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如何正确应用 癫痫治疗指南 为什么我们需要指南主要癫痫治疗指南的重要结论指南对各类癫痫患者的具体指导意见如何正确看待使用指南 抗癫痫药物的发展 癫痫临床诊治的过程TheProcessofClinicalInference 试验证据ExperimentalEvidence 专家意见ExpertOpinion 行动Action 个人经验PersonalExperience 临床指南的目的 指南是指一种系统性阐述 用以帮助执业医师以及患者对于特定临床情况作出适当医疗决定的指导性文件 InstituteofMedicine 1990 为什么我们需要指南主要癫痫治疗指南的重要结论指南对各类癫痫患者的具体指导意见如何正确看待使用指南 Newerdrugsforepilepsyinadults NICE March 2004 Contents1Guidance2Clinicalneedandpractice3Thetechnology4Evidenceandinterpretation5Recommendationsforfurtherresearch6ImplicationsfortheNHS7Implementationandaudit8Relatedguidance9ReviewofguidanceAppendixA AppraisalCommitteeAppendixB SourcesofevidenceAppendixC Detailoncriteriaforaudit IntheUK theNationalInstituteforClinicalExcellenceCommitteeexaminedrandomisedclinicaltrialsandsystematicreviewscomparingnewantiepilepticdrugswithplacebo witholderdrugs orwithothernewcompounds TheUKguidelinesdidnotconsiderzonisamide notyetavailableinEurope andfelbamate alastresortagentbecauseofbonemarrowandlivertoxicity butincludedvigabatrininthereview Pregabalinhasnotbeenreviewed possiblybecauseofinsufficientevidenceatthetimeofpreparationoftheguidelines NICE指南成人及儿童的抗癫痫新药 2004 推荐用于以下患者的新药 TPM LTG LEV OXC TGB GBP VGB 一种传统抗癫痫药无效或因以下原因不适合应用传统抗癫痫药 存在药物禁忌症与患者正在服用的其他药物存在相互作用已知个体对其耐受性差患者是一个存在怀孕可能的妇女患者 或需要治疗至育龄期 NICEGuidelinesDiagnosisandmanagementoftheepilepsiesinadultsandchildreninprimaryandsecondarycare 2004 AEDtreatmentstrategyshouldbeindividualisedseizuretypeepilepsysyndromeco medicationandco morbiditytheindividual slifestylepreferencesoftheindividualandtheirfamilyand orcarersasappropriate www nice org uk NICEGuidelinesCriticisms LargelydrivenbyeconomicconcernsunderNHSProportionofprescriptions 0 1 1991 to20 2002 Proportionofcosts 69 2002 ScopenarrowCriteriatorateevidencenotclearlydefinedClassificationofevidencenotclearlydescribedOldAEDsnotsubjecttosameevaluationConditionsforuseofnewAEDsasmonotherapyrestrictive EfficacyandTolerabilityoftheNewAntiepilepticDrugs I TreatmentofNew OnsetEpilepsy AAN EpilepsiaVolume45Issue5Page401 May2004 EfficacyandtolerabilityofthenewantiepilepticdrugsII treatmentofrefractoryepilepsy ANN Neurology 2004Apr27 62 8 1261 73 Definitionsforclassificationofevidence RCT randomizedcontrolledtrial AAN AES指南新抗癫痫药 U级 证据不足 FrenchJetal Neurology2004 62 1252 60 Neurology2004 62 1261 73 AAN AESGuidelines StrengthsFocusesoncomparingeffectivenessRatingcriteriasimilartootherinterventionsCriticismsOldAEDsnotevaluatedHeterogenityinoutcomesamongstudiesnotconsideredDidnotclearlydistinguishdifferenceagegroupsDidnotaddressmedico legalimplicationsofdiscrepanciesbetweenguidelinerecommendationsandlicensingstatus ILAETreatmentGuidelines Evidence basedAnalysisofAntiepilepticDrugEfficacyandEffectivenessasInitialMonotherapyforEpilepticSeizuresandSyndromes2006 Ratingscaleofevidenceforpotentiallyrelevantstudies Applicationofevidence ratingcriteriaforefficacy effectivenessstudies Relationbetweenclinicaltrialratings levelofevidenceandconclusion ILAE指南新诊断单药治疗的建议 ILAEGuidelinesCriticisms StrengthsClearlydefinedscopeanddefinedratingcriteriaOlderdrugsincludedinevaluationInternationalrepresentationCriticismsEvaluatedevidence notpracticeToostrict Potentiallyunder valuingimportantevidenceOpenlabelRCTsShorter 1yr trialsTrialswithforcedexitcriteria 为什么我们需要指南主要癫痫治疗指南的重要结论指南对各类癫痫患者的具体指导意见如何正确看待使用指南 新诊断癫痫 Newlydiagnosedepilepsy Partial mixed Adultswithpartial onsetseizures ILAE NewerandoldAEDs NumberofrelevantstudiescategorizedbyclassofstudyandAEDinvolved AdequatecomparatorsforthiscategoryareCBZandPHTCBZandPHTareestablishedasefficaciousoreffectiveasinitialmonotherapyforadultswithnewlydiagnosedoruntreatedpartial onsetseizures levelA VPAisprobablyefficaciousoreffectiveasinitialmonotherapyforadultswithnewlydiagnosedoruntreatedpartial