年龄相关性黄斑变性抗VEGF治疗的循证医学证据

眼科学

循证眼科学（3）年龄相关性黄斑变性抗VEGF治疗的循证医学证据—

Lucentis和Avastin以及aflibercept治疗年龄相关性黄斑变性哪一个好？什么是CATT和IVAN？CATT：TheComparisonofAge-relatedDegenerationTreatmentsTrials,美国国立卫生研究院和美国国家眼科研究所IVAN：TheInhibitVEGFinAge-relatedchoroidalNeovascularisation英国国家健康研究院27s—1m3s概况年龄相关性黄斑变性

（ARMD）：

※发达国家60岁以上人群主要致盲原因

※超过75岁人群接近30%有症状

1m4s—1m53sPriyaRR,ChewEY,SwaroopA.Geneticstudiesofage-relatedmaculardegeneration:lessons,challenges,andopportunitiesfordiseasemanagement.Ophthalmology,2012;119（12）:2526-36.1m4s—1m53s治疗

抗血管生成药物激光治疗药物1m54s-2m15s基因治疗干细胞治疗人工视觉光学假体1m54s-2m15s1m54s-2m15s认识抗血管生成药物DavisJ,etal.AmJOphthalmol.2011;152（4）:509-14.TorjesenI.BMJ,2012,1;344:e3012.2m15s—4m提出问题安全性哪一个高？

※国内2009年的“Avastin事件”※Lucentis被批准的适应症就是AMD※且有NICE（theNationalInstituteforHealthandClinicalExcellence

（NICE））推荐

4m1s—4m53s※Avastin被批准的适应症抗癌※Avastin行玻璃体腔注射以后出现全身严重系统性反应比Lucentis多见治疗效果哪一个好？

※德国44.9%眼科医生认为效果一样或者相当TorjesenI.WhyusingAvastinforeyediseaseissodifficult.BMJ,2012,1;344:e3012.KühnT.KlinMonblAugenheilkd.2011;228（7）:607-12.4m1s—4m53s谁能够回答这些问题？真的是这样的吗？4m54s-4m58s循证医学（EBM）4m58s—5m1sEBM基本概念1992年JAMA杂志发表了EBM工作组：EBM即“遵循证据的医学”1996年著名临床流行病学专家David将EBM定义：“谨慎地、明确地、明智地应用所能获得的最好研究结果以确定对患者的治疗措施”。5m1s---5m33s核心思想是：医疗决策应根据现有的最好研究结果（证据）来进行。5m1s---5m33s循证医学临床证据的分级5m33s---6m6sAMD治疗的循证医学证据Ⅱ级证据—来自一个设计良好的RCTⅠ级证据—所有设计良好的多中心RCT及所进行的meta-分析

★证明某种疗法有效性和安全性最可靠的证据

★

RCT和meta-分析是评价临床治疗效果的金指标6m6s—6m33sⅠ级证据2个Lucentis和Avastin治疗AMD的RCT：

※CATT（TheComparisonofAMDTreatmentsTrials,美国国家眼科研究所）※IVAN（TheInhibitVEGFinAge-relatedchoroidalNeovascularisation,英国）6m33s—7m16s1个Avastin治疗AMD的RCT：

※NATTB（NeovascularAge-RelatedMacularDegenerationTreatmentTrialUsingBevacizumab，中国）6m33s—7m16s2个Lucentis和Avastin及aflibercept治疗AMDmeta分析：※BevacizumabversusRanibizumabforWetAMD:Ameta-AnalysisofRandomizedControlledClinicalTrials（中国）※Efficacyandadverseeventsofaflibercept,ranibizumabandbevacizumabinage-relatedmaculardegeneration:atrade-offanalysis（瑞士）TheCATTResearchGroup2008.4~2009.12—2011,2012

