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低剂量兔抗胸腺细胞球蛋白与巴利昔单抗用于肾移植诱导治疗的比较

Low-dose rabbit anti-thymoglobin globulin versus basiliximab for induction therapy in kidney transplantation.

作者信息

Patel Himanshu V, Kute Vivek B, Vanikar Aruna V, Shah Pankaj R, Gumber Manoj R, Engineer Divyesh P, Trivedi Hargovind L

机构信息

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.

出版信息

Saudi J Kidney Dis Transpl. 2014 Jul;25(4):819-22. doi: 10.4103/1319-2442.135057.

Abstract

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.

摘要

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。

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