在储存在DEHT/PAGGSM和DEHP/SAGM容器中的红细胞缩物中,细菌的增殖是可比的
Sandra Ramirez-Arcos1,2, Yuntong Kou1, Dilini Kumaran1
1Product & Process Development, Canadian Blood Services, Ottawa, Ontario, Canada.
Vox sanguinis
|February 11, 2026
概括
储存在DEHT/PAGGSM袋中的红血细胞缩物 (RBCCs) 显示出与DEHP/SAGM袋中的细菌生长相似. 这表明没有DEHP的容器不会增加RBCC存储的细菌安全风险.
科学领域:
- 生物医学科学 生物医学科学
- 输血药物 输血药物 输血药物
- 材料科学是一种材料科学.
背景情况:
- 欧盟将在2030年之前禁止在医疗器械中使用二二甲基甲酸盐 (DEHP).
- DEHP是聚乙烯 (PVC) 血囊中的塑化剂,对于红细胞缩物 (RBCC) 储存至关重要.
- 目前正在探索无DEHP的替代品,如二甲二甲基甲甲酸盐 (DEHT).
研究的目的:
- 为了比较储存在DEHT/PAGGSM容器中的RBCC中的细菌生长与DEHP/SAGM容器中的细菌生长.
- 评估没有DEHP的RBCC储存溶液的细菌安全性.
主要方法:
- 准备RBCC并分为两个存储条件:DEHT/PAGGSM和DEHP/SAGM.
- 这些袋子被注射了特定的细菌 (Yersinia enterocolitica,Serratia liquefaciens,Listeria monocytogenes,Cutibacterium acnes).
- 在43天的时间内,在1-6°C的温度下监测细菌数量.
主要成果:
- 在两种储存条件之间,没有观察到Y. enterocolitica,S. liquefaciens和C. acnes的细菌生长显著差异.
- 最初L. monocytogenes在DEHT/PAGGSM袋中的数量暂时较低,但在第43天达到类似水平.
- 在第14天,一些物种的细菌负载达到高水平 (10~10~9 CFU/mL).
结论:
- 储存在DEHT/PAGGSM容器中的RBCC与DEHP/SAGM袋中的RBCC相比,不会增加细菌安全风险.
- 没有DEHP的RBCC储存溶液在细菌污染方面似乎是安全的.
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