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大规模简单试验引出复杂问题
A Large, Simple Trial Leading to Complex Questions


David P. Harrington ... 呼吸系统疾病 • 2020.12.02
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SARS-CoV-2迅速传播,COVID-19又缺乏有效疗法,这使得患者和临床医师面对前所未有的状况,即意义不明的治疗方案在接受临床研究评估的同时也在全球应用。世界卫生组织(WHO)Solidarity试验1的写作委员会此次在本刊发表了引起极大关注的4种药物治疗方案的期中结果:瑞德西韦、羟氯喹、洛匹那韦和干扰素β-1a治疗方案。在代表WHO全部六个地区的30个国家405家医院,研究者将11,330例成人患者随机分组,他们接受上述治疗方案之一(如果有)或各医院的标准治疗。此篇论文报道了每种治疗方案与标准治疗相比,28天期间的死亡率比:瑞德西韦,0.95(95%置信区间[CI],0.81~1.11);羟氯喹,1.19(95% CI,0.89~1.59);洛匹那韦,1.00(95% CI,0.79~1.25);干扰素β-1a,1.16(95% CI,0.96~1.39)。





作者信息

David P. Harrington, Ph.D., Lindsey R. Baden, M.D., and Joseph W. Hogan, Sc.D.
From the Department of Biostatistics, Harvard T.H. Chan School of Public Health, and the Department of Data Sciences, Dana–Farber Cancer Institute, Boston (D.P.H.); and the Department of Biostatistics, Brown University School of Public Health, Providence, RI (J.W.H.).

 

参考文献

1. WHO Solidarity Trial Consortium. Repurposed antiviral drugs for Covid-19 — interim WHO Solidarity trial results. N Engl J Med. DOI: 10.1056/NEJMoa2023184.

2.Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the treatment of Covid-19 — final report. N Engl J Med 2020;383:1813-1826.

3.Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. JAMA 2020;324:1048-1057.

4.Wang Y, Zhang D, Du G, et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet 2020;395:1569-1578.

5.Rubin D, Chan-Tack K, Farley J, Sherwat A. FDA approval of remdesivir — a step in the right direction. N Engl J Med. DOI: 10.1056/NEJMp2032369.

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