Measurement and analysis of hemolysis rate at the end of storage period of red cells suspension
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摘要: 目的 检测并分析悬浮红细胞储存期末(储存有效期的第29~35天)的溶血率，为临床科学安全用血提供依据。方法 将2021年1月—2022年12月质控抽检的悬浮红细胞共计96袋，在2-6℃条件下保存，对质量指标进行连续监测，收集检测结果并分析。结果 所有样本外观、标签、容量均正常，无菌试验结果均为无菌生长，血细胞比容(HCT)为0.52±0.04，血红蛋白(HB)浓度为(167±14) g/L，HCT比较差异无统计学意义(P＞0.05)、HB比较差异无统计学意义(P＞0.05)。储存期末溶血率分别为(0.08 ±0.04)%、(0.11±0.05)%、(0.11±0.05)%、(0.14±0.06)%、(0.14±0.07)%、(0.17±0.08)%、(0.19±0.08)%，平均(0.13±0.07)%。第1天与第2、3天比较结果一致(P均＞0.05)，第1天与后4 d比较差异有统计学意义(P均 < 0.05)，第2、3、4、5天两两比较结果一致(P均＞0.05)，第2、3天与第6、7天比较差异有统计学意义(P均 < 0.05)。第4、5天与第6天比较差异无统计学意义(P均＞0.05)，第4天与第7天比较差异有统计学意义(P < 0.05)，第5、6天和第7天比较差异无统计学意义(P均＞0.05)。结论 本研究所有样本储存期末各项常规指标检测结果符合要求，相邻两天溶血率比较没有突然改变的趋势，但随着保存时间的延长，溶血率有增高趋势。对储存期末前3 d和后4 d的悬浮红细胞有针对性地选择不同的洗涤液及离心参数去除血浆中游离HB，理论上对提高储存期末悬浮红细胞输注安全性及有效性有所帮助。同时血站、用血医院及相关管理部门应进一步采取适当措施充分利用血液资源的同时也保证临床用血的科学、合理。Abstract: Objective To detect and analyze the hemolysis rate of red cells suspension at the end of their storage period (29th to 35th days of storage validity), in order to provide a basis for scientific and safe blood use.Methods A total of 96 bags of suspended red blood cells were sampled for quality control from January 2021 to December 2022 and stored at 2-6 ℃. The quality indicators were continuously monitored, and the test results were collected and analyzed.Results All samples were in this study, with normal appearance and labeling. The results of the sterility test showed sterile growth, hematocrit (HCT) was 0.52±0.04 and hemoglobin concentration was (167 ± 14)g/L. HCT comparison showed no significant difference(P > 0.05), while HB comparison showed no significant difference(P > 0.05). The hemolysis rates at the end of storage were(0.08±0.04)%, (0.11±0.05)%, (0.11±0.05)%, (0.14±0.06)%, (0.14±0.07)%, (0.17±0.08)% and (0.19±0.08)%, respectively. The average was (0.13 ± 0.07)%. The comparison results on the first day were consistent with those on the second and third days(P > 0.05). There was a significant difference between the first day and the last four days(P < 0.05), and the comparison results on the second, third, fourth, and fifth days were consistent(P > 0.05). There was a significant difference between the second, third, and sixth, seventh days(P < 0.05). There was no significant difference in the results between the fourth, fifth, and sixth days(P > 0.05), but there was a significant difference in the results between the fourth day and seventh day(P < 0.05). There was no significant difference in the comparison results between the fifth, sixth and seventh days(P > 0.05).Conclusion The testing results of all routine indicators at the end of the storage period of all samples in this study met the requirements, and there was no sudden change in the hemolysis rate between the adjacent two days. However, with the extension of storage time, the hemolysis rate showed an increasing trend. Targeted selection of different washing solutions and centrifugation parameters to remove free hemoglobin from plasma for suspended red blood cells from the first three days and the last four days at the end of storage period would be theoretically helpful in improving the safety and effectiveness of suspended red blood cell infusion at the end of storage period. At the same time, blood stations, blood hospitals, and relevant management departments should further take appropriate measures to fully utilize blood resources while ensuring scientific and reasonable clinical blood use.
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Key words:
- red cells suspension /
- end of storage period /
- hemolysis rate /
- clinical blood use
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表 1 悬浮红细胞储存期末质量指标连续监测结果
X±S 储存期末 例数 HCT HB/(g/L) CFHb/(g/L) 溶血率/% D1 96 0.51±0.04 167±16 0.29±0.16 0.08±0.04 D2 96 0.52±0.04 166±15 0.39±0.19 0.11±0.05 D3 96 0.52±0.04 166±14 0.41±0.22 0.11±0.05 D4 96 0.52±0.04 167±15 0.50±0.25 0.14±0.061) D5 96 0.53±0.04 166±14 0.52±0.30 0.14±0.071) D6 96 0.53±0.04 165±13 0.59±0.30 0.17±0.081)2)3) D7 96 0.53±0.04 167±14 0.68±0.30 0.19±0.081)2)3)4) 平均值 96 0.52±0.04 167±14 0.42±0.27 0.13±0.07 与D1比较，1)P < 0.05；与D2比较，2)P < 0.05；与D3比较，3)P < 0.05；与D4比较，4)P < 0.05。 
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