Performance evaluation of all-round automatic air-cooled cryoprecipitate coagulation factor preparation instrument
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摘要: 通过设置不同风速及送风模式，以探讨风冷冷沉淀凝血因子制备仪最佳性能，明确该制备仪在制备冷沉淀凝血因子过程中各参数的设定。每次取20袋200 mL规格冰冻生理盐水，设置5种不同的风速及送风模式(实验组)，监测冰冻生理盐水袋底部和顶部的温度变化，融化过程中液体随时被蠕动泵转移至空袋中，当融化至40~50 mL时，蠕动泵停止工作，闭合导管，记录融解时间；每次取20袋200 mL规格的新鲜冰冻血浆，用融化时间最短的3种模式制备冷沉淀凝血因子，测定冷沉淀凝血因子FⅧ和纤维蛋白原(FIB)含量。5种不同融解模式浆袋底部风场温度为3.4~4.0℃，顶部风场温度为4.0~6.0℃，除模式1顶部风场温度为6.0℃外，其余温度均控制在(4.0±0.5)℃，模式1与其他4个模式比较，差异有统计学意义(P< 0.01)；5种模式融解时间为96.9~315.8 min，前后2模式比较，差异有统计学意义(P< 0.01)。模式3、模式4、模式5制备的冷沉淀凝血因子FⅧ和FIB含量呈上升趋势，差异均无统计学意义。随机挑选符合制备冷沉淀凝血因子要求的200 mL新鲜冰冻血浆(FFP) 80袋为对照组。对照组与实验组模式3、模式4、模式5制备的冷沉淀凝血因子FⅧ和FIB含量比较，差异有统计学意义。模式5融解时间最短，制备的冷沉淀凝血因子FⅧ和FIB含量最高，是最优模式，值得推广。Abstract: By setting different wind speeds and different blowing modes, the optimal performance of the air-cooled cryoprecipitate coagulation factor preparation instrument was discussed, and the parameter settings of the preparation instrument in the process of preparing cryoprecipitate coagulation factors were clarified. Take 20 bags of 200 mL specification frozen saline each time, set 5 different wind speeds and blowing modes, monitor the temperature changes at the bottom and top of the bag body, and transfer the liquid during the melting process to the empty bag by the peristaltic pump at any time. When 40-50 mL was injected, the peristaltic pump stopped working, the catheter was closed, and the melting time was recorded; 20 bags of FFP with a specification of 200 mL were taken each time, and the cryoprecipitate coagulation factor was prepared in the three modes with the shortest melting time, and the cryoprecipitate coagulation factor FⅧ and fibrinogen(FIB) content. Under the five different melting modes, the temperature of the bottom wind field of the pulp bag is 3.4-4.0 ℃, and the temperature of the top wind field is 4.0-6.0 ℃, respectively. Except for mode 1, the temperature of the top wind field is 6.0 ℃, and the other temperatures are controlled at(4.0±0.5) ℃, mode 1 compared with the other four modes, the difference was statistically significant(P< 0.01); the melting time of the five modes was 96.9-315.8 minutes, respectively, compared with the two modes before and after, the difference was all statistically significant(P< 0.01). The contents of cryoprecipitate coagulation factor FⅧ and FIB prepared by mode 3, mode 4 and mode 5 in the experimental group showed an upward trend, and the comparison was not statistically significant. The content of cryoprecipitate coagulation factor FⅧ and FIB prepared by mode 3, mode 4 and mode 5 in the control group and the experimental group were statistically significant. Mode 5 has the shortest melting time and the highest content of cryoprecipitated coagulation factor FⅧ and FIB, which is the optimal mode and is worth popularizing.
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Key words:
- cryoprecipitate coagulation factor /
- preparation /
- quality /
- wind speed /
- air cooling
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表 1 5种不同融解模式效果比较
X ±S 模式1 模式2 模式3 模式4 模式5 底部风场温度/℃ 4.00±0.23 3.80±0.19 3.40±0.21 3.60±0.26 3.60±0.18 顶部风场温度/℃ 6.00±0.39 4.00±0.29 4.20±0.26 4.20±0.25 4.20±0.21 融解时间/min 315.8±21.5 164.3±13.2 144.6±10.5 117.7±5.3 96.9±3.5 
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表 2 对照组和实验组制备效果比较
n=20，X ±S 模式3 模式4 模式5 F P 对照组 F P 融解时间/min 146.1±15.1 109.3±10.5 95.5±8.7 99.2 ＜0.001 75.5±13.2 120.5 ＜0.001 FⅧ/(IU·2U-1) 132.7±36.6 139.3±41.8 143.9±28.7 0.48 0.62 91.3±25.2 10.2 ＜0.001 FIB/(mg·2U-1) 252.3±56.2 261.9±64.5 268.3±48.9 0.38 0.39 193.2±55.6 7.4 ＜0.001
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