两种冷沉淀凝血因子制备方法的比较研究

Quality evaluation of two preparation strategies of cryoprecipitate

目的分析不同仪器制备冷沉淀凝血因子的Ⅷ因子含量和纤维蛋白原含量。方法将来源于400 m L全血的新鲜冰冻血浆（FFP）随机分为2组,第1组使用CYTOTHERM-4T.6C低温融化箱制备,第2组使用ZBK-LCD-A1型冷沉淀制备仪制备,用血凝仪检测Ⅷ因子含量、纤维蛋白原含量,根据检测结果做统计学分析。结果 2组不同仪器制备的Ⅷ因子（FⅧ∶C）含量分别为（94.2±18.1）和（113.0±32.9）IU,纤维蛋白原（Fgb）含量分别为（218.1±39.3）和（230.9±34.1）mg;Ⅷ因子含量合格率分别为79.2%和100%,纤维蛋白原含量合格率分别为97.9%和93.8%。经统计学分析,2种仪器制备的Ⅷ因子含量及合格率有统计学差异,纤维蛋白原含量及合格率无统计学差异。结论 2种仪器制备的冷沉淀凝血因子均符合国家标准,ZBK-LCD-A1型冷沉淀凝血因子制备仪制备质量更优,效率更高。

Objective To analyze the FⅧ content and fibrinogen content in cryoprecipitate products prepared by different instruments and protocols. Methods Fresh frozen plasma（ FFP） prepared from 400 m L whole blood was randomly divided into 2 groups. The first group was prepared by CYTOTHERM-4 T. 6 C low temperature melting tank; The second group was prepared by ZBK-LCD-A1 type cold precipitation preparation instrument. Blood coagulation analyzer was used for F Ⅷand fibrinogen content detection,which served the bases for statistical analysis. Results Product analysis results by the two instruments： Factor Ⅷ（ FⅧ ∶ C） ：（ 94. 2 ± 18. 1） vs（ 113. 0 ± 32. 9） IU; Fibrinogen（ Fgb） content：（ 218. 1 ± 39. 3） vs（ 230. 9±34. 1） mg; Factor Ⅷ content qualification rates： 79. 2% vs 100%; Fibrinogen content qualification rates 97. 9% vs93. 8%. FⅧ concent results presented statistically significant differences while fibrinogen content results showed otherwise.Conclusion Both preparation strategies met national standards. The preparation quality of ZBK-LCD-A1 type is better and the efficiency is higher.