| 3 | Pharmacokinetic variability of factor VIII concentrates in Chinese pediatric patients with moderate or severe hemophilia A显示文摘Importance:The use of factor VIII(FVIII)concentrates under pharmacokinetic(PK)guidance has become the main approach for treatment of hemophilia.However,limited PK research has been conducted in Chinese pediatric patients.Objective:To investigate the PK parameters of various FVIII concentrates in Chinese pediatric patients.Methods:Seventy-nine patients were enrolled(28 treated with Kogenate FS^(®),23 treated with Advate^(®),and 28 treated with GreenMono^(™)).All enrolled patients participated in single-dose PK analysis after at least a 3-day washout period.Blood samples were collected predose,as well as at 1 h,9 h,24 h,and 48 h after infusion;FVIII levels were measured using a one-stage clotting assay,von Willebrand Factor Antigen(VWF:Ag)levels and blood types were also determined.PK parameters were evaluated by WAPPS-Hemo.Results:Mean values of terminal elimination half-life time(t_(1/2))for the Kogenate FS^(®),Advate^(®),and GreenMono^(™)FVIII groups were 12.24 h,10.18 h,and 9.62 h;median clearance values were 4.16,6.23,and 5.11 mL kg^(-1)h^(-1);and median in vivo recovery values were 1.97,1.55,and 1.61 IU/dL per IU/kg.Longer t_(1/2),higher in vivo recovery,and lower clearance were observed in patients with higher VWF:Ag level who were treated with recombinant concentrates.Interpretation:Chinese pediatric patients with hemophilia had FVIII PK characteristics similar to those previously observed in non-Chinese children,including large variation among individuals.VWF:Ag level and FVIII brand were associated with differences in FVIII PK.Thus,PK-guided dosing should be used to optimize individualized therapy in Chinese children. | Zhenping Chen Kun Huang Gang Li Yingzi Zhen Xinyi Wu DiAi Guoqing Liu Zekun Li Iorio Alfonso Runhui Wu | 2021 | Pediatric Investigation2021，5，1： | 0 |
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