ULR 7365-GRITA-Groupe de Recherche sur les Formes Injectables et Technologies Associées, Université de Lille, CHU Lille, Lille, France.
Macopharma, Tourcoing, France.
Vox Sang. 2023 Jul;118(7):533-542. doi: 10.1111/vox.13446. Epub 2023 May 28.
Polyvinyl chloride (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) is a widely used material for medical transfusion devices. Not covalently bound to PVC, DEHP can migrate into blood products during storage. Recognized as an endocrine disruptor and raising concerns about its potential carcinogenicity and reprotoxicity, DEHP is gradually being withdrawn from the medical device market. Therefore, the use of alternative plasticizers, such as diisononylcyclohexane-1,2-dicarboxylate (DINCH) and di(2-ethylhexyl) terephthalate (DEHT), as potential candidates for the replacement of DEHP in medical transfusion devices has been investigated. The purpose of this study was to evaluate the quantity of PVC-plasticizers in the blood components according to their preparation, storage conditions and in function of the plasticizer.
Whole blood was collected, and labile blood products (LBPs) were prepared by the buffy-coat method with a PVC blood bag plasticized either with DEHP, DINCH or DEHT. DINCH and DEHT equivalent concentrations were quantified in LBPs by liquid chromatography-tandem mass spectrometry or coupled with UV and compared to DEHP equivalent concentrations.
The plasticizer equivalent concentration to which a patient is exposed during a transfusion depends on the preparation of LBPs as well as their storage conditions, that is, temperature and storage time. At day 1, for all LBPs, the migration of DEHP is 5.0 and 8.5 times greater than DINCH and DEHT, respectively. At the end of the 49 days storage period, the DEHP equivalent concentration in red blood cells concentrate is statistically higher when compared to DINCH and DEHT, with maximal values of 1.85, 1.13 and 0.86 μg/dm /mL, respectively.
In addition to lower toxicity, transfused patients using PVC-DEHT or PVC-DINCH blood bags are less exposed to plasticizers than using PVC-DEHP bags with a ranging exposure reduction from 38.9% to 87.3%, due to lower leachability into blood components.
邻苯二甲酸二（2-乙基己基）酯（DEHP）增塑的聚氯乙烯（PVC）是一种广泛用于医疗输液设备的材料。DEHP 与 PVC 未发生共价结合，可在储存过程中迁移到血液制品中。DEHP 被认为是一种内分泌干扰物，其潜在的致癌性和生殖毒性引起了人们的关注，因此正在逐步从医疗器械市场中撤出。因此，人们研究了使用替代增塑剂，如二异壬基环己烷-1,2-二羧酸酯（DINCH）和邻苯二甲酸二（2-乙基己基）酯（DEHT），作为替代 DEHP 的潜在候选物，用于医疗输液设备。本研究的目的是根据其制备、储存条件以及增塑剂的类型，评估血液成分中 PVC 增塑剂的含量。
采集全血，采用 PVC 血袋制备不稳定血液成分（LBPs），血袋增塑剂分别为 DEHP、DINCH 或 DEHT。采用液相色谱-串联质谱法或与 UV 耦合法定量测定 LBPs 中的 DINCH 和 DEHT 等效浓度，并与 DEHP 等效浓度进行比较。
患者在输血过程中接触的增塑剂等效浓度取决于 LBPs 的制备以及储存条件，即温度和储存时间。在第 1 天，对于所有 LBPs，DEHP 的迁移量分别是 DINCH 和 DEHT 的 5.0 倍和 8.5 倍。在 49 天的储存期结束时，与 DINCH 和 DEHT 相比，红细胞浓缩物中 DEHP 的等效浓度更高，最大值分别为 1.85、1.13 和 0.86μg/dm /mL。
与使用 PVC-DEHP 血袋相比，使用 PVC-DEHT 或 PVC-DINCH 血袋的患者在接受输血时接触的增塑剂较少，接触量减少 38.9%至 87.3%，这是由于向血液成分中浸出的量较少。
