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使用定量临床药理方法来支持哺乳期的莫克西德克丁剂量建议
Nolan D Wood1, Danelle Smith2, Sally A Kinrade2
1Certara, Princeton, New Jersey, United States of America.
PLoS neglected tropical diseases
|August 5, 2024
概括
当母乳养期间使用时,moxidectin对婴儿是安全的. 母乳中氧化的含量在服用后两天内迅速下降到安全值,支持其在大规模药物管理计划中的使用.
科学领域:
- 药理动力学 药理动力学
- 公共卫生 公共卫生
- 热带医学 热带医学
背景情况:
- 莫克西德克丁是FDA批准的,用于12岁及以上个体的肉病治疗.
- 大规模药物管理 (MDA) 计划旨在控制和消除瘤.
- 哺乳期妇女在流行地区很常见,因此需要在母乳养期间使用moxidectin的安全数据.
研究的目的:
- 为了确定莫克西德因在母乳中的分泌和婴儿暴露.
- 为MDA计划中哺乳期妇女提供支持moxidectin剂量建议的数据.
主要方法:
- 对非临床和临床数据的定量分析.
- 非分组分析和群体药动力学 (popPK) 建模.
- 基于生理学的药理动力学 (PBPK) 建模.
主要成果:
- 母乳中的莫西德丁度反映了血水平,在剂量后大约4小时达到峰值.
- 母乳中氧化丁的含量迅速下降,在两天内低于安全值.
- 暴露量低于EMA/FDA可接受的每日摄入量和世卫组织推的婴儿相对剂量 (RID) 安全值.
结论:
- 莫克西德克丁的转移到母乳中是最小的,并迅速下降.
- 在MDA计划期间,莫克西德丁可能对通过母乳暴露的婴儿是安全的.
- 调查结果支持关于在哺乳期人口中使用moxidectin来控制乳腺癌的政策决策.
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