Food and Drug Administration, Office of Counterterrorism and Emerging Threats, Silver Spring, MD 20993.
Food and Drug Administration, Office of the Chief Scientist, Silver Spring, MD 20993.
Microbiol Spectr. 2016 Jun;4(3). doi: 10.1128/microbiolspec.EI10-0014-2016.
The 2014 Ebola virus disease (EVD) epidemic in West Africa was unprecedented in its geographical distribution, scale, and toll on public health infrastructure. Standard public health measures were rapidly overwhelmed, and many projections on outbreak progression through the region were dire. At the beginning of the outbreak there were no treatments or vaccines that had been shown to be safe and effective for treating or preventing EVD, limiting health care providers to offer supportive care under extremely challenging circumstances and at great risk to themselves. Over time, however, drugs and vaccines in the development pipeline were prioritized based on all available research data and were moved forward for evaluation in clinical trials to demonstrate safety and efficacy. The armamentarium against EVD eventually included biologics such as monoclonal antibodies, convalescent plasma, and vaccines as well as small molecule therapeutics such as small interfering RNAs and nucleoside analogs. This article provides a high-level overview of the interventions and prophylactics considered for use in the outbreak and discusses the challenges faced when attempting to deploy investigational countermeasures in the midst of an evolving epidemic.
2014 年西非埃博拉病毒病(EVD)疫情在地理分布、规模和对公共卫生基础设施的破坏程度上均前所未有。标准的公共卫生措施迅速被淹没,许多关于疫情在该地区蔓延的预测都非常可怕。在疫情爆发初期,尚无经过证实安全有效的治疗或预防 EVD 的药物或疫苗,这使得医疗保健提供者只能在极其具有挑战性的情况下提供支持性护理,而且自身面临巨大风险。然而,随着时间的推移,根据所有可用的研究数据,研发管道中的药物和疫苗被优先考虑,并推进到临床试验中以证明其安全性和有效性。埃博拉病毒的防治手段最终包括生物制剂如单克隆抗体、恢复期血浆和疫苗,以及小分子治疗药物如小干扰 RNA 和核苷类似物。本文提供了对疫情中考虑使用的干预措施和预防措施的高级别概述,并讨论了在疫情演变过程中尝试部署研究性对策时面临的挑战。