全血于22℃保存24h分离制备悬浮红细胞及浓缩血小板的质量评价

Quality evaluation of red blood cell suspension and platelet concentrate separated and prepared from whole bloodstored at 22℃ for 24 hours

目的评价全血于22 ℃保存24 h分离制备悬浮红细胞及浓缩血小板的质量。方法采用简单随机抽样法选择2014年5月至2015年2月广东省茂名市中心血站招募的60例献血者为研究对象。研究对象纳入标准：所有献血者献血前体检及相关血液学检查结果符合《献血者健康检查要求》（GB18467-2011）的相关规定。将60例献血者随机分为2组，每组各30例。两组献血者均分别采用五联采血袋采集全血各400 mL，共计60袋全血。研究组献血者全血置于22 ℃保存和运输，并于采血后24 h制备悬浮红细胞和浓缩血小板。对照组献血者全血于22 ℃保存和运输，并于采血后8 h内制备悬浮红细胞和浓缩血小板。两组献血者全血均采用白膜法制备悬浮红细胞和浓缩血小板。悬浮红细胞4 ℃保存至储存期末（制备后35 d），采用Bact/ALERT全自动微生物检测系统对其进行无菌试验；并比较两组悬浮红细胞的红细胞计数、血细胞比容（HCT）、血红蛋白（Hb）水平、游离血红蛋白（FHb）水平、储存期末溶血率，以及K＋、Na＋、Cl－浓度。浓缩血小板22 ℃保存至储存期末（制备后5 d），采用Bact/ALERT全自动微生物检测系统对其进行无菌试验；并比较两组浓缩血小板的血小板含量、红细胞混入量、FHb水平、储存期末pH值、黏附率、聚集率及K＋、Na＋、Cl－浓度。结果①研究组与对照组悬浮红细胞储存35 d后，均无细菌生长；两组浓缩血小板储存5 d后，均无细菌生长；②研究组与对照组悬浮红细胞储存35 d后，其血细胞比容（HCT）、血红蛋白（Hb）水平、储存期末溶血率均符合《全血及成分血质量要求》（GB18469-2012）的相关规定；两组悬浮红细胞的红细胞计数、HCT、Hb水平、FHb水平、储存期末溶血率及K＋、Na＋、Cl－浓度比较，差异均无统计学意义（t＝0.55、0.51、1.18、0.48、0.72、2.86、2.07、2.40，P〉0.05）；③两组浓缩血小板储存5 d后，其血小板含量、红细胞混入量、储存期末pH值均符合《全血及成分血质量要求》（GB18469-2012）的相关规定；两组浓缩血小板的血小板含量、红细胞混入量、FHb水平、血小板黏附率、血小板聚集率，储存期末pH值，以及K＋、Na＋、Cl－浓度比较，差异均无统计学意义（t＝0.17、0.16、0.56、2.43、0.36、2.50、1.85、1.75、0.32，P〉0.05）。结论22 ℃保存24 h制备的悬浮红细胞、浓缩血小板的质量符合国家标准，全血22 ℃保存过夜分离制备悬浮红细胞、浓缩血小板的方法可行。

Objective To evaluate the quality of red blood cell suspension and platelet concentrate separated and prepared from whole blood stored at 22℃ for 24 h. Methods From May 2014 to February 2015, a total of 60 voluntary blood donors who were recruited by Maoming Central Blood Station of Guangdong Province were included into this study, using simple random sampling method. The inclusion criterion for subjects was that the physical examination and related hematology tests results of all blood donors before blood donation met the relevant regulations in the Whole Blood and Blood Component Donor Selection Requirements （GB18467-2011）. All the 60 donors were randomly divided into study group （n = 30） and control group （n：30）. A total of 60 bags of whole blood （400 mL） were collected from the blooddonors in the two groups, using quintuple blood collection bags. In the study group, the whole blood was stored and transported at 22℃, and prepared into red blood cell suspension and platelet concentrate 24 h after blood collection. In the control group, the whole blood was also stored and transported at 22 ℃, and prepared into red blood cell suspension and platelet concentrate within 8 h after blood collection. The preparation of red blood cell suspension and platelet concentrate in both groups was conducted by the buffy coat method. Red blood cell suspension was stored at 4 ℃until the end of the storage period （35 d after preparation）, and its sterility test was using Bact/ALERT full-automatic microbial detection system. Moreover, red blood cell count, hematocrit （HCT）, hemoglobin （Hb） level, free hemoglobin （FHb） level, hemolytic ratio at the end of the storage period, and K＋ , Na＋ and C1- concentrations in red blood cell suspension were compared between the study group and control group. Also, platelet concentrate was stored at 22 ℃ until the end of the storage period （5 d after preparation）, and its sterilty test was using Bact/ ALERT full-automatic microbial detection system. Additionally, platelet content, red cell volume, FHb level, pH value at the end of the storage period, adhesion rate, aggregation rate, and K＋ , Na＋ and C1- concentrations in platelet concentrate were compared between the study group and control group. Results （1） In the study group and the control group, there was no bacterial growth found in red blood cell suspension 35 d after storage, and in platetet concentrate 5 d after storage. （2） In the red blood cell suspension of both groups 35 d after storage, all test results of HCT, Hh level and hemolytic ratio at the end of the storage period met the relevant requirements in Quality Requirements for Whole Blood and Blood Components （GB18469-2012）. There were no significant differences comparisons of red blood cell count, HCT, level of Hb, level of FHb, hemolytic ratio at the end of the storage period, and K＋ , Na＋ and C1- concentrations in the red blood cell suspension of both groups （t=0.55, 0.51, 1.18, 0.48, 0.72, 2.86, 2.07, 2.40; P〉0.05）. （3） In the platelet concentrate of both groups 5 d after storage, all test results of platelet content, red cell volume and pH value at the end of the storage period met the relevant requirements in Quality Requirements for Whole Blood and Blood Components （GB18469-2012）. There were no significant differences comparisons of platelet content, red cell volume, level of FHb, platelet adhesion rate, platelet aggregation rate, K＋ , Na＋ and CI- concentrations, and pH value in the platelet concentrate of both groups （t=0.17, 0.16, 0.56, 2.43, 0.36, 2.50, 1.85, 1.75, 0.32; P〈0.05）. Conclusions Thequality of the red blood cell suspension and platelet concentrate prepared by whole blood stored at 22℃ for 24 h met national standards. Therefore, the separation and preparation of red blood cell suspension and platelet concentrate using whole blood stored at 22 ℃ overnight is feasible.