Kellner S, Stöcker U, Fürst G
Infusionsther Klin Ernahr. 1985 Aug;12(4):208-10.
In 50 plasma samples flash frozen at -40 degrees C within 6 h and in 50 samples flash frozen within 18 h after phlebotomy, both coagulation factors II, V, VII, VIII, IX and X as well as AT III, APTT and Quick were measured. Only factor VIII in 18-h plasma showed an average decrease from 0,99 IU/ml to 0,85 IU/ml, i. e. 15% compared to 6-h plasma. None of the other coagulation factors or parameters exhibited any change beyond normal ranges. Furthermore, 150 6-h and 150 18-h plasma samples were taken from routine production and after thawing were tested for factor VIII- and factor-V activity. In a long-term study following a one year's storage at -30 degrees C of 30 samples of 6-h plasma and 30 samples of 18-h plasma, a decrease was found with factor VIII from 0,97 IU/ml to 0,93 IU/ml in 6 h-plasma and from 0,90 IU/ml to 0,86 IU/ml in 18 h-plasma. Our results demonstrate that only minor differences exist in activity of coagulation factors of 6-h and 18-h plasma. Hence follows that by observing the instructions described, freezing must take place within an 18-h period after phlebotomy which thus allows 12 more hours for production without losses in activity.
对50份在采血后6小时内于-40℃速冻的血浆样本以及50份在采血后18小时内速冻的血浆样本,测定了凝血因子II、V、VII、VIII、IX和X以及抗凝血酶III(AT III)、活化部分凝血活酶时间(APTT)和凝血酶原时间(Quick)。仅18小时血浆中的因子VIII显示平均水平从0.99 IU/ml降至0.85 IU/ml,即与6小时血浆相比降低了15%。其他凝血因子或参数均未出现超出正常范围的变化。此外,从常规生产中采集了150份6小时和150份18小时的血浆样本,解冻后检测因子VIII和因子V活性。在一项长期研究中,将30份6小时血浆样本和30份18小时血浆样本在-30℃储存一年后,发现6小时血浆中的因子VIII从0.97 IU/ml降至0.93 IU/ml,18小时血浆中的因子VIII从0.90 IU/ml降至0.86 IU/ml。我们的结果表明,6小时和18小时血浆的凝血因子活性仅存在微小差异。因此,按照所述说明,采血后必须在18小时内进行冷冻,这样在生产过程中就可以多留出12个小时而不会造成活性损失。