重组人凝血因子Ⅷ在重型血友病A患者中的药代动力学研究  

Pharmacokinetics of Recombinant Human Coagulation Factor Ⅷ Preparations in Patients with Severe Hemophilia A

作　　者：林传明[1] 黄走方[1] 辛柳燕 李林 杨翔 李婷[1] 陈懿建[1] LIN Chuan-Ming;HUANG Zou-Fang;XIN Liu-Yan;LI Lin;YANG Xiang;LI Ting;CHEN Yi-Jian(Department of Hematology,The First Affiliated Hospital of Gannan Medical College,Ganzhou 341000,Jiangxi Province,China)

机构地区：[1]赣南医学院第一附属医院血液科,江西赣州341000

出　　处：《中国实验血液学杂志》2023年第6期1787-1790,共4页Journal of Experimental Hematology

基　　金：江西省教育厅科学技术研究项目(GJJ211518);赣州市指导性科技计划项目(GZ2020ZSF027)。

摘　　要：目的:应用myPKFiT计算重组人凝血因子Ⅷ在重型血友病A患者中的药代动力学参数,为血友病A患者提供个体化治疗方案。方法:纳入自2021年1月至2021年12月共42名应用重组人凝血因子Ⅷ进行预防治疗的重型血友病A患者,采用myPKFiT计算FⅧ药代动力学参数,并制定血友病A患者个体化治疗方案。结果:42例重型血友病A患者中位年龄31(16-50)岁,平均体重为54.0±9.9 kg,FⅧ的半衰期为12.05±1.6 h,FⅧ活性至基线1%以上的时间为62.3±15.3 h,应用myPKFiT指导后0出血率由39%显著提高至49%,年出血率由3.6±2.5降低至2.1±2.0,年关节出血率由3.2±2.2降低至1.9±0.9,均有统计学差异(P<0.05)。结论:重型血友病A患者通过myPKFiT测定药代动力学参数指导个体化治疗可以显著降低患者的年出血率和年关节出血率。Objective:To calculate the pharmacokinetic parameters of recombinant human coagulation factor Ⅷ using myPKFiT in patients with severe hemophilia A,and provide an individualized treatment plan for patients.Methods:A total of 42 patients with severe hemophilia A who were treated with recombinant human coagulation factor Ⅷ were included from January 2021 to December 2021.myPKFiT was used to calculate the pharmacokinetic parameters of FⅧ,and the individualized treatment plan for hemophilia A patients was formulated.Results:The median age of 42 patients with severe hemophilia A was 31(16-50)years old,the average weight was 54.0 ± 9.9kg,the half-life of FⅧ was12.05 ± 1.6h,the time to more than 1% of the baseline was 62.3 ± 15.3h,and the0bleeding rate after the guidance of myPKFiT was significantly increased from39% to49%,the Annual bleeding rate was reduced from3.6 ± 2.5to2.1± 2.0,and the Annual joint bleeding rate was reduced from3.2 ± 2.2 to 1.9 ± 0.9,all of which were statistically different(P<0.05).Conclusion:Individualized therapy in patients with severe hemophilia A who were guided by myPKFiT assay of pharmacokinetics parameters can significantly reduce the annual bleeding rate and annual joint bleeding rate of patients.

关 键 词：重型血友病A 重组人凝血因子Ⅷ 药代动力学 

分 类 号：R554.1[医药卫生—血液循环系统疾病]