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用于治疗COVID-19的免疫调节剂随机主协议(ACTIV-1 IM)中的资源使用情况:二次数据分析

Resource Use in the Randomized Master Protocol for Immune Modulators for Treating COVID-19 (ACTIV-1 IM): A Secondary Data Analysis.

作者信息

Lachiewicz Anne M, Shah Miloni, Der Tatyana, Cyr Derek, Al-Khalidi Hussein R, Lindsell Christopher, Iyer Vivek, Khan Akram, Panettieri Reynold, Rauseo Adriana M, Maillo Martin, Schmid Andreas, Jagpal Sugeet, Powderly William G, Bozzette Samuel A

机构信息

Division of Infectious Diseases, University of North Carolina, Chapel Hill, NC, USA.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.

出版信息

CHEST Crit Care. 2024 Dec;2(4). doi: 10.1016/j.chstcc.2024.100095. Epub 2024 Aug 22.

Abstract

BACKGROUND

Coronavirus disease 2019 (COVID-19) pneumonia requires considerable healthcare resources.

RESEARCH OBJECTIVE

Examine if a single dose of infliximab or abatacept, in addition to remdesivir and steroids, decreased resource utilization among participants hospitalized with COVID-19 pneumonia.

STUDY DESIGN AND METHODS

Accelerating COVID-19 Therapeutic Interventions and Vaccines Immunomodulator (ACTIV-1 IM) master protocol was a randomized, placebo-controlled trial examining the potential benefit in time to recovery and mortality of immunomodulators infliximab, abatacept, and cenicriviroc. This observational study performs a secondary analysis of the infliximab, abatacept, and common placebo participants to examine resource utilization. Hospital days, intensive care unit days, days with supplemental oxygen, days with high flow nasal cannula or non-invasive ventilation, ventilator days, and days of extracorporeal membrane oxygenation were each examined. Proportional odds models were used to compare days alive and free of resource use over 28 days between infliximab and placebo groups and between abatacept and placebo groups.

RESULTS

Infliximab infusion, compared to placebo, was associated with greater odds of being alive and free of all interventions tested. Abatacept use was associated only with greater odds of days alive and free of hospitalization and supplemental oxygen.

INTERPRETATION

Infliximab and abatacept use were associated with decreased use of healthcare resources over 28 days compared to placebo, but the absolute differences were small.

CLINICAL TRIAL REGISTRATION

www.clinicaltrials.gov (NCT04593940).

摘要

背景

2019年冠状病毒病(COVID-19)肺炎需要大量医疗资源。

研究目的

研究在接受瑞德西韦和类固醇治疗的基础上,单剂量英夫利昔单抗或阿巴西普是否能降低COVID-19肺炎住院患者的资源利用率。

研究设计与方法

加速COVID-19治疗干预和疫苗免疫调节剂(ACTIV-1 IM)主方案是一项随机、安慰剂对照试验,旨在研究免疫调节剂英夫利昔单抗、阿巴西普和西尼考韦在恢复时间和死亡率方面的潜在益处。本观察性研究对英夫利昔单抗、阿巴西普和普通安慰剂参与者进行二次分析,以检查资源利用率。分别检查住院天数、重症监护病房天数、吸氧天数[1]、高流量鼻导管或无创通气天数、呼吸机使用天数和体外膜肺氧合天数。使用比例优势模型比较英夫利昔单抗组与安慰剂组以及阿巴西普组与安慰剂组在28天内存活且未使用资源的天数。

结果

与安慰剂相比,输注英夫利昔单抗与在所有测试干预中存活且未接受干预的更高几率相关。使用阿巴西普仅与存活且未住院和未吸氧的天数增加几率相关。

解读

与安慰剂相比,使用英夫利昔单抗和阿巴西普在28天内与医疗资源使用减少相关,但绝对差异较小。

临床试验注册

www.clinicaltrials.gov(NCT04593940)。

[1] 原文中“days with supplemental oxygen”直译为“使用补充氧气的天数”,这里意译为“吸氧天数”更符合中文表达习惯。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a49a/11600409/1568c3382b76/nihms-2033793-f0001.jpg

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