PROSPECTIVE STUDY TO DETERMINE THE EFFICACY AND SAFETY OF AZATHIOPRINE

确定硫唑嘌呤功效和安全性的前瞻性研究

• 批准号: 6304925
• 负责人: Robert E Shaddy
• 金额: $ 0.16万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304925
• 关键词: azathioprine; child (0-11); clinical research; clinical trial phase I; drug adverse effect; drug screening /evaluation; heart surgery; homologous transplantation; human subject; human therapy evaluation; immunotherapy; pediatric pharmacology

In this study, the effect of a drug that suppresses the immune system was studied on children who received a human autopsy valve at the time of surgery for repair of a congenital heart defect. To do this, one-half of the children received this medication and the other one-half did not. Blood samples were drawn on all children 1 week, 1 month, and 3 months after surgery and the immune response of the children to the human autopsy valve was measured. Heart ultrasound tests were obtained to see whether there was any difference between the 2 groups with regard to valve function. No difference was found between groups with regard to the immune response or valve function.

在这项研究中，研究了一种抑制免疫系统的药物对儿童的影响，这些儿童在手术修复先天性心脏缺陷时接受了人体解剖瓣膜。为了做到这一点，一半的孩子接受了这种药物，另一半没有。 在手术后1周、1个月和3个月对所有儿童抽取血液样本，并测量儿童对人体解剖瓣膜的免疫反应。进行心脏超声检查，以观察两组之间在瓣膜功能方面是否存在任何差异。 两组之间在免疫应答或瓣膜功能方面没有发现差异。