Ghoneim M A, Sobh M A, Shokeir A A, Bakr M A, el-Sherif A K, Fouda M A
Urology and Nephrology Center, Mansoura University, Egypt.
Nephrol Dial Transplant. 1993;8(6):551-6. doi: 10.1093/ndt/8.6.551.
Two consecutive prospective randomized trials were performed to study three immunosuppressive protocols in 195 kidney transplant recipients. Only adult primary renal transplant recipients with one haplotype HLA mismatch were included. All patients received kidneys from living related donors and had previous donor non-specific blood transfusions. Study I included 112 recipients who were randomly assigned to receive either azathioprine (Aza) and prednisolone (P) (n = 54) or cyclosporin (CsA) and P (n = 58). Patients in this study were followed up for 3-6 years (mean 50 +/- 8 months). Study II included 83 recipients who were randomly assigned to receive either triple therapy of Aza-CsA-P (n = 41) or conventional therapy of Aza-P (n = 42). Patients in this study were followed up for a period of 32 +/- 10 (range 26-43) months. Analysis of data in the two studies demonstrated the absence of statistically significant differences in graft or patient survival rates over short- and long-term follow-up periods among recipients of the conventional immunotherapy and those receiving the CsA-P or the triple therapy. The overall frequency of acute rejection episodes was not significantly different between the two treatment groups of each study. Serum creatinine was significantly higher in the CsA-P group while the incidence of infection was significantly lower in the triple group. When switching from one regimen to another is considered, at least 75% of the one-haplotype HLA mismatched live-related donor renal transplants could be maintained on conventional immunotherapy with comparable degree of success to those treated with the CsA-P or the triple therapy. However, in at least 15% of patients with conventional immunotherapy, CsA could reverse ongoing rejections and can therefore be considered as a rescue treatment.
进行了两项连续的前瞻性随机试验,以研究195例肾移植受者的三种免疫抑制方案。仅纳入了单倍型HLA错配的成年原发性肾移植受者。所有患者均接受来自活体亲属供者的肾脏,且既往有供者非特异性输血史。研究I纳入了112例受者,他们被随机分配接受硫唑嘌呤(Aza)和泼尼松龙(P)(n = 54)或环孢素(CsA)和P(n = 58)治疗。该研究中的患者随访了3 - 6年(平均50±8个月)。研究II纳入了83例受者,他们被随机分配接受Aza - CsA - P三联疗法(n = 41)或Aza - P传统疗法(n = 42)。该研究中的患者随访了32±10(范围26 - 43)个月。两项研究的数据分析表明,在短期和长期随访期间,传统免疫疗法的受者与接受CsA - P或三联疗法的受者在移植物或患者存活率方面没有统计学上的显著差异。每项研究的两个治疗组之间急性排斥反应发作的总体频率没有显著差异。CsA - P组的血清肌酐显著更高,而三联组的感染发生率显著更低。当考虑从一种方案转换到另一种方案时,至少75%的单倍型HLA错配的活体亲属供者肾移植可以通过传统免疫疗法维持,其成功程度与接受CsA - P或三联疗法的患者相当。然而,在至少15%接受传统免疫疗法的患者中,CsA可以逆转正在进行的排斥反应,因此可被视为一种挽救治疗。