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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,ZilisJ,CrooksC,DisneyL,LiuM,PettyS,SallS,FolkJC,AlyT,BrothertonA,CritserD,HinzCJ,KarakasS,KirschnerV,LesterC,MontagueC,RussellS,StockmanH,TaylorB,VerdickR,WalshireJ,ThompsonJT,ConnellB,ConstantineM,DavisJLJr,HolsappleG,HunterL,LenaneC,MitchellR,RusselL,SjaardaR,BrownDM,BenzM,BurnsL,CarranzaJG,FishR,GoatesD,HayS,JeffersT,KegleyE,KubeckaD,McGilvraS,RichterB,SneedV,StoeverC,TellezI,WongT,KimI,AndreoliC,BarresiL,BrettS,CallahanC,CapaccioliK,CarliW,CoppolaM,EmmanuelN,EvansC,FaganA,GrilloM,HeadJ,KieserT,LeeE,LordU,MiretskyE,PalitschK,PetrinT,ReaderL,ReznichenkoS,RobertsonM,SmithJ,VavvasD,WellsJ,CahillC,ClarkW,HenryK,JohnsonD,MillerP,ClarkL,SpiveyR,SwinfordT,TaylorM,LambertM,ChaseK,FredricksonD,KhawlyJ,LazarteV,LowdD,MillerP,WillisA,FerronePJ,AlmonteM,ArnottR,AvilesI,CarbonS,ChitjianM,DAmoreK,ElliottC,FastenbergD,GolubB,GrahamK,LavornaA,MurphyL,PalomoA,PuglisiC,RheeD,RomeroJ,RosenblattB,SalcedoG,SchlameussM,ShakinE,SookhaiV,KaiserR,AffelE,BrownG,CentinaroC,FineD,FinemanM,FormosoM,GargS,GrandeL,HerbertC,HoA,HsuJ,JayM,LavetskyL,LiebenbaumE,MaguireJ,MonsonegoJ,O'ConnorL,PierceL,RegilloC,RosarioM,SpirnM,VanderJ,WalshJ,DavidorfFH,BarnettA,ChangS,ChristoforidisJ,ElliottJ,JusticeH,LetsonA,McKinneyK,PerryJ,SalernoJA,SavageS,ShelleyS,SingermanLJ,ConeyJ,DuBoisJ,DuBoisK,GreanoffG,HimmelmanD,IlcM,McnamaraE,NovakM,PendergastS,RathS,Smith-BrewerS,TannerV,WeissDE,ZegarraH,HalperinL,AramayoP,DhallaM,FernandezB,FernandezC,LopezJ,LopezM,MarianoJ,MurphyK,SherleyC,VekslerR,RahhalF,BabikianR,BoyerD,HamiS,KessingerJ,KurokouchiJ,MukarramS,PachmanS,ProtacioE,SierraJ,TabandehH,ZamboniA,ElmanM,BelzJ,ButcherT,CainT,CoffeyT,FirestoneD,GoreN,SingletaryP,SotirakosP,StarrJ,MeredithTA,BarnhartCJ,CantrellD,Esquejo-LeonR,HoughtonO,KaurH,NDureF,GlatzerR,JoffeL,SchindlerR,MartinDF,FineSL,KatzM,MaguireMG,Brightwell-ArnoldM,GlaserR,HallJ,HarkinsS,HuangJ,KhvatovA,McWilliamsK,NolteSK,PeskinE,PistilliM,RyanS,SchnaderA,YingGS,JaffeG,Afrani-SakyiJ,BalsleyB,BennettLS,BrooksA,Brower-LingschA,BruceL,BurnsR,BusianD,ChoongJ,CloaningerL,DeCroosFC,DuBoisE,El-DairiM,GachS,HallK,HawksT,HuangC,HeydaryC,HoA,KiniS,McCallM,MuhammadD,NicholsonJ,QueenJ,RievesP,ShieldsK,SkalakC,SpeckerA,StinnettS,SubramaniamS,TenbrinkP,WilliamsDF,BeardsleyS,BennettS,CantrillH,Chan-TramC,CheshierH,DaviesJ,DevS,EnloeJ,FollanoG,GilbertP,JohnsonJ,JonesT,MaylebenL,MittraR,MoosM,NeistR,OestreichN,QuiramP,RamsayR,RyanE,SchindeldeckerS,SteeleT,TonsfeldtJ,ValardiS,FishGE,AguadoHA,ArceneauxS,ArnwineJ,BellK,BellT,BolemanB,BradleyP,CallananD,CoorsL,CreightonJ,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,FulwylieC,IngramW,LathamS,LesterG,LiuJ,LobesL,LuckoNM,MerlottiL,OlsenK,PuskasD,RathP,SchuecklerL,SchultzC,ShultzH,SteinbergD,VyasA,WhaleK,YeckelK,OrthDH,ArredondoLS,BrownS,CiscatoBJ,CivantosJM,FigliuloC,HasanS,KosinskiB,MuirD,NelsonK,PackoK,PollackJS,RezaeiK,SheltonG,Townsend-PatrickS,WalshM,McDonaldHR,AnsariN,ByeA,FuAD,GroutS,IndermillC,JohnsonRN,JumperJM,LinaresS,LujanBJ,MundenA,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,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,RaoPK,ResselT,SchrempS,SgorlonM,ShearsS,ThomasM,TimmaC,VaughnA,WaltersC,WeeksR,WehmeierJ,WrightT,BerinsteinDM,AyyadA,BaraziMK,BickhartE,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,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,MartinD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