Krishnan Anoushka, Teixeira-Pinto Armando, Chan Doris, Chakera Aron, Dogra Gursharan, Boudville Neil, Irish Ashley, Morgan Kelly, Phillips Jessica, Wong Germaine, Lim Wai H
Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia.
Sydney School of Public Health, University of Sydney, Camden, NSW, Australia.
Clin Transplant. 2017 Oct;31(10). doi: 10.1111/ctr.13043. Epub 2017 Aug 19.
This is an 18-month prospective, randomized controlled trial (RCT) designed to compare the effect of early conversion from cyclosporin to everolimus/mycophenolic acid (E-MPA) between 3 and 4 months post-transplant to cyclosporin/mycophenolic acid (CsA-MPA) on left ventricular mass index (LVMI) at 3 and 18 months post-transplant (primary outcome). Secondary outcomes included estimated glomerular filtration rate (eGFR), viral infection, and adverse events. Twenty-four patients were randomized in a 1:1 ratio to E-MPA or CsA-MPA groups. There were no significant differences in mean (SD) LVMI at 3 (51.6±18.5 vs 53.7±15.7 g/m ) and 18 months (52.7±16.3 vs 51.7±16.8 g/m ) between CsA-MPA and E-MPA groups. The incidence of viral infections was reduced in E-MPA compared to CsA-MPA treatment groups (8% vs 50%, P=.02), but the incidences of acute rejection, adverse events, and drug discontinuation were similar between groups. There was an overall increase in eGFR with time (0.04 log- mL/min/1.73 m per 6 months, P=.012) but no significant difference between the two groups across time (0.11 log- mL/min/1.73 m , P=.311). Immunosuppressive regimen comprising early conversion from cyclosporine to everolimus was not associated with a regression of LVMI, but a lower risk of viral infections was observed.
这是一项为期18个月的前瞻性随机对照试验（RCT），旨在比较移植后3至4个月从环孢素早期转换为依维莫司/霉酚酸（E-MPA）与环孢素/霉酚酸（CsA-MPA）对移植后3个月和18个月时左心室质量指数（LVMI）的影响（主要结局）。次要结局包括估计肾小球滤过率（eGFR）、病毒感染和不良事件。24例患者按1:1比例随机分为E-MPA组或CsA-MPA组。CsA-MPA组和E-MPA组在3个月（51.6±18.5 vs 53.7±15.7 g/m）和18个月（52.7±16.3 vs 51.7±16.8 g/m）时的平均（标准差）LVMI无显著差异。与CsA-MPA治疗组相比，E-MPA组的病毒感染发生率降低（8% vs 50%，P = 0.02），但两组间急性排斥反应、不良事件和停药的发生率相似。eGFR随时间总体增加（每6个月增加0.04 log- mL/min/1.73 m²，P = 0.012），但两组在各时间点无显著差异（0.11 log- mL/min/1.73 m²，P = 0.311）。从环孢素早期转换为依维莫司的免疫抑制方案与LVMI的降低无关，但观察到病毒感染风险较低。
