Am J Transplant:对于新肾移植患者来说,EVR + rCNI方案与标准护理具有相当的疗效和移植功能

2020-10-01 MedSci原创 MedSci原创

TRANSFORM是一项为期24个月的前瞻性、开放标签试验,纳入2037名新生肾移植受者,在移植后24小时内随机(1:1)接受依维莫司(EVR)联合减少暴露的钙尿素抑制剂(EVR + rCNI)或霉酚

TRANSFORM是一项为期24个月的前瞻性、开放标签试验,纳入2037名新生肾移植受者,在移植后24小时内随机(1:1)接受依维莫司(EVR)联合减少暴露的钙尿素抑制剂(EVR + rCNI)或霉酚酸酯联合标准暴露的CNI。

结果,与之前报道的12个月的研究结果一致,在第24个月时,EVR + rCNI方案对经活检证实的急性排斥反应(tBPAR)或估计肾小球滤过率(eGFR)<50 mL/min/1.73 m2的主要终点实现了非劣效性(47.9% vs 43.7%;差异=4.2%;95%置信区间=-0.3,8.7;P = .006)。两组平均eGFR稳定至第24个月(52.6 vs 54.9 mL/min per 1.73 m2 )。在接受治疗的患者中,EVR + rCNI组的新生供体特异性抗体(dnDSA)发生率较低(12.3% vs 17.6%)。虽然EVR+rCNI因不良事件导致的停药率较高(27.2% vs 15.0%),但巨细胞病毒(2.8% vs 13.5%)和BK病毒(5.8% vs 10.3%)感染率较低。即使在D+/R-高危组中,EVR+rCNI的巨细胞病毒感染率也显著降低(P < .0001)。

 

总之,相对于标准护理,EVR + rCNI方案具有相当的疗效和移植功能,且tBPAR和dnDSA率较低,病毒感染发生率显著降低,最长可达24个月。

 

原始出处:

 

Stefan P BergerClaudia Sommerer, et al., Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study. Am J Transplant. 2019 Nov;19(11):3018-3034. doi: 10.1111/ajt.15480. 

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    2021-04-10 bsmagic9140
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    2021-06-18 xuyu
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    2020-10-01 内科新手

    谢谢梅斯提供这么好的信息,学到很多

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