采用非模型依赖方法评估的凝血因子IX单剂量药代动力学。

Single-dose pharmacokinetics of factor IX evaluated by model-independent methods.

作者信息

Longo G, Cinotti S, Filimberti E, Giustarini G, Messori A, Morfini M, Ferrini P R

机构信息

Hemophilia Center, Ospedale di Careggi, Florence, Italy.

出版信息

Eur J Haematol. 1987 Nov;39(5):426-33. doi: 10.1111/j.1600-0609.1987.tb01450.x.

DOI:10.1111/j.1600-0609.1987.tb01450.x

PMID:3691761

Abstract

We studied the pharmacokinetic data of 13 subjects with hemophilia B treated with a single-dose of a Factor IX concentrate (Bebulin TIM2, N = 9; Preconativ, N = 4). The decay curves of Factor IX were evaluated by model-independent methods and the following pharmacokinetic parameters (mean +/- SD) were estimated: clearance (ml/h/kg) = 4.99 +/- 2.01; mean residence time (h) = 22.9 +/- 10.6; volume of distribution (ml/kg) = 99.9 +/- 35.5. The in vivo recovery (59.8% +/- 16.9%) was found to be inversely correlated with the volume of distribution. No significant difference in the pharmacokinetic parameters was found between patients treated with Preconativ and those treated with Bebulin. A model-dependent compartmental evaluation of the 13 decay curves showed that the two-compartment model was better than the one-compartment model in 7 cases (53.8%), but the improvement of fit resulting from the two-compartment model was statistically significant in only 2 cases (15.4%).

摘要

我们研究了13例接受单剂量凝血因子IX浓缩物治疗的B型血友病患者的药代动力学数据（Bebulin TIM2，N = 9；Preconativ，N = 4）。采用非模型依赖方法评估凝血因子IX的衰减曲线，并估算了以下药代动力学参数（平均值±标准差）：清除率（ml/h/kg）= 4.99 ± 2.01；平均驻留时间（h）= 22.9 ± 10.6；分布容积（ml/kg）= 99.9 ± 35.5。发现体内回收率（59.8% ± 16.9%）与分布容积呈负相关。接受Preconativ治疗的患者与接受Bebulin治疗的患者在药代动力学参数上未发现显著差异。对13条衰减曲线进行的模型依赖房室评估显示，两房室模型在7例（53.8%）中优于单房室模型，但两房室模型拟合优度的改善仅在2例（15.4%）中具有统计学意义。