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PrognosticModelforthePatientswithSevereLiverDiseaseWenfangWu1,JingZhang,BinrongMa,JinqiuHe,LunliZhang,ChunyiZou,ShaojieXin,ChangyanLin1DepartmentofBiologyMedicalEngineeringCapitalMedicalUniversity,100069Beijing,Chinawuwenfang99718yahoo.com.cnBeijingAnZhenHospitalBeijing,ChinaAbstracttoanalyzeprognosticfactorsofpatientswithsevereliverdiseaseanddevelopaprognosticmodelforthemwhichisfitfultothecharacteristicsofourcountry.FromMarch2002toJune2007,the527patientswithsevereliverdiseasewereevaluated,thefollowupinformationwerecollectedincludethesurvivalstatedeath/survival.ThesurvivalmodelwasestablishedbyusingCOXproportionalhazardmodel.New400caseswereusedtotestandevaluatethedecisioncapabilityofthemodel.NineprognosticfactorswereextractedbyusingCOX,theprognosticindexPIwascalculated.BystatisticsanalyzetocomparetheROCareaAUCofthissystemmodelwithCTPandMELD,thissystemmeldisbetterthanCTPandMELD.Thedevelopedmodelisfitfultothecharacteristicsofourcountrywheretherearealotofvirushepatitispatients,sothemodelisvaluableinprognosticevaluationofsevereliverpatientsandveryusefultoguidecliniciansinselectingtreatmentmethodsinChina.KeywordsSevereLiverDiseasePrognosisCox′sproportionalhazardmodelI.IntroductionHepatitisisamajordiseaseinChina.Thedeathrateisabout70forseverehepatitis.Theresultsfromtheinternalmedicaltherapyarehardtobesatisfactory.Withrapiddevelopmentofscienceandtechnologyinrecentlyyears,artificialliverhasbeenbecominganimportantcuremethodandhasbeenusedbythehospitalsatdifferentlevels.Thematurationoflivertransplantationtechniquemakesitoneofthemosteffectivetherapiesforthepeopleatthefinalstagesoftheliverdisease.However,becauseofthelimitationofliversourceandthehighexpenseforthetreatment,mostofthesuffererscannotbenefitfromit.Therefore,itisthecommonconcernforthesufferersandpersonsworkingontheliverdiseasetochoosepropertreatmentmethodwiththewelltime,soastoimprovethesurvivalrateandtheirlifequality.Thekeytosolvethisproblemistheprognosiswithhighprecisionandproperevaluationofthediseaseanditstherapy.Foryears,multipleresearcheshavebeenconductedforprognosisjudgmentoftheliverdisease.ThemostsignificantaretheChildTurcottePugh(CTP)classificationandmodelforendstageliverdiseaseMELD,whichhavebeenwidelyusedtoprognosisofthefinalstageofliverdisease,esp,thehepatocirrhosis,andhavebeenthebasisoftheliverdistributionforitstransplantation.However,virusisthemainreasonfortheliverdiseaseinourcountry.Thehighoccurringrateofhepatocirrhosisfromthehepatitisandchronicseverehepatitisisdifferentfromitsacutebreakoutinabroad.Therefore,theprognosissystemfromothercountriesisnotalwaysapplicabletoourcountry.Theresearchersinourcountryaretryingtofindouttheprognosisguidelinethatissuitabletothesituationofourcountry,toconstructtheprognosissystemforthesufferersofliverdiseases,esp,forthevirushepatitis.However,therehavebeennoreportofthestudywithbigsample,multiplecenters,andwithlongtimesurvivinganalysisbasedonthefollowupsurvey.