深低温保存血小板的标准制定及质量控制  

Standard establishment and quality control of cryopreserved platelets

作　　者：邢颜超[1] 李卉[2] 刘景汉[2] 王德清[2] 何新健[1] 姜文亭[1] 

机构地区：[1]兰州军区乌鲁木齐总医院输血科,新疆乌鲁木齐830000 [2]解放军总医院输血科

出　　处：《中国输血杂志》2008年第11期846-848,共3页Chinese Journal of Blood Transfusion

基　　金：国家自然科学基金(编号30271443);军队"十一五"重大专项课题基金(编号06Z059)资助课题

摘　　要：目的探讨建立系统完善的深低温保存血小板的制备标准与质控标准。方法制定200 m l全血中血小板的批量分离和深低温保存,包括采血、离心、分离、加入二甲亚砜(DMSO)、深低温保存和复温的全过程的制备标准;建立深低温保存血小板冻存前和复温后的质控标准,并按标准抽检1年中使用的48袋(每月4袋)深低温保存前后的血小板。结果48袋深低温保存血小板的保存的时间跨度为5—275 d;冻存前血小板平均容量为(91.21±12.35)m l/袋,平均含量为(3.13±0.51)×1010/袋,血小板体积分布宽度(PDW)的均值为17.06±0.51,平均血小板体积(MPV)的均值为(9.65±0.90)fl,红细胞污染数的均值(0.51±0.09)×109/袋,白细胞污染数的均值(0.96±0.23)×108/袋;HBsAg、抗-HCV、抗-H IV、梅毒特异性抗体阴性,丙氨酸氨基转移酶(ALT)在正常范围内;深低温保存血小板复温后pH值的均值为(7.20±0.86),血小板计数(P lt)平均回收率的均值为(96.78±1.34)%,MPV的平均增加值为(13.56±3.04)%;复温后细菌培养结果阴性,HBsAg、抗-HCV、抗-H IV、梅毒特异性抗体阴性,ALT在正常范围内;48袋深低温保存血小板的外观及化验检测结果均合格。结论所建立的深低温保存血小板的制备标准及质控标准能保证该成分临床应用的安全性和有效性。Objective To establish a set of guidelines and principles of preparation and quality control of cryopreserved platelets, derived from the volunteer donors. Methods The standard preparation procedure of cryopreserved platelets included blood collection, centrifugation, upper platelet harvested, DMSO infusion, freezing and thawing. Meanwhile, the standard quality control was also established. Four hags of cryopreserved platelets were spot checked monthly according to the standard quality control. Results A total of 48 bags （ 4 bags per month ） of cryopreserved platelets ,with storage period varied from 5 to 275 days, were spot checked by quality control lab. Before freezing, the mean indexes of cryopreserved platelets per bag were as follows ： volume （ 91.21 ± 12. 35 ） ml, platelet count （Plt ） （ 3. 13 ± 0. 51 ） × 10^10 platelet distribution width （PDW） 17.06 ＋0. 51 ,mean platelet volume （ MPV） （9.65 ±0. 90）fl. The contamination of red and white blood cells per bag were （ 0.51 ± 0. 09 ） × 10^9 and （ 0. 96± 0. 23 ） × 10^8, respectively. After thawing, the mean indexes were as follows ： pH 7. 20 ± 0. 86, Pit and MPV （ 96. 7 ± 1.34 ） % and （ 13.56 ± 3.04 ） %, respectively. All bacteria cultures were negative. The tests for HBsAg, anti-HCV, anti-HIV and TP were all negative before freezing and after thawing. The ALT values were all among normal range. Conclusion The standard establishment of preparation and quality control of cryopreserved platelets could assure their safety and efficiency in clinical practice.

关 键 词：血小板 深低温保存 质控 输血 

分 类 号：R457.12[医药卫生—治疗学] R331.143[医药卫生—临床医学]