b┦癌盆┦フfノのw┦ X Gemtuzumab Ozogamicin

癌盆]bonemarrow^sb癌的いAO@贺壶Xn舱麓AウDntd矗ㄑΘ剪灿MAH莱IS惠DCτ癌盆ダ灿MΤG贺n\A@OyWネzAGOyだてzAWネDn蝴壁s]clone^AだてhOΘΘ剪灿MAㄢ贺\ゲ斗Oキ颗A~ㄏo灿Mタ`ネのoiAτ蝴ō砰胺dC┦癌盆┦フf]acutemyelodleukemiaFAML^ō砰いぃΘ剪癌盆灿Mぃ_aWネAτぃiだてAyΘぃΘ剪灿ME栋LhA旧PΘ剪灿M计qぃìτまo@贺efAo摸フfObΘ~Hい程`ǎ┦フfA瘤Mㄠ担MCぶ~]iwW┦癌盆┦フfAq`Θ~Hwf诀|耕jAキАΩwf~闹b62~64烦Cヘeb瓣AC~Τ10000WsWfㄒAㄤい|だぇTせQ烦HWρHCo贺]ぃタ`フy灿MеtbGの癌盆い仓nτyΘhBPVHのX{HYゼgv励A`vY蔼FGf隆tA度Τ15%wiHFき~]t^HWsvAτBAYㄏΩv励GnAYぃn伐北AеNS_oFA@ス_oAq`v励G]ぃp材@ΩC

GB┦癌盆┦フf]AML^v励G

パv励мNsBF灿M簿从iBAㄏo┦癌盆┦フfv励iJ@s{OC肚参WA┦癌盆┦フfv励p购7+3て厩v励AHcytarabine]100-200mg/m2/dayFs尿Cぱ^AXㄖdaunorubicin]45mg/m2/dayFs尿Tぱ^A贺励kiHΤ60~80%Чw秆v]completeremission^AτBAΝ戳v励[├j秸┮孔ytotalcellkillzA{w砰ずフf灿MAYㄏuΤ@摧sAhΤiA_oA┮HAQ荷快kNw砰ずぇフf灿M缎埃爱bCwbgL旧J励k]inductiontherapy^Aq`|[W1~2ΩPjdT励k]consolidationtherapy^の尿戳蝴励k]maintenancetherapy^AHFЧ蔫防フf灿MヘCOAㄆ龟WAnNw砰ずフf灿MЧ缎埃OぃiAzL@sv励AoΤ20~30%wiH铂隆A┮HA陪ボunNフf灿M防Y@计ヘAō砰K灿MiNiHㄓ秆MフfC

b_oの螟v励┦癌盆┦フfwAnFЧw秆Gx螟Aヘe材GΩv励Чw秆vq10%~80%ぃ单ADnvT]~闹B_o丁の膀]S┦AYぃiyF灿M簿从]hematopoieticstem-celltransplantationFHSCT^ALfsv]disease-freesurvival^5~10%FYiyF灿M簿从AhiNLfsv矗蔼25~40%CぃOCH常AXi簿从AτB簿从ㄓ方]ぃoA┮HAヘe度Τぶ计HiHAXノoよkAoisv励よkKnC~ㄓAK励kv亥iSYàAヘeAк砰мNoiw讽Θ剪AWカv励┦к砰媚wΤQX贺AgemtuzumabozogamicinKOㄤい@贺C

TB媚S┦G

GemtuzumabozogamicinO@媚Pк砰挡X砰（p瓜@）Aウパ膀]XΘкCD33虫к砰]recombinanthumanizedanti-CD33monoclonalantibody^虑パ@Nac-gammalinkermoleculeMㄣΤ灿Mr┦кネ]cytotoxicantibiotic^calicheamicin舱XτΘA]b90%┦癌盆┦フfw癌盆灿M]myeloidblastcell^WA常o{ΤCD33кA┮HgemtuzumabozogamiciniM@挡Xbフf灿MWA癸フf灿Mi}aA程沧旧Pフf灿M`C瘤MCD33к]sbタ`Θ剪y灿MいAㄏooㄇタ`y灿M]|D}aτ玻ネ癌盆ыは莱A]DnyF灿MBDy灿Mの舱麓常OdBぃvTA┮H癌盆ыは莱Oif┦C