（NIH,NEI）

44个单位，861位合作者参加前瞻性多中心研究1208例年龄≥50岁剂量：★Lucentis—0.5mg（0.05ml）

★Avastin—1.25mg（0.05ml）7m16s—8m15s随机分4组：

★月用Lucentis—每28天一次，301人；★月用Avastin—每28天一次，286人;★需要时用Lucentis—仅在出现活动性病灶时，298人

★需要时用Avastin—仅在出现活动性病灶时，300人7m16s—8m15sWilliamsDF,BeardsleyS,BennettS,CantrillH,Chan-TramC,CheshierH,DamatoK,DaviesJ,DevS,EnloeJ,FollanoG,GilbertP,JohnsonJ,JonesT,MaylebenL,MittraR,MoosM,NeistR,OestreichN,QuiramP,RamsayR,RyanE,SchindeldeckerS,SnaterJ,SteeleT,SeldersD,Collaborators（893）TonsfeldtJ,ValardiS,FishGE,AguadoHA,ArceneauxS,ArnwineJ,BellK,BellT,BradleyP,CallananD,CoorsL,CreightonJ,CrewT,CummingsK,DockC,DuignanK,FullerD,GrayK,HendrixB,HesseN,JaramilloD,JostB,LashS,LonsdaleL,MackensM,MutzK,PottsM,SanchezB,SnyderW,SolleyW,TarterC,WangR,WilliamsP,PerkinsSL,AndersonN,ArnoldA,BlaisP,GoogeJ,HigdonTT,HuntC,JohnsonM,MillerJ,MooreM,MorrisCK,MorrisC,OelrichS,OliverK,SeitzV,WhetstoneJ,DoftBH,BedelJ,BergrenR,BorthwickA,ConradP,FecA,FulwylieC,IngramW,LathamS,LesterG,LiuJ,LobesL,LuckoNM,MechlingH,MerlottiL,McBroomK,OlsenK,PuskasD,RathP,SchmuckerM,SchuecklerL,SchultzC,ShultzH,SteinbergD,VyasA,WhaleK,YeckelK,OrthDH,ArredondoLS,BrownS,CiscatoBJ,CivantosJM,FigliuloC,HasanS,KosinskiB,MuirD,NelsonK,PackoK,PollackJS,RezaeiK,SheltonG,Townsend-PatrickS,WalshM,McDonaldH,AnsariN,ByeA,FuAD,GroutS,IndermillC,JohnsonRN,JumperJ,LinaresS,LujanBJ,MundenA,PersonsM,RodriguezR,RoseJM,TeskeB,UriasY,YoungS,DreyerRF,DanielH,ConnaughtonM,HandelmanI,HobbsS,HoernerC,HudsonD,KopferM,LeeM,LemleyC,LoganJ,MaC,MalletC,MillironA,PetersM,WohlseinH,PearlmanJA,AndrewsM,BartlettM,CarlsonN,CoxE,EquiR,GonzalezM,GriffinS,HogueF,KennedyL,KryuchkovL,LopezC,LopezD,LuevanoB,McKennaE,PatelA,ReedB,SecorN,SisonIR,TsaiT,VarghisN,WallerB,WendelR,YebraR,RothDB,DeinzerJ,FineH,GreenF,GreenS,KeyserB,LeffS,LevitonA,MartirA,MosenthineK,MuscleS,OkorenL,ParkerS,PrennerJ,PriceN,RogersD,RosasL,SchlosserA,StudenkoL,TantumT,WheatleyH,TreseMT,AabergT,BellT,BezaireD,BridgesC,BryantD,CaponeA,ColemanM,ConsoloC,CookC,DuLongC,GarretsonB,GrootenT,HammersleyJ,HassanT,JessickH,JonesN,KinsmanC,KrumlaufJ,LewisS,LockeH,MargherioA,MarkusD,MarshT,NealS,NoffkeA,OhK,PenceC,PrestonL,RaphaelianP,ReganVR,RobertsP,RubyA,SarrafizadehR,ScherfM,ScottS,SneedS,StaplesL,TerryB,TreseMT,VidetichJ,WilliamsG,ZajechowskiM,JosephDP,BlinderK,BoydL,BuckleyS,CrowM,DinataleA,EngelbrechtN,ForkeB,GabelD,GrandG,Grillion-CeroneJ,HolekampN,KellyC,NobelG,PeppleK,RaeberM,RaoP,ResselT,SchrempS,SgorlonM,ShearsS,ThomasM,TimmaC,VaughnA,WaltersC,WeeksR,WehmeierJ,WrightT,BerinsteinDM,AyyadA,BaraziMK,BickhartE,BradyT,ByankL,CroniseA,DennyV,DunnC,FloryM,FrantzR,GarfinkelRA,GilbertW,LaiMM,MelamudA,NewgenJ,NewtonS,OliverD,OsmanM,SandersR,vonFrickenM,DugelP,ArenasS,BaleaG,BartoliD,BucciJ,CorneliusJA,DickensS,DohertyD,DunlapH,GoldenbergD,JamalK,JimenezN,KavanaghN,KunimotoD,MartinJ,MinerJ,MobleyS,ParkD,QuinlanE,SipperleyJ,SlagleC,SmithD,YafchakM,YagerR,FlaxelCJ,BaileyS,FrancisP,HowellC,HwangT,IraS,KleinM,LauerA,LiesegangT,LundquistA,NolteS,NolteSK,PickellS,PopeS,RossiJ,SchainM,SteinkampP,ToomeyMD,VahrenwaldD,WestK,HubbardB,AndelmanS,BergstromC,BrowerJ,CribbsB,CurtisL,DobbsJ,DuBoisL,GaultneyJ,GibbsD,JordanD,LeefD,MartinDF,MylesR,OlsenT,SchwentB,SrivastavaS,WaldronR,AntoszykAN,BalasubramaniamU,BrooksD,BrownJ,BrowningD,ClarkL,EnnisS,HeldS,HelmsJV,HerbyJ,KarowA,LeotaudP,MassiminoC,McClainD,McOwenM,MindelJ,PereiraC,PierceR,PowersM,PriceA,RohrerJ,SandersJ,AveryRL,AveryK,BasefskyJ,BecknerL,CastellarinA,CouvillionS,GiustJ,GiustM,NasirM,PieramiciD,RabenaM,RisardS,SeeR,SmithJ,WanL,BakriSJ,Abu-YaghiN,BarkmeierA,BergK,BurringtonJ,EdwardsA,GoddardS,HowardS,IezziR,LewisonD,LinkT,McCannelCA,OverendJ,PachJ,RuszczykM,ShultzR,StephanC,VogenD,BradfordRHJr,BergmanV,BurrisR,ButtA,DanielsB,DwigginsC,FransenS,GuerreroT,HaivalaD,HarrisA,IcksS,KingsleyR,ReddenL,RichmondR,RossB,WhiteK,YoungbergM,ToppingTM,BennettS,ChongS,CiottiM,ClearyT,CoreyE,DonovanD,FrederickA,FreeseL,GrahamM,GudN,HowardT,JonesM,MorleyM,MosesK,StoneJ,TyR,WiegandT,WilliamsL,WinderB,AwhCC,AmonetteM,ArrindellE,BeckD,BusbeeB,DilbackA,DownsS,GuidryA,GutowG,HardinJ,HinesS,HutchinsE,LaCivitaK,LesterA,MalottL,McCainM,MiracleJ,MoffatK,PalazzottaL,RobinsonK,SonkinP,TravisA,WallaceRT,WintersKJ,WrayJ,HarrisAE,BunnellM,CrooksK,FitzgeraldR,JavidC,KewC,KillE,KlineP,KreienkampJ,MartinezM,MooreRA,SaavedraE,TaylorL,WalshM,WilsonL,CiullaTA,CoyleE,HarringtonT,HarrisC,HoodC,KerrI,MaturiR,MooreD,MorrowS,SavageJ,SinkB,SteeleT,ThukralN,WilburnJ,WalkerJP,BanksJ,CiampagliaD,DyshanowitzD,FrederickJ,GhumanA,GrodinR,KieselC,KnipsE,McCueJ,OrtizM,PetersC,RaskauskasP,SchoemanE,SharmaA,WingG,YoungbloodR,ChandraSR,AltaweelM,BlodiB,BurkeK,DietzmanKA,GottliebJ,KnutsonG,KrolnikD,NorkT,OlsonS,PetersonJ,ReedS,SoderlingB,SomersG,StevensT,WealtiA,BearellyS,BranchaudB,BryantJW,CrowellS,FekratS,GammageM,HarrisonC,JonesS,McClainN,McCuenB,MruthyunjayaP,QueenJ,SarinN,SkalakC,SkellyM,SunerI,TomanyR,WelchL,ParkSS,CassidyA,ChandraK,GoodI,ImsonK,KaurS,MetzlerH,MorseL,RedenboE,SalvadorM,TelanderD,ThomasM,WallaceC,BarrCC,BattcherA,BottorffM,ChasteenM,ClarkK,DenningD,SchoenD,SchultzA,TempelE,WheelerL,WhittingtonGK,StoneTW,BlevinsT,BuckM,CruzL,HeathW,HolcombD,IsernhagenR,KiddT,KitchensJ,SearsC,SladeE,VanArsdallJ,VanHooseB,WolfeJ,WoodW,Zi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