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Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point.

通过非专利药物的真实世界再利用快速实现效益: 以新型冠状病毒肺炎大流行为例。

  • 影响因子:0
  • DOI:10.2196/19199
  • 作者列表:"Rogosnitzky M","Berkowitz E","Jadad AR
  • 发表时间:2020-05-13
Abstract

:Real-world drug repurposing-the immediate "off-label" prescribing of drugs to address urgent clinical needs-is a widely overlooked opportunity. Off-label prescribing (ie, for a nonapproved indication) is legal in most countries and tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, health crises may mean that real-world repurposing is the only realistic source for solutions. Optimal real-world repurposing requires a track record of safety, affordability, and access for drug candidates. Although thousands of such drugs are already available, there is no central repository of off-label uses to facilitate immediate identification and selection of potentially useful interventions during public health crises. Using the current coronavirus disease (COVID-19) pandemic as an example, we provide a glimpse of the extensive literature that supports the rationale behind six generic drugs, in four classes, all of which are affordable, supported by decades of safety data, and targeted toward the underlying pathophysiology that makes COVID-19 so deadly. This paper briefly summarizes why cimetidine or famotidine, dipyridamole, fenofibrate or bezafibrate, and sildenafil citrate are worth considering for patients with COVID-19. Clinical trials to assess efficacy are already underway for famotidine, dipyridamole, and sildenafil, and further trials of all these agents will be important in due course. These examples also reveal the unlimited opportunity to future-proof our health care systems by proactively mining, synthesizing, cataloging, and evaluating the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.

摘要

: 真实世界的药物再利用 -- 立即 “非标签” 处方药物来解决紧急的临床需求 -- 是一个被广泛忽视的机会。非标签处方 (即,对于未经批准的适应症) 在大多数国家是合法的,并且倾向于将责任和成本分别转移给医生和患者。然而,健康危机可能意味着现实世界的再利用是解决方案的唯一现实来源。最佳真实世界再利用需要安全性、可负担性和候选药物获取的跟踪记录。虽然已经有成千上万种这样的药物,但在公共卫生危机期间,没有一个超标签用途的中央储存库,以方便立即识别和选择潜在有用的干预措施。以目前的冠状病毒疾病 (新型冠状病毒肺炎) 大流行为例,我们提供了大量的文献,支持六种仿制药的基本原理,分为四类,所有这些都是负担得起的,由几十年的安全性数据支持,并针对使新型冠状病毒肺炎如此致命的潜在病理生理学。简要总结为什么西咪替丁或法莫替丁、双嘧达莫、非诺贝特或苯扎贝特、枸橼酸西地那非对新型冠状病毒肺炎患者值得考虑。评估法莫替丁、潘生丁和西地那非疗效的临床试验已经在进行中,所有这些药物的进一步试验在适当时候都很重要。这些例子还揭示了通过主动挖掘、综合、编目和评估成千上万安全、成熟的非标签治疗机会,为我们的医疗保健系统提供了无限的机会,以证明我们的未来,和负担得起的仿制药。

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发表时间:2020-04-01
来源期刊:Infection
DOI:10.1007/s15010-020-01401-y
作者列表:["Cheng ZJ","Shan J"]

METHODS::There is a current worldwide outbreak of a new type of coronavirus (2019-nCoV), which originated from Wuhan in China and has now spread to 17 other countries. Governments are under increased pressure to stop the outbreak spiraling into a global health emergency. At this stage, preparedness, transparency, and sharing of information are crucial to risk assessments and beginning outbreak control activities. This information should include reports from outbreak sites and from laboratories supporting the investigation. This paper aggregates and consolidates the virology, epidemiology, clinical management strategies from both English and Chinese literature, official news channels, and other official government documents. In addition, by fitting the number of infections with a single-term exponential model, we report that the infection is spreading at an exponential rate, with a doubling period of 1.8 days.

呼吸道感染方向

呼吸道感染分为上呼吸道感染与下呼吸道感染。上呼吸道感染是指自鼻腔至喉部之间的急性炎症的总称,是最常见的感染性疾病。下呼吸道感染是最常见的感染性疾患,治疗时必须明确引起感染的病原体以选择有效的抗生素。

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