ヘe瓣~[媚恨zЫ]FoodandDrugAdministrationFFDA^qLgemtuzumabozogamicinノHv励t60烦HWACD33кк砰は莱锭┦AΩ_oBLkAノㄤLて厩励k┦癌盆┦フfwAㄏノ警q9mg/m2AR块`ぶㄢpA荡癸ぃiHеtR`gよΑ（IVpushorbolus）倒PAㄢΩ警q倒媚丁jぶㄢP戳AτF磷K@ㄇ块`は莱AbIゴgemtuzumabozogamicine@pAゲ斗ㄏノ@ㄇw媚ApfAacetaminophen650~1000@Jのdiphenhydramine50@JAぇC|p临惠[AㄢΩacetaminophenA~Aノ媚eのノ媚@pA]惠Iゴ50@JmethylprednisoloneApAKi耕Τ北块`は莱]gemtuzumabozogamicinrelatedinfusionreactions^CDn块`は莱oNBH鸥AC溃MIlx螟耕ぶǎAq`eoネb块`24pずA┮HAゲ斗Kち[诡Cτgemtuzumabozogamicinノp_oAMLぇ挡GのA讽警qh|bs顶qいC

GemtuzumabozogamicinbΩv励ぇAP娩Gダ灿M（blastcellinperipheralblood）陪帝搭ぶ丁ㄢP戳CH9mg/m2警q块`30だ牧o{wP娩Gダ灿MWCD33挡XBΤ80-100%wQGemtuzumabozogamicin┮沮Cv励媚~ぇい@{戈|ゼミACalicheamicinbI戳45~60pA块`bYㄇw程ㄎw秆は莱11P戳C`ǎ捌@ノp块`闽ㄆン（oNBH鸥K）q`oネb材@Ω块`挡AㄤLp潸みB姑RBKK.单A常耕淮LAぃYAτ癌盆ы]OifAo`NOAgemtuzumabozogamiciniま_R峨┦ef]veno-occlusivediseaseFVOD^A@ㄇ厨iXㄏノgemtuzumabozogamicinㄓv励AMLi|yΘxr┦]hepatotoxicity^AvTxu回BH帝R蔼溃gCぷㄤOㄏノXㄖ励kBe纯Τx纽ef┪iyF灿M簿从AO蔼MIsA┮HAゲ斗YK菏北CㄤLgp~F坊秆gs]tumorlysissyndrome^┮yΘ蔼Э荒gA瘤M`ǎAizLw┦倒ぉallopurinolのAqG砰ㄓэ到C~A洛励Hゲ斗`NO媚癸庇P,L阶ts┪块`惠磷Btsui磷N旅Os8pC

矗ㄑA讽矫毙]Oゲ斗A矗眶wAYキΤAノкG井T媚ApaspirinBticlopidineK单AeW[XぇMIA┮H惠i洛vAパ洛v蝶O_~尿Aノ┪惠A秸俱警qFv励戳丁ぃn耻sのHKAノヴゼg洛vボ媚AOタ`ネ@B都A蝴f的M间ApΤoNBH鸥┪ㄤLX薄ぇ渡VA斗ǔtP洛vp蹈C

|BGemtuzumabozogamicin闽{sG

┦癌盆┦フfv励wiJ@s{OAgemtuzumabozogamicin瘤wb2000~5るqLFDAノHv励t60烦HWACD33кк砰は莱锭┦AΩ_oBLkAノㄤLて厩励k┦癌盆┦フfwAOAFTwウwの励A\hjsごb尿iいC

b@兜q1997~}lsいAΜ栋Fy@104wAoㄇwㄓ15の稼25洛励いみAА材@Ω_o┦癌盆┦フfΘHwALHgemtuzumabozogamicin讽虫@v励媚A警q9mg/m2AR块`ぶㄢpAHぶ14ぱぃWL28ぱ丁jAIゴ程hTΩ警q媚At~AH1991~1994~A材@Ω_o┦癌盆┦フfΘHwAノ肚参励k]蹦s尿块`cytarabineCぱA[Wmitoxantrone^v励讽菌v癸酚舱Ao挡G（p@）ObsvWtぃh]gemtuzumabozogamicin舱sv89%F癸酚舱95%^Ab|ぱ计WNΤ陪ぇt钵Agemtuzumabozogamicin舱いΤ43%wAb材@Ωv励ぃノ|A癸酚舱h100%惠|Fτb惠|wいAㄏノgemtuzumabozogamicinwキА|ら19ぱA癸酚舱h蔼F35ぱA耕ぇUAgemtuzumabozogamicin舱wΤ耕ㄎネ~借C

bt~@jsA]A142Ω_oBCD33e锭┦ぇAMLwAキА~闹61烦AΩ_o丁キА11.1るA癸o142wAP妓倒P9mg/m2@gemtuzumabozogamicinAㄤい109b丁jぶ14ぱ倒P材GΩ警qAτΤ5倒P材TΩ警qAo挡G（pG）O俱砰w秆v]overallrateofremissionFOR^30%AㄤいAΤ23wЧw秆]completeremissionFCR16%^Fτ19ww秆ApOゼЧ^ど]remissionwithincompleteplateletrecoveryFCRp13%^AキАFw秆丁60ぱAτbo142wいAΤ65]46%^b倒P材@Ω警qA癌盆い灿MwぃWL5%FC

