van Gelder T, Zietse R, Mulder A H, Yzermans J N, Hesse C J, Vaessen L M, Weimar W
Department of Internal Medicine I, University Hospital Rotterdam, The Netherlands.
Transplantation. 1995 Aug 15;60(3):248-52. doi: 10.1097/00007890-199508000-00007.
In a double-blind, randomized, placebo-controlled trial, BT563, a murine IgG1 anti-IL-2R antibody, was given as a rejection prophylaxis after kidney transplantation. Drug-related side effects were not observed. During the 10-day course of BT563, no rejections (0/27) were found, whereas a rejection episode occurred in 7 patients (7/29) (P = 0.01) during placebo treatment. Within the first 4 postoperative weeks, freedom from rejection in the BT563 group and in the placebo group was 96% vs. 76% (P = 0.05). Due to rejection in the placebo group, 2 grafts were lost. At 3 months, an overall rejection incidence in the BT563 and placebo group was found of 3/27 (11%) vs. 8/29 (28%) patients (P = 0.18). Infectious complications were distributed equally between the 2 groups. CMV disease, found in 3 placebo-treated patients, occurred after rejection treatment (2/3). Within the BT563 group, 1 patient lost his graft due to renal artery thrombosis, 2 grafts were lost as a result of technical failure, and 2 patients had a squamous cell carcinoma that could be treated curatively. We conclude that the use of the anti-IL-2R mAb BT563 effectively prevents rejection after kidney transplantation without increasing infectious complications.
在一项双盲、随机、安慰剂对照试验中，小鼠IgG1抗IL-2R抗体BT563在肾移植后用于预防排斥反应。未观察到与药物相关的副作用。在BT563治疗的10天疗程中，未发现排斥反应（0/27），而在安慰剂治疗期间，7例患者（7/29）发生了排斥反应（P = 0.01）。术后前4周内，BT563组和安慰剂组的无排斥反应率分别为96%和76%（P = 0.05）。由于安慰剂组发生排斥反应，2个移植物丢失。3个月时，BT563组和安慰剂组的总体排斥反应发生率分别为3/27（11%）和8/29（28%）患者（P = 0.18）。感染并发症在两组之间分布相同。3例接受安慰剂治疗的患者发生巨细胞病毒病，均在排斥反应治疗后发生（2/3）。在BT563组中，1例患者因肾动脉血栓形成失去移植物，2例移植物因技术故障丢失，2例患者患有可治愈的鳞状细胞癌。我们得出结论，使用抗IL-2R单克隆抗体BT563可有效预防肾移植后的排斥反应，且不会增加感染并发症。
