Kung S-C, Parikh M, Fyfe B, Xiao S-G, Sierka D, Heifets M, Moritz M, Anil Kumar M-S
Hahnemann University Hospital, Philadlephia, PA 19102, USA.
Transplant Proc. 2004 Mar;36(2 Suppl):475S-477S. doi: 10.1016/j.transproceed.2004.01.049.
This study compares outcomes of kidney transplantation with two distinct induction protocols Basiliximab (Simulect) versus Muromonab (OTK 3) in the setting of cyclosporine (Neoral)-based immunosuppression. Postinduction protocols included either total prednisone avoidance or prednisone sparing versus standard prednisone dosing. Two hundred forty five adult patients receiving kidney transplantation between 1995 and 2000 were included in the study. Treatment in group 1 was OKT 3 + Neoral + adjunct + standard prednisone; group 2, Simulect + Neoral + adjunct + steroid sparing; group 3, Simulect + Neoral + adjunct + no prednisone. The demographics between all groups were similar. The mean (+/- SD) trough cyclosporine levels at 1 month were 276 +/- 128 versus 291 +/- 180 versus 398 +/- 365 (P=.020); at 3 months were 261 +/- 120 versus 280 +/- 152 versus 399 +/- 408 (P=.32); at 12 month were 235 +/- 144 versus 245 +/- 154 versus 234 +/- 132 (P=.96). Creatinine clearance at 1 month was 59 +/- 24 versus 58 +/- 18 versus 47 +/- 23 mL/min (P=.004); at 3 months was 66 +/- 28 versus 62 +/- 22 versus 53 +/- 25 mL/min (P=.007); at 12 months was 68 +/- 38 versus 65 +/- 22 versus 64 +/- 29 mL/min (P=.556). Serum creatinine at 1 month was 1.8 +/- 0.9 versus 1.6 +/- 1.2 versus 2.8 +/- 2.21 mg/dL (P=.005); at 3 months was 1.7 +/- 0.6 versus 1.9 +/- 1.0 versus 2.3 +/- 1.3 mg/dL (P=.007); at 12 months was 1.9 +/- 1.3 versus 2.1 +/- 1.0 versus 2.3 +/- 1.7 mg/dL (P=.179). The incidence of acute rejection within 1 year in the respective groups were 28% versus 15% versus 16%. Therefore, we conclude that using Simulect in transplant recipients results in long-term patient and graft survival similar to those achieved with OKT 3. The use of Simulect resulted in significant reduction in clinical rejection incidence within the first year regardless of steroid use. Thus, the use of Simulect allows complete steroid avoidance in Neoral-based immunosuppression regimen.
本研究比较了在基于环孢素(新山地明)的免疫抑制方案中,两种不同的诱导方案——巴利昔单抗(舒莱)与莫罗单抗(OKT 3)用于肾移植的效果。诱导后的方案包括完全避免使用泼尼松或减少泼尼松用量与标准泼尼松给药。1995年至2000年间接受肾移植的245例成年患者纳入本研究。第1组的治疗方案为OKT 3+新山地明+辅助用药+标准泼尼松;第2组为舒莱+新山地明+辅助用药+减少类固醇用量;第3组为舒莱+新山地明+辅助用药+不使用泼尼松。所有组之间的人口统计学特征相似。1个月时环孢素的平均(±标准差)谷浓度分别为276±128、291±180和398±365(P = 0.020);3个月时分别为261±120、280±152和399±408(P = 0.32);12个月时分别为235±144、245±154和234±132(P = 0.96)。1个月时肌酐清除率分别为59±24、58±18和47±23 mL/分钟(P = 0.004);3个月时分别为66±28、62±22和53±25 mL/分钟(P = 0.007);12个月时分别为68±38、65±22和64±29 mL/分钟(P = 0.556)。1个月时血清肌酐分别为1.8±0.9、1.6±1.2和2.8±2.21 mg/dL(P = 0.005);3个月时分别为1.7±0.6、1.9±1.0和2.3±1.3 mg/dL(P = 0.007);12个月时分别为1.9±1.3、2.1±1.0和2.3±1.7 mg/dL(P = 0.179)。各相应组1年内急性排斥反应的发生率分别为28%、15%和16%。因此,我们得出结论,在移植受者中使用舒莱可使患者和移植物的长期存活情况与使用OKT 3时相似。无论是否使用类固醇,使用舒莱均可显著降低第一年临床排斥反应的发生率。因此,在基于新山地明的免疫抑制方案中,使用舒莱可完全避免使用类固醇。