一种国产红细胞洗涤机的性能评价  

Performance Evaluation of a Domestic Red Blood Cell Washing Machine

作　　者：时卉丽[1] 牛宏伟[1] 杨凤霞[1] 李玉秋[2] 程菲[2] 李建民[2] 

机构地区：[1]河北省血液中心质量法规处,石家庄0500711 [2]河北省血液中心成分科,石家庄0500711

出　　处：《中国医药导刊》2017年第1期79-80,共2页Chinese Journal of Medicinal Guide

基　　金：河北省2013年医学科研课题指令性课题(项目编号:20130134);课题名称:国产红细胞洗涤机的性能评价

摘　　要：目的:对一种国产红细胞洗涤机的性能进行评价研究。方法:随机抽取60袋悬浮红细胞,分为两组,实验组采用国产智能红细胞洗涤机及配套耗材制备洗涤红细胞,对照组用手工法制备,按照新版国家标准分别对实验组和对照组的血红蛋白含量、上清蛋白质含量、单位耗费时间和储存期末红细胞溶血率以及无菌实验相关指标进行检测分析。并观测相应制备产品在不同储存期各项质量指标的变化情况。结果:实验组红细胞洗涤机制备的洗涤红细胞的血红蛋白含量、上清蛋白质含量、单位耗费时间和储存期末红细胞溶血率分别是(49.13±4.64)g/bag、(0.39±1.10)g/bag、(32.97±6.23)min/bag和(0.31±0.09)%。对照组手工制备的洗涤红细胞的血红蛋白含量、上清蛋白质含量、单位耗费时间和储存期末红细胞溶血率分别是(43.05±4.87)g/bag、(0.38±1.24)g/bag、(54.50±6.85)min/bag和(0.53±0.12)%。血红蛋白含量、单位耗费时间和储存期末红细胞溶血率两组比较具有统计学差异(P<0.05)。结论:机器产品质量指标更优于手工方法,国产智能红细胞洗涤机更安全、高效。Objective：To use the national standard to compare the quality of washed red blood cells（washed RBCs）prepared by red blood cell washing machine and handmade.Methods：60 bags of RBCs were randomly divided into 2groups（n =30） that were experience group and control group respectively.Washed RBCs were prepared by red blood cell washing machine and handmade on experience group and control group respectively.The level of hemoglobin（Hb）,supernatant protein,unit time and the rate of hemolysis were measured by the 2012 national standard.Results：The level of Hb,supernatant protein,unit time and the rate of hemolysis in experience group were（49.13 ±4.64） g/bag,（0.39 ± 1.10）g/bag,（32.97 ±6.23）min/bag and（0.31 ±0.09）%respectively.The level of Hb,supernatant protein,unit time and the rate of hemolysis in control group were（43.05 ±4.87） g/bag,（0.38 ± 1.24） g/bag,（54.50 ± 6.85） min/bag and（0.53 ±0.12）%.The differences in Hb,unit time and the rate of hemolysis were statistically significant between these 2groups（P〈0.05）.Conclusion：All of the preparing products can meet the requirements of the new national standard in two groups.The quality of washed RBCs prepared by red blood cell washing machine was better than by handmade.The method of red blood cell washing machine was safter and shorter time.

关 键 词：洗涤红细胞 智能红细胞洗涤机 国标 质量 

分 类 号：R446[医药卫生—诊断学]