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霉酚酸酯吗替麦考酚酯维持治疗肾移植患者:TranCept STAY 研究的长期结果。

Mycophenolate mofetil maintenance therapy in renal transplant patients: long-term results of the TranCept STAY study.

机构信息

Department of Nephrology, Clinic rechts der Isar, Technical University Munich, Munich, Germany.

出版信息

Clin Transplant. 2012 Nov-Dec;26(6):919-26. doi: 10.1111/ctr.12008. Epub 2012 Sep 19.

DOI:10.1111/ctr.12008
PMID:22994923
Abstract

BACKGROUND

This prospective observational study documented long-term renal function in transplant recipients receiving mycophenolate mofetil (MMF).

METHODS

Kidney allograft recipients>6 months post-transplantation, with a glomerular filtration rate (GFR)>20 mL/min, receiving MMF from time of transplantation were enrolled and followed for four yr. Subgroups were identified based on time between transplantation and enrollment: Y<1 (6 months-1 yr); Y1-2 (>1-2 yr); Y2-5 (>2-5 yr) and Y>5 (>5 yr).

RESULTS

A total of 2040 patients were analyzed; 780, 410, 541 and 309 in subgroups Y<1, Y1-2, Y2-5 and Y>5. For all patients combined GFR decreased during the observational period by approximately 1 mL/min/yr (median GFR (mL/min) was 50.8, 50.5, 48.7, and 47.6 at one, two, three, and four yr). Survival estimates for decline in renal function (>20% GFR decline at one time point) were 78%, 66%, 57%, and 51% at one, two, three and four yr, with no significant differences between subgroups (p>0.05). In adult patients, higher doses of MMF (≥1 g/d) were associated with better GFR outcomes (median GFR (mL/min) 48.1 vs. 39.9 at four yr post-enrollment; p=0.0037). When comparing the effects of MMF combined with calcineurin inhibitors (CNIs), GFR was increased with lower doses of tacrolimus or cyclosporin. There were no major tolerability or acute rejection problems and graft survival was similar in all subgroups (graft survival estimates for all patients combined were 99%, 95%, 92%, and 90% at one, two, three, and four yr).

CONCLUSIONS

Long-term MMF immunosuppression preserves renal function and higher MMF doses combined with lower CNI doses may provide better patient outcomes.

摘要

背景

本前瞻性观察研究记录了接受吗替麦考酚酯(MMF)的移植受者的长期肾功能。

方法

移植后>6 个月、肾小球滤过率(GFR)>20mL/min 的肾移植受者,从移植时开始接受 MMF,并随访 4 年。根据移植后到入组的时间将患者分为亚组:Y<1(6 个月-1 年);Y1-2(>1-2 年);Y2-5(>2-5 年)和 Y>5(>5 年)。

结果

共分析了 2040 例患者;780、410、541 和 309 例患者分别入组 Y<1、Y1-2、Y2-5 和 Y>5 亚组。在所有患者中,GFR 在观察期间每年下降约 1mL/min/yr(中位数 GFR(mL/min)在 1、2、3 和 4 年时分别为 50.8、50.5、48.7 和 47.6)。肾功能下降(一次下降>20%GFR)的生存估计值在 1、2、3 和 4 年时分别为 78%、66%、57%和 51%,各亚组间无显著差异(p>0.05)。在成年患者中,较高剂量的 MMF(≥1g/d)与更好的 GFR 结局相关(4 年时 MMF 治疗组和安慰剂组的 GFR 中位数分别为 48.1 和 39.9mL/min;p=0.0037)。比较 MMF 联合钙调磷酸酶抑制剂(CNI)的作用时,发现较低剂量的他克莫司或环孢素可增加 GFR。没有出现严重的药物耐受性或急性排斥反应问题,所有亚组的移植物存活率相似(所有患者的移植物存活率估计值在 1、2、3 和 4 年时分别为 99%、95%、92%和 90%)。

结论

长期 MMF 免疫抑制可保留肾功能,较高剂量的 MMF 联合较低剂量的 CNI 可能为患者提供更好的结局。

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