NEJM：地塞米松治疗COVID-19

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地塞米松治疗COVID-19

Dexamethasone and Covid-19

2021年2月25日

朗读者：Dr. Stephen Morrissey, NEJM执行主编

2020年COVID-19住院患者的病死率高，尤其是接受有创机械通气的患者，我们亟需对重症患者有效的药物。短视频中总结了关于地塞米松的研究发现。

NEJM医学前沿地塞米松治疗COVID-19小程序

地塞米松治疗COVID-19住院患者

Dexamethasone in Hospitalized Patients with Covid-19

摘 要

背景

2019冠状病毒病（COVID-19）可伴发弥漫性肺损伤。糖皮质激素有可能通过调节炎症介导的肺损伤来降低进展至呼吸衰竭和死亡的风险。

Background

Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.

方法

我们在COVID-19住院患者中开展了一项开放标签的对照试验，目的是比较多种可能的治疗方案的疗效。我们将患者随机分组，分别接受口服或静脉输注地塞米松（每日一次，每次6 mg，疗程最长为10天）或仅接受常规治疗。主要结局是28天死亡率。现报告上述评估的最终结果。

Methods

In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the final results of this assessment.

结果

共计2104例患者分配至地塞米松组，4321例分配至常规治疗组。随机分组后28天内，地塞米松组和常规治疗组分别有482例（22.9%）和1110例（25.9%）患者死亡（针对年龄校正的率比，0.83，95%置信区间[CI]，0.75⁓0.93，P<0.0001）。死亡率的组间差异（比例和绝对差异）因随机分组时患者接受的呼吸支持水平不同而有很大差别。对于随机分组时接受有创机械通气（29.3% vs. 41.4%；率比，0.64；95% CI，0.51⁓0.81）和仅吸氧但未接受有创机械通气（23.3% vs. 26.2%；率比，0.82；95% CI，0.72⁓0.94）的患者，地塞米松组的死亡率均低于常规治疗组；但对于未接受呼吸支持的患者（17.8% vs. 14.0%；率比，1.19；95% CI，0.92⁓1.55），地塞米松组的死亡率并未低于常规治疗组。

Result

A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.92 to 1.55).

结论

在COVID-19住院患者中，对于随机分组时接受有创机械通气和仅吸氧的患者，地塞米松降低了28天死亡率；但对于未接受呼吸支持的患者，地塞米松未能降低死亡率。（由英国医学研究委员会[Medical Research Council]和英国国家卫生研究院[National Institute for Health Research]等资助；RECOVERY在ClinicalTrials注册号为NCT04381936；在ISRCTN注册号为50189673.）

Conclusions

In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.)

The RECOVERY Collaborative Group. Dexamethasone in Hospitalized Patients with Covid-19. DOI: 10.1056/NEJMoa2021436