Department of Organ Transplantation, IMSS UMAE Hospital de Especialidades 14 Adolfo Ruiz Cortines, Veracruz, Mexico.
Department of Organ Transplantation, IMSS UMAE Hospital de Especialidades 14 Adolfo Ruiz Cortines, Veracruz, Mexico.
Transplant Proc. 2021 Apr;53(3):1005-1009. doi: 10.1016/j.transproceed.2020.01.054. Epub 2020 Mar 13.
Thymoglobulin is used effectively as induction agent in kidney transplantation but the optimal dose is not well established.
Demonstrate that low-dose thymoglobulin (3 mg/kg) has similar efficacy and safety compared to basiliximab induction in low-risk kidney transplantation under standard maintenance immunosuppression DESIGN, SETTING, PARTICIPANTS: Prospective randomized study in kidney transplant patients (12/2016-05/2018).
Recipients > 18 years, first living donor transplant.
Second and multiorgan transplant, ABO incompatibility, positive cross-match, panel reactive antibodies (PRA) > 30%, positive donor-specific antibody, human immunodeficiency virus, hepatitis B surface antigen, hepatitis C virus positive, white blood cells < 2000 cells/mm, platelets < 75,000 cells/mm and malignancy.
Group A: basiliximab (20 mg D0 and D4). Group B: thymoglobulin (3 mg/kg total). Maintenance immunosuppression: tacrolimus, mycophenolate mofetil, and steroids.
Biopsy-proven acute rejection (BPAR), delayed graft function, slow graft function, leukopenia, infections, adverse events, graft loss, estimated glomerular filtration rate, and death within 12 months.
100 patients (basiliximab, n = 53) (thymoglobulin, n = 47) were included. Donor and recipient characteristics were similar except for longer dialysis (basiliximab), PRA class I (1.2% basiliximab, 4.5% thymoglobulin), HLA match (basiliximab 2.8, thymoglobulin 2.2), and cytomegalovirus status. BPAR rate was basiliximab 3.8% and thymoglobulin 6.4% (P = ns). Delayed graft function (basiliximab 3.8%; thymoglobulin 4.3%), slow graft function, and 12-month leukopenia (basiliximab 11.3%, thymoglobulin 21.3%) were similar between groups (P = ns). There was no difference in infections and adverse events between groups. Patient and graft survival were as follows: basiliximab 98.1% and 92.5%, thymoglobulin 100% and 93.6% (P = ns).
Low-dose thymoglobulin induction (3 mg/kg) can be used effectively and safely in low-risk kidney transplantation with good results during the first year post-transplant.
他克莫司用于诱导肾移植效果显著,但最佳剂量尚未确定。
在标准维持免疫抑制下,证明低剂量他克莫司(3mg/kg)与巴利昔单抗诱导在低危肾移植中的疗效和安全性相当。
设计、地点、参与者:2016 年 12 月至 2018 年 5 月间进行的肾移植患者前瞻性随机研究。
年龄>18 岁,首次活体供者移植。
二次和多器官移植,ABO 不相容,交叉配型阳性,群体反应性抗体(PRA)>30%,供体特异性抗体阳性,人类免疫缺陷病毒,乙型肝炎表面抗原,丙型肝炎病毒阳性,白细胞<2000 个/毫米,血小板<75000 个/毫米,恶性肿瘤。
A 组:巴利昔单抗(20mg D0 和 D4)。B 组:他克莫司(3mg/kg 总量)。维持免疫抑制:他克莫司、霉酚酸酯、和皮质类固醇。
活检证实的急性排斥反应(BPAR)、延迟移植物功能、移植物功能缓慢、白细胞减少、感染、不良事件、移植物丢失、估计肾小球滤过率和 12 个月内死亡。
共纳入 100 例患者(巴利昔单抗组,n=53)(他克莫司组,n=47)。除透析时间较长(巴利昔单抗)、I 类 PRA(巴利昔单抗 1.2%,他克莫司 4.5%)、HLA 匹配(巴利昔单抗 2.8,他克莫司 2.2)和巨细胞病毒状态外,供者和受者特征相似。巴利昔单抗组和他克莫司组的 BPAR 发生率分别为 3.8%和 6.4%(P=ns)。延迟移植物功能(巴利昔单抗 3.8%;他克莫司 4.3%)、移植物功能缓慢和 12 个月白细胞减少(巴利昔单抗 11.3%,他克莫司 21.3%)两组间相似(P=ns)。两组间感染和不良事件无差异。患者和移植物存活率分别为:巴利昔单抗组 98.1%和 92.5%,他克莫司组 100%和 93.6%(P=ns)。
低剂量他克莫司(3mg/kg)可有效、安全地用于低危肾移植,在移植后第一年有良好的效果。