搜索
Page1of15200610200702201008201011®®ValganciclovirHydrochlorideTabletsYanSuanXieGengXiLuoWeiPian1.L-,-2[(2--1,6--6--9H--9-)]-3--2.9-[[2--1-]]L-NNHH2NONNOOHOONH2.HClC12H22N6O5·HCl390.83AIDSCMVCMV450mg()Page2of15---10CMVCMV900mg450mg21CMVCMV900mg450mgCMV900mg450mg10200900mg450mg101001CrCl(ml/min)/≥60900mg2900mg140-59450mg2450mg125-39450mg1450mg2110-24450mg21450mg210=[]])/[011.0()72(])[()140(lmolkgμ×××−=0.85×(CrCl10ml/min)Page3of15()500/μl25,000/μl,8g/dlAIDSCMV792821722n=79n=7916%10%11%6%9%5%8%4%8%14%--6%3≥5%,CMV3n=370900mg900mgCMV65%930n=370%38%26%25%24%22%21%14%13%9%CMVPage4of153≥5%,n=244n=1261010028n=244%30%28%24%23%22%21%20%20%20%18%16%100CMV≥2%18%10%14%9%1009%7%6%5%3CMV≥5%CMV100n=370%n=244%n=126%3830292523232016141314146202069641210266—9626131420131552116357111916746624832212155554147Page5of152033/1248103—9779——7426—16——5119182227142016711655228259106184573467414616689111052224617813——614976933110148201567726113571712276—2430—181553-5--Page6of15114142881881678456561961463911112821371116—5915613831815(n=614)5%,:4CMVn=370%n=244%n=126%ANC/ul5001653500--7501732750--10001752g/dl6.57126.5--8.010578.0--9.5143125/μl25,00030225000--50,00051350,000--100,00211821Page7of15mg/dl2.5214211.5—2.5114547CMVANC500/ul16%5%1003%CMV100200-••Page8of15()500/μL25,000/μL,8g/dl1011//CrCl10ml/min-Page9of159012%--Page10of1520%40%AUC17%3g6gAUC84124%510mg/kg/3867%MMFMMFMPAGMPAMMFMMFAUC0-813%16.3%15%AUC0-8CmaxCmin12%Page11of15B10()•••••EXP()2’-,HCMV-1-2HSV-1HSV-2-678HHV-678EB-VZVCMVUL97HSVHCMV186~24Page12of15DNAaDNADNAbDNADNACMVIC500.08μM0.02ug/ml14μM3.5ug/mlAIDSWV15376CMV46%32/697%4/55CMVCMVAIDSCMVCMVCMV900mgCMV226160219125CMVAUCCMVCMVCMVD+/R-10900mg1000mg100CMVCMV6CMVn=23912.1%n=12515.2%100CMV629.7%n=12536.0%CMV20012CMV200100326CMVD+/R-CMV1002001:1900mg110200900mg110100100Page13of1512CMV66CMV112900mg,1100900mg,1200Cochran-Mantel-Haenszelp-CMV271/163(43.6%)36/155(23.2%)0.0001CMV60/163(36.8%)25/155(16.1%)0.00011CMVCMV2CMVCMV52CMVCMV1210098.1%160/16320098.2%152/1551210017.2%28/16320011.0%17/155UL97DNAUL54UL97UL54CMV148CMVPMNLCMV3612182.2%6.5%12.8%15.3%UL97CMV1006CMVPMNLCMV24519810010321.9%24550CMV12529CMV26.9%Page14of15110mg/mlHIVCMVAIDSCMV60%24AUC24Cmax1%3%4502625mgAUC900mgAUC24Cmax30%14%0.551μg/ml12%0.680±0.161/kg1000mg12%81.5±22%Page15of15CrCl10ml/min450mg4n=28900mg60%AUC0-24h5mg/kg30°C60/36RochePharma(Schweiz)Ltd.Schoenmattstrasse2CH-4153ReinachSwitzerlandPatheonInc.2100SyntexCourt,CDN-Mississauga,Ontario,Canada,L5N7K9F.Hoffmann-LaRocheAGWurmiswog4303KaiseraugstSwitzerland