Zuckermann Andreas, Wang Shoei-Shen, Ross Heather, Frigerio Maria, Eisen Howard J, Bara Christoph, Hoefer Daniel, Cotrufo Maurizio, Dong Gaohong, Junge Guido, Keogh Anne M
Department of Cardiothoracic Surgery, University of Vienna, 1090 Vienna, Austria.
J Transplant. 2011;2011:535983. doi: 10.1155/2011/535983. Epub 2011 Sep 13.
A six-month, multicenter, randomized, open-label study was undertaken to determine whether renal function is improved using reduced-exposure cyclosporine (CsA) versus standard-exposure CsA in 199 de novo heart transplant patients receiving everolimus and steroids ± induction therapy. Mean C(2) levels were at the low end of the target range in standard-exposure patients (n = 100) and exceeded target range in reduced-exposure patients (n = 99) throughout the study. Mean serum creatinine at Month 6 (the primary endpoint) was 141.0 ± 53.1 μmol/L in standard-exposure patients versus 130.1 ± 53.7 μmol/L in reduced-exposure patients (P = 0.093). The incidence of biopsy-proven acute rejection ≥3A at Month 6 was 21.0% (21/100) in the standard-exposure group and 16.2% (16/99) in the reduced-exposure group (n.s.). Adverse events and infections were similar between treatment groups. Thus, everolimus with reduced-exposure CsA resulted in comparable efficacy compared to standard-exposure CsA. No renal function benefits were demonstrated; that is possibly related to poor adherence to reduced CsA exposure.
一项为期六个月的多中心、随机、开放标签研究旨在确定，在199例接受依维莫司和类固醇±诱导治疗的初发心脏移植患者中，与标准剂量环孢素（CsA）相比，减少剂量的CsA是否能改善肾功能。在整个研究过程中，标准剂量组（n = 100）的平均C(2)水平处于目标范围的下限，而减少剂量组（n = 99）的平均C(2)水平超过了目标范围。在第6个月（主要终点）时，标准剂量组患者的平均血清肌酐为141.0±53.1μmol/L，而减少剂量组患者为130.1±53.7μmol/L（P = 0.093）。在第6个月时，经活检证实的≥3A级急性排斥反应的发生率在标准剂量组为21.0%（21/100），在减少剂量组为16.2%（16/99）（无统计学差异）。治疗组之间的不良事件和感染情况相似。因此，与标准剂量的CsA相比，减少剂量的CsA与依维莫司联合使用时疗效相当。未显示出对肾功能有改善作用；这可能与减少CsA剂量的依从性差有关。
