那他珠单抗在妊娠和哺乳期的应用。
Natalizumab during pregnancy and lactation.
机构信息
Neuroimmunological Lab, Center of Clinical Neuroscience, Department of Neurology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany/Multiple Sclerosis Center, Center of Clinical Neuroscience, Department of Neurology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
Department of Neurology, St. Josef-Hospital Bochum, Ruhr University Bochum, Bochum, Germany.
出版信息
Mult Scler. 2018 Oct;24(12):1627-1634. doi: 10.1177/1352458517728813. Epub 2017 Aug 31.
BACKGROUND
Managing medication during pregnancy and lactation in multiple sclerosis (MS) patients needs to balance potential risks to the newborn with the substantial risks of ongoing disease activity.
OBJECTIVE
To evaluate the potential transfer of natalizumab (NAT) into breast milk and into the serum of newborn babies in women who continued NAT treatment during pregnancy and lactation.
METHODS
Serum samples of 11 mother-infant pairs and mother milk samples of a further 4 women were analyzed for free NAT using a HL60 cell-based fluorescence-activated cell sorting (FACS) assay. Two mother-baby pairs were analyzed for cell-bound NAT, very-late-antigen (VLA)-4 expression, and saturation with NAT on immune cells by FACS analysis.
RESULTS
In the majority of the mother-infant serum pairs (6/11) and in all breast milk samples, free NAT was detectable. Cell-bound NAT was measurable in both mother-baby pairs with significant higher levels in babies. VLA-4 expression seems to be higher in newborns. Saturation with NAT was comparable between newborns and mothers.
CONCLUSION
NAT can pass placental barrier before delivery and into breast milk. Measurable NAT on neonatal lymphocytes may have functional impact. Further investigations are needed to clarify safety and risk of NAT exposure during pregnancy and lactation.
背景
在多发性硬化症（MS）患者中，管理怀孕期间和哺乳期的药物需要在新生儿潜在风险与持续疾病活动的巨大风险之间取得平衡。
目的
评估替加珠单抗（natalizumab，NAT）在怀孕期间和哺乳期继续接受 NAT 治疗的女性的母乳和新生儿血清中的潜在转移。
方法
使用 HL60 细胞基于荧光激活细胞分选（FACS）的测定法分析了 11 对母婴血清样本和另外 4 名妇女的母乳样本中的游离 NAT。通过 FACS 分析，对 2 对母婴对细胞结合的 NAT、非常晚期抗原（VLA）-4 表达以及免疫细胞与 NAT 的饱和情况进行了分析。
结果
在大多数母婴血清对（6/11）和所有母乳样本中，均可检测到游离的 NAT。在两个母婴对中均可检测到细胞结合的 NAT，婴儿中的水平明显更高。新生儿的 VLA-4 表达似乎更高。新生儿和母亲之间的 NAT 饱和程度相当。
结论
NAT 可在分娩前穿过胎盘屏障并进入母乳。新生儿淋巴细胞上可测量的 NAT 可能具有功能影响。需要进一步研究以阐明怀孕期间和哺乳期 NAT 暴露的安全性和风险。
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