单采红细胞在体内的存活情况：用40%（重量/体积）甘油冷冻，在ACP 215中进行去甘油处理，然后在AS-3中于4℃储存长达21天。

In vivo survival of apheresis RBCs, frozen with 40-percent (wt/vol) glycerol, deglycerolized in the ACP 215, and stored at 4 degrees C in AS-3 for up to 21 days.

作者信息

Valeri C R, Ragno G, Pivacek L, O'Neill E M

机构信息

Naval Blood Research Laboratory, Boston University School of Medicine, 625 Albany Street, Boston, MA 02118, USA.

出版信息

Transfusion. 2001 Jul;41(7):928-32. doi: 10.1046/j.1537-2995.2001.41070928.x.

DOI:10.1046/j.1537-2995.2001.41070928.x

PMID:11452162

Abstract

BACKGROUND

The FDA has approved the storage of frozen RBCs at -80 degrees C for 10 years and the postwash storage at 4 degrees C for no more than 24 hours. The 4 degrees C postwash storage period is limited to 24 hours, because the current deglycerolization systems are functionally open systems.

STUDY DESIGN AND METHODS

Two units of RBCs were collected from each of 13 healthy male volunteers. The RBCs were collected in CP2D by the FDA-approved protocol for an automated apheresis device (MCS, LN8150, Haemonetics) and were stored at 4 degrees C in AS-3 for 6 days. Using a single disposable glycerolization set in an automated, functionally closed system (ACP 215, Haemonetics) each unit was transferred to a 1000-mL PVC plastic bag and glycerolized to a concentration of 40-percent (wt/vol) glycerol and frozen at -80 degrees C. A single disposable deglycerolization set in the ACP 215 was used to deglycerolize the 2 units from the same donor. The deglycerolized RBCs were stored at 4 degrees C in AS-3 for as long as 21 days.

RESULTS

The mean +/- SD freeze-thaw-wash recovery value was 89.4 +/- 3 percent. The residual hemolysis in the RBCs stored at 4 degrees C in AS-3 for 21 days after deglycerolization was 0.9 +/- 0.2 percent, and the units were negative for both aerobic and anaerobic bacteria. The mean Nageotte WBC count was 9 x 10(6) per unit. When the deglycerolized RBCs were given as an autologous transfusion after storage at 4 degrees C in AS-3 for the 7- to 18-day period, the mean +/- SD 24-hour posttransfusion survival was 77 +/- 7 percent, and the index of therapeutic effectiveness was 69 +/- 8 percent.

CONCLUSION

Two units of human RBCs collected from a single donor by apheresis in the MCS using an LN8150 set can be glycerolized sequentially with a single disposable set and deglycerolized sequentially with another single disposable set in the ACP 215. The previously frozen RBCs stored in AS-3 for 7 to 18 days at 4 degrees C had acceptable hemolysis and an acceptable mean 24-hour posttransfusion survival value and index of therapeutic effectiveness.

摘要

背景

美国食品药品监督管理局（FDA）已批准将冰冻红细胞在-80℃储存10年，洗涤后在4℃储存不超过24小时。洗涤后在4℃的储存期限制为24小时，因为目前的去甘油化系统在功能上属于开放系统。

研究设计与方法

从13名健康男性志愿者中每人采集两单位红细胞。红细胞通过FDA批准的用于自动单采设备（MCS，LN8150，Haemonetics公司）的方案采集于CP2D中，并在4℃的AS-3中储存6天。使用自动功能封闭系统（ACP 215，Haemonetics公司）中的单个一次性甘油化装置，将每个单位的红细胞转移至1000 mL的聚氯乙烯塑料袋中，甘油化至甘油浓度为40%（重量/体积），并在-80℃冷冻。使用ACP 215中的单个一次性去甘油化装置对来自同一供体的两单位红细胞进行去甘油化。去甘油化的红细胞在4℃的AS-3中储存长达21天。

结果

冻融洗涤回收率的平均值±标准差为89.4±3%。去甘油化后在4℃的AS-3中储存21天的红细胞中的残余溶血率为0.9±0.2%，且这些单位的需氧菌和厌氧菌检测均为阴性。Nageotte白细胞计数平均值为每单位9×10⁶个。当去甘油化的红细胞在4℃的AS-3中储存7至18天后进行自体输血时，输血后24小时存活率的平均值±标准差为77±7%，治疗效果指数为69±8%。