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适应性平台试验在新型冠状病毒感染大流行中的应用:以RECOVERY为例的方法学反思与未来展望

  • 余怀淼 ,
  • 罗磊 ,
  • 杨文龙
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  • 南昌大学第二附属医院感染性疾病科 (江西 南昌 330006 )

收稿日期: 2026-01-22

  网络出版日期: 2026-06-30

基金资助

江西省自然科学基金项目(20192BAB205014);南昌大学第二附属医院博士启动基金项目(B2273);北京肝胆相照公益基金会临床科研专项资助基金项目(iGandanF-1082024-LG009)

Application of adaptive platform trials in the COVID-19 pandemic: Methodological reflections and future perspectives using RECOVERY as an example

  • Huaimiao YU ,
  • Lei LUO ,
  • Wenlong YANG
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  • Department of Infectious Diseases,The Second Affiliated Hospital of Nanchang University,Nanchang 330006,Jiangxi,China

Received date: 2026-01-22

  Online published: 2026-06-30

摘要

新型冠状病毒感染(COVID-19)大流行早期,住院患者药物治疗长期处于候选药物众多而高质量证据不足的状态。Randomised Evaluation of COVID-19 Therapy(RECOVERY)试验以适应性、多臂、平台化设计,在较短时间内系统评估多种候选治疗,不仅确立了地塞米松、托珠单抗和巴瑞替尼等药物在特定住院患者中的临床价值,也以高质量随机证据否定了羟氯喹、阿奇霉素、洛匹那韦/利托那韦等多种无效干预。该文以RECOVERY为主线,在梳理其关键结果的基础上,重点讨论其如何推动住院COVID-19治疗从“广谱尝试”转向“基于疾病阶段、炎症表型、宿主免疫状态及给药时机的分层决策”,并进一步总结其在突发传染病研究中的方法学遗产、临床遗产和循证医学警示。该文认为,RECOVERY的真正价值不仅在于发现若干有效药物,更在于证明突发传染病情境下可以通过嵌入式平台试验快速生成可改变实践的高质量证据,并据此形成动态修正的治疗策略。

本文引用格式

余怀淼 , 罗磊 , 杨文龙 . 适应性平台试验在新型冠状病毒感染大流行中的应用:以RECOVERY为例的方法学反思与未来展望[J]. 实用医学杂志, 2026 , 42(12) : 2252 -2258 . DOI: 10.3969/j.issn.1006-5725.2026.12.022

Abstract

During the early stage of the COVID-19 pandemic, the decision-making regarding the treatment of hospitalized patients was marked by an urgent clinical requirement but a lack of high-quality evidence. The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, leveraging its adaptive multi-arm platform design, quickly assessed multiple candidate therapies within a unified framework. It confirmed the clinical efficacy of dexamethasone, tocilizumab, and baricitinib in specific hospitalized patients, while disproving the effectiveness of several interventions such as hydroxychloroquine, azithromycin, and lopinavir/ritonavir with strong randomized evidence. Using RECOVERY as the core framework, this review explores how the trial transformed the treatment of hospitalized COVID-19 patients from widespread empirical use to stratified decision-making based on disease stage, inflammatory phenotype, host immune status, and treatment timing. It also outlines RECOVERY′s methodological, clinical, and evidentiary contributions for future emerging infectious diseases. We contend that the significant contribution of RECOVERY lies not only in identifying effective therapies but also in demonstrating that embedded platform trials can rapidly generate evidence that can change clinical practice and support the development of dynamically updated treatment strategies during public health emergencies.

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