Department of Radiation Oncology, University of Rochester Medical Center, 601 Elmwood Avenue, Box 647, Rochester, NY 14642, USA.
Radiat Res. 2010 Apr;173(4):557-78. doi: 10.1667/RR1880.1.
Since September 11, 2001, there has been the recognition of a plausible threat from acts of terrorism, including radiological or nuclear attacks. A network of Centers for Medical Countermeasures against Radiation (CMCRs) has been established across the U.S.; one of the missions of this network is to identify and develop mitigating agents that can be used to treat the civilian population after a radiological event. The development of such agents requires comparison of data from many sources and accumulation of information consistent with the "Animal Rule" from the Food and Drug Administration (FDA). Given the necessity for a consensus on appropriate animal model use across the network to allow for comparative studies to be performed across institutions, and to identify pivotal studies and facilitate FDA approval, in early 2008, investigators from each of the CMCRs organized and met for an Animal Models Workshop. Working groups deliberated and discussed the wide range of animal models available for assessing agent efficacy in a number of relevant tissues and organs, including the immune and hematopoietic systems, gastrointestinal tract, lung, kidney and skin. Discussions covered the most appropriate species and strains available as well as other factors that may affect differential findings between groups and institutions. This report provides the workshop findings.
自 2001 年 9 月 11 日以来，人们已经认识到恐怖主义行为（包括放射性或核袭击）可能带来威胁。美国已经建立了一个辐射医学对策中心（CMCR）网络；该网络的任务之一是确定和开发减轻剂，以便在放射性事件后用于治疗平民。此类试剂的开发需要比较来自许多来源的数据，并积累符合食品和药物管理局（FDA）“动物规则”的信息。考虑到需要在整个网络中就适当的动物模型使用达成共识，以便能够在机构间进行比较研究，并确定关键研究和促进 FDA 批准，在 2008 年初，每个 CMCR 的研究人员组织并召开了一次动物模型研讨会。工作组进行了审议和讨论，探讨了可用于评估多种相关组织和器官（包括免疫和造血系统、胃肠道、肺、肾和皮肤）中试剂疗效的广泛动物模型。讨论涵盖了最适合的物种和品系，以及可能影响不同组别和机构之间差异发现的其他因素。本报告提供了研讨会的结果。
