Teresa Baker, Ulrike Lorch, Yu Bagger, Carina Holmqvist, Daniël M Jonker, Lorien E Urban, Thomas W Hale
{"title":"母乳中未检测到催产素受体激动剂 Merotocin 的可测量转移。","authors":"Teresa Baker, Ulrike Lorch, Yu Bagger, Carina Holmqvist, Daniël M Jonker, Lorien E Urban, Thomas W Hale","doi":"10.1089/bfm.2024.0044","DOIUrl":null,"url":null,"abstract":"<p><p><b><i>Objective:</i></b> The study aimed to assess the transfer of merotocin from systemic circulation to breast milk in early postpartum women and women with established lactation. <b><i>Methods:</i></b> 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 (<i>n</i> = 6) or 16 μg (<i>n</i> = 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. <b><i>Results:</i></b> 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. <b><i>Conclusion:</i></b> Merotocin was undetectable in breast milk after single iv administration of up to 20 μg in early postpartum women and women with established lactation.</p>","PeriodicalId":9142,"journal":{"name":"Breastfeeding Medicine","volume":null,"pages":null},"PeriodicalIF":2.1000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"No Measurable Transfer of Oxytocin-Receptor Agonist Merotocin Detected in Human Breast Milk.\",\"authors\":\"Teresa Baker, Ulrike Lorch, Yu Bagger, Carina Holmqvist, Daniël M Jonker, Lorien E Urban, Thomas W Hale\",\"doi\":\"10.1089/bfm.2024.0044\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b><i>Objective:</i></b> The study aimed to assess the transfer of merotocin from systemic circulation to breast milk in early postpartum women and women with established lactation. <b><i>Methods:</i></b> 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 (<i>n</i> = 6) or 16 μg (<i>n</i> = 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. <b><i>Results:</i></b> 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. <b><i>Conclusion:</i></b> Merotocin was undetectable in breast milk after single iv administration of up to 20 μg in early postpartum women and women with established lactation.</p>\",\"PeriodicalId\":9142,\"journal\":{\"name\":\"Breastfeeding Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Breastfeeding Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1089/bfm.2024.0044\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/3/26 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breastfeeding Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1089/bfm.2024.0044","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/3/26 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
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.
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.