全自动冷沉淀制备仪制备冷沉淀凝血因子体外质量评价  

In vitro quality evaluation of coagulation factors prepared by automatic cryoprecipitation preparation instrument

作　　者：钟志梅 王姣杰[1] 张姣姣 安慧娟[1] 沙枫[1] Zhong Zhimei;Wang Jiaojie;Zhang Jiaojiao;An Huijuan;Sha Feng(Component Room,Henan Red Cross Blood Center,Zhengzhou Henan 450012,China)

机构地区：[1]河南省红十字血液中心成分室,河南郑州450012

出　　处：《实用医技杂志》2023年第1期37-40,共4页Journal of Practical Medical Techniques

摘　　要：目的评价全自动冷沉淀制备仪制备冷沉淀凝血因子的质量变化。方法按随机数字表法抽取100份冷沉淀,其中50份为低温水浴融化箱制备的冷沉淀(对照组),另外50份为全自动冷沉淀制备仪制备的冷沉淀(试验组),通过检测2组冷沉淀凝血因子容量、Ⅷ因子含量、纤维蛋白原含量,比较2组冷沉淀凝血因子质量变化和合格率、不合格率,并分析不合格制剂原因。结果2种制备方式制备的冷沉淀凝血因子,其容量及纤维蛋白原含量相似,差异均无统计学意义(P>0.05),试验组FⅧ含量高于对照组,差异具有统计学意义(P<0.05);2组冷沉淀凝血因子合格率均在80%以上,均符合国家质控要求,试验组合格率略高于对照组,两者差异无统计学意义(P>0.05);2组冷沉淀凝血因子不合格原因主要与Ⅷ因子含量不合格有关,试验组Ⅷ因子含量相关不合格率低于对照组。结论全自动冷沉淀制备仪制备的冷沉淀凝血因子质量优、效率高,并能实现信息更完整,容易追溯制备的每个过程等优势,采用全自动冷沉淀制备仪制备冷沉淀凝血因子方式值得推荐。Objective To evaluate the quality change of coagulation factors prepared by fully automatic cryoprecipitation preparation instrument.Methods One hundred cryoprecipitates were randomly selected,50 of which were cryoprecipitate prepared by low tempreture water bath melting box(control group),and the other 50 were cryoprecipitate prepared by fully automatic cryoprecipitate preparation instrument(experimental group).By testing the cryoprecipitate coagulation factor capacity,factorⅧcontent and fibrinogen content of the two groups,the quality change of cryoprecipitate coagulation factor and the qualified rate and unqualified rate of the two groups were compared.The reasons of unqualified preparations were analyzed.Results The capacity and fibrinogen content of cryoprecipitate prepared by the two methods were similar,and there was no statistically significant difference.The content of factorⅧin the experimental group was higher than that of the control group,and the difference was statistically significant(P<0.05).The qualified rate of cryoprecipitate coagulation factors in the two groups was above 80%,which met the national quality control requirements.The qualified rate of the experimental group was slightly higher than that of the control group,but there was no statistically significant difference between the two groups(P>0.05).The unqualified factor of cryoprecipitate in two groups was mainly related to the unqualified factorⅧcontent,but the unqualified rate of factorⅧcontent in the experimental group was lower than that in the control group.Conclusion The cryoprecipitate prepared by fully automatic cryoprecipitate preparation instrument has the advantages of high quality,high efficiency,more complete information,and easy traceability of each process of preparation.It is worth recommending the way of preparing cryoprecipitate coagulation factors by the fully automatic cryoprecipitate preparation instrument.

关 键 词：血液凝固因子 全自动冷沉淀制备仪 质量控制 

分 类 号：R457.1[医药卫生—治疗学]