Mathias Helen C, Ozalp Farük, Will Malcolm B, Borland William, Payne Carol, Kerr Myra, Lockhart Jane, Murday Andrew J
Scottish Cardiopulmonary Transplant Unit, Glasgow Royal Infirmary, Glasgow, UK.
J Heart Lung Transplant. 2005 Dec;24(12):2137-43. doi: 10.1016/j.healun.2005.04.019. Epub 2005 Oct 14.
Cyclosporine monitoring using 2-hour post-dose samples (C2) is thought to be more efficacious than using pre-dose levels (C0) in managing immunosuppression for transplant patients. We evaluated the effect of C2 monitoring on cyclosporine dose and clinical parameters in stable heart transplant patients.
125 stable heart transplant patients were randomized to C0 or C2 monitoring of cyclosporine levels for a period of six months. All patients had both C0 and C2 samples taken, and clinicians were blinded to one of the samples depending on randomization. The primary endpoint was the relative change in cyclosporine (Neoral) dose during the study period and secondary endpoints were change in creatine clearance, mortality, infection, and acute rejection.
There was a significant decrease in the cyclosporine dose for the C2 group as compared with the C0 group (-11 mg/day and -26 mg/day respectively, p = 0.0025). No proven rejection episodes occurred in either group and there was no significant difference in the incidence of infection (C0 6, C2 10; p = 0.14), the change in renal function (change in creatine clearance C(0) +0.54 ml/min; C2 -0.16 ml/min; p = 0.61), the number of blood tests or dose adjustments between groups over the study period. Analysis of the blinded samples revealed that the reduction of cyclosporine dose in the C2 group could not be accounted for by reduced immunosuppression .
C2 monitoring allows a significant cyclosporine dose reduction without compromising patient outcome in stable heart transplant patients. Further studies are required to ascertain whether this dose reduction can be translated into clinical benefit.
对于移植患者的免疫抑制管理，使用给药后2小时样本（C2）监测环孢素被认为比使用给药前水平（C0）更有效。我们评估了C2监测对稳定的心脏移植患者中环孢素剂量和临床参数的影响。
125名稳定的心脏移植患者被随机分为C0或C2环孢素水平监测组，为期6个月。所有患者均采集了C0和C2样本，临床医生根据随机分组对其中一个样本不知情。主要终点是研究期间环孢素（新山地明）剂量的相对变化，次要终点是肌酐清除率的变化、死亡率、感染和急性排斥反应。
与C0组相比，C2组的环孢素剂量显著降低（分别为-11毫克/天和-26毫克/天，p = 0.0025）。两组均未发生经证实的排斥反应，感染发生率（C0组6例，C2组10例；p = 0.14）、肾功能变化（肌酐清除率变化C(0) +0.54毫升/分钟；C2组 -0.16毫升/分钟；p = 0.61）、研究期间两组间的血液检查次数或剂量调整方面均无显著差异。对不知情样本的分析显示，C2组环孢素剂量的降低不能用免疫抑制的降低来解释。
C2监测可在不影响稳定的心脏移植患者预后的情况下显著降低环孢素剂量。需要进一步研究以确定这种剂量降低是否能转化为临床益处。