onsetseizures levelB Summaryandconclusions GBP LTG OXC PB TPM andVGBarepossiblyefficaciousoreffectiveasinitialmonotherapyforadultswithnewlydiagnosedoruntreatedpartial onsetseizures levelC CZPandPRMarepotentiallyefficaciousoreffectiveasinitialmonotherapyforadultswithnewlydiagnosedoruntreatedpartialonsetseizures levelD Summaryandconclusions Childrenwithpartial onsetseizures ILAE NewerandoldAEDs NumberofrelevantstudiescategorizedbyclassofstudyandAEDinvolved AdequatecomparatorsforthiscategoryisOXCOXCisestablishedasefficaciousoreffectiveasinitialmonotherapyforchildrenwithnewlydiagnosedoruntreatedpartial onsetseizures levelA OXCdemonstratedsuperioreffectiveness comparedwithPHT andequalefficacy Summaryandconclusions CBZ PB PHT TPM andVPAarepossiblyefficaciousoreffectiveasinitialmonotherapyforchildrenwithnewlydiagnosedoruntreatedpartial onsetseizures levelC LTGandVGBarepotentiallyefficaciousoreffectiveasinitialmonotherapyforchildrenwithnewlydiagnosedoruntreatedpartial onsetseizures levelD Summaryandconclusions ElderlyAdultswithpartial onsetseizures ILAE NumberofrelevantstudiescategorizedbyclassofstudyandAEDinvolved theadequatecomparatorsforthiscategoryareLTGandGBP LTGandGBPareestablishedasefficaciousoreffectiveasinitialmonotherapyforelderlyadultswithnewlydiagnosedoruntreatedpartial onsetseizures levelA Summaryandconclusions CBZispossiblyefficacious effectiveasinitialmonotherapyforelderlyadultswithnewlydiagnosedpartial onsetseizures levelC TPMandVPAarepotentiallyefficaciousoreffectiveasinitialmonotherapyforelderlyadultswithnewlydiagnosedpartial onsetseizures levelD Summaryandconclusions Newlydiagnosticpartialepilepsy ILAE NewerandoldAEDs Adultswithgeneralized onsettonic clonicseizures ILAE NumberofrelevantstudiescategorizedbyclassofstudyandAEDinvolved Noadequatecomparatorexistsforthiscategory CBZ LTG OXC PB PHT TPM andVPAarepossiblyefficacious effectiveasinitialmonotherapyforadultswithGTCseizuresandmaybeconsideredforinitialtherapyinselectedsituations levelC GBPandVGBarepotentiallyefficacious effectiveasinitialmonotherapyforadultswithgeneralizedonsetTCseizures levelD Summaryandconclusions Childrenwithgeneralized onsettonic clonicseizures ILAE NumberofrelevantstudiescategorizedbyclassofstudyandAEDinvolved NoAEDsreachedthehighestlevelsofevidence levelAorB forefficacy effectivenessforchildrenwithGTCseizures Noadequatecomparatorexistsforthiscategory CBZ PB PHT TPM andVPAarepossiblyefficacious effectiveforchildrenwithGTCseizures levelC Summaryandconclusions Conclusion 其他综合征 新诊断癫痫 失神发作 Newlydiagnosedepilepsy Absence NewerAEDs Childrenwithabsenceseizures ILAE NumberofrelevantstudiescategorizedbyclassofstudyandAEDinvolved NoAEDsreachthehighestlevelsofevidence levelAorB forefficacy effectivenessforchildrenwithabsenceseizures Noadequatecomparatorexistsforthiscategory ESM LTG andVPAarepossiblyefficacious effectiveforchildrenwithabsenceseizures levelC Summaryandconclusions Basedsolelyonscatteredreports classIV thefollowingAEDsmayprecipitateoraggravateabsenceseizures CBZ OXC PB PHT TGB andVGB Summaryandconclusions Childrenwithbenignepilepsywithcentrotemporalspikes BECTS 新诊断 BECTSRCTs AtotalofthreeRCTsspecificallyexaminedtheinitialmonotherapyofchildrenwithBECTSNoneoftheseRCTsmetthecriteriaforaclassIorIIstudy theotherRCTdidnotreportefficacyoreffectivenessasaprimaryoutcomevariableandisnotfurtherconsideredintheanalysis Overviewofevidence NoAEDreachesthehighestlevelsofevidence levelAorB forefficacy effectivenessforchildrenwithBECTS Noadequatecomparatorexistsforthiscategory CBZandVPAarepossiblyefficaciousoreffectiveasinitialmonotherapyforchildrenwithBECTS levelC Summaryandconclusions GBPandSTMarepotentiallyefficaciousoreffectiveasin

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