协和专家临床药理学讲座药物治疗课件

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1、AdverseReactions:APotentialConsequenceofDrugTherapyAudreyF.Jakubowski,Ph.D.November30,1999OutlineWhatisadrug?Drugtherapy:BenefitandRiskMonitoringadversedrugreactionsStudyingnewdrugsRegulatoryDefinitionsPharmacovigilanceDefinitionofaDrugChemicalsubstanceornaturalproductCanprevent,diagnoseortr

2、eatdiseaseCanalterpharmacologicfunctionAvailableinastabledosageformWorksbyinteractingwithtissues,organs,cells,receptors,enzymes,transportchannelsHistoryofDrugsAncientcivilizationsusedamixtureofmagic,religionanddrugstotreatdiseaseMostdrugsinantiquitycamefromplantandanimalpartsorfluidsUndersta

3、ndingofdrugmechanismsincreasedinparallelwithknowledgeofanatomy,physiology,biochemistryandchemistryDrugTherapyhasBenefitandRiskBenefitcure/improvediseaseorsymptomsreducemorbidityincreasequalityoflifeRiskadverseeffectsunpleasant,e.g.nauseaserious,e.g.deathcostsPhysician’sDilemmaManydrugsavaila

4、bleChinesetraditionalmedicinesWesterndrugsChoosethedrugwiththegreatestpotentialtotreatorcurediseaseForthisPatient:Dotherisksassociatedwiththisdrugoutweighthebenefits?ImpactmorethanthetherapeuticsiteMetabolitesmayhaveactivityDrugscaninduceorinhibitthemetabolismofotherdrugsAgeandraceimpactdrug

5、metabolismChildrenmetabolizemorerapidlythanadultsElderlyoftenhaveimpairedmetabolismRacialdifferences5-10%Asiansvs.50%CaucasiansareslowacetylatorsCytochromeP-450isoformpatternsdifferamongAsiansandCaucasiansDetectingAdverseEventsConsiderwhetheranyeffectassociatedwiththeuseofadrugiscausedbythed

6、rugDramaticAEsareeasiertodetectanaphylacticreactionwithinminutesofinjectionofpenicillinAEsthatmimicdiseaseoroccurafterprolongedtreatmentaremoredifficultphocomeliaafterthalidomidetreatmentTypesofAdverseEffects(1)Knowntooccurfrompharmacologyofthedrugandaredose-relatedhemorrhageduetoanticoagula

7、ntsUnpredictable,notdose-relatedbonemarrowsuppressionbychloramphenicolEffectsthatoccurduringchronictreatmentcolonicdysfunctionduetolaxativesiatrogenicCushing’ssyndromewithprednisoloneTypesofAdverseEffects(2)Delayedeffectsoccurinoffspringofpatientcr