Brackmann H H, Egbring R, Ferster A, Fondu P, Girardel J M, Kreuz W, Masure R, Miloszewski K, Stibbe J, Zimmermann R
Institut für experimentelle Hämatologie und Transfusionsmedizin, Universität Bonn, Germany.
Thromb Haemost. 1995 Aug;74(2):622-5.
The pharmacokinetics and tolerability of factor XIII (FXIII) from plasma were compared with those of FXIII from placenta in a randomised, double-blind, crossover study involving 13 patients with congenital FXIII deficiency. Both FXIII activity and FXIII antigen were monitored. No difference was seen in the mean half-lives of the two preparations (9.3 days and 9.1 days for plasma and placenta FXIII activity, respectively). Response was similar for both preparations, but was slightly greater for FXIII from plasma (1.6 ormula: see text] vs 1.5 [formula: see text]). Similar results were found for recovery (65% vs 60%). The area under the data completed by extrapolation was significantly higher for FXIII from plasma. No differences between preparations in terms of efficacy or tolerability were observed. It can be concluded that treatment with FXIII concentrate from plasma is as efficient as with FXIII concentrate from placenta in terms of recovery and half-life. Both preparations were equivalent in terms of safety during the observation period. With the administration of monthly injections of approximately 30 U/kg serious bleeding events were prevented and no other serious adverse events occurred.
在一项涉及13名先天性因子 XIII（FXIII）缺乏症患者的随机、双盲、交叉研究中，比较了血浆来源的FXIII和胎盘来源的FXIII的药代动力学及耐受性。对FXIII活性和FXIII抗原均进行了监测。两种制剂的平均半衰期未见差异（血浆和胎盘来源的FXIII活性的半衰期分别为9.3天和9.1天）。两种制剂的反应相似，但血浆来源的FXIII反应略大（1.6 [公式：见正文] 对1.5 [公式：见正文]）。回收率方面也得到了相似结果（65%对60%）。通过外推法完成的数据的曲线下面积，血浆来源的FXIII显著更高。在疗效或耐受性方面未观察到制剂之间存在差异。可以得出结论，就回收率和半衰期而言，血浆来源的FXIII浓缩物治疗与胎盘来源的FXIII浓缩物治疗一样有效。在观察期内，两种制剂在安全性方面相当。通过每月注射约30 U/kg，预防了严重出血事件，且未发生其他严重不良事件。
