Université Clermont Auvergne, Clermont Auvergne INP, CNRS, CHU Clermont Ferrand, ICCF, F-63000 Clermont-Ferrand, France.
Univ. Lille, CHU Lille, ULR 7365-GRITA-Groupe de Recherche sur les Formes Injectables et les Technologies Associées, F-59000 Lille, France.
Sci Total Environ. 2023 Feb 1;858(Pt 3):159994. doi: 10.1016/j.scitotenv.2022.159994. Epub 2022 Nov 8.
Phthalates and other plasticisers are extensively used in medical devices (MD) from which they can leach out and lead to potential multiple problems for the patients. This exposure is a major issue because it is associated with reproductive and neurodevelopment disorders. The Neonatal Intensive Care Units (NICU) population is at high risk due to the daily intensive medical interventions, the reduced ability of newborns to remove these contaminants and their higher sensitivity to endocrine disruptors. We conducted a multicentric biomonitoring study to assess and compare the urinary levels of DEHP (di-(2-ethylhexyl)phthalate), DEHTP (di-(2-ethylhexyl)terephthalate) and TEHTM (tri-(2-ethylhexyl)trimellitate) metabolites as biomarkers of this exposure during and after the newborns' stay in NICU. Daily urinary samples were collected in NICU and at discharge from the hospital for each patient. MD sources and exposure factors were also investigated. 508 urinary samples from 97 patients enrolled in centres 1 and 2 (C1/C2) were collected. The exposure of newborns to DEHP was greater than that of DEHTP and TEHTM, with a median concentration of DEHP metabolites (C1:195.63 ng/mL;C2:450.87 ng/mL) respectively 5 to 10 times higher and 57 to 228 times higher than the median concentrations of DEHTP and TEHTM metabolites. The urinary concentrations of DEHP and TEHTM metabolites were significantly lower at discharge than in NICU, with a 18-and 35-fold decrease for DEHP and a 4 and 8-fold decrease for TEHTM, respectively for C1 and C2, but were similar for DEHTP metabolites. MD used for respiratory assistance, infusion therapy,enteral nutrition and transfusion were the main sources of exposure. Smaller gestational age and body weight significantly increased the newborns' exposure. The elevated levels of DEHP metabolites in NICU patients are still alarming. Additional efforts are necessary to promote its substitution in MD by possibly safer alternatives such as TEHTM and DEHTP, particularly when used for the care of newborns.
邻苯二甲酸酯和其他增塑剂广泛应用于医疗器械（MD）中，这些化合物可能会从医疗器械中浸出，对患者造成潜在的多种问题。这种接触是一个主要问题，因为它与生殖和神经发育障碍有关。由于新生儿重症监护病房（NICU）的日常密集医疗干预、新生儿去除这些污染物的能力降低以及对内分泌干扰物的更高敏感性，新生儿重症监护病房的人群面临更高的风险。我们进行了一项多中心生物监测研究，以评估和比较 DEHP（邻苯二甲酸二（2-乙基己基）酯）、DEHTP（邻苯二甲酸二（2-乙基己基）酯）和 TEHTM（三（2-乙基己基）三羟甲基丙烷）代谢物的尿液水平，这些代谢物作为新生儿在 NICU 期间和之后接触这种物质的生物标志物。每天为每位患者在 NICU 住院期间和出院时收集尿液样本。还调查了 MD 来源和暴露因素。从中心 1 和 2（C1/C2）入组的 97 名患者共采集了 508 份尿液样本。与 DEHTP 和 TEHTM 相比，新生儿接触 DEHP 的程度更大，DEHP 代谢物的中位数浓度（C1：195.63ng/mL；C2：450.87ng/mL）分别高 5 至 10 倍和 57 至 228 倍。与 NICU 相比，DEHP 和 TEHTM 代谢物的尿液浓度在出院时明显降低，C1 和 C2 的 DEHP 分别降低了 18 倍和 35 倍，TEHTM 降低了 4 倍和 8 倍，但 DEHTP 代谢物相似。用于呼吸辅助、输液治疗、肠内营养和输血的 MD 是主要的暴露源。较小的胎龄和体重显著增加了新生儿的暴露量。NICU 患者中 DEHP 代谢物水平升高仍然令人担忧。需要进一步努力，通过可能更安全的替代品（如 TEHTM 和 DEHTP）来促进其在 MD 中的替代，特别是在新生儿护理中。
