Niemczyk M, Nowak M, Pilecki T, Wyzgał J, Ziółkowski J, Zygier D, Paczek L
Transplantation Institute, Department of Immunology, Transplant Medicine and Internal Diseases, Warsaw Medical University, ul. Nowogrodzka 59, 02-006 Warsaw, Poland.
Transplant Proc. 2006 Jan-Feb;38(1):74-7. doi: 10.1016/j.transproceed.2005.11.092.
The aim of this study was an economic evaluation of three sirolimus (SRL)-based regimens in the first 2 years after renal transplantation.
The three SRL-based immunosuppressive regimens in renal transplant patients between June 2000 and September 2002 were: (1) SRL + steroids + cyclosporine (CsA) permanently; (2) SRL + steroids + tacrolimus (Tac); and (3) SRL + steroids + CsA, with CsA discontinuation at 3 months posttransplant. Ten patients were included in each group in an intent-to-treat analysis. Cost was calculated according to the hospital price list and recast into euros (EUR) with a 5% discount rate.
The number of patients free of an acute rejection episode during 2 years posttransplant were 6, 8, and 5, with 2-year graft and patient survivals of 9, 10, and 9 for regimens 1, 2, and 3, respectively. As differences in clinical effects were not statistically significant, cost analysis was appropriate instead of cost-effectiveness analysis. The mean cost of the 2-year treatment was 15,759 EUR; 25,593 EUR; and 21,197 EUR per patient for regimens 1, 2, and 3, respectively. Sensitivity analysis for the main variables confirmed that the results were not dependent on changes in costs.
Regimen 1 was the most economical immunosuppressive therapy during the 2 years after kidney transplantation. Studies on a larger group of longer observation would be more useful for clinical analysis.
本研究旨在对肾移植术后头两年内三种基于西罗莫司（SRL）的治疗方案进行经济学评估。
2000年6月至2002年9月期间，肾移植患者采用的三种基于SRL的免疫抑制方案为：（1）SRL + 类固醇 + 长期使用环孢素（CsA）；（2）SRL + 类固醇 + 他克莫司（Tac）；（3）SRL + 类固醇 + CsA，肾移植术后3个月停用CsA。每组纳入10例患者进行意向性分析。成本根据医院价格表计算，并以5%的贴现率换算为欧元（EUR）。
移植后2年内无急性排斥反应发作的患者数量分别为6例、8例和5例，方案1、2和3的2年移植物和患者生存率分别为9例、10例和9例。由于临床效果差异无统计学意义，因此进行成本分析而非成本效益分析是合适的。方案1、2和3的2年治疗平均成本分别为每位患者15,759欧元、25,593欧元和21,197欧元。对主要变量的敏感性分析证实，结果不依赖于成本变化。
方案1是肾移植术后2年内最经济的免疫抑制治疗方案。对更大规模、更长观察期的研究进行临床分析将更有用。
