Does reduction in mycophenolic acid dose compromise efficacy regardless of tacrolimus exposure level? An analysis of prospective data from the Mycophenolic Renal Transplant (MORE) Registry.
Does reduction in mycophenolic acid dose compromise efficacy regardless of tacrolimus exposure level? An analysis of prospective data from the Mycophenolic Renal Transplant (MORE) Registry.
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DOI：
10.1111/j.1399-0012.2012.01694.x
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发表时间：
2013-01
影响因子：
2.1
通讯作者：
Chan L
中科院分区：
文献类型：
--
作者：
Langone A;Doria C;Greenstein S;Narayanan M;Ueda K;Sankari B;Pankewycz O;Shihab F;Chan L
关于减少霉酚酸(MPA)剂量对疗效的影响以及伴随的他克莫司暴露的影响，缺乏前瞻性的数据。霉酚性肾移植(MORE)登记是一项前瞻性的观察性研究，研究对象是在常规管理下接受甲孕酮治疗的新肾移植患者。在870名接受他克莫司治疗的患者中，评估了减量、中断或停用(剂量变化)的效果：375例(43.1%)减少了他克莫司(基线时≤为7 ng/m L)，495例(56.9%)标准他克莫司(7 ng/m L)，589例(67.7%)和281例(32.3%)肠溶霉酚酯钠。在基线至1个月、1~3个月、3~6个月、6~12个月期间，9.3%(78/838)、16.6%(132/794)、20.7%(145/701)和13.1%(70/)的患者需要改变甲孕酮的剂量。这些患者在一年内经历了经活检证实的急性排斥反应的风险增加，并将他克莫司暴露在模型中(危险比[HR]2.60，95%可信区间1.28-5.29，p=0.008)或排除(危险比2.58，95%可信区间1.28-5.23，p=0.008)。当包括他克莫司暴露时(HR2.23；95%CI1.01-4.89，p=0.047)，但当排除他克莫司暴露时(HR2.16；95%CI0.99-4.79；p=0.054)，MPA剂量的变化与移植物失败显著相关。这些结果表明，无论他克莫司的低谷水平如何，减少或停用甲孕酮都会对移植物的预后产生不利影响。
Prospective data are lacking concerning the effect of reduced mycophenolic acid (MPA) dosing on efficacy and the influence of concomitant tacrolimus exposure. The Mycophenolic Renal Transplant (MORE) Registry is a prospective, observational study of de novo kidney transplant patients receiving MPA therapy under routine management. The effect of MPA dose reduction, interruption, or discontinuation (dose changes) was assessed in 870 tacrolimus-treated patients: 375 (43.1%) reduced tacrolimus (≤7 ng/mL at baseline) and 495 (56.9%) standard tacrolimus (>7 ng/mL); enteric-coated mycophenolate sodium 589 (67.7%) and mycophenolate mofetil 281 (32.3%). During baseline to month 1, months 1–3, months 3–6, and months 6–12, 9.3% (78/838), 16.6% (132/794), 20.7% (145/701), and 13.1% (70/535) patients, respectively, required MPA dose changes. These patients experienced an increased risk of biopsy-proven acute rejection at one yr with tacrolimus exposure either included in the model (hazard ratio [HR] 2.60, 95% CI 1.28–5.29, p = 0.008) or excluded (HR 2.58, 95% CI 1.28–5.23, p = 0.008). MPA dose changes were significantly associated with one yr graft failure when tacrolimus exposure was included (HR 2.23; 95% CI 1.01–4.89, p = 0.047) but not when tacrolimus exposure was excluded (HR 2.16; 95% CI 0.99–4.79; p = 0.054). These results suggest that reducing or discontinuing MPA can adversely affect graft outcomes regardless of tacrolimus trough levels.
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影响因子：
2.1
作者：
Pelletier, RP;Akin, B;Ferguson, RM
通讯作者：
Ferguson, RM
影响因子：
6.2
作者：
Bolin, Paul;Tanriover, Bekir;Tomlanovich, Stephen J.
通讯作者：
Tomlanovich, Stephen J.
影响因子：
2.1
作者：
Bunnapradist, Suphamai;Ambuehl, Patrice M.
通讯作者：
Ambuehl, Patrice M.
影响因子：
0.9
作者：
Khosroshahi, H. T.;Shoja, M. M.;Amjadi, M.
通讯作者：
Amjadi, M.
影响因子：
8.8
作者：
Salvadori, M;Holzer, H;Hall, M
通讯作者：
Hall, M