Thomas D P, Hampton K K, Dasani H, Lee C A, Giangrande P L, Harman C, Lee M L, Preston F E
BioProducts Laboratory, Elstree, Herts.
Br J Haematol. 1994 Aug;87(4):782-8. doi: 10.1111/j.1365-2141.1994.tb06738.x.
A prospective cross-over study was carried out on 19 patients with haemophilia B. comparing the pharmacokinetics of a purified factor IX concentrate prepared by metal chelate affinity chromatography (9MC) with a conventional three-factor prothrombin complex concentrate (9A). The highly purified factor IX concentrate was shown to have a half-life comparable to the PCC; the in vivo recovery of the purified concentrate was significantly greater than that of the complex (P < 0.01). The 20% change in the value of the International Standard for Factor IX Concentrate, introduced in 1988, might have been expected to lower the recovery values. However, the in vivo recovery for both concentrates was somewhat higher than reported previously, particularly in the older literature. In nine patients, serial assays for fibrinopeptide A, prothrombin fragment F1+2 and thrombin-antithrombin complexes (TAT) were performed to assess the potential thrombogenicity of the two concentrates. Evidence was obtained that there was significantly less activation of coagulation following administration of purified factor IX (9MC), as compared to the activation that occurred after the PCC.
对19例B型血友病患者进行了一项前瞻性交叉研究，比较了通过金属螯合亲和层析制备的纯化IX因子浓缩物（9MC）与传统的三因子凝血酶原复合物浓缩物（9A）的药代动力学。结果显示，高度纯化的IX因子浓缩物的半衰期与凝血酶原复合物相当；纯化浓缩物的体内回收率显著高于复合物（P<0.01）。1988年引入的IX因子浓缩物国际标准值有20%的变化，可能预期会降低回收率。然而，两种浓缩物的体内回收率均略高于先前报道，尤其是在较早的文献中。对9例患者进行了纤维蛋白肽A、凝血酶原片段F1+2和凝血酶-抗凝血酶复合物（TAT）的系列检测，以评估两种浓缩物的潜在血栓形成性。结果表明，与凝血酶原复合物给药后发生的激活相比，纯化IX因子（9MC）给药后凝血激活明显较少。