Ⅱ.DataandMethodsA.CasechoicesAccordingtopreventionandcureprojectofthehepatitis2000,527cases,agedfrom1475,arediagnosedashepatitisandhepatocirrhosisfromMarch2002toJune2007.ThesecasescamefromfivehospitalsincludingtheBeijingYouanHospitalAffiliatedtoCapitalUniversityofMedicalSciences,theNinthPeoplesHospitalofNanchanginJiangXiProvince,theFirstHospitalAffiliatedtotheJiangXiMedicineUniversity,theSixthPeoplesHospitalofDaLianinLiaoNingProvinceandtheProjectNameWuJiePingMedicalFoundation320.6750.09071,theCapitalFundofMedicalResearchandDevelopment(20022039)9781424447138/10/25.00©2010IEEE302HospitaloftheChinesePeopleArmy.B.Recordingindices241intotalznormalindicesSex,age,diagnosticclassification,diagnosticstages,pathogeny,complications,returnafterleavinghospital,inducementofdisease,etc.zcomplicationstheinformationofasciticfluid,HCD,HRS,alimentarytracthemorrhage,pleuraleffusion,spontaneousperitonitis,disturbanceofacidbasebalanceandothercomplications.zLaboratoryandmedicalimagingindicesliverfunctionalandbiochemicalindices,bloodroutineexaminationindices,bloodcoagulatingindices,pathogenindicesandimagingindices.C.AnalysismethodsandstatisticalmethodsSurvivingstatusaliveordeadofthesuffererwasrecorded.Thecurrentbodystatuslivertransplantation,hepatocirrhosis,chronichepatitis,andhealthetcwererecordedforthealive,whilethetimedaysinprecisionandthereasonliverdiseaseornot,toexcludethedeathfromotherdiseaseforthedeathwererecorded.AdatabasewasconstructedwithEpidata3.02basedonallthesematerials,includingalltheindicesrecordedandresultsfromthefollowupvisiting.TheCoxproportionalhazardsregressionanalysisbuiltinSPSS13.0wasappliedtothedata.Theregressionequationswerecreatedfromthegroupoftheindiceswhichcanreflecttheprognosisoftheseverehepatitis.Statisticalsignificancewasdefinedasp0.05.Ⅲ.ResultsA.Resultsofstatisticalanalysis1ThemainindicesoftheroutineexaminationaDistributionofetiologicalagentsintheselectedsufferersIntheselected527cases,61.1arehepatitisI40677.0arehepatitisII20.4arehepatitisIII264.9arehepatitisV5610.6aremixed40.8aredrugrelated40.8arealcoholrelated10.2isselfimmunerelatedand224.2arefromothersource.bDiagnosisoftheselectedcasesInthe527selectedcases,397.4casesareacuteseverehepatitis,519.7aresubacuteseverehepatitis,chronicseverehepatitisare40576.9,andchronichepatitis(trendingtosevere)are326.0.cAlimentarytracthemorrhagewhendiagnosedWhendiagnosed,nobleedinginthealimentarycanalwasfoundin433cases82.2,whiletheother94cases17.8werefoundbleeding.dAsciteswhendiagnosedIntheselected527cases,25548.4havenoascites,12423.5caseshavesmallamountofascites,8315.7middleamount,and6512.3caseshavelargeamount.2StatisticalresultsofauxiliaryexanimationOfthe527selectedcases,themainindicesfromthelaboratoryandmedicalimagingexaminationareshowninTable1.TABLE1VariableInformationofAuxiliaryExanimationvariablmmmsALTu/l2951ASTu/l2951AST/A10TBILm0520DBIL420d/t0ALBg/2330CHOm1640CRmg/10PTs2530INR0210PTA00Noteallvaluesisnaturallogarithminthetable3SurvivalofthesufferersTable2showsthesurvivalinformationofthe527patients.B.ScreeningoftheindependentprognosticfactorsFiftytwoindices,criticaltothesurvivaltimeofthepatients,wasselectedfromtheoriginal241indices,whicharefromthesurvivalanalysisofKaplanMeiermethods,andstatisticalanalysistheLogRanktestandBreslowtesttothesurvivalrateofpatientsinthenearandfarfuture.Classificationmethodswereappliedtothe52indicestoreducetheeffectsofthepossiblemultivariablecodependence.Theresulting33indicesfromtheclassificationmethodcouldbeusedtoconstructtheregressionmodel.TABLE2SurvivalInformationofPatientsgroupNpercentsurvivaltime30daysofsurvivaltime60daysofsurvivaltime90daysofsurvivaltime180daysofsurvivaltimeoneyearofsurvivaltimedeath35867.951.118.512.811.018.816.021.117.035.717.028.718.0survival16932.1682.7611.030.060.090.0180.0360.0total527100.0253.73421.93035.534.047.234.079.634.0141.334.0NoteeveryvaluebetweenparenthesesismedianinthetableC.ConstructionoftheregressionequationCoxproportionalhazardregressionwasappliedtothe33indicesfromtheaboveanalysis.ThePvaluewassettobelessthan0.05forthevariablesacceptedorremovedfromthemodel.X2testwasappliedtotheregressionequationfittingprocess,inwhichtheX2valueis145.3p0.001.Nineindiceswerefinallyretainedintheregressionequation.Whichwerealimentarytracthemorrhageh43,age,degreeofascitesc5,ALTinitsnaturallogarithm,AST/ALTinnaturallogarithm,TBILinnaturallogarithm(mg/dl),CHinnaturallogarithm,Crmg/dlinnaturallogarithm,andPTAinnaturallogarithm.Table3showsalltheindicesretainedintheregressionequation.ThebaselinecumhazardofregressionmodelislistedinTable4.Inthisstudy,theprognosticindexformulationfortheseverehepatitissufferersisPI0.493h430.028age0.189c50.233lnalt0.379lnast/alt0.424lntbil0.369lnch0.17lncr0.899lnptaThecumulativesurvivalfunctionoftheeachsuffererinstagescanbecalculatewiththisformula0,thpietsethth−wherepiisprognosticindex,h0tisbaselinecumhazard,htiscumhazard,stiscumsurvival.TABLE3VariableInformationinCoxFunctionVariableBSEWaldPORH43.493.14910.990.0011.637AGE.028.00534.832.0001.029C5.189.0629.242.0021.208LNALT.233.07011.003.0011.262LNASTALT.379.1269.040.0031.461LNTBIL.424.1389.470.0021.528LNCH.369.11310.715.001.691LNCR.170.0853.988.0461.186LNPTA.899.14041.102.000.407TABLE4BaselineCumHazardofModeltime30d60d90d180d360dh0tbaselinecumhazard0.0170.0250.0270.0290.030D.ComparisonbetweenresultsfromtheprognosticmodelinthisstudyandthosefromCTPandMELDInordertoverifytheresultsofthisstudy,theinformationof400patientswascollected.Foreachpatient,thecumsurvival,CTPscore,andMELDscorearecalculated.TheRoccurveandtheareaunderthecurveareusedtoestimatetheveracityofthepatientssurvivalindifferentstagessuchas30days,60days,90days,180daysandoneyear.Asthestatisticalresultsfromtable5and6,theregressionmodelinthisstudyhasbetterpredictionatthedifferentstagesthantheCTPandMELDmodel.Therefore,themodelinthisstudyismoreapplicabletoliverdiseasesufferersinourcountry.TABLE5AUCofThreeModelsmodeltime30d60d90d180d360dctp61.962.562.062.862.2meld68.464.663.362.062.2thissystemmodel78.280.179.278.978.5TABLE6AUC′sComparisonofThreeModelstimecomparewithctpcomparewithmeldzpzp30d4.090.012.510.0560d4.400.013.950.0190d4.240.013.990.01180d3.900.014.100.01360d3.950.013.950.01Ⅳ.DiscussionsInthisstudy,aprognosticformula,suitabletothesituationofChinaandtoestimatetheprognosisofseverehepatitisandliverfunctionfailure,wasderivedbasedonCoxproportionalhazardregressionmodelanalysisofthedatafromtheinpatientsandtheirfollowupsurvey.Thesedatawerecollectedfromalargepoolofsamplesfromdifferenthospitalsaroundthecounty.Theriskprognosticformuladerivedfromthisstudyinclude9indiceswhichareregularlyusedinclinicalalimentarytracthemorrhage,age,degreeofascites,ALTinnaturallogarithm,AST/ALTinnaturallogarithm,TBIL(mg/dl)innaturallogarithmCHinnaturallogarithm,Crmg/dlinnaturallogarithm,andPTAinnaturallogarithm.TheTBILanddegreeofascitesaresameasthoseinCTPscoringandclassification.TherearecorrelationsbetweenthePTAandthePTintheCTPscoringsystem.CRandTBILaresameasthoseintheMELDmodelwhicharebeingwidelyusedinabroad.Alimentarytracthemorrhageandascitesarecomplicationsusuallyseenintheseverehepatitispatientandoneofthemajorreasonsleadingtothedeathofpatients.Anyexpertofliverdiseaseagreesthatthesetwocomplicationsarethefirsthandthreattopatientslife,sincethesepatientshavebadprognosis.Previousfindingsindicatethatprognosisbecomeworsewithage.Itwasreportedthatprognosisisbadwhenageisover50andthatthedeathrateweretheleastbetweenagesof3140.TheincreaseofALTreflectsdegreeoftheinflammation.Itchangeswiththedevelopmentofdisease.IftheincreaseofALTiscompaniedbytheseverityoficterus,prognosisisbad.Inrecentyears,AST/ALThasbeenwidelyusedtoaccesstheliverdiseasedevelopment.Someresearchesshowthattheratioofthemishighlyrelatedwiththedegreeoftheliverfibrosiscausedbythechronichepatitisformanyreasons,andrelatedwithdegreeofthehepatocirrhosisincreaseoftheratioindicatesmoredamageoftheliverfunction.TheconclusionofsomereviewpaperswasthatAST/ALTisareliableindexinestimatingwhetherthechronicsuffererscausedbythehepatitisCvirusarethestageoffibrosisorstageofhepatocirrhosis.HeumannsstudysuggestedthatthecontinuousincreaseoftheAST/ALTindicatedincreaseofthedeathriskforthesuffererscausedbyhepatitisCvirus.Recently,GianninisstudyshowedthatthecombinationofAST/ALTwiththeMELDmodelcanimprovetheveracityofthemediumtermandshorttermprognosisofsufferers.TheratioofAST/ALTappeasesintheequationsofthethisstudypromptthatthisprognosismodelismoresuitedtobeusedinChina,especiallybecauseofthefactthatthereasonsoftheliverdiseasesaremainlyvirusrelated.TheincreaseofTBILrepresentsthewidedamageofthelivercellsduringtheliverdiseases.Becauseoftheabroadpathologicalchangesofthelivercells,icterusoccurswhentheabsorption,synthesization,andevacuationofBILdisfunctioned.TBILisaffectedbyotherfactors.Forinstance,hemolysiscausedbythealcoholrelatedliverdiseasecanleadtotheincreaseofnoncombinedBIL.Sotheveracityofthiskindofliverdiseasewasaffected.However,TBILwasstilldeemedtobeanindexthathashighsensitivityandcandirectlyreflectthechangeofliverfunctionwhenliverwasdamagedLiveristhemainorgantosynthesizetheCH,60~80ofcholesterininthebloodarecomefromliver.Therefore,theleveloftheCHinthebloodcanreflectthefunctionoflivertosynthesizethecholestrin,andindirectlyreflectthedegreeofpathologicalchangesoflivertissue.TheinfluenceofCHtotheprognosisofhepatitisisrecentlygottenattentionofmanyresearchers.SomeresearchinChinashowedthattheaffinityofthedecreaseofCHandprognosis.Consequently,CHisanimportantfactortoestimatetheprognosisofsevereliverdisease.WhenpatientshavedisfunctionofthekidneyandincreaseofCr,theprognosisofthesuffererisusuallynotgood.Inthisresearch,14091.5sufferersaredeadinthe153withliverkidneysyndrome.SotheincreaseoftheCrisusuallyanimportantfactortoinvestigatetheshorttermprognosisofthesufferer.Malincoc,thefounderoftheMELD,suggestedthatonedrawbackofCTPisitdoesnotuseCr,theimportantfactor.
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