食品药品监督管理局批准青蒿琥酯治疗重症疟疾：足以实现最佳实践吗？
Food and Drug Administration Approval of Artesunate for Severe Malaria: Enough to Achieve Best Practice?
机构信息
Division of Infectious Diseases and International Medicine, Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Center for Global Health and Social Responsibility, University of Minnesota, Minneapolis, Minnesota, USA.
出版信息
Clin Infect Dis. 2023 Feb 8;76(3):e864-e866. doi: 10.1093/cid/ciac728.
Intravenous artesunate has been the global standard of care for severe malaria for over 2 decades. Yet, until recently, artesunate has only been available to patients through an expanded-access protocol from the Centers for Disease Control and Prevention. In May 2020, the Food and Drug Administration approved artesunate, allowing US hospitals to stock the drug and ensuring prompt treatment for this life-threatening infection. However, because of artesunate's high cost and the infrequency of severe malaria in the United States, hospitals may be reluctant to stock the drug. As US health systems weigh the decision to stock artesunate, we propose a hospital tier framework to inform this decision and support clinicians caring for patients who present with severe malaria.
静脉注射青蒿琥酯作为全球治疗重症疟疾的标准已有 20 多年了。然而，直到最近，青蒿琥酯仅能通过美国疾病控制与预防中心的扩大准入方案获得。2020 年 5 月，食品和药物管理局批准了青蒿琥酯的使用，允许美国医院储备该药，以确保对这种危及生命的感染的及时治疗。然而，由于青蒿琥酯的高成本和美国重症疟疾的罕见性，医院可能不愿意储备该药。当美国卫生系统权衡储备青蒿琥酯的决定时，我们提出了一个医院分层框架来为这一决策提供信息，并支持照顾患有重症疟疾的患者的临床医生。
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