红细胞类血液成分质量监测数据的评估与探讨  

Assessment and discussion of quality monitoring data for red blood cell preparations

作　　者：卿芸 代华友 杨俊鸿[1] 许茜 吴思其 田耘博[1] 黄霞[1] QING Yun;DAI Huayou;YANG Junhong;XU Qian;WU Siqi;TIAN Yunbo;HUANG Xia(Chongqing Blood Center,Chongqing 400052,China)

机构地区：[1]重庆市血液中心,重庆400052

出　　处：《中国输血杂志》2025年第2期227-232,243,共7页Chinese Journal of Blood Transfusion

基　　金：重庆市卫生健康委医学科研项目(2024WSJK062)。

摘　　要：目的 评估红细胞类成分血质量监测指标数据特征,为持续改进血液质量提供参考依据。方法 汇总重庆血站2019—2023年6类红细胞血液成分的质量抽检数据。针对相同的指标,不同种类血液成分间及与GB18469的比较,监测其质量指标的数值范围;比较制备流程对红细胞的损失和/或损伤,探讨不同制备流程对红细胞质量带来的影响。结果 6类红细胞血液成分外观与无菌试验符合率均为100%,其余项目均≥75%。悬浮红细胞的血细胞比容符合率75%最低,中位数为0.52,靠近GB18469下限(0.50),其余种类的血细胞比容中位数都处于GB18469中线水平,不同种类红细胞血液成分的实际血红蛋白含量都显著高于其对应的GB18469要求(P<0.05),不同种类红细胞血液成分的储存期末溶血率均显著低于GB18469要求(P<0.05)。1 U滤白流程使血红蛋白含量损失约5%,对储存期末溶血率有显著影响(P<0.05);洗涤流程使血红蛋白含量损失<3%,对储存期末溶血率无显著影响(P>0.05);浓缩流程使血红蛋白含量损失<3%,对储存期末溶血率的影响显著(P<0.05)。结论 不同血液制备过程对红细胞类血液成分的影响在可控范围内且均满足GB18469要求,质量监测数据能够为临床血液选择、效果评价和相关标准修订提供参考。Objective To assess the data characteristics of quality monitoring indicators for red blood cell(RBC)preparations,so as to provide reference for continuous improvement of blood quality.Methods The quality inspection data of 6 types of RBC preparations from Chongqing blood center from 2019 to 2023 were summarized.For the same indicators,the numerical range of quality indicators was monitored by comparing different types of preparations with the national standard GB18469.The loss and/or damage to RBCs caused by different preparation process were compared,and the impact of different preparation processes on the quality of RBCs was discussed.Results The appearance and sterility test compliance rates of the six types of RBC preparations were both 100%,while the compliance rates of other items were all≥75%.The compliance rate of hematocrit for suspended RBCs was the lowest at 75%,with a median of 0.52,which was close to the lower limit of GB18469,while the medians of hematocrit for the other types were all at the midline level of GB18469.The Hb content for different types of RBCs was significantly higher than the corresponding requirements of GB18469(P<0.05).The hemolysis rate at the end of storage for different types of RBCs was significantly lower than the requirements of GB18469(P<0.05).The 1 U leukoreduction process resulted in a hemoglobin content loss of about 5%and had a significant impact on the hemolysis rate at the end of storage(P<0.05).The washing process resulted in a hemoglobin content loss of<3%and had no significant impact on the hemolysis rate at the end of storage(P>0.05).The concentration process resulted in a hemoglobin content loss of<3%and had a significant impact on the hemolysis rate at the end of storage(P<0.05).Conclusion The impact of different processes on RBC preparations is within a controllable range and meets the requirements of GB18469.The quality monitoring data can provide a reference for clinical blood selection,effectiveness evaluation and revision of related standards.

关 键 词：红细胞 血液成分 质量差异 质量控制 GB18469 

分 类 号：R457.12[医药卫生—治疗学]