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贝利尤单抗在肾移植中的应用。

Belatacept in kidney transplantation.

机构信息

Kidney Transplant Service, University of California, San Francisco, California 94143-0780, USA.

出版信息

Curr Opin Organ Transplant. 2012 Dec;17(6):640-7. doi: 10.1097/MOT.0b013e32835a4c0d.

Abstract

PURPOSE OF REVIEW

In June 2011 the US Food and Drug Administration approved belatacept (Nulojix; Bristol-Myers Squibb, Princeton, New Jersey, USA) for the prophylaxis of organ rejection in adult kidney transplant recipients. This review will discuss the use of belatacept for the prevention of acute rejection as part of a maintenance immunosuppression regimen.

RECENT FINDINGS

Belatacept is a selective costimulation blocker designed to provide effective immunosuppression while avoiding the toxicities associated with calcineurin inhibitors. Phase 3 trial data have demonstrated that belatacept is noninferior to cyclosporine in 1-year patient and allograft survival. Three-year data demonstrate an ongoing improvement in mean measured glomerular filtration rate in belatacept-treated versus cyclosporine-treated patients. Overall, there seemed to be an improvement in cardiometabolic parameters in patients treated with belatacept compared with cyclosporine. There was a trend toward higher rates of early rejection episodes in patients treated with belatacept. One safety issue that must be considered when using belatacept is the potential for increased risk of posttransplant lymphoproliferative disease, especially in Epstein-Barr virus-seronegative recipients or patients treated with lymphocyte-depleting agents.

SUMMARY

Belatacept is the first new agent available in kidney transplant that may achieve the goal of improved long-term renal function.

摘要

目的综述

2011 年 6 月,美国食品和药物管理局批准贝利尤单抗(Nulojix;百时美施贵宝,新泽西州普林斯顿,美国)用于预防成人肾移植受者的器官排斥反应。这篇综述将讨论贝利尤单抗在预防急性排斥反应方面的应用,作为维持性免疫抑制方案的一部分。

最新发现

贝利尤单抗是一种选择性共刺激阻断剂,旨在提供有效的免疫抑制作用,同时避免钙调磷酸酶抑制剂相关的毒性。3 期临床试验数据表明,贝利尤单抗在 1 年患者和移植物存活率方面不劣于环孢素。3 年数据显示,接受贝利尤单抗治疗的患者平均肾小球滤过率持续改善,而接受环孢素治疗的患者则没有。总的来说,与接受环孢素治疗的患者相比,接受贝利尤单抗治疗的患者的心脏代谢参数似乎有所改善。与接受环孢素治疗的患者相比,接受贝利尤单抗治疗的患者早期排斥反应的发生率呈上升趋势。在使用贝利尤单抗时必须考虑的一个安全问题是,移植后淋巴增殖性疾病的风险可能增加,尤其是在 EBV 血清阴性受者或接受淋巴细胞耗竭剂治疗的患者中。

总结

贝利尤单抗是肾移植中第一个新的治疗药物,可能实现改善长期肾功能的目标。

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