年齡相關(guān)性黃斑變性抗VEGF治療的循證醫(yī)學(xué)證據(jù)

眼科學(xué)

循證眼科學(xué)（3）年齡相關(guān)性黃斑變性抗VEGF治療的循證醫(yī)學(xué)證據(jù)—

Lucentis和Avastin以及aflibercept治療年齡相關(guān)性黃斑變性哪一個(gè)好？什么是CATT和IVAN？CATT：TheComparisonofAge-relatedDegenerationTreatmentsTrials,美國(guó)國(guó)立衛(wèi)生研究院和美國(guó)國(guó)家眼科研究所IVAN：TheInhibitVEGFinAge-relatedchoroidalNeovascularisation英國(guó)國(guó)家健康研究院27s—1m3s概況年齡相關(guān)性黃斑變性

（ARMD）：

※發(fā)達(dá)國(guó)家60歲以上人群主要致盲原因

※超過(guò)75歲人群接近30%有癥狀

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

抗血管生成藥物激光治療藥物1m54s-2m15s基因治療干細(xì)胞治療人工視覺光學(xué)假體1m54s-2m15s1m54s-2m15s認(rèn)識(shí)抗血管生成藥物DavisJ,etal.AmJOphthalmol.2011;152（4）:509-14.TorjesenI.BMJ,2012,1;344:e3012.2m15s—4m提出問(wèn)題安全性哪一個(gè)高？

※國(guó)內(nèi)2009年的“Avastin事件”※Lucentis被批準(zhǔn)的適應(yīng)癥就是AMD※且有NICE（theNationalInstituteforHealthandClinicalExcellence

（NICE））推薦

4m1s—4m53s※Avastin被批準(zhǔn)的適應(yīng)癥抗癌※Avastin行玻璃體腔注射以后出現(xiàn)全身嚴(yán)重系統(tǒng)性反應(yīng)比Lucentis多見治療效果哪一個(gè)好？

※德國(guó)44.9%眼科醫(yī)生認(rèn)為效果一樣或者相當(dāng)TorjesenI.WhyusingAvastinforeyediseaseissodifficult.BMJ,2012,1;344:e3012.KühnT.KlinMonblAugenheilkd.2011;228（7）:607-12.4m1s—4m53s誰(shuí)能夠回答這些問(wèn)題？真的是這樣的嗎？4m54s-4m58s循證醫(yī)學(xué)（EBM）4m58s—5m1sEBM基本概念1992年JAMA雜志發(fā)表了EBM工作組：EBM即“遵循證據(jù)的醫(yī)學(xué)”1996年著名臨床流行病學(xué)專家David將EBM定義：“謹(jǐn)慎地、明確地、明智地應(yīng)用所能獲得的最好研究結(jié)果以確定對(duì)患者的治療措施”。5m1s---5m33s核心思想是：醫(yī)療決策應(yīng)根據(jù)現(xiàn)有的最好研究結(jié)果（證據(jù)）來(lái)進(jìn)行。5m1s---5m33s循證醫(yī)學(xué)臨床證據(jù)的分級(jí)5m33s---6m6sAMD治療的循證醫(yī)學(xué)證據(jù)Ⅱ級(jí)證據(jù)—來(lái)自一個(gè)設(shè)計(jì)良好的RCTⅠ級(jí)證據(jù)—所有設(shè)計(jì)良好的多中心RCT及所進(jìn)行的meta-分析

★證明某種療法有效性和安全性最可靠的證據(jù)

★

RCT和meta-分析是評(píng)價(jià)臨床治療效果的金指標(biāo)6m6s—6m33sⅠ級(jí)證據(jù)2個(gè)Lucentis和Avastin治療AMD的RCT：

※CATT（TheComparisonofAMDTreatmentsTrials,美國(guó)國(guó)家眼科研究所）※IVAN（TheInhibitVEGFinAge-relatedchoroidalNeovascularisation,英國(guó)）6m33s—7m16s1個(gè)Avastin治療AMD的RCT：

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

（NIH,NEI）

44個(gè)單位，861位合作者參加前瞻性多中心研究1208例年齡≥50歲劑量：★L(fēng)ucentis—0.5mg（0.05ml）

★Avastin—1.25mg（0.05ml）7m16s—8m15s隨機(jī)分4組：

★月用Lucentis—每28天一次，301人；★月用Avastin—每28天一次，286人;★需要時(shí)用Lucentis—僅在出現(xiàn)活動(dòng)性病灶時(shí)，298人

★需要時(shí)用Avastin—僅在出現(xiàn)活動(dòng)性病灶時(shí)，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,Van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