PDF(Pubmed)
Abstract：
UNASSIGNED: Globally, more than half of women take medicines whilst breastfeeding. Data concerning the exposure of the breastfed infant to drugs and any related risks are sparce. Lactation studies are only rarely performed close to licensing for medicines anticipated to be widely used in women of childbearing age. Medicines taken by breastfeeding mothers on tuberculosis (TB) treatment can be transferred to the breastfed infant. Potential effects of anti-tuberculosis medicines on nursing infants are not well understood. Similarly, women face mental health challenges while taking medications, including postpartum depression, hence the need to assess the psychological behavior of a breastfeeding woman. Potential risks are the development of adverse drug effects in the breastfed infant and selection for resistance, whereas potential benefits might include exposure to potentially prophylactic concentrations of the drug. Pharmacokinetic studies are therefore necessary to understand this situation fully.
UNASSIGNED: This study will enroll 20 mothers receiving first-line anti-tuberculosis medicines, together with their breastfed infants, with the aim of characterizing the breastmilk transfer of the medicines from the mother to the infants. Samples of maternal blood, breastmilk, and breastfeeding infant\'s blood will be obtained at specific time points for bioanalysis of drug concentrations. Pharmacokinetic data will be analyzed using a population pharmacokinetic approach. Additionally, the study will assess the psychological status of breastfeeding women and the well-being of their infants. Maternal depression is linked to long-term negative consequences for the infant\'s physiological regulation, poor growth-promoting setting for the infants, and inappropriate interactive conduct, characterized by low compassion, constrained range of emotional expression, and varying provision of the infant\'s budding engagement.
UNASSIGNED: This study will provide the first systematic characterization of mother-to-infant transfer of first-line anti-tuberculosis medicines through breast milk. A mathematical pharmacokinetics model characterizing plasma-to-breastmilk transfer of rifampicin, isoniazid, ethambutol, and pyrazinamide will be developed and used to characterize infant exposure through breast milk. Our findings will contribute towards treatment optimization in breastfeeding and provide a framework to foster other lactation pharmacokinetic studies.
UNASSIGNED: This study will enroll 20 mothers receiving first-line anti-tuberculosis medicines, together with their breastfed infants, with the aim of characterizing the breastmilk transfer of the medicines from the mother to the infants. Samples of maternal blood, breastmilk, and breastfeeding infant\'s blood will be obtained at specific time points for bioanalysis of drug concentrations. Pharmacokinetic data will be analyzed using a population pharmacokinetic approach. Additionally, the study will assess the psychological status of breastfeeding women and the well-being of their infants. Maternal depression is linked to long-term negative consequences for the infant\'s physiological regulation, poor growth-promoting setting for the infants, and inappropriate interactive conduct, characterized by low compassion, constrained range of emotional expression, and varying provision of the infant\'s budding engagement.
UNASSIGNED: This study will provide the first systematic characterization of mother-to-infant transfer of first-line anti-tuberculosis medicines through breast milk. A mathematical pharmacokinetics model characterizing plasma-to-breastmilk transfer of rifampicin, isoniazid, ethambutol, and pyrazinamide will be developed and used to characterize infant exposure through breast milk. Our findings will contribute towards treatment optimization in breastfeeding and provide a framework to foster other lactation pharmacokinetic studies.
摘要：
■全球，超过一半的妇女在母乳喂养时服用药物。有关母乳喂养婴儿暴露于药物和任何相关风险的数据很少。对于预期在育龄妇女中广泛使用的药物，很少进行哺乳期研究。母乳喂养母亲接受结核病（TB）治疗的药物可以转移给母乳喂养的婴儿。抗结核药物对哺乳婴儿的潜在影响尚不清楚。同样，女性在服用药物时面临心理健康挑战，包括产后抑郁症,因此需要评估母乳喂养妇女的心理行为。潜在的风险是在母乳喂养的婴儿中产生不良药物作用和选择耐药性，而潜在的益处可能包括暴露于潜在预防浓度的药物.因此，药代动力学研究对于充分了解这种情况是必要的。
这项研究将招募20名接受一线抗结核药物治疗的母亲，和他们母乳喂养的婴儿一起，目的是表征药物从母亲到婴儿的母乳转移。母体血液样本,母乳,和母乳喂养婴儿的血液将在特定的时间点获得的药物浓度的生物分析。药代动力学数据将使用群体药代动力学方法进行分析。此外,这项研究将评估母乳喂养妇女的心理状况和婴儿的健康状况。母亲抑郁与婴儿生理调节的长期负面后果有关，婴儿生长促进环境不佳，和不适当的互动行为，以低同情心为特征，情感表达的范围受到限制，以及婴儿萌芽参与的不同规定。
■这项研究将提供通过母乳将一线抗结核药物母婴转移的第一个系统表征。表征利福平血浆到母乳转移的数学药代动力学模型，异烟肼,乙胺丁醇,吡嗪酰胺将被开发并用于表征婴儿通过母乳暴露的特征。我们的发现将有助于优化母乳喂养的治疗方法，并为促进其他泌乳药代动力学研究提供框架。
这项研究将招募20名接受一线抗结核药物治疗的母亲，和他们母乳喂养的婴儿一起，目的是表征药物从母亲到婴儿的母乳转移。母体血液样本,母乳,和母乳喂养婴儿的血液将在特定的时间点获得的药物浓度的生物分析。药代动力学数据将使用群体药代动力学方法进行分析。此外,这项研究将评估母乳喂养妇女的心理状况和婴儿的健康状况。母亲抑郁与婴儿生理调节的长期负面后果有关，婴儿生长促进环境不佳，和不适当的互动行为，以低同情心为特征，情感表达的范围受到限制，以及婴儿萌芽参与的不同规定。
■这项研究将提供通过母乳将一线抗结核药物母婴转移的第一个系统表征。表征利福平血浆到母乳转移的数学药代动力学模型，异烟肼,乙胺丁醇,吡嗪酰胺将被开发并用于表征婴儿通过母乳暴露的特征。我们的发现将有助于优化母乳喂养的治疗方法，并为促进其他泌乳药代动力学研究提供框架。
