重庆地区不同血液制剂质量检测回顾性分析  

Retrospective analysis of quality data of different blood components in Chongqing

作　　者：骆展鹏[1] 傅奇[1] 曾北南 杨春燕[1] 杨丹蓉 彭楷[1] 汪娟[1] LUO Zhanpeng;FU Qi;ZENG Beinan;YANG Chunyan;YANG Danrong;PENG Kai;WANG Juan(Chongqing Blood Center,Chongqing 400015,China.)

机构地区：[1]重庆市血液中心,重庆400015

出　　处：《中国输血杂志》2022年第9期980-982,共3页Chinese Journal of Blood Transfusion

基　　金：2022年重庆市科卫联合面上项目(2022MSXM134)。

摘　　要：目的通过回顾性分析重庆地区各级血站近2年不同血液制剂抽检结果,为制定相对统一的质量控制策略,从而达到辖区内各血站同质化建设的要求提供参考。方法回顾性分析重庆地区6家采供血机构血液制剂关键质量检测数据。按各单位近2年临床发放量,选择确定去白细胞悬浮红细胞、冷沉淀凝血因子、病毒灭活新鲜冰冻血浆、单采血小板作为研究对象。收集并分析2019年1月~2021年6月上述各类血液制剂质量抽检结果数据。结果5家血站制备的去白细胞悬浮红细胞(1 U),其Hb、白细胞残留量、期末溶血率有差异(P<0.05);Hct无差异(P>0.05)。3家血站制备的冷沉淀凝血因子(1 U),Ⅷ因子含量和纤维蛋白原含量均有差异(P<0.05);5家血站制备的冷沉淀凝血因子(2 U),Ⅷ因子含量和纤维蛋白原含量均有差异(P<0.05)。3家血站制备的病毒灭活新鲜冰冻血浆,Ⅷ因子含量、血浆蛋白浓度、亚甲蓝残留量结果均有差异(P<0.05)。2家血站制备的单采血小板,Plt、WBC混入量、RBC混入量,期末pH值均有差异(P<0.05)。结论不同血站提供的血液制剂其质量指标虽然满足国标的要求,但各血站之间存在一定差异,因此需要明确和统一采集、制备、储存和运输过程中的关键点控制策略,从而减小彼此间的差异,为下一步同质化建设确定方向和依据。Objective To provide reference for formulating relatively unified quality control strategies and meeting the requirements of homogenization construction of blood banks across Chongqing area by retrospectively analyzing sampling results of different blood components during the past two years in all levels of blood banks in Chongqing area.Methods The key quality data of blood components prepared by 6 blood banks in Chongqing were analyzed retrospectively.According to the issuing units to the clinical during the past two years,the research objects were selected as leukocyte-depleted suspended RBCs,cryoprecipitate,pathogen inactivated fresh frozen plasma(FFP)and apheresis platelets.The quality data of the above-mentioned blood components from January 2019 to June 2021 were collected and analyzed.Results For leukocyte-depleted suspended RBCs(1U)prepared by 5 blood banks,statistically significant differences in Hb,residual white blood cells and hemolysis rate at the end of storage,except for Hct,were noticed(P<0.05).For cryoprecipitate,the content of blood coagulation factorⅧand fibrinogen were statistically different among 3 blood banks in 1U specification(P<0.05)and among 5 blood banks in 2U specification(P<0.05).For pathogen inactivated FFP,the content of blood coagulation factorⅧ,plasma proteins,and residual methylene blue were statistically different among 3 blood banks(P<0.05).For apheresis platelets,Plt,white/red blood cells contamination and pH at the end of storage were statistically different among 3 blood banks(P<0.05).Conclusion The quality data of blood components,prepared by different blood banks,meet the requirements of national standard,however,certain differences are existing among blood banks.Key points during the process of collection,preparation,storage and transportation need to be cleared and unified,so as to reduce the differences between each other,and determine the direction and basis for homogeneity construction in the next step.

关 键 词：血液制剂 质量检测 同质化 

分 类 号：R457.12[医药卫生—治疗学]