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在疾病大流行的背景下开展临床研究
Research in the Context of a Pandemic


H. Clifford Lane ... 传染病 呼吸系统疾病 • 2021.02.25
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目前关于2019冠状病毒病(COVID-19)治疗方法的文献中充斥着小样本量临床试验中取得成功的个例报道,以及在基本未考虑未知混杂因素所产生影响的情况下宣称治疗有效的观察性队列研究。如果COVID-19治疗这一领域要向前发展,COVID-19患者结局要获得改善,我们需要减少小规模或结论不明确的研究,增加类似RECOVERY合作研究组1在本刊发表的地塞米松试验这样的研究。

RECOVERY试验明确显示,糖皮质激素地塞米松对随机分组时接受机械通气的COVID-19患者有益。地塞米松组患者的28天死亡率为29.3%,而常规治疗组为41.4%。相反,地塞米松对随机分组时无须吸氧的患者无益:在这一人群中,地塞米松组和常规治疗组的28天死亡率分别为17.8%和14.0%。对于随机分组时吸氧但无须有创机械通气的这一异质性患者人群,地塞米松组的死亡率为23.3%,常规治疗组为26.2%。





作者信息

H. Clifford Lane, M.D., and Anthony S. Fauci, M.D.
From the Division of Clinical Research (H.C.L.) and Office of the Director (A.S.F.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.

 

参考文献

1. The RECOVERY Collaborative Group. Dexamethasone in hospitalized patients with Covid-19. N Engl J Med 2021;384:693-704.

2. Coronavirus disease 2019 (COVID-19) treatment guidelines. Bethesda, MD: National Institutes of Health (https://www.covid19treatmentguidelines.nih.gov. opens in new tab).

3. “Solidarity” clinical trial for COVID-19 treatments. Geneva: World Health Organization, 2020 (https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments. opens in new tab).

4. Beigel JH, Tomashek KM, Dodd LE. Remdesivir for the treatment of Covid-19 — preliminary report. N Engl J Med 2020;383:992-994.

5. Peto R, Collins R, Gray R. Large-scale randomized evidence: large, simple trials and overviews of trials. J Clin Epidemiol 1995;48:23-40.

6. National Academies of Sciences, Engineering, and Medicine. Integrating clinical research into epidemic response: the Ebola experience. Washington, DC: National Academies Press, 2017.

7. Mulangu S, Dodd LE, Davey RT Jr, et al. A randomized, controlled trial of Ebola virus disease therapeutics. N Engl J Med 2019;381:2293-2303.

8. Collins FS, Stoffels P. Accelerating COVID-19 therapeutic interventions and vaccines (ACTIV): an unprecedented partnership for unprecedented times. JAMA 2020;323:2455-2457.

9. COVID-19 treatments could be fast-tracked through new national clinical trial initiative. Press release of the U.K. Department of Health and Social Care, April 29, 2020 (https://www.gov.uk/government/news/covid-19-treatments-could-be-fast-tracked-through-new-national-clinical-trial-initiative. opens in new tab).

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