CAJ | 학술논문

目的：探讨虹吸法制备冷沉淀不合格发生率及不合格的原因，为采供血机构制备出高质量的冷沉淀提供理论依据。方法回顾性分析2011年1月~2014年1月期间我血液中心质控科对我科采用虹吸法制备的冷沉淀质量控制结果，统计不合格原因，计算不合格率，并从各个环节探讨影响冷沉淀质量的因素。结果每个月随机抽检4袋，连续36个月，共抽检144袋，不合格产品共计17袋，不合格率为11.8%；不合格产品中，均为Ⅷ因子含量不足。结论冷沉淀不合格原因主要为Ⅷ因子含量不足，从原料血、原料血浆及冷沉淀制备等多个环节进行控制可以减少或预防不合格产品的出现。
목적：탐토홍흡법제비랭침정불합격발생솔급불합격적원인，위채공혈궤구제비출고질량적랭침정제공이론의거。방법회고성분석2011년1월~2014년1월기간아혈액중심질공과대아과채용홍흡법제비적랭침정질량공제결과，통계불합격원인，계산불합격솔，병종각개배절탐토영향랭침정질량적인소。결과매개월수궤추검4대，련속36개월，공추검144대，불합격산품공계17대，불합격솔위11.8%；불합격산품중，균위Ⅷ인자함량불족。결론랭침정불합격원인주요위Ⅷ인자함량불족，종원료혈、원료혈장급랭침정제비등다개배절진행공제가이감소혹예방불합격산품적출현。
Objective To explore the incidence and the reason of substandard cryoprecipitate prepared from fresh frozen plasma with siphonage method and provide a theoretical basis for preparing high-quality cryoprecipitate for blood collection agencies. Methods Quality control results of cryoprecipitate with siphonage method were dealed by retrospective analysis from January 2011 to January 2014 in our Blood Centre. Substandard reasons were counted, sub-standard rates were calculated, then factors influencing the quality of cryoprecipitate were analyzed from different links. Results Four bags were randomly sampled per month, for 36 consecutive months, and 144 bags were sampled totally. 17 bags of 144 were substandard prouducts, substandard rate was 11.8%. The content of factor Ⅷ of 17 bags were in-adequate. Conclusion The inadequate content of factor Ⅷ is the main reason of the substandard cryoprecipitate pre-pared from fresh frozen plasma with siphonage method, it can be reduced or prevented the emergence of substandard prouducts by controling whole blood, fresh frozen plasma and cryoprecipitate prepared and so on.