病毒灭活血浆制备冷沉淀凝血因子的质量研究

Cryoprecipitate coagulation factor prepared by virus inactivated plasma

目的:通过对以病毒灭活血浆为原料制备的冷沉淀凝血因子的含量和活性进行检测,分析其可行性,并为进一步提高输血安全提供依据。方法:联袋常规采集血液100袋(400mL/袋),分离出血浆(200mL/袋)后每袋平均分为两袋,分别作为对照组新鲜冰冻血浆和实验组病毒灭活血浆。两组血浆制备后分别提取冷沉淀凝血因子速冻保存备用,测定其相关指标。结果:实验组(病毒灭活血浆)血浆凝血因子Ⅱ、Ⅴ、ⅤⅡ、ⅤⅢ、ⅠX、X低于对照组(新鲜冰冻血浆),差异均有统计学意义(P<0.01),纤维蛋白原(Fg)无统计学差异(P>0.05);实验组血浆凝血酶原时间(PT)、凝血酶时间(TT)与对照组差异无统计学意义(P>0.05),活化部分凝血酶原时间(APTT)高于对照组,差异有统计学意义(P<0.01);实验组血浆球蛋白(G)低于对照组、A/G高于对照组,与对照组差异有统计学意义(P<0.01),总蛋白(TP)、白蛋白(ALB)无统计学差异(P>0.05)。结论:病毒灭活技术对血液中的有效成分产生不同程度的损伤,除凝血因子FⅧ和FⅨ以外(小于70%),其余在可接受的范围内。

Objective： To investigate the effect of plasma viral inactivation on the activity of main coagulation factors, and the feasibility for preparation of cryoprecipitate with viral inactivation plasma. Methods. A total of 100 prepared plasma were equally splited into two aliquots, experimental group （virus inactivated blood plasma） and control group （fresh frozen plasma）. Variables of two groups were compared. Results： The difference of FⅡ,Ⅴ,Ⅶ, Ⅷ, Ⅸ, Ⅹ ,G, A/G and APTT were significant between the two groups （P〈0. 01）. In the experimental group plasma PTTT there was no statistically sig- nificant difference in Fg, PT, TT, TP, or ALB compared with the control group. Conclusions：Virus inactivated technology produce different degrees of damage to the effective components in the blood, besides clotting factor FⅧ and FIX （〈70%）, and the rest is in the acceptable range.