去白细胞红细胞制备的质量控制

The Quality Control of Leukodepleted Red Cell

目的 探索去白细胞红细胞 (LDRC)在制备全程中质量控制的方法 ,优化其制作条件 ,提高其质量 ,保证其临床使用的安全和有效。方法 随机抽取 6 2袋红细胞悬液 (15 0ml/袋 ,由 2 0 0ml全血制备 ) ,采用多元回归分析法对各因素进行分析 ,研究其对白细胞去除效果的影响 ;测定血液滤除前后游离血红蛋白的值 (n =8)。按1%比例抽查并行细菌培养。观察输注后的临床不良反应。结果 ⑴红细胞悬液内血浆的含量与白细胞滤除后袋内残余白细胞计数呈正相关 (P =0 0 0 0 ) ;红细胞悬液内血小板的含量与白细胞滤除后袋内残余白细胞计数数呈负相关 (P =0 0 0 0 )。快速滤除和慢速滤除将增高残存白细胞的数目 ,降低滤除效果。⑵优化质控条件制备LDRC ,将白细胞滤除的时间控制在 10～ 4 0min内 ,结果残余白细胞计数 <1× 10 6/袋的LDRC所占的百分比由4 6 9%提高至 90 91%;白细胞清除率 >3log(99 9%) /袋的LDRC所占的百分比由 5 6 1%提高至 78 1%。⑶红细胞回收率的平均值为 (90 4 8± 4 73) %;游离血红蛋白在白细胞滤除前后的平均值分别为 91 2 5g/l、96 0 0g/l,差别不显著。⑷LDRC在 4℃冰箱储存 1～ 5d ,血培养检测未见细菌生长。⑸临床输注后未见明显不良反应。结论 在制备LDRC过程中 。

Objective To explore the quality control method of leucodepleted red cell concentrate (LDRC) preparation ,to choice an optimal processing , in order to raise the quality of LDRC,so as to ensure the efficiency and safty for the preparation application.Methods 62 bag red cells concentrates suspensin(each 150ml,preparation from 200ml whole blood) were investigated.By linear regression multianalyzed the effects of some factors on efficiency for removal of leukocytes from red cell concentrates.Free hemoglobin value(n=8) was detected before and after leukodepleted filtration.1% samples were tested and bacterial cultured,and observed the clinical adverse effects after LDRC tranfusion.Results ⑴The plasma and platelet in red cell contentrate before filtration,the time of filtration had influence significantly on the result of leukocyte depletion.⑵The percentage of leukodepleted red cell in which residual leukocyte less than 5×10 6/unit and 1×10 6/unit were 100% and 46.9%. The percentage of leukodepleted red cell in which the leukocyte removal efficiency more than 2log(99%)and 3log(99.9%) were 100% and 56.1% .After controlling the time of filtration,the percentage of leukodepleted red cell in which residual leukocyte less than 1×10 6/unit was up from 46.9% to 90.91% and the percentage of leukodepleted red cell in which the leukocyte removal efficiency more than 3log(99.9%)/bag was up from 56.1% to 78.1%.⑶Red blood cell recovery rate was (90.48±4.73)%. There was no significant change of free hemoglublin before and after filtration.⑷No bacteria were detected by germiculture.⑸Evident side effects was no seen after transfusion.Conclusions During the course of removal of leukocytes from red cell concentrates by filtration, the sustained quality control is necessary for improving the quality of leukodepleted red cell.So enforcing aseptic manipulation rigorously and controlling the components of blood,the time of blood storage and filtration appropriately are quite important.