Making trials part of good clinical care: lessons from the RECOVERY trial.
Making trials part of good clinical care: lessons from the RECOVERY trial.
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DOI：
10.7861/fhj.2021-0083
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发表时间：
2021-07-01
期刊：
影响因子：
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通讯作者：
Haynes, Richard
中科院分区：
文献类型：
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作者：
Pessoa-Amorim, Guilherme;Campbell, Mark;Haynes, Richard
当COVID-19于2020年初袭击英国时，没有已知的治疗方法，导致约四分之一因这种疾病住院的患者死亡。在世界各地，可能的治疗方法被用于大量患者，但没有任何可靠的安全性和有效性评估。迅速提供高质量的证据至关重要。RECOVERY是一项精简、务实、随机对照试验，旨在应对这一挑战。截至2021年4月，超过39，000名患者已从英国178家医院入组。在启动后的100天内，RECOVERY证明地塞米松可以提高严重疾病患者的生存率;这一结果在英国迅速实施，并在国际上挽救了数十万人的生命。重要的是，它还表明，其他广泛使用的治疗方法（如羟氯喹和阿奇霉素）对住院患者没有意义的益处。这只有通过大量患者的随机化和采用注重质量的简化和务实的程序，以及专注于单一目标的广泛合作才有可能。RECOVERY说明了临床试验和医疗保健如何整合，即使在大流行病中。这种方法提供了新的机会，不仅可以为大流行病提供高质量医疗保健所需的证据，还可以为给患者和医疗系统带来负担的许多其他疾病提供证据。
When COVID-19 hit the UK in early 2020, there were no known treatments for a condition that results in the death of around one in four patients hospitalised with this disease. Around the world, possible treatments were administered to huge numbers of patients, without any reliable assessments of safety and efficacy. The rapid generation of high-quality evidence was vital. RECOVERY is a streamlined, pragmatic, randomised controlled trial, which was set up in response to this challenge. As of April 2021, over 39,000 patients have been enrolled from 178 hospital sites in the UK. Within 100 days of its initiation, RECOVERY demonstrated that dexamethasone improves survival for patients with severe disease; a result that was rapidly implemented in the UK and internationally saving hundreds of thousands of lives. Importantly, it also showed that other widely used treatments (such as hydroxychloroquine and azithromycin) have no meaningful benefit for hospitalised patients. This was only possible through randomisation of large numbers of patients and the adoption of streamlined and pragmatic procedures focused on quality, together with widespread collaboration focused on a single goal. RECOVERY illustrates how clinical trials and healthcare can be integrated, even in a pandemic. This approach provides new opportunities to generate the evidence needed for high-quality healthcare not only for a pandemic but for the many other conditions that place a burden on patients and the healthcare system.