病毒性肝炎研究进展.ppt

**Slide*.BiochemicalandHistologicResponses:DefinitionsAbiochemicalresponsetotreatmentisthenormalizationofpreviouslyelevatedALTlevels.1AsustainedbiochemicalresponseisdefinedasnormalserumALTlevelsattheendoffollow-up(24weeksposttreatment).Patientswhoexhibitabiochemicalresponseduringtherapydonotnecessarilyattainavirologicalresponse(ie,HCVRNAclearance);nevertheless,thelong-termprognosis(8to11yearsposttherapy)ofthesepatientshasbeenreportedtobeasgoodasthatofvirologicalresponders.2Ahistologicresponsereferstoanimprovement(ie,decrease)ofatleast

2pointsinthe22-pointKnodellHistologicActivityIndex(HAI)scoreattheendoffollow-up(24weeksposttreatment).3? 1.PerryCM,JarvisB.Drugs.2001;61:2263-2288.2.ShindoMetal.Hepatology.2001;33:1299-1302.3.HeathcoteEJetal.NEnglJMed.2000;343:1673-1680.**Slide*.Intent-to-TreatAnalysisDropoutisacommonphenomenoninclinicaltrialsofdrugtreatmentsinvolvinglongitudinalassessmentsforafixeddurationoffollow-up.Forthesetrials,intent-to-treat(ITT)analysisisusuallypreferredbecausetimeeffectsareseeninpractice.1TheITTanalysismandatesthatallsubjectsrandomizedtoatreatmentarmshouldbeincludedintheanalysis.1Itincludesallrandomlyassignedpatientsenrolledinaclinicaltrialandusesacompleteoutcomesdatasetforeachpatient.Datafromallpatientsareanalyzed,andstudyresultsrepresentthecompleteanalysis.Nonrespondersarethosewhowithdrawordropoutorwhodonotsustainavirologicalresponse.? 1.MazumdarSetal.JPsychiatrRes.1999;33:87-95.**Slide*.LimitationsofConventionalIFNAlfaTherapyConventionalIFNalfaadministeredasasubcutaneous(sc)injectionisrapidlyabsorbed,withwidefluctuationsinserumconcentrations.Thepeakserumconcentrationofasinglescinjectionof36MIUofIFNalfa-2a(ROFERON?-A,Hoffmann-LaRoche)r