患者从 ECMO 回路中接触到 PVC 增塑剂。

Patients' exposure to PVC plasticizers from ECMO circuits.

机构信息

a Département de médecine périopératoire , CHU Clermont-Ferrand , Clermont-Ferrand , France.

b LIOAD INSERM UMR_S 791 , Université de Nantes , Nantes , France.

出版信息

Expert Rev Med Devices. 2018 May;15(5):377-383. doi: 10.1080/17434440.2018.1462698. Epub 2018 Apr 16.

DOI:10.1080/17434440.2018.1462698

PMID:29658331

Abstract

BACKGROUND

ECMO is a therapeutic act with a high risk of exposure to diethylhexylphthalate (DEHP), plasticizer from PVC tubings. The replacement of this plasticizer with alternative compounds is recommended but the risks associated with the use of new plasticizers have not been evaluated in ECMO situations.

METHODS

Ex vivo ECMO models were performed with different flow rates over 6 days to evaluate the migration of plasticizers and their potential toxic risk for patient. The release of plasticizers during ECMO was measured and compared to reference value (derived no effect level, DNEL) and to cytotoxic concentration carried out with MTT test.

RESULTS

Trioctyltrimellitate (TOTM), main plasticizer present in circuit (44% w/w), is weakly released during ECMO. Concentrations are not cytotoxic and exposure doses are lower than DNEL. In contrast, DEHP doses are higher than the DNEL despite a lower presence of DEHP in the circuit (0.2%). We have shown that DEHP is not coming from the circuit but from the priming bag. Replacing this bag with a multilayer one avoids the exposure to DEHP.

CONCLUSION

Our study shows that circuits made of PVC plasticized with TOTM against DEHP improves the safety of ECMO.

摘要

背景

ECMO 是一种具有高接触邻苯二甲酸二辛酯（DEHP）风险的治疗手段，DEHP 是 PVC 管的增塑剂。建议用替代化合物替代这种增塑剂，但尚未在 ECMO 情况下评估新增塑剂的使用风险。

方法

通过 6 天的不同流速进行体外 ECMO 模型，以评估增塑剂的迁移及其对患者的潜在毒性风险。测量 ECMO 过程中释放的增塑剂，并与参考值（无效应水平，DNEL）和 MTT 试验进行的细胞毒性浓度进行比较。

结果

三辛基邻苯二甲酸酯（TOTM）是回路中主要的增塑剂（44% w/w），在 ECMO 过程中释放较弱。浓度没有细胞毒性，暴露剂量低于 DNEL。相比之下，尽管回路中 DEHP 的含量较低（0.2%），但 DEHP 的剂量仍高于 DNEL。我们已经表明，DEHP 不是来自回路，而是来自预充袋。用多层预充袋代替该袋可避免接触 DEHP。