一项多中心研究：用40%（重量/体积）甘油冷冻人红细胞，并在去甘油后于4℃在AS-3中储存15天的体外和体内值评估：ACP 215中红细胞处理的评估

A multicenter study of in vitro and in vivo values in human RBCs frozen with 40-percent (wt/vol) glycerol and stored after deglycerolization for 15 days at 4 degrees C in AS-3: assessment of RBC processing in the ACP 215.

作者信息

Valeri C R, Ragno G, Pivacek L E, Srey R, Hess J R, Lippert L E, Mettille F, Fahie R, O'Neill E M, Szymanski I O

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):933-9. doi: 10.1046/j.1537-2995.2001.41070933.x.

DOI:10.1046/j.1537-2995.2001.41070933.x

PMID:11452163

Abstract

BACKGROUND

The FDA has approved the storage of frozen RBCs at -80 degrees C for 10 years. After deglycerolization, the RBCs can be stored at 4 degrees C for no more than 24 hours, because open systems are currently being used. Five laboratories have been evaluating an automated, functionally closed system (ACP 215, Haemonetics) for both the glycerolization and deglycerolization processes.

STUDY DESIGN AND METHODS

Studies were performed at three military sites and two civilian sites. Each site performed in vitro testing of 20 units of RBCs. In addition, one military site and two civilian sites conducted autologous transfusion studies on ten units of previously frozen, deglycerolized RBCs that had been stored at 4 degrees C in AS-3 for 15 days. At one of the civilian sites, 10 volunteers received autologous transfusions on two occasions in a randomized manner, once with previously frozen RBCs that had been stored at 4 degrees C in AS-3 for 15 days after deglycerolization and once with liquid-preserved RBCs that had been stored at 4 degrees C in AS-1 for 42 days.

RESULTS

The mean +/- SD in vitro freeze-thaw-wash recovery value was 87 +/- 5 percent; the mean +/- SD supernatant osmolality on the day of deglycerolization was 297 +/- 5 mOsm per kg of H(2)O, and the mean +/- SD percentage of hemolysis after storage at 4 degrees C in AS-3 for 15 days was 0.60 +/- 0.2 percent. The paired data from the study of 10 persons at the civilian site showed a mean +/- SD 24-hour posttransfusion survival of 76 +/- 6 percent for RBCs that had been stored at 4 degrees C for 15 days after deglycerolization and 72 +/- 5 percent for RBCs stored at 4 degrees C in AS-1 for 42 days. At the three sites at which 24-hour posttransfusion survival values were measured by three double-label procedures, a mean +/- SD 24-hour posttransfusion survival of 77 +/- 9 percent was observed for 36 autologous transfusions to 12 females and 24 males of previously frozen RBCs that had been stored at 4 degrees C in AS-3 for 15 days after deglycerolization.

CONCLUSION

The multicenter study showed the acceptable quality of RBCs that were glycerolized and deglycerolized in the automated ACP 215 instrument and stored in AS-3 at 4 degrees C for 15 days.

摘要

背景

美国食品药品监督管理局（FDA）已批准在-80℃下储存冰冻红细胞10年。脱甘油后，由于目前使用的是开放系统，红细胞可在4℃下储存不超过24小时。五个实验室一直在评估一种用于甘油化和脱甘油过程的自动化、功能封闭系统（ACP 215，Haemonetics公司）。

研究设计与方法

研究在三个军事地点和两个民用地点进行。每个地点对20单位红细胞进行体外测试。此外，一个军事地点和两个民用地点对10单位先前冷冻、脱甘油且已在AS-3中于4℃储存15天的红细胞进行自体输血研究。在其中一个民用地点，10名志愿者以随机方式接受了两次自体输血，一次使用脱甘油后在AS-3中于4℃储存15天的先前冷冻红细胞，一次使用在AS-1中于4℃储存42天的液态保存红细胞。

结果

体外冻融洗涤回收率的平均值±标准差为87±5%；脱甘油当天上清液渗透压的平均值±标准差为297±5毫摩尔每千克水，在AS-3中于4℃储存15天后溶血百分比的平均值±标准差为0.60±0.2%。来自民用地点10人研究的配对数据显示，脱甘油后在4℃储存15天的红细胞输血后24小时存活率的平均值±标准差为76±6%，在AS-1中于4℃储存42天的红细胞为72±5%。在通过三种双标记程序测量输血后24小时存活率的三个地点，对12名女性和24名男性进行的36次自体输血中，脱甘油后在AS-3中于4℃储存15天的先前冷冻红细胞输血后24小时存活率的平均值±标准差为77±9%。