Patel Himanshu V, Kute Vivek B, Vanikar Aruna V, Shah Pankaj R, Gumber Manoj R, Engineer Divyesh P, Trivedi Hargovind L
Department of Nephrology and Clinical Transplantation, Laboratory Medicine, Transfusion Services and Immunohematology, Institute of Kidney Diseases and Research Center, Dr. H. L. Trivedi Institute of Transplantation Sciences, Ahmedabad, India.
Saudi J Kidney Dis Transpl. 2014 Jul;25(4):819-22. doi: 10.4103/1319-2442.135057.
We conducted a single-center prospective double-arm open-labeled study on kidney transplant patients from 2010 to 2011 to evaluate the efficacy of induction therapy using low, single-dose rabbit-antithymocyte globulin (r-ATG), 1.5 mg/kg on Day 0 (n = 80, 60 males, mean age 35.9 years), versus basiliximab (Interleukin-2 blocker) 20 mg on Days 0 and 4 (n = 20, 12 males, mean age 45.1 years) on renal allograft function in terms of serum creatinine (SCr), rejection and infection episodes and patient/graft survival and cost. Demographic and post-transplant follow-up including immunosuppression was similar in both groups. In the r-ATG group, donors were unrelated (spouse, n = 25), deceased (n = 31) and parents/siblings (others), with a mean HLA match of 1.58. Donors in the basiliximab group were living unrelated (spouse, n = 15) and deceased (n = 5), with a mean HLA match of 1.56. No patient/graft was lost in the r-ATG group over a mean of one year follow-up, and the mean SCr was 1.28 mg/dL with 7.5% acute rejection (AR) episodes; infections were also not observed. In the basiliximab group, over the same period of follow-up, there was 95% death-censored graft survival, and the mean SCr was 1.23 mg/dL with 10% AR episodes. One patient died due to bacterial pneumonia and one succumbed to coronary artery disease; one graft was lost due to uncontrolled acute humoral and cellular rejection. The cost of r-ATG and basiliximab were $600 and $2500, respectively. We conclude that induction immunosuppressive therapy with a low-dose r-ATG may be a better option as compared with basiliximab in terms of graft function, survival and cost benefit in kidney transplant patients.
2010年至2011年,我们对肾移植患者开展了一项单中心前瞻性双臂开放标签研究,以评估使用低剂量单剂量兔抗胸腺细胞球蛋白(r-ATG)(第0天1.5 mg/kg,n = 80,60例男性,平均年龄35.9岁)与巴利昔单抗(白细胞介素-2阻断剂)(第0天和第4天各20 mg,n = 20,12例男性,平均年龄45.1岁)进行诱导治疗对肾移植功能的疗效,评估指标包括血清肌酐(SCr)、排斥反应和感染事件以及患者/移植物存活情况和成本。两组的人口统计学特征和移植后随访情况(包括免疫抑制)相似。在r-ATG组中,供体为非亲属(配偶,n = 25)、已故供体(n = 31)和父母/兄弟姐妹(其他),平均HLA配型为1.58。巴利昔单抗组的供体为活体非亲属(配偶,n = 15)和已故供体(n = 5),平均HLA配型为1.56。在平均一年的随访期内,r-ATG组无患者/移植物丢失,平均SCr为1.28 mg/dL,急性排斥(AR)事件发生率为7.5%;也未观察到感染情况。在巴利昔单抗组,在相同的随访期内,死亡截尾的移植物存活率为95%,平均SCr为1.23 mg/dL,AR事件发生率为10%。1例患者死于细菌性肺炎,1例死于冠状动脉疾病;1个移植物因急性体液和细胞排斥反应失控而丢失。r-ATG和巴利昔单抗的成本分别为600美元和2500美元。我们得出结论,就肾移植患者的移植物功能、存活情况和成本效益而言,与巴利昔单抗相比,低剂量r-ATG诱导免疫抑制治疗可能是更好的选择。