EFFICACY & SAFETY OF IV & ORAL MYCOPHENOLATE MOFETIL & AZATHIOPRINE

这是一项多中心、随机、双盲、双模拟对照研究，评估静脉注射霉酚酸酯或硫唑嘌呤在接受首次身体肝移植的患者中的有效性和安全性，其中每种药物均与环孢素(Neole)和皮质类固醇联合使用。主要目的是：1)证明霉酚酸酯可降低移植后前6个月内的患者比例，这些患者在移植后头12个月内经历(A)一种或多种经治疗的、经活组织检查证实的急性移植排斥反应，并伴有提示排斥反应的生化异常，或(B)死亡/再移植和2)移植物丢失(死亡/再移植)。由于这项研究招募的患者都是移植后的重病患者，GCRC的一名护士前往罗切斯特卫理公会医院为药代动力学研究进行抽血。我们预计有80名患者，但登记已经停止。我们仍在跟踪所有患者。

This is a multicenter, randomized, double-blind, double-dummy comparative study assessing the efficacy and safety of IV followed by oral mycophenolate mofetil or azathioprine, each in combination with cyclosporine (Neoral) and corticosteroids, in patients receiving their first cadaveric liver allograft. The primary objectives are 1) to demonstrate that mycophenolate mofetil reduces the proportion of patients who experience in the first six months posttransplantation (a) one or more epidoses of treated, biopsy-proven acute allograft rejection with biochemical abnormalities suggestive of rejection, or (b) death/retransplantation and 2) graft loss (death/retransplantation) during the first 12 months of posttransplantation. Since the patients recruited for the study are post-transplant and very ill, a GCRC nurse travels to Rochester Methodist Hospital to perform the blood draws for the pharmacokinetic studies. We had anticipated 80 patients, but enrollment has stopped. we are still following all patients.