Nafar Mohsen, Dalili Nooshin, Poor-Reza-Gholi Fatemeh, Ahmadpoor Pedram, Samadian Fariba, Samavat Shiva
Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Clin Transplant. 2017 Jun;31(6). doi: 10.1111/ctr.12977. Epub 2017 Apr 18.
Thymoglobulin is used effectively as an induction agent in kidney transplantation, but there is no consensus on the optimal dose. In order to delineate the safest effective dose, an open-labeled randomized clinical trial was designed.
In this study, 90 adult kidney transplant recipients (KTR) were randomized before transplantation in three groups to receive thymoglobulin: Arm A (4.5 mg/kg in 3 days), Arm B (4.5 mg/kg single bolus dose), and Arm C (6 mg/kg in 3 days). Renal function, infections, and rate of readmissions were evaluated during the first post transplantation year.
Ninety adult kidney recipients were enrolled (51% deceased donor). No significant statistical difference was found in acute rejection episodes or type of rejection between these groups, although patients in Arm A showed more severe histopathologic changes according to Banff 2013 criteria, in renal biopsies (P=.03). At the first month after transplantation serum Cr was lower (P=.001) and GFR was higher (P=.04) in Arm A, but there was no significant difference among the three groups at 3, 6, and 12 months post-transplant.
Although all regimens showed the same efficacy regarding the rate of rejection episodes, 3-day 4.5 mg/kg Thymoglobulin had significantly fewer complications.
胸腺球蛋白在肾移植中作为诱导剂使用效果良好，但最佳剂量尚无定论。为了确定最安全有效的剂量，设计了一项开放标签的随机临床试验。
在本研究中，90名成年肾移植受者（KTR）在移植前被随机分为三组接受胸腺球蛋白治疗：A组（3天内给予4.5mg/kg）、B组（单次推注剂量4.5mg/kg）和C组（3天内给予6mg/kg）。在移植后的第一年评估肾功能、感染情况和再入院率。
纳入了90名成年肾移植受者（51%为死亡供体）。这些组之间在急性排斥反应发作或排斥反应类型上未发现显著统计学差异，尽管根据2013年班夫标准，A组患者在肾活检中的组织病理学变化更为严重（P = 0.03）。移植后第一个月，A组的血清肌酐较低（P = 0.001），肾小球滤过率较高（P = 0.04），但移植后3、6和12个月时三组之间无显著差异。
尽管所有方案在排斥反应发生率方面显示出相同的疗效，但3天给予4.5mg/kg的胸腺球蛋白并发症明显较少。
