Kuypers D R J, Neumayer H H, Fritsche L, Budde K, Rodicio J L, Vanrenterghem Y
Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium.
Transplantation. 2004 Oct 27;78(8):1204-11. doi: 10.1097/01.tp.0000137793.23371.42.
Studies have provided conflicting results as to the protective role of calcium channel blockers (CCB) in cyclosporine-treated patients with regard to blood pressure control and preservation of renal graft function. Lacidipine is a dihydropyridine CCB that possesses antioxidative, anti-atherosclerotic, and anti-adhesion properties and was shown to prevent cyclosporine-induced nephrotoxicity in a rat model.
We conducted a multicenter prospective, randomized, placebo-controlled study in 131 de novo recipients of a cadaveric renal allograft on cyclosporine therapy. The aim of this 2-year study was to assess the effects of lacidipine on graft function (plasma iohexol clearance), renal plasma flow, anastomotic arterial blood flow, deterioration of renal function, blood pressure, acute rejection, and hospitalization rate.
A total of 118 recipients were available for intention-to-treat analysis on efficacy (lacidipine: n=59; placebo: n=59). Graft function assessed by serum creatinine concentration and glomerular filtration rate measured as plasma iohexol clearance, was persistently better in lacidipine-treated patients from 1 year onwards (respectively, P<0.01 and P<0.05). Renal plasma flow and anastomotic blood flow were not significantly higher in lacidipine-treated patients. Three patients on lacidipine therapy and four on placebo experienced treatment failure defined as an increase in serum creatinine from baseline of more than 60% (log-rank test: P=0.57). Study groups did not differ in acute rejection rate, trough blood cyclosporine concentrations, blood pressure, number of antihypertensive drugs, hospitalization rate, and adverse event rate.
The use of calcium channel blockers in cyclosporine-treated renal recipients results in a significantly better allograft function at 2 years and this effect is independent of blood pressure lowering.
关于钙通道阻滞剂（CCB）在接受环孢素治疗的患者中对血压控制和肾移植功能保护作用的研究结果相互矛盾。拉西地平是一种二氢吡啶类CCB，具有抗氧化、抗动脉粥样硬化和抗黏附特性，在大鼠模型中显示可预防环孢素诱导的肾毒性。
我们对131例接受尸体肾移植并接受环孢素治疗的初治受者进行了一项多中心前瞻性、随机、安慰剂对照研究。这项为期2年的研究旨在评估拉西地平对移植肾功能（血浆碘海醇清除率）、肾血浆流量、吻合口动脉血流量、肾功能恶化、血压、急性排斥反应和住院率的影响。
共有118例受者可进行意向性疗效分析（拉西地平组：n = 59；安慰剂组：n = 59）。从1年起，用血清肌酐浓度评估的移植肾功能以及以血浆碘海醇清除率测量的肾小球滤过率，在接受拉西地平治疗患者中持续更好（分别为P<0.01和P<0.05）。接受拉西地平治疗患者的肾血浆流量和吻合口血流量没有显著更高。3例接受拉西地平治疗的患者和4例接受安慰剂治疗的患者出现治疗失败，定义为血清肌酐较基线水平升高超过60%（对数秩检验：P = 0.57）。研究组在急性排斥反应率、环孢素谷浓度、血压、抗高血压药物数量、住院率和不良事件率方面没有差异。
在接受环孢素治疗的肾移植受者中使用钙通道阻滞剂可使2年时移植肾功能显著更好，且这种作用独立于血压降低。
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