Colostrum From Mothers Treated With Cyclosporine

使用环孢素治疗的母亲的初乳

• 批准号: 6693946
• 负责人: KRISTINA D THIAGARAJAN
• 金额: $ 9.07万
• 依托单位: UNIVERSITY OF TENNESSEE KNOXVILLE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6693946
• 关键词: FK506; T lymphocyte; clinical research; colostrums; cyclosporines; enzyme linked immunosorbent assay; female; flow cytometry; high performance liquid chromatography; human subject; immunoglobulins; immunosuppression; interleukin 1; interleukin 10; interleukin 2; interleukin 4; interleukin 6; lactation; mother /infant health care; postpartum; prolactin; women's health

DESCRIPTION (provided by applicant): The candidate's long-term goal is to develop interventions that support women who require immunosuppressive therapy during their childbearing years to achieve optimal health. The immediate goal is to describe and compare the quantity of immune factors and prolactin present in colostrum from those mothers' treated with immunosuppresive agents and those mother's who are not. To achieve these goals, a focused research career development plan is proposed, including intensive study of: (1) lymphocytes, cytokines and immunoglobulins in relation to colostrum and breast milk, (2) immunsuppression in women during lactation, (3) and longiturdinal design. Increasingly, women after organ transplants and/or with autoimmune diseases who are treated with immunosuppressive drugs become pregnant and interested in breast-feeding. Over 50% of infants born to cyclosporine and tacrolimus treated mothers are low birth weight (LBW) and preterm compared to 5% in the general population. The benefits of administering colostrum to this high-risk infant population are substantial. However, since cyclosporine and tacrolimus is excreted in breast milk, breast-feeding is not recommended, despite current studies that report infants do not absorb detectable amounts of cyclosporine. No studies have described the effects of cyclosponne or tacrolimus on the immune factors of colostrum that are so valued for the infant. The purpose of the proposed study is to investigate the effects of cyclosporine and tacrolimus on specific immune factors found in breast milk (IL-1b, IL-4, IL-10, IgA, IgE, IgG, and IgM) and prolactin that are known to have a direct relationship with cyclosporine and tacrolimus in the adult systemic immune system. Specific aims include measuring immune factors, prolactin and levels of cyclosporine and tacrolimus in colostrum on days 1 and 3, post partum. Mothers will be 18 to 45 yrs of age and approximately 20 treatment-subjects and 20 control-subjects will be recruited and matched according to post partum duration. We will measure immune factors and protactin by method of ELISA. Tacrolimus and cyclosporine will be quantified using HPLC method and lymphocytes utilizing flow cytometry. Data analysis will include descriptive statistics, Students' t-test to make comparisons and Pearson's Product moment for correlations.

描述（由申请人提供）：候选人的长期目标是开发干预措施，支持在育龄期间需要免疫抑制治疗的女性以实现最佳健康。近期目标是描述和比较接受免疫抑制剂治疗的母亲和未接受免疫抑制剂治疗的母亲的初乳中存在的免疫因子和催乳素的数量。为了实现这些目标，提出了一项重点研究职业发展计划，包括深入研究：（1）与初乳和母乳相关的淋巴细胞、细胞因子和免疫球蛋白，（2）哺乳期妇女的免疫抑制，（3）和纵向设计。接受免疫抑制药物治疗的器官移植后和/或患有自身免疫性疾病的女性越来越多地怀孕并对母乳喂养感兴趣。接受环孢素和他克莫司治疗的母亲所生婴儿中，超过 50% 为低出生体重 (LBW) 和早产儿，而普通人群中这一比例为 5%。对这一高危婴儿群体施用初乳的好处是巨大的。然而，由于环孢素和他克莫司会在母乳中排泄，因此不建议母乳喂养，尽管目前的研究报告婴儿不会吸收可检测量的环孢素。尚无研究描述环孢素或他克莫司对初乳免疫因子的影响，而初乳免疫因子对婴儿来说非常重要。拟议研究的目的是调查环孢素和他克莫司对母乳中已知的特定免疫因子（IL-1b、IL-4、IL-10、IgA、IgE、IgG 和 IgM）和催乳素的影响与成人全身免疫系统中的环孢素和他克莫司有直接关系。具体目标包括测量产后第 1 天和第 3 天初乳中的免疫因子、催乳素以及环孢素和他克莫司的水平。母亲年龄为 18 至 45 岁，将招募大约 20 名治疗受试者和 20 名对照受试者，并根据产后持续时间进行匹配。我们将通过 ELISA 方法测量免疫因子和 protactin。他克莫司和环孢菌素将使用 HPLC 方法进行定量，淋巴细胞使用流式细胞术进行定量。数据分析将包括描述性统计、用于比较的学生 t 检验以及用于相关性的 Pearson 乘积矩。