Dartmouth Medical School, Hanover, NH, USA.
Transfusion. 2012 Jul;52(7):1439-45. doi: 10.1111/j.1537-2995.2011.03506.x. Epub 2011 Dec 30.
The plasticizer di-2-ethylhexyl phthalate (DEHP) is a common component in medical plastics. There is motivation to replace this component; however, DEHP is necessary to prevent excessive hemolysis in stored red blood cells (RBCs). Our objective is to evaluate a candidate replacement plasticizer (Hexamoll, di-isononyl cyclohexane-1,2-dicarboxylic acid [DINCH], BASF Corp.) compared to DEHP in an in vitro feasibility study. We hypothesize that the candidate will provide at least equivalent protection against hemolysis for RBCs stored for 42 days and periodic mixing of RBCs will add additional protection against hemolysis.
Whole blood was collected into citrate-phosphate-dextrose; combined into pools of 2 ABO identical whole blood units; and divided, leukoreduced, centrifuged, and separated into plasma and RBCs. Additive solution was added, and the RBCs were stored for 42 days at 1 to 6°C. In three parts of this study, split pools were paired as DINCH-polyvinyl chloride (PVC) with weekly mixing versus DINCH-PVC with no mixing, DINCH-PVC mixed versus DEHP-PVC no mix, and DINCH-PVC versus DEHP-PVC with neither mixed. A standard panel of in vitro RBC characteristics was determined on Days 0 and 42.
Mixing DINCH-PVC weekly improved Day 42 hemolysis (0.36 ± 0.07% vs.0.56 ± 0.15%, p = 0.002), and mixed DINCH-PVC bags were noninferior to unmixed DEHP-PVC bags (p ≤ 0.05). DINCH-PVC bags stored without weekly mixing were inferior to unmixed DEHP-PVC bags for hemolysis on Day 42, although no individual bag exceeded 0.8% hemolysis.
Periodic mixing of RBCs stored in DINCH-PVC provides additional protection against hemolysis. Unmixed DINCH-PVC bags were inferior to DEHP-PVC bags for prevention of hemolysis, but remain a candidate for replacement DEHP in RBC storage bags.
增塑剂邻苯二甲酸二（2-乙基己基）酯（DEHP）是医用塑料的常见成分。有动机用其他成分替代这种成分；但是，DEHP 是防止储存的红细胞（RBC）过度溶血所必需的。我们的目标是评估候选替代增塑剂（己二酸二异壬酯，二异壬基环己烷-1,2-二羧酸[DINCH]，巴斯夫公司）与体外可行性研究中的 DEHP 进行比较。我们假设候选物将至少能为储存 42 天的 RBC 提供同等的溶血保护，并且定期混合 RBC 将增加对溶血的额外保护。
全血采集到柠檬酸盐-磷酸盐-葡萄糖中；合并成 2 个 ABO 相同的全血单位池；然后进行分离，白细胞减少，离心，血浆和 RBC 分离。加入添加剂溶液，将 RBC 在 1 至 6°C 下储存 42 天。在本研究的三个部分中，将分割的池配对为每周混合的 DINCH-聚氯乙烯（PVC）与无混合的 DINCH-PVC、混合的 DINCH-PVC 与无混合的 DEHP-PVC 以及 DINCH-PVC 与无混合的 DEHP-PVC。在第 0 天和第 42 天，对体外 RBC 特征的标准面板进行了测定。
每周混合 DINCH-PVC 可改善第 42 天的溶血（0.36 ± 0.07%对 0.56 ± 0.15%，p = 0.002），混合的 DINCH-PVC 袋与未混合的 DEHP-PVC 袋相当（p ≤ 0.05）。未每周混合的 DINCH-PVC 袋在第 42 天的溶血方面不如未混合的 DEHP-PVC 袋，但没有单个袋的溶血超过 0.8%。
在 DINCH-PVC 中储存的 RBC 定期混合可提供额外的溶血保护。未混合的 DINCH-PVC 袋在防止溶血方面不如 DEHP-PVC 袋，但仍是 RBC 储存袋中 DEHP 的替代候选物。
