Department of Nephrology, Transplantation and Internal Medicine, Medical University of Silesia, Katowice, Poland.
Department of Internal Medicine and Oncological Chemotherapy, Medical University of Silesia, Katowice, Poland.
Clin Transplant. 2019 Oct;33(10):e13680. doi: 10.1111/ctr.13680. Epub 2019 Aug 30.
Antithymocyte globulin (ATG) is widely used as an induction therapy after kidney transplantation. The present study aimed to compare the effectiveness and safety of induction therapy between two ATG formulations, Grafalon (Fresenius ) and Thymoglobulin (Sanofi ), in kidney transplant patients.
This study included 140 consecutive kidney transplant recipients, 71 treated with Grafalon and 69 treated with Thymoglobulin, in the period between February 2010 and January 2018. To optimize therapy costs, considering the periodically limited drug availability and the substantial drug waste in the case of Grafalon, Thymoglobulin induction was introduced into the immunosuppressive protocol.
The ATG total dose in mg/kg of body mass [median: 5.3 (3.7-7.1) vs 8.6 (4.3-17.3); P < .001] was significantly lower in the Thymoglobulin subgroup. There were 7 (5%) graft losses and 15 (10.7%) deaths during the first 12 months, with 66.7% of deaths due to infection complications. Patients treated with Thymoglobulin were characterized by a lower absolute lymphocyte count at day 7 and during the 12 months of follow-up, compared with the Grafalon group [236 (205-267) vs 483 (372-594), respectively; P < .001]. Logistic regression analysis showed that a lymphocyte count < 200/µL at day 7 (OR = 10.5; 95%CI, 1.6-69.0; P = .01) and age >50 years (OR = 14.6; 95%CI, 1.4-155.0; P = .03), but not type of ATG, independently increased the risk of death due to infection. The 12-month acute rejection rate was higher in the Grafalon group (25.3% vs 10.1%, P = .02).
Treatment with Thymoglobulin in kidney transplant recipients resulted in more pronounced lymphopenia and a lower 12-month rate of acute rejection.
抗胸腺细胞球蛋白（ATG）广泛用作肾移植后的诱导治疗。本研究旨在比较两种 ATG 制剂——Grafalon（Fresenius）和 Thymoglobulin（Sanofi）在肾移植患者中的诱导治疗效果和安全性。
本研究纳入了 2010 年 2 月至 2018 年 1 月期间的 140 例连续肾移植受者，71 例接受 Grafalon 治疗，69 例接受 Thymoglobulin 治疗。为了优化治疗成本，考虑到 Grafalon 药物供应的周期性限制以及药物浪费的情况，在免疫抑制方案中引入了 Thymoglobulin 诱导治疗。
Thymoglobulin 组的 ATG 总剂量（以每公斤体重毫克计[中位数：5.3（3.7-7.1）vs 8.6（4.3-17.3）]；P<0.001）显著较低。在第 12 个月前，有 7 例（5%）移植物丢失和 15 例（10.7%）死亡，66.7%的死亡归因于感染并发症。与 Grafalon 组相比，Thymoglobulin 组患者在第 7 天和第 12 个月的随访期间的绝对淋巴细胞计数较低[分别为 236（205-267）和 483（372-594）；P<0.001]。Logistic 回归分析显示，第 7 天的淋巴细胞计数<200/µL（OR=10.5；95%CI，1.6-69.0；P=0.01）和年龄>50 岁（OR=14.6；95%CI，1.4-155.0；P=0.03）是感染性死亡的独立危险因素，而不是 ATG 的类型。Grafalon 组第 12 个月的急性排斥反应率较高（25.3% vs 10.1%，P=0.02）。
肾移植受者接受 Thymoglobulin 治疗后淋巴细胞减少更为明显，第 12 个月急性排斥反应率较低。