b42俱砰w秆]OR^w尿v励いAΤ15钡yF灿M簿从]HSCT^A4钡て厩励kAㄤl23hぃt~钡v励Fτb100SΤw秆]noremissionFNR^wいAhΤ12钡yF灿M簿从]HSCT^A42钡て厩励kAㄤl46hぃt~~尿钡v励FbЧw秆wいAキАL_os丁A尿Τ钡yF灿M簿从Pぃt~钡v励だO8.9るの2.1るAτキАs丁hだO14.5るの12.8るCbSΤw秆wいA尿Τ钡yF灿M簿从Pぃt~钡i@Bv励bキАs丁だO4.2るの2.5るA┮HAv励ぃ恨ΤLw秆A钡yF灿M簿从wАis耕丁Cτb钡gemtuzumabozogamicinv励Чw秆wA尿A钡て厩励kAキАiAsぶ4.7るAτSΤw秆wAYP妓钡て厩励kAhiAsv4るC

t@よA瘤M┦癌盆┦フfbㄠ担ōWぃ`oネAごΤsw癸291~16烦┦癌盆┦フfㄠ担igemtuzumabozogamicinw┦MΤ┦蝶A警qq6~9mg/m2A丁j14ぱ倒ぉㄢΩ警qA┮Τw常Τ癌盆ы薄AㄤLr┦临]A材T/材|蔼x荒g]hyperbilirubinemia^Bx酶计WどK单AxずR峨┦ef]veno-occlusivediseaseFVOD^O耕Y捌@ノA程sg喷XAw┦倒ぉdefibrotideiHCVODoネvCgLヘes参po{A癸ㄠ担τēAgemtuzumabozogamicin警q6mg/m2Oi耕wBΤAτ尿赣匡拒贺v励よΑAh惠ヵ苦洛v暗{蝶P_ApG薄pB兵ン\i杠AyF灿M簿从临O程DnσqC

gL戳VOAK励kwb砾g{pv励WΤ@uぇaAぃ恨OQノ]D笆K┪Oк砰Q笆Kv励A常矗ㄑF砾gw@捣s榔Agemtuzumabozogamicin虫к砰v励媚Awb2000~5るQFDAノHv励t60烦HWACD33кк砰は莱锭┦AΩ_oBLkAノㄤLて厩励k┦癌盆┦フfwAgLXjs陪ボAウぃ度ΤBwCτBA\hwbEAR块`Чy暗[诡Yi^aA癸ai矗蔼wネ~借CゼㄓAK励kNま烩奸yA戳gパja@PVOAoiBwBΤ励kAH搭淮砾gwv励戳丁iHhWC

せB把σゅmG

1.LangK,MenzinJ,EarleCC,etal.Outcomesinpatientstreatedwithgemtuzumabozogamicinforrelapsedacutemyelogenousleukemia.AmJHealth-SystPharm2002;59:941-8.

2.SieversEL,LarsonRA,StadtmauerEA,etal.EfficacyandSafetyofGemtuzumabOzogmicininPatientsWithCD33-PositiveAcuteMyeloidLeukemiainFirstRelapse.JournalofClinicalOncology2001;19:3244-54.

3.BrossPF,BeitzJ,ChenG,etal.ApprovalSummary:GemtuzumabOzogamicininRelapsedAcuteMyeloidLeukemia.ClinicalCancerResearch2001;7:1490-6.

4.ArceciRJ,SandeJ,LangeB,etal.SafetyandefficacyofGemtuzumabOzogmicininpediatricpatientswithadvancedCD33+acutemyeloidleukemia.TheAmericanSocietyofHematology2005;106:1183-8.

5.GilesF,EsteyE,OˇBrienS.GemtuzumabOzogmicinintheTreatmentofAcuteMyeloidLeukemia.AmericanCancerSociety2003;98:2095-104.

6.Productpackageinsert.

瓜@BGemtuzumabOzogmicinぇ挡cΑ3

@B_o┦癌盆┦フfwv励せg挡Gゑ耕1

OzogamicinGroup

HistoricalControl

OzogamicinGroup

HistoricalControl

a:UnadjustedanalysesincludednonparametricWilcoxontestsforfollow-upandhospitaldaysandCochranVMantelVHaenszeltestsforsurvivalandpercentagewith<7hospitaldays.

b:Adjustedanalysesincludedleast-squaresregressionofthemeansforhospitaldaysandlogisticregressionforsurvival.Modelswereadjustedforage,sex,race,durationoffirstremission,studylocation（UnitedStatesorEurope）,durationoffollow-up,andsettingondateofreinductionchemotherapy（hospitalorambulatorycare）.