRSdatabaseofShanghaiWiththefamousdevelopmenttoolofPowerBuilderandSQLServer2000，WeprogrammedthreeCOI'emodulestoperformdatacoding，signaldetectionandreportgenerationrespectively．Fiveinternationallyrecognizedmethodsfor

2、quantitativesignaldetectionwergintegratedintothissystem，includingBayesianconfidencepropagationneuralnetworkmethod(BCPHN)，empiricalBayesiangammaPoissonshrinker(GPS)，proportionalADRreportingratio(PRR)andrepottingod出ratio(ROR)．Inordertocodetextinformation，WCestablishedgenericd

3、rugnalTledictionaryandADRterminologydictionaryrespectively．Wealsobuiltabrandnamelibraryofdrugstoresolvetheproblemofonedrugwithmultiplesynonymsoralias．ADRinformationfromliteraturesanddruginsertpackageswereextractedforestablishmentofknownADRlibrary,whichWasusedforautomaticfil

4、trationofsuspectedADRsignals．Combinationofdescriptivestatisticalanal),sisandquantitativesignaldetectiontechnologyisoneoftheprominentfeaturesofthissystemwhichcouldrealizeautomaticADRsignaldetectionandprovidedecision—makingsupportforearliersignalwarning．Thesystem’Scapacityfor

5、signaldetectionwastestedwiththeADRreportscollectedinyear2003and2004fromtheADRSRSdatabaseofShahlghal．Theresultsshowedthatthesystemranstably,producedreasonablesignalfistandcleargraphicaloutput，whichachievedtheexpectedgoals．Simultaneoususeofdifferentquantitativemethodsimproved

6、theaccuracyandefficiencyofsignaldetection．PartⅡ：ApplicationofquantitativesignaidetectionsystemtoADRSRSdatabaseofShanghaiHavingprovedcredibleperformanceofthesystem，WeputittouseinShanghaiSRSdatabasecontaining3years’ADRreportingdatabetween2003and2005forsignaldetectionandanalys

7、is．Results1．Totally18702ADRreportswerecollectedduringtheperiodbetween2003and2005inShanghaiADRMonitoringCenter,including8889differentdrug-AEpairs，amongwhich718pairswerescreenedoutassuspectedsignalsfortheirsignals仕engthmeetingthecriteriaofatleatoneoffivedetectionmethods，accou

8、ntingfor8．1％ofalldrug-AEpairs．Itisnoteworthythat76．5percentofthosesuspectedsignals