Department of Transplant Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Nephrology (Carlton). 2016 Oct;21(10):821-7. doi: 10.1111/nep.12738.
Optimal tacrolimus exposure in transplant recipients is not well established. The results from the Symphony study indicated that low-target tacrolimus (trough concentrations 3-7 µg/L) in de novo standard risk renal transplant recipients should be appropriate. The aim of this study was to evaluate real-life outcomes when applying a similar strategy in a clinical setting.
A single-centre analysis was conducted in standard risk renal transplant recipients receiving low-target tacrolimus, mycophenolate mofetil, glucocorticoids and basiliximab induction. One-year estimated glomerular filtration rate (eGFR, Cockcroft-Gault), one-year biopsy-proven acute rejection rate and graft- and patient survival up to 3 years post-transplant were compared with the outcomes in the Symphony study.
From 1 January 2009 to 31 March 2013, we included 406 patients. One year after transplantation, the mean ± SD eGFR was 76.8 ± 28.3 mL/min (Symphony: 65.4 ± 27.0 mL/min, P < 0.001). Biopsy-proven acute rejections were seen in 14.5% of the patients (Symphony: 12.3%, P = 0.35). Kaplan-Meier estimates [95% confidence interval] of three-year death-censored graft- and patient survival were 96.6% [94.2-99.0%] (Symphony: 93%) and 95.0% [92.6-97.3%] (Symphony: 95%), respectively.
Low-target tacrolimus-based immunosuppression is safe and effective also in a standard clinical setting in de novo standard risk renal transplant recipients.
移植受者中最佳他克莫司暴露量尚未确定。Symphony 研究的结果表明,新诊断的标准风险肾移植受者中低目标他克莫司(谷浓度 3-7μg/L)应该是合适的。本研究旨在评估在临床环境中应用类似策略的实际结果。
对接受低目标他克莫司、霉酚酸酯、糖皮质激素和巴利昔单抗诱导的标准风险肾移植受者进行单中心分析。比较 1 年估算肾小球滤过率(Cockcroft-Gault)、1 年活检证实的急性排斥反应率以及移植后 3 年内移植物和患者的存活率与 Symphony 研究的结果。
2009 年 1 月 1 日至 2013 年 3 月 31 日,我们纳入了 406 例患者。移植后 1 年,平均(±SD)eGFR 为 76.8±28.3mL/min(Symphony:65.4±27.0mL/min,P<0.001)。14.5%的患者出现活检证实的急性排斥反应(Symphony:12.3%,P=0.35)。3 年死亡风险调整的移植物和患者存活率的 Kaplan-Meier 估计值[95%置信区间]分别为 96.6%[94.2-99.0%](Symphony:93%)和 95.0%[92.6-97.3%](Symphony:95%)。
在新诊断的标准风险肾移植受者中,基于低目标他克莫司的免疫抑制治疗在标准临床环境中也是安全有效的。