■虽然建议母乳喂养,关于药物转移到人乳及其对哺乳婴儿的安全性的知识是有限的。以前只有一篇论文描述了两名患者在产后5个月和6个月时母乳喂养期间富马酸二甲酯(DMF)的转移,分别。当前的病例报告描述了富马酸单甲酯(MMF)的母体药代动力学数据,DMF的活性代谢产物,和婴儿产后3个月的MMF暴露估计。
■一名32岁的白人妇女开始使用DMF治疗(120毫克,2倍/天),用于产后3个月的多发性硬化症,在她的婴儿从母乳喂养断奶后。出生后第99天,患者在初始剂量治疗6天后24小时内收集了4份牛奶样本.此外,我们收集了一份母体血液样本,以计算牛奶-血浆(M/P)比.使用液相色谱与质谱联用方法分析样品。
■在人乳样品中观察到MMF的宽范围的测量的稳态浓度(5.5-83.5ng/mL)。MMF的估计每日婴儿剂量值,以150和200毫升/千克/天人乳摄入量计算,分别为5.76和7.68μg/kg/天,相对婴儿剂量为0.16%和0.22%。观察到的平均M/P比为0.059,类似于使用经验Koshimichi模型预测的M/P比(0.06)。
■将此病例报告与先前描述的两个病例相结合,估计婴儿暴露量很低,尽管有相关的患者内和患者间的变异性。研究应进一步关注婴儿暴露和安全性。
UNASSIGNED: While breastfeeding is recommended, knowledge regarding medicine transfer to human milk and its safety for nursing infants is limited. Only one paper has previously described dimethyl fumarate (DMF) transfer during breastfeeding in two patients at 5 and 6 months postpartum, respectively. The current case report describes maternal pharmacokinetic data of monomethyl fumarate (MMF), the active metabolite of DMF, and infant exposure estimations of MMF at 3 months postpartum.
UNASSIGNED: A 32-year-old Caucasian woman started DMF therapy (120 mg, 2x/day) for multiple sclerosis at 3 months postpartum, after weaning her infant from breastfeeding. On day 99 after birth, the patient collected four milk samples over 24 h after 6 days of treatment at the initial dose. Additionally, a single maternal blood sample was collected to calculate the milk-to-plasma (M/P) ratio. The samples were analyzed using liquid chromatography coupled with the mass spectrometry method.
UNASSIGNED: A wide range of measured steady-state concentrations of MMF (5.5-83.5 ng/mL) was observed in human milk samples. Estimated daily infant dosage values for MMF, calculated with 150 and 200 mL/kg/day human milk intake, were 5.76 and 7.68 μg/kg/day, and the relative infant doses were 0.16 and 0.22%. The observed mean M/P ratio was 0.059, similar to the M/P ratio predicted using the empirical Koshimichi model (0.06).
UNASSIGNED: Combining this case report with the two previously described cases, the estimated infant exposure is low, albeit with relevant intra- and inter-patient variabilities. Research should further focus on infant exposure and safety.