目的 对比两代冷沉淀制备仪制备的冷沉淀凝血因子（冷沉淀）的容量以及凝血因子Ⅷ（FⅧ）含量、纤维蛋白原（Fib）含量等质量受控情况,探讨二代设备的技术改进对产品质量的提升效果。方法 将400mL全血制备的新鲜冰冻血浆（FFP）随机分为两组,分别使用ZBK-LCD-A1型（第一代）和ZBK-LCD-A3型（第二代）设备制备冷沉淀凝血因子,检测其凝血因子Ⅷ（FⅧ）、纤维蛋白（Fib）含量及每袋成品容量值,进行t检验、卡方统计学分析,同时比较两代设备制备每袋冷沉淀凝血因子所用时长,计算制备效率。结果 第二代设备制备的冷沉淀凝血因子中,FⅧ含量为（145.48±54.32）IU,显著高于第一代设备的（88.32±42.89）IU,FⅧ含量符合率显著提升;Fib含量及单袋容量无明显差异;二代设备效率更高,具有统计学差异。结论 第二代设备通过优化温度控制、改进夹管蠕动泵和预设产品重量等措施,显著提升冷沉淀凝血因子质量和制备效率。
Abstract
Objective To investigate the quality control parameters, including volume, Factor Ⅷ (FⅧ) content per bag, and fibrinogen (Fib) content per bag, of cryoprecipitate prepared by two generations of cryoprecipitate preparation instruments. In order to evaluate the advantages of the second-generation device. Methods Fresh frozen plasma (FFP) derived from 400ml whole blood units was randomly divided into two groups. Cryoprecipitate was prepared using the ZBK-LCD-A1(first generation) and ZBK-LCD-A3(second generation) instruments, respectively. The FⅧ content, Fib content, and volume of the cryoprecipitate were measured. Statistical analysis using t-tests and chi-square tests was performed. The preparation time per bag for each generation of instrument was also compared to calculate preparation efficiency. Results The FⅧ content in cryoprecipitate prepared by the second-generation instrument was (145.48±54.32) IU significantly higher than that of the first-generation instrument (88.32±42.89) IU. The FⅧ compliance rate increased. Fib content and the volume increased. But the Fib compliance rate showed no statistically significant difference. The average preparation time per bag for the second-generation instrument showed a statistically significant difference compared to the first-generation instrument. Conclusion The second-generation instrument significantly improves the quality and preparation efficiency of cryoprecipitate by optimizing temperature control, improving the peristaltic pump with tube clamping, and presetting product weight, among other measures.
关键词
冷沉淀凝血因子 /
冷沉淀制备仪 /
凝血因子Ⅷ /
纤维蛋白原 /
质量控制
Key words
cryoprecipitated antihemophilic factor /
cryoprecipitate preparation instruments /
factor VIII (FⅧ) /
fibrinogen /
quality control
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] 王培华. 输血技术学[M]. 北京: 人民卫生出版社, 2003: 34.
[2] 周永嘉. 种设备虹吸法制备冷沉淀凝血因子的质量和方法比较[J]. 中国输血杂志, 2019, 32(9): 952-954.
[3] 中华人民共和国国家卫生健康委员会. WS/T623-2018. 全血和成分血使用. 北京: 中国标准出版社, 2018: 275-279.
[4] Green L, Bolton-Maggs P, Beattie C.British Society of Haematology Guidelines on the spectrum of fresh frozen plasma and cryoprecipitate products: their handling and use in various patient groups in the absence of major bleeding. Br J Haematol 2018; 181(1): 54-67.
[5] 高峰. 输血与输血技术[M]. 北京: 人民卫生出版社, 2003: 160-161.
[6] 肖乐宇. 冷沉淀凝血因子制备仪制备冷沉淀的质量评价[J]. 中国输血杂志, 2016, 29(01): 96-97.
[7] 叶青梅. WT-CII全自动冷沉淀制备仪与过夜融化离心法制备冷沉淀凝血因子的质量对比[J]. 齐齐哈尔医学院学报, 2022, 43(09): 870-873.
[8] 陈菊芬, 沈磁石, 叶有玩, 等. 不同时间制备的血浆及冷沉淀的质量比较[J]. 中国输血杂志, 2013, 26(5): 454-456.
[9] 扬丽, 陈健. 冷沉淀制备仪虹吸法与低温水浴箱融化离心法制备冷沉淀的对比研究[J]. 中国卫生产业, 2018, 15(17): 173-174.
[10] 任明臣, 李建伟, 蒲维薇, 等. 采后不同时间分离的血浆所制备的冷沉淀中凝血因子Ⅷ和血浆蛋白原的含量分析[J]. 疾病监测与控制, 2017, 11(11): 904-905.
[11] 易中梅, 王红苹, 李晨晨. 等. 全血手工制备浓缩血小板后的血浆再制备冷沉淀的质量评价[J]. 中国输血杂志, 2013, 26(2): 117-120.
[12] 王媛, 刘国英, 孔大为, 李建斌, 等. 冷沉淀凝血因子融化后储存温度和时间对凝血因子的影响[J]. 中国输血杂志, 2024, 37(4): 425-430.
[13] 吴南, 张志安, 尤榕, 等. 国内24家血液中心全血分离制备成分血的现状研究[J]. 中国输血杂志, 2020, 33(11): 1132-1136.
[14] Gimeno-LLuch, I. ; Benito-Jardón, M. ; Guerrero-Barberà, G. ; Burday, N. ; Costell, M. The Role of the Fibronectin Synergy Site for Skin Wound Healing. Cells 2022, 11, 2100.
[15] 孙昌魁, 王甜甜, 王杰, 房云海. 冷沉淀在罕见出血性疾病中的精准输注[J]. 中国输血杂志, 2025, 38(9): 1150-1153.
[16] 肖成, 徐应芳, 李江, 等. 冷沉淀凝血因子的制备及其临床应用研究进展[J]. 医学综述, 2020, 26(5): 883-887.
[17] 单泓, 李建斌, 别立莉, 等. 血浆保存时间和制备方法对冷沉淀凝血因子质量的影响[J]. 河南医学研究, 2021, 30(5): 795-798.
基金
湖南省卫生健康委卫生科研课题项目“长沙地区临床用血现状及发展趋势分析”（W20243276）
PDF(2102 KB)
