TOLERABILITY OF NEORAL IN STABLE RENAL TRANSPLANT PATIENTS

稳定肾移植患者对新奥乐的耐受性

• 批准号: 5217654
• 负责人: ALAN B LEICHTMAN
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5217654
• 关键词: clinical research; cyclosporines; human subject; human therapy evaluation; kidney disorder chemotherapy; kidney transplantation; pharmacokinetics; transplant rejection

Greater predictability in the oral dosing of cyclosporin A (CSA) may minimize the number and duration of subtherapeutic or toxic events in organ transplantation, thus improving allograft survival. We have recently established that the bioavailability of the standard formulation of CSA (Sandimmune) in stable renal transplant recipients under steady state conditions is largely determined by both enteric and hepatic P4503A4 activity. Recently, a newly developed microemulsion formulation of CSA (Neoral) has demonstrated improved and more predictable bioavailability compared to Sandimmune. As a result, the improved correlation between trough CSA levels and AUC may facilitate the management of transplant patients, particularly those with CSA absorption difficulties. The improved pharmacokinetics associated with Neoral may be largely due to the ability of the microemulsified CSA to bypass enteric metabolism.

环孢菌素A（CSA）口服给药的可预测性更高， 尽量减少亚治疗或毒性事件的数量和持续时间， 器官移植，从而提高同种异体移植物存活率。 我们有 最近确定标准制剂的生物利用度 CSA（Sandimmune）在稳定肾移植受者中的稳定 状态条件在很大程度上取决于肠和肝 P4503A4活性。 最近，一种新开发的微乳制剂 CSA（Neoral）的性能得到改善， 与Sandimmune相比的生物利用度。 因此，改进的 CSA谷水平和AUC之间的相关性可能有助于 管理移植患者，特别是CSA吸收患者 困难 与Neoral相关的药代动力学改善可能 这主要是由于微乳化CSA绕过 肠代谢