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检测哺乳期炎症性肠病母亲的母乳中的英夫利昔单抗。

Detection of infliximab in breast milk of nursing mothers with inflammatory bowel disease.

机构信息

Dept. of Gastroenterology, Sheba Medical Center & Sackler School of Medicine, Tel-Aviv University, Israel.

出版信息

J Crohns Colitis. 2011 Dec;5(6):555-8. doi: 10.1016/j.crohns.2011.05.006.

DOI:10.1016/j.crohns.2011.05.006
PMID:22115374
Abstract

INTRODUCTION

Limited data suggest the absence of infliximab in breast milk, thereby implying the safety of this drug during breast-feeding. We aimed to re-evaluate the presence of infliximab in breast milk of nursing IBD patients.

METHODS

Serum and breast milk were obtained post-partum from 3 breast-feeding patients with Crohn's disease before and after re-initiation of infliximab. ELISA assay was employed to measure infliximab level in maternal serum and in breast milk. The level of infliximab was also measured in breast milk of a control group of 8 nursing healthy mothers.

RESULTS

Infliximab was undetectable in breast milk prior to the first infusion and was also not measurable in 8 lactating women not exposed to infliximab. Infliximab levels in breast milk rose up to 101ng/ml within 2-3days of the infusion. These levels of infliximab in breast milk were roughly 1/200th of the level in blood.

CONCLUSIONS

In contrast with prior reports, infliximab can be detected in the breast milk of nursing mothers. The miniscule amounts of infliximab transferred in breast milk are unlikely to result in systemic immune-suppression of the infant. Nonetheless, local effects of this exposure on the neonates' intestine and potential immune sensitization or tolerization towards the drug can not be excluded and merit further investigations.

摘要

介绍

有限的数据表明英夫利昔单抗不存在于母乳中,这意味着在母乳喂养期间使用这种药物是安全的。我们旨在重新评估哺乳期 IBD 患者母乳中英夫利昔单抗的存在情况。

方法

在重新开始英夫利昔单抗治疗之前和之后,从 3 名患有克罗恩病的母乳喂养患者产后获得血清和母乳。采用 ELISA 法检测母血清和母乳中的英夫利昔单抗水平。还测量了 8 名未接触英夫利昔单抗的母乳喂养健康母亲母乳中的英夫利昔单抗水平。

结果

在第一次输注之前,母乳中未检测到英夫利昔单抗,在 8 名未接触英夫利昔单抗的哺乳期妇女中也无法测量到。在输注后 2-3 天内,母乳中的英夫利昔单抗水平上升至 101ng/ml。这些母乳中的英夫利昔单抗水平大约是血液中的 1/200。

结论

与之前的报告相反,哺乳期母亲的母乳中可以检测到英夫利昔单抗。母乳中转移的英夫利昔单抗量极小,不太可能导致婴儿全身免疫抑制。然而,这种暴露对新生儿肠道的局部影响以及对药物的潜在免疫致敏或耐受不能排除,需要进一步研究。

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