通讯作者: 韩晓燕, lvgb13@163.com

DOI：10.12201/bmr.202603.00002

Analysis of influencing factors on hemolysis rate at the end of storage period of leukocyte-reduced red blood cells and exploration of quality control standards

• 摘要：目的 通过对本血站5年间去白细胞悬浮红细胞储存期末溶血率及相关质控指标的分析，探索献血者对各项质控指标的因素影响，制定对本地区适宜的储存期末溶血率内控标准。方法 收集本血站2021年1月-2025年11月共计246份去白细胞悬浮红细胞血液产品，检测血红蛋白浓度(Hb)、血细胞比容(Hct)以及上清液游离血红蛋白浓度(FHb)，计算出储存期末溶血率，对比现行《全血及成分血质量要求》（GB 18469-2012）中储存期末溶血率0.8%的标准，分析其差异性；根据献血者人群结构分析各项指标的影响因素。结果 去白细胞悬浮红细胞5年间储存期末溶血率平均值±标准差(%)为0.071±0.039，远低于0.8%的国家标准；性别、年龄、职业、血型对于储存期末溶血率无统计学意义，献血者性别是Hb（P<0.01）、Hct（P<0.01）和FHb（P<0.05）的影响因素，均为男性组>女性组；所有样品储存期末溶血率数据均<0.4%，95%的样本数据在0.137%之前。结论 246例样本数据分析结果显示，献血者的性别是Hb、Hct和FHb的影响因素，储存期末溶血率不受献血者性别、年龄、职业、血型因素的影响；去白细胞悬浮红细胞储存期末溶血率现行国家标准<0.8%的合格范围对于本地区而言偏大，可考虑制定适宜本地区的质控指标，将本地区溶血率的内控标准设定为<0.3%，将更有利于本地区血液质量控制以及保障血液质量安全。

  关键词： 去白细胞悬浮红细胞；储存期末溶血率；内控标准；质量控制; ; ; 

   

  Abstract: Objective By analyzing the hemolysis rate and related quality control indexes at the end of storage period of leucocyte-reduced red blood cells in our blood station during the past 5 years, the influence factors of donors on various quality control indexes were explored, and the appropriate internal control standard of hemolysis rate at the end of storage period in our area was established. Methods A total of 246 leucocyte-reduced red blood cell suspension products were collected from January 2021 to November 2025, hemoglobin concentration (Hb), hematocrit (Hct) and supernatant free hemoglobin concentration (FHb) were detected, hemolysis rate at the end of storage period was calculated, and compared with the current Quality Requirements for Whole Blood and Blood Components.(GB18469 -2012), and analyze the difference of hemolysis rate at the end of storage; Analyzing the influencing factors of various indicators based on the population structure of blood donors. Results The average hemolysis rate of leucocyte-reduced red blood cells at the end of 5 years storage was 0.071±0.039, far lower than the national standard of 0.8%. Sex, age, occupation and blood type had no statistical significance on the hemolysis rate at the end of storage. The sex of blood donors was Hb.(P<0.01), Hct (P<0.01) and FHb (P<0.05) were male group> female group; The hemolysis rate data at the end of storage for all samples were <0.4%, and 95% of the samples were before 0.137%. Conclusion The results of data analysis of 246 samples showed that the sex of blood donors was the influential factor of Hb, Hct and FHb, and the hemolysis rate at the end of storage period was not affected by the sex, age, occupation and blood group of blood donors. The current national standard of hemolysis rate <0.8% at the end of storage period of leucocyte-reduced red blood cells is too large for this region. Therefore, quality control indexes suitable for this region can be considered. Setting the internal control standard of hemolysis rate <0.3% will be more conducive to blood quality control and blood quality safety in this region.

  Key words: Leucocyte-reduced red blood cells; Hemolysis rate at the end of storage period; Internal control standard; Quality control

  提交时间：2026-03-02

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• 序号	提交日期	编号	操作
  1	2026-01-26	10.12201/bmr.202603.00002V1	下载

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