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在患有复发性简单性疹的哺乳期患者中,阿米纳维尔转移到母乳中:单臂开放标签研究的研究协议

Sachi Koinuma¹, Mikako Goto¹, Jumpei Saito²

¹The Japan Drug Information Institute in Pregnancy, National Center for Child Health and Development, Tokyo, Japan.

Frontiers in pediatrics

|April 25, 2025

概括

这项研究调查了使用患者发起治疗 (PIT) 的复发性简单性疹 (RHS) 患者的阿米纳维尔转移到母乳中. 结果将评估婴儿暴露风险,并为安全母乳养治疗指南提供信息.

科学领域:

药理学药理学是指药理学的学科.
孕产妇和胎儿医学孕产妇和胎儿医学
病毒学病毒学

背景情况:

复发性简单疹 (RHS) 影响了用抗疹病毒药物治疗的患者.
在日本,阿米纳美维尔用于通过患者启动治疗 (PIT) 治疗RHS.
对于母乳养RHS患者的阿米纳维尔转移到母乳中的数据是有限的.

研究的目的:

评估阿米纳维尔转移到母乳中的情况.
为了评估母婴使用阿米纳维尔的婴儿药物暴露风险.
为RHS提供安全母乳养治疗的证据.

主要方法:

单臂,开放标签,多中心干预研究.
用Amenamevir治疗RHS的哺乳期患者的招募.
在母乳中使用液体染色学-质谱学量化阿米纳维尔的量化.
主要结局:基于C_{ave[AUC(0-24小时) ]的相对婴儿剂量 (RID).}

主要成果:

将确定母乳中的阿米纳米维尔度.
相对婴儿剂量 (RID) 将使用C_{ave[AUC(0-24小时) ]},C_max和C_{ave[AUC(0-48小时) ]}来计算.
该研究将确定阿米纳维尔转移到母乳中的概况.

结论:

在PIT期间将提供关于阿米纳维尔转移到母乳中的证据.
如果RID<10%,阿米纳美维尔PIT可能成为哺乳期患者的安全标准治疗.
这项研究支持RHS的母乳养母亲做出明智的临床决定.

关键词:

艾米尼尼维尔艾米尼维尔母乳养哺乳期母乳养牛奶的转移牛奶的转移患者开始治疗 (PIT)复发性简单性疹 (RHS) 复发性简单性疹相对婴儿剂量 (RID)

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