Longo G, Matucci M, Messori A, Morfini M, Rossi-Ferrini P
Thromb Res. 1986 May 15;42(4):471-6. doi: 10.1016/0049-3848(86)90210-0.
We evaluated the pharmacokinetic properties of Kryobulin TIM3, a new heat-treated Factor VIII concentrate which has recently become available in Europe. Twelve patients with classic hemophilia were studied. In each patient, Factor VIII was given as a single dose (ranging from 11.6 to 30.3 units/kg) after which eight serial blood samples were drawn to characterize the disappearance of Factor VIII from the plasma. Model-independent (noncompartmental) methods were used for pharmacokinetic analysis. The following pharmacokinetic parameters of Factor VIII (mean +/- SD) were estimated: clearance = 3.83 +/- 0.99 ml/h/kg; mean residence time = 15.9 +/- 4.5 h; volume of distribution at steady state = 55.6 +/- 9.3 ml/kg; in-vivo recovery = 129 +/- 29%. The pharmacokinetic parameters of Kryobulin TIM3 obtained in our study are very similar to those previously reported for the untreated concentrate. Thus, our findings suggest that the dosing guidelines previously available for the untreated concentrate need not be revised when using the treated product.
我们评估了Kryobulin TIM3的药代动力学特性，这是一种新型热处理的凝血因子VIII浓缩物，最近已在欧洲上市。对12例典型血友病患者进行了研究。给每位患者单次注射凝血因子VIII（剂量范围为11.6至30.3单位/千克），之后采集8份系列血样以表征血浆中凝血因子VIII的消失情况。采用非房室模型方法进行药代动力学分析。估算了凝血因子VIII的以下药代动力学参数（均值±标准差）：清除率 = 3.83 ± 0.99毫升/小时/千克；平均驻留时间 = 15.9 ± 4.5小时；稳态分布容积 = 55.6 ± 9.3毫升/千克；体内回收率 = 129 ± 29%。我们研究中获得的Kryobulin TIM3的药代动力学参数与先前报道的未处理浓缩物的参数非常相似。因此，我们的研究结果表明，使用经处理的产品时，先前适用于未处理浓缩物的给药指南无需修订。
