Gheith Osama A, Nematalla Ahmed H, Bakr Mohamed A, Refaie Ayman, Shokeir Ahmed A, Ghoneim Mohamed A
Urology & Nephrology Center, Mansoura, Egypt.
Exp Clin Transplant. 2011 Apr;9(2):121-7.
Steroids have had the main role in renal transplant for more than 4 decades. However, chronic use of steroids is associated with many comorbidities, owing to a lack of assessing cost-benefit of steroid avoidance in live-donor renal allotransplants. In this prospective, randomized, controlled study, we aimed to assess the cost-benefit of a steroid-free immunosuppression regimen among Egyptian live-donor renal transplants.
One hundred patients were randomly allocated to receive tacrolimus, mycophenolate mofetil, and steroids for only 3 days (n=50 patients; study group) or tacrolimus, mycophenolate mofetil, and steroids on a maintenance basis (n=50 patients; control group). All patients received basiliximab (Simulect) induction, with median follow-up of 12 months.
Both groups showed comparable graft and patient survivals, rejection episodes, and graft functioning. Posttransplant comorbidities were significantly more prevalent in the steroid-maintenance group. Hypertension was detected in 4% of steroid-free group versus 24% in the steroid-maintenance group (P = .0009). Posttransplant diabetes mellitus, serious infections, and hyperlipidemia were significantly more prevalent in the steroid-maintenance group (P < .05). Associated hospitalization costs were 2.2-fold higher in the steroid-maintenance group than they were in the steroid-free group. One year after transplant, the cost of managing posttransplant comorbidities was significantly higher in steroid-maintenance group, despite comparable costs of immunosuppression.
In low, immunologic risk recipients of live-donor renal transplants, using basiliximab induction and maintenance with tacrolimus, mycophenolate mofetil, steroid avoidance was associated with lower first annual total costs despite comparable immunosuppression costs, which was attributed to lower costs of associated morbidities.
四十多年来,类固醇在肾移植中一直发挥着主要作用。然而,由于缺乏对活体供肾同种异体移植中避免使用类固醇的成本效益评估,长期使用类固醇与许多合并症相关。在这项前瞻性、随机、对照研究中,我们旨在评估埃及活体供肾移植中无类固醇免疫抑制方案的成本效益。
100例患者被随机分配接受他克莫司、霉酚酸酯和仅使用3天的类固醇(n = 50例患者;研究组)或他克莫司、霉酚酸酯并持续使用类固醇(n = 50例患者;对照组)。所有患者均接受巴利昔单抗(舒莱)诱导治疗,中位随访时间为12个月。
两组的移植物和患者存活率、排斥反应发作次数及移植物功能均相当。移植后合并症在类固醇维持组中明显更为普遍。无类固醇组中4%的患者检测出高血压,而类固醇维持组中这一比例为24%(P = 0.0009)。移植后糖尿病、严重感染和高脂血症在类固醇维持组中明显更为普遍(P < 0.05)。类固醇维持组的相关住院费用比无类固醇组高2.2倍。移植一年后,尽管免疫抑制费用相当,但类固醇维持组中处理移植后合并症的费用明显更高。
在低免疫风险的活体供肾移植受者中,使用巴利昔单抗诱导并联合他克莫司、霉酚酸酯维持治疗且避免使用类固醇,尽管免疫抑制费用相当,但与较低的首年总费用相关,这归因于相关合并症的费用较低。