Morfini M, Mannucci P M, Longo G, Cinotti S, Messori A
Hematology Department, University Hospital of Florence, Italy.
Thromb Res. 1991 Feb 1;61(3):285-90. doi: 10.1016/0049-3848(91)90105-6.
Hemofil M, Monoclate HT, and Monoclate P are high-purity Factor VIII concentrates, obtained from plasma by immunoaffinity chromatography with monoclonal antibodies specific for Factor VIII (Hemofil M) or von Willebrand Factor (Monoclate HT and Monoclate P). The concentrates are subjected to virucidal treatments: a solvent/detergent method (TNBP/Na-cholate) for Hemofil M, heating in the lyophilized state and in solution (pasteurization) for Monoclate HT and Monoclate P, respectively. Since these differences in the manufacturing process might result in different in vivo characteristics of the concentrates, we compared their in vivo behavior in a cross-over, single-dose, pharmacokinetic study performed in 10 non-bleeding patients with severe hemophilia A. The experimental conditions (Factor VIII dose, number and timing of blood sampling, Factor VIII assay methods, calculation of pharmacokinetic parameters) were identical for the three products. The results showed that the clearance, the mean residence time, and the volume of distribution did not differ among the three products.
Hemofil M、Monoclate HT和Monoclate P是高纯度的凝血因子VIII浓缩物，通过使用针对凝血因子VIII（Hemofil M）或血管性血友病因子（Monoclate HT和Monoclate P）的单克隆抗体进行免疫亲和层析从血浆中获得。这些浓缩物经过灭病毒处理：Hemofil M采用溶剂/去污剂法（TNBP/胆酸钠），Monoclate HT和Monoclate P分别在冻干状态和溶液状态下加热（巴氏消毒）。由于制造工艺的这些差异可能导致浓缩物在体内具有不同的特性，我们在一项交叉、单剂量药代动力学研究中比较了它们在10名非出血性重度甲型血友病患者体内的行为。三种产品的实验条件（凝血因子VIII剂量、采血次数和时间、凝血因子VIII检测方法、药代动力学参数计算）相同。结果表明，三种产品的清除率、平均驻留时间和分布容积没有差异。
