STABLE RENAL TRANSPLANT PATIENTS CONVERTED FROM SANDIMMUNE TO NEORAL

稳定的肾移植患者从 SANDIMUNE 转为 NEORAL

• 批准号: 6244019
• 负责人: JOHN C CURTIS
• 金额: $ 2.46万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-10 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6244019
• 关键词: artificial immunosuppression; clinical research; cyclosporines; dosage; dosage forms; human subject; human therapy evaluation; kidney pharmacology; kidney transplantation

Cyclosporine A is an established form of immunosuppressive treatment in organ transplantation involving kidney, liver, or heart. The absorption of cyclosporine during chronic administration of Sandimmune soft gelatin capsules and oral solution is known to be highly variable. Patients taking the soft gelatin capsules or oral solution were monitored at repeated intervals for cyclosporin A levels over a period of time and subsequent dose adjustments were made in order to avoid either toxicity due to high levels or possible organ rejection due to low levels of cyclosporine A. Results: 1) conversion of stable renal transplant patients from Sandimmune to Neoral requires a dose reduction to achieve similar trough levels; 2) a high, > 4 mg/kg, Sandimmune dose before conversion is most predictive of need for dose reduction. Converting from QD Sandimmune to BID Neoral is also predictive; 3) there is no statistical support for the hypothesis that African Americans and Whites differ in absorption of Sandimmune or Neoral. Both groups improved after conversion.

环孢素A是一种已确立的免疫抑制治疗形式， 涉及肾脏、肝脏或心脏的器官移植。 吸收 Sandimmune软明胶长期给药期间的环孢素 已知胶囊和口服溶液是高度可变的。 患者 服用软明胶胶囊或口服溶液， 在一段时间内重复测定环孢菌素A水平， 随后进行剂量调整以避免毒性 由于高水平或可能的器官排斥，由于低水平的 环孢菌素A 结果：1）稳定的肾移植患者从 Sandimmune到Neoral需要减少剂量以达到相似的效果 谷水平; 2）转换前高剂量（> 4 mg/kg）Sandimmune 最能预测需要减少剂量。 从QD转换 Sandimmune对BID Neoral也具有预测性; 3）无统计学意义 支持非裔美国人和白人在 Sandimmune或Neoral的吸收。 两组在治疗后均有所改善。 转换.