Multicenter evaluation of efficacy and safety of low-dose versus high-dose valganciclovir for prevention of cytomegalovirus disease in donor and recipient positive (D plus/R plus ) renal transplant recipients
Multicenter evaluation of efficacy and safety of low-dose versus high-dose valganciclovir for prevention of cytomegalovirus disease in donor and recipient positive (D plus/R plus ) renal transplant recipients
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DOI：
10.1111/tid.12609
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发表时间：
2016-12-01
影响因子：
2.6
通讯作者：
Gabardi, Steven
中科院分区：
文献类型：
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作者：
Heldenbrand, Seth;Li, Chenghui;Gabardi, Steven
背景资料：巨细胞病毒（CMV）供者阳性/受者阳性（D+/R+）人群是肾移植受者（RTR）中比例最大的人群。在中等风险D+/R+人群中预防CMV的指南包括用缬更昔洛韦（VGCV）900 mg/天预防3个月。据我们所知，这项研究是第一个头对头分析，比较了VGCV 450与900 mg/天3个月的疗效和安全性CMV预防D+/R+ RTR.Methods：多中心，回顾性分析评估了478成人RTR之间的2008年1月和2011年10月。研究受试者接受VGCV 450 mg/天（第1组; n=398）或900 mg/天（第2组; n=89）x3个月预防CMV。根据肾功能调整所有VGCV。本研究纳入的所有组均接受研究批准的诱导和维持免疫抑制方案。主要终点是CMV疾病的发病率在12 months.Results：移植物丢失率，患者生存率，T细胞和/或抗体介导的排斥反应，血液学不良事件，机会性感染，早期VGCV停药进行了评估。患者的人口统计学是可比的，但有显着差异，种族和供体类型之间的groups.Conclusion：CMV疾病的发生率在12个月之间的组（3.5%比3.4%，P=1.000）是相似的。对数秩检验发现，两组之间发生CMV的时间无统计学显著差异（P=.939）。
Background: The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population is the largest proportion of renal transplant recipients (RTR). Guidelines for prevention of CMV in the intermediate-risk D+/R+ population include prophylaxis with valganciclovir (VGCV) 900 mg/day for 3 months. This study is the first head-to-head analysis, to our knowledge, comparing the efficacy and safety CMV prophylaxis of VGCV 450 vs 900 mg/day for 3 months in D+/R+ RTR.Methods: A multicenter, retrospective analysis evaluated 478 adult RTR between January 2008 and October 2011. Study participants received VGCV 450 mg/day (Group 1; n=398) or 900 mg/day (Group 2; n=89) x3 months for CMV prophylaxis. All VGCV was adjusted for renal function. All groups included in this study received study-approved induction and maintenance immunosuppression regimens. The primary endpoint was incidence of CMV disease at 12 months.Results: The rates of graft loss, patient survival, T-cell and/or antibody-mediated rejection, hematological adverse events, opportunistic infections, and early VGCV discontinuation were evaluated. Patient demographics were comparable, but had significant differences in ethnicity and donor type between the groups.Conclusion: The occurrence of CMV disease at 12 months was similar between the groups (3.5% vs 3.4%; P=1.000). Log-rank test found no statistically significant difference in the time to development of CMV between the 2 groups (P=.939).