4种冷沉淀凝血因子制备方法的比较研究

Comparative study on four preparation methods of cold precipitated coagulation factors

目的探讨4种制备方法对冷沉淀凝血因子质量的影响。方法将160袋新鲜冰冻血浆随机分成4组,每组40袋,分别用4种不同制备方法[Pool方法(A组)、虹吸法(B组)、水浴离心法(C组)及基于虹吸法改良的全自动冷沉淀制备仪法(D组)]制备冷沉淀凝血因子。比较4组凝血因子Ⅷ(FⅧ)、纤维蛋白原(FIB)水平及其回收率。结果4组FⅧ和FIB水平比较,差异有统计学意义(P<0.05)。A组FⅧ水平与D组比较,差异有统计学意义(P<0.05);B组FⅧ水平分别与C组、D组比较,差异有统计学意义(P<0.05)。B组FIB水平分别与A组、C组、D组比较,差异有统计学意义(P<0.05)。4组FⅧ回收率比较,差异有统计学意义(P<0.05)。4组FIB回收率比较,差异无统计学意义(P>0.05)。A组FⅧ回收率与D组比较,差异有统计学意义(P<0.05);B组FⅧ回收率分别与C组、D组比较,差异有统计学意义(P<0.05)。结论采用基于虹吸法改良的全自动冷沉淀制备仪制备冷沉淀凝血因子的方法最优,其可有效控制制备操作过程中影响质量的诸多因素,有效降低人力成本。

Objective To investigate the effect of four preparation methods on the quality of cryoprecipitated coagulation factor.Methods 160 bags of fresh frozen plasma were randomly divided into four groups,40 bags in each group,and cold precipitated clotting agents were prepared by four different preparation methods[Pool method(group A),siphon method(group B),water bath centrifugation method(group C),and automatic cold precipitation preparation instrument method based on siphon method(group D)].The levels and recovery rates of FⅧ,FIB in the four groups were compared.Results The FⅧand FIB levels in the four groups were statistically significant(P<0.05).The level of FⅧin the group A was significantly higher than that in the group D(P<0.05).The level of FⅧin the group B was significantly higher than that in the group C and D(P<0.05).The level of FIB in the group B was significantly higher than that in the group A,C and D(P<0.05).The recovery rates of FⅧin the four groups were statistically significant(P<0.05).There were no significant differences in the FIB recovery rates among the four groups(P>0.05).The recovery rate of FⅧin the group A was significantly higher than that in the group D(P<0.05).The recovery rate of FⅧin the group B was significantly higher than that in the group C and D(P<0.05).Conclusion The method of preparing cryoprecipitate coagulation factor with the improved automatic cryoprecipitate preparation instrument based on siphon method is optimal,which can effectively control many factors that affect the quality in the preparation process,and effectively reduce the labor cost.