Division of Special Pathogen and Transplant Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.
Am J Transplant. 2011 May;11(5):896-906. doi: 10.1111/j.1600-6143.2011.03525.x.
The Food and Drug Administration (FDA) held an open public workshop in June 2010 to discuss the current state of science related to antibody-mediated rejection (AMR) in kidney transplantation. Desensitization, acute AMR and chronic AMR (CAMR) were considered in the context of clinical trial design. Participants discussed experiences with HLA antibody detection and quantitation and the utility of monitoring donor-specific antibodies (DSAs) to inform the management of patients with AMR. The role for animal models was discussed. Diagnostic and prognostic features of histology were presented, followed by discussion of sensitivity and specificity of various criteria. The published literature on treatment of acute AMR was summarized, which consisted of case series and limited data from controlled clinical trials. Considerations for future clinical trials were presented, including endpoints and statistical evaluations of outcome. Although many issues need further consideration, the meeting enabled an important exchange of ideas between experts in the field.
美国食品和药物管理局（FDA）于 2010 年 6 月举办了一次公开的公众研讨会，讨论与肾移植中抗体介导的排斥反应（AMR）相关的当前科学状况。在临床试验设计的背景下考虑了脱敏、急性 AMR 和慢性 AMR（CAMR）。与会者讨论了 HLA 抗体检测和定量的经验，以及监测供体特异性抗体（DSA）以告知 AMR 患者管理的实用性。还讨论了动物模型的作用。介绍了组织学的诊断和预后特征，随后讨论了各种标准的敏感性和特异性。总结了有关急性 AMR 治疗的已发表文献，其中包括病例系列和来自对照临床试验的有限数据。提出了未来临床试验的考虑因素，包括终点和结果的统计评估。尽管仍有许多问题需要进一步考虑，但会议使该领域的专家之间进行了重要的思想交流。
