In this prospective, randomized, double-blind trial, 39 LTX recipients were transplanted and received placebo (n = 19; GFR, 102 ml/min/1.73 m2 [range, 91-113 ml/min/1.73 m2]) or felodipine (n = 20, GFR, 96 ml/min/1.73 m2 [range, 88-104 ml/min/1.73 m2]). Pre-operative treatment was titrated post-operatively to 10 mg or the maximum tolerable dose. The primary end-point was the change in GFR using Cr-51-labeled EDTA from LTX to 12 weeks thereafter, and follow-up was 52 weeks.
The treatment group showed an absolute mean decline in GFR of 31 ml/min/1.73 m2 (95% CI: -40 to 22 ml/min/1.73 m2), whereas that of the placebo group was 48 ml/min/1.73 m2 (95% confidence interval [CI]: -56 to 40 ml/min/1.73 m2). Thus, the difference between groups at 12 weeks was 17 ml/min/1.73 m2 (95% CI: 4-29 ml/min/1.73 m2; p = 0.01). Half of the patients were unable to complete the 3-month primary follow-up, and the analysis includes these patients by intention-to-treat. After 52 weeks (40 weeks after termination of treatment), the treatment effect was maintained at 12 ml/min/1.73 m2 (95% CI: 0-24 ml/min/1.73 m2, p = 0.05). The number of days with registered hypotension was significantly higher in the felodipine group than in the placebo group (39 days vs 13 days, rate ratio: 2.9 [95% CI: 1.5-5.3]).
Use of felodipine in select patients was associated with greater preservation in renal function early (90 days) after LTX. The observed benefits were attenuated by 1 year, although trends in better renal function were noted.
在这个前景中,随机化,双盲审判,39例LTX受者移植并接受安慰剂(n=19;GFR,102毫升/分钟/1.73平方米[范围,91-113ml/min/1.73m2])或非洛地平(n=20,GFR,96毫升/分钟/1.73平方米[范围,88-104毫升/分钟/1.73平方米])。术前治疗在术后滴定至10mg或最大耐受剂量。主要终点是使用Cr-51标记的EDTA从LTX到12周后GFR的变化,随访52周。
治疗组GFR的绝对平均下降为31ml/min/1.73m2(95%CI:-40至22ml/min/1.73m2),而安慰剂组为48ml/min/1.73m2(95%置信区间[CI]:-56~40ml/min/1.73m2).因此,12周时组间差异为17ml/min/1.73m2(95%CI:4-29ml/min/1.73m2;p=0.01).一半的患者无法完成3个月的主要随访,分析包括这些患者的意向治疗。52周后(治疗终止后40周),治疗效果维持在12ml/min/1.73m2(95%CI:0-24ml/min/1.73m2,p=0.05)。非洛地平组低血压登记天数明显高于安慰剂组(39天对13天,率比率:2.9[95%CI:1.5-5.3])。
在某些患者中使用非洛地平与LTX后早期(90天)肾功能的更大保留相关。观察到的益处在1年内减弱,尽管观察到肾功能改善的趋势。