目的 了解血站冷沉淀凝血因子的质量状况,为临床输注提供准确的数据支持。 方法 统计2015年1月—2017年12月某血站抽检及跟踪检测的172份冷沉淀凝血因子质量监测结果,分析Ⅷ因子含量不合格的原因。 结果 172份冷沉淀凝血因子外观、容量、无菌试验合格率100.0%,Ⅷ因子含量合格率83.1%(143/172),纤维蛋白原含量合格率98.3%(169/172)。29份Ⅷ因子含量不合格的冷沉淀多数分布在夏季和春节前后。 结论 优化流程,增加速冻设备;严格按操作规程作业,降低人为因素对质量的影响;融化后尽快输注,减少Ⅷ因子活性的衰减,确保其安全有效。

Objective To understand the quality status of cryoprecipitated antihemophilicfactor in a blood station, so as to provide the accurate datum support for clinical infusion. Methods From January 2015 to December 2017, 172 samples of cryoprecipitated antihemophilic factor and coagulation factors were collected and tracked, and the causes of unqualified content of factor Ⅷ were analyzed. Results Among the 172 samples of cryoprecipitation coagulation factor, the qualified rates of appearance, volume, and aseptic test were all 100%. The qualified rate of Ⅷ factor content was 83.1% (143/172). The qualified rate of fibrinogen content was 98.3% (169/172). Among the 29 samples of unqualified content of factor Ⅷ, the majority of cold precipitation was distributed around summer and Spring Festival. Conclusion It is necessary to optimize the process, increase the quick-freezing equipment, and strictly follow the operating procedures, and so on, so as to improve the efficiency and safety of the infusion.