首页> 美国卫生研究院文献>Current Controlled Trials in Cardiovascular Medicine >Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial
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Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial

机译:RIACT研究的原理和设计:一项多中心安慰剂对照双盲研究以测试利妥昔单抗在肾移植患者中急性B细胞浸润​​性肾小管间质排斥反应的疗效:一项随机对照试验的研究方案

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摘要

BackgroundAcute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90%) of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However, there is increasing evidence that intragraft B-cells are also important in the T-cell-mediated rejections. First, a significant proportion of patients with acute T-cell-mediated rejection have B-cells present in the infiltrates. Second, the outcome of these patients is inferior, which has been related to an inferior response to the conventional anti-rejection therapy. Third, treatment of these patients with an anti-CD20 antibody (rituximab) improves the allograft outcome as reported in single case observations and in one small study. Despite the promise of these observations, solid evidence is required before incorporating this treatment option into a general treatment recommendation.
机译:背景急性异体肾移植排斥反应是导致移植物功能下降的主要原因,并对移植物的长期存活产生负面影响。绝大部分急性排斥反应(90%)是T细胞介导的,因此,抗排斥疗法的目标是T细胞介导的排斥过程机制。但是,越来越多的证据表明,移植物中的B细胞在T细胞介导的排斥反应中也很重要。首先,在急性T细胞介导的排斥反应中,很大一部分患者的浸润组织中存在B细胞。其次,这些患者的结果较差,这与对常规抗排斥疗法的反应较差有关。第三,如单例观察和一项小型研究中所报道,用抗CD20抗体(利妥昔单抗)治疗这些患者可改善同种异体移植的结果。尽管有这些观察结果的希望,但在将该治疗方案纳入一般治疗建议之前,仍需要可靠的证据。

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