母乳中未检测到催产素受体激动剂 Merotocin 的可测量转移。

IF 2.1 3区 医学 Q2 OBSTETRICS & GYNECOLOGY
Breastfeeding Medicine Pub Date : 2024-06-01 Epub Date: 2024-03-26 DOI:10.1089/bfm.2024.0044
Teresa Baker, Ulrike Lorch, Yu Bagger, Carina Holmqvist, Daniël M Jonker, Lorien E Urban, Thomas W Hale
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引用次数: 0

摘要

研究目的本研究旨在评估产后早期妇女和已泌乳妇女体内美洛托昔从全身循环到母乳的转移情况。研究方法这是一项由两部分组成的多中心、开放标签、平行组研究。模仿鼻内药代动力学特征,以单次 90 分钟静脉注射(iv)的方式给药美洛托辛。在 A 部分中,12 名早期产后妇女在分娩后 4 天内接受了 4 微克(6 人)或 16 微克(6 人)剂量的美洛托辛。在 B 部分中,6 名泌乳期妇女接受了 20 μg 的美洛托辛。在不同的时间点测定血浆和母乳中美罗托辛的总浓度及其在母乳中排泄的代谢物。还对研究的两个部分进行了不良事件(AEs)评估。研究结果在产后早期组和哺乳期组(平均年龄 26.3 岁;83.3% 白种人)中,母乳中的美洛托辛及其代谢物在所有时间点均低于定量限(25.0 pg/mL)。仅在产后早期妇女中就发生了 16 例治疗突发 AE,包括 7 例子宫痉挛和 3 例乳房充血。其中1例为中度,其他均为轻度。结论对早期产后妇女和已泌乳的妇女单次静脉注射美洛托昔20微克后,母乳中检测不到美洛托昔。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
No Measurable Transfer of Oxytocin-Receptor Agonist Merotocin Detected in Human Breast Milk.

Objective: The study aimed to assess the transfer of merotocin from systemic circulation to breast milk in early postpartum women and women with established lactation. Methods: This was a two-part, multicenter, open-label, parallel-group study. Merotocin was administered as a single 90-minute intravenous (iv) infusion mimicking the intranasal pharmacokinetic profile. In Part A, 12 early postpartum women received doses of either 4 μg (n = 6) or 16 μg (n = 6) of merotocin within 4 days of delivery. In Part B, six women with established lactation received 20 μg of merotocin. The total concentration of merotocin in plasma and breast milk and its metabolites excreted in breast milk were measured at various time points. Adverse events (AEs) were also assessed for both parts of the study. Results: In both early postpartum and established lactation groups (mean age, 26.3 years; 83.3% Caucasian), merotocin and its metabolites in breast milk were below the limit of quantification (25.0 pg/mL) at all time points. Sixteen treatment-emergent AEs occurred in early postpartum women only, including seven events of uterine spasm and three of breast engorgement. There was one moderate event, whereas all the other events were considered mild. Conclusion: Merotocin was undetectable in breast milk after single iv administration of up to 20 μg in early postpartum women and women with established lactation.

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来源期刊
Breastfeeding Medicine
Breastfeeding Medicine OBSTETRICS & GYNECOLOGY-PEDIATRICS
CiteScore
4.20
自引率
11.10%
发文量
130
审稿时长
6-12 weeks
期刊介绍: Breastfeeding Medicine provides unparalleled peer-reviewed research, protocols, and clinical applications to ensure optimal care for mother and infant. The Journal answers the growing demand for evidence-based research and explores the immediate and long-term outcomes of breastfeeding, including its epidemiologic, physiologic, and psychological benefits. It is the exclusive source of the Academy of Breastfeeding Medicine protocols. Breastfeeding Medicine coverage includes: Breastfeeding recommendations and protocols Health consequences of artificial feeding Physiology of lactation and biochemistry of breast milk Optimal nutrition for the breastfeeding mother Breastfeeding indications and contraindications Managing breastfeeding discomfort, pain, and other complications Breastfeeding the premature or sick infant Breastfeeding in the chronically ill mother Management of the breastfeeding mother on medication Infectious disease transmission through breast milk and breastfeeding The collection and storage of human milk and human milk banking Measuring the impact of being a “baby-friendly” hospital Cultural competence and cultural sensitivity International public health issues including social and economic issues.
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