用 myPKFiT 评估韩国 A 型血友病患者的 FVIII 药代动力学特征:回顾性病历审查。

IF 2.3 Q2 HEMATOLOGY
Young-Shil Park, Ki-Young Yoo, Sang Kyu Park, Taiju Hwang, Aeran Jung, Eun Jin Choi
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引用次数: 0

摘要

目的:本研究旨在调查韩国患者体内因子 VIII(FVIII)的药代动力学(PK),因为有关韩国人群中 FVIII 的 PK 信息有限:我们使用 myPKFiT 收集了中重度血友病 A 患者的 FVIII PK 结果。根据年龄、血型、抑制剂史、von Willebrand因子抗原(vWF:Ag)水平和体重指数评估了PK变化。此外,还特别分析了每种产品在严重病例中的 PK 曲线与预防方案之间的相关性:结果:分别获得了48例和81例接受辛可克α和鲁米奥可克αpegol治疗的患者的PK数据。octocog alfa 和 rurioctocog alfa pegol 的中位半衰期分别为 9.9(范围:6.3-15.2)小时和 15.3(范围:10.4-23.9)小时。每种产品的 PK 曲线并不因年龄组而异;但与非 O 型血患者相比,O 型血患者的半衰期和达到 1%的时间较短。在回归分析中,octocog alfa 的 PK 随年龄的不同而有显著的统计学差异,而 rurioctocog alfa pegol 的 PK 则与 vWF:Ag 相关。只有rurioctocog alfa pegol的使用频率与达到1%的时间存在统计学意义上的显著差异,尽管决定系数很小:这项研究证实,韩国 A 型血友病患者在 FVIII 的 PK 方面存在明显的患者间差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of FVIII pharmacokinetic profiles in Korean hemophilia A patients assessed with myPKFiT: a retrospective chart review.

Purpose: This study aimed to investigate the pharmacokinetics (PK) of factor VIII (FVIII) in Korean patients, as limited information is available on the PK of FVIII in this population.

Methods: We collected the FVIII PK results from patients with moderate-to-severe hemophilia A using myPKFiT. PK variations were assessed according to age, blood type, inhibitor history, von Willebrand factor antigen (vWF:Ag) level, and body mass index. Additionally, the correlation between the PK profile and prophylaxis regimen was specifically analyzed for each product in severe cases.

Results: The PK data of 48 and 81 patients treated with octocog alfa and rurioctocog alfa pegol, respectively, were obtained. The median half-lives of octocog alfa and rurioctocog alfa pegol were 9.9 (range: 6.3-15.2) h and 15.3 (range: 10.4-23.9) h, respectively. The PK profiles for each product did not differ according to age group; however, blood type-O patients had shorter half-lives and time to 1% compared to non-blood type-O patients. In regression analysis, the PK of octocog alfa showed a statistically significant difference according to age, whereas the PK of rurioctocog alfa pegol correlated with vWF:Ag. Only the frequency of rurioctocog alfa pegol use showed a statistically significant difference in relation to time to 1%, although the coefficient of determination was small.

Conclusion: This study confirmed significant interpatient variation in the PK of FVIII among Korean patients with hemophilia A. To achieve optimized prophylaxis, personalizing the regimen based on the PK profile of each individual patient is essential.

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来源期刊
Blood Research
Blood Research HEMATOLOGY-
CiteScore
3.70
自引率
0.00%
发文量
64
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