Coate Eric A, Kocsis Andrew G, Peters Kristen N, Anderson Paul E, Ellersieck Mark R, Fine Deborah M, Anderson Deborah M
Department of Veterinary Pathobiology, Regional Biocontainment Laboratory, University of Missouri, Columbia, MO, USA.
Pathog Dis. 2014 Jul;71(2):265-75. doi: 10.1111/2049-632X.12176. Epub 2014 May 16.
Development of new vaccines, diagnostics, and therapeutics for biodefense or other relatively rare infectious diseases is hindered by the lack of naturally occurring human disease on which to conduct clinical trials of efficacy. To overcome this experimental gap, the U.S. Food and Drug Administration established the Animal Rule, in which efficacy testing in two well-characterized animal models that closely resemble human disease may be accepted in lieu of large-scale clinical trials for diseases with limited natural human incidence. In this report, we evaluated the Brown Norway rat as a model for pneumonic plague and describe the natural history of clinical disease following inhalation exposure to Yersinia pestis. In high-capacity, high-containment housing, we monitored temperature, activity, heart rate, and rhythm by capturing electronic impulses transmitted from abdominal telemeter implants. Using this system, we show that reduced activity and development of fever are sensitive indications of disease progression. Furthermore, we identified heart arrhythmias as contributing factors to the rapid progression to lethality following the fever response. Together, these data validate the Brown Norway rat as an experimental model for human pneumonic plague and provide new insight that may ultimately lead to novel approaches in postexposure treatment of this devastating infection.
用于生物防御或其他相对罕见传染病的新型疫苗、诊断方法和治疗手段的研发,因缺乏可用于进行疗效临床试验的自然发生的人类疾病而受到阻碍。为克服这一实验空白,美国食品药品监督管理局制定了“动物规则”,即对于自然发生的人类发病率有限的疾病,在两种特征明确且与人类疾病极为相似的动物模型中进行疗效测试,可替代大规模临床试验。在本报告中,我们评估了棕色挪威大鼠作为肺鼠疫模型的情况,并描述了吸入鼠疫耶尔森菌后临床疾病的自然病程。在高容量、高防护的饲养环境中,我们通过捕捉从腹部遥测植入物传输的电子脉冲来监测体温、活动、心率和心律。利用该系统,我们发现活动减少和发热是疾病进展的敏感指标。此外,我们确定心律失常是发热反应后迅速发展至死亡的促成因素。这些数据共同验证了棕色挪威大鼠作为人类肺鼠疫实验模型的有效性,并提供了新的见解,最终可能会带来针对这种毁灭性感染的暴露后治疗新方法。