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早期使用皮质类固醇可能会延长 COVID-19 肺炎非重症监护病房患者的 SARS-CoV-2 脱落:一项多中心、单盲、随机对照试验。

Early Use of Corticosteroid May Prolong SARS-CoV-2 Shedding in Non-Intensive Care Unit Patients with COVID-19 Pneumonia: A Multicenter, Single-Blind, Randomized Control Trial.

机构信息

Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing Institute of Respiratory Medicine, Beijing, China,

Beijing You-An Hospital, Capital Medical University, Beijing, China.

出版信息

Respiration. 2021;100(2):116-126. doi: 10.1159/000512063. Epub 2021 Jan 22.

Abstract

BACKGROUND

There is still no clinical evidence available to support or to oppose corticosteroid treatment for coronavirus disease 2019 (COVID-19) pneumonia.

OBJECTIVE

To investigate the efficacy and safety of corticosteroid given to the hospitalized patients with COVID-19 pneumonia.

METHODS

This was a prospective, multicenter, single-blind, randomized control trial. Adult patients with COVID-19 pneumonia who were admitted to the general ward were randomly assigned to either receive methylprednisolone or not for 7 days. The primary end point was the incidence of clinical deterioration 14 days after randomization.

RESULTS

We terminated this trial early because the number of patients with COVID-19 pneumonia in all the centers decreased in late March. Finally, a total of 86 COVID-19 patients underwent randomization. There was no difference of the incidence of clinical deterioration between the methylprednisolone group and control group (4.8 vs. 4.8%, p = 1.000). The duration of throat viral RNA detectability in the methylprednisolone group was 11 days (interquartile range, 6-16 days), which was significantly longer than that in the control group (8 days [2-12 days], p = 0.030). There were no significant differences between the 2 groups in other secondary outcomes. Mass cytometry discovered CD3+ T cells, CD8+ T cells, and NK cells in the methylprednisolone group which were significantly lower than those in the control group after randomization (p < 0.05).

CONCLUSIONS

From this prematurely closed trial, we found that the short-term early use of corticosteroid could suppress the immune cells, which may prolong severe acute respiratory syndrome coronavirus 2 shedding in patients with COVID-19 pneumonia.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT04273321.

摘要

背景

目前尚无临床证据支持或反对皮质类固醇治疗 2019 冠状病毒病(COVID-19)肺炎。

目的

研究皮质类固醇治疗 COVID-19 肺炎住院患者的疗效和安全性。

方法

这是一项前瞻性、多中心、单盲、随机对照试验。收入普通病房的 COVID-19 肺炎成年患者被随机分为接受或不接受甲基强的松龙治疗 7 天。主要终点是随机分组后 14 天临床恶化的发生率。

结果

由于 3 月底所有中心的 COVID-19 肺炎患者数量减少,我们提前终止了这项试验。最终,共有 86 名 COVID-19 患者接受了随机分组。甲基强的松龙组和对照组临床恶化的发生率无差异(4.8%比 4.8%,p=1.000)。甲基强的松龙组的咽喉病毒 RNA 可检测持续时间为 11 天(四分位间距,6-16 天),明显长于对照组(8 天[2-12 天],p=0.030)。两组其他次要结局无显著差异。质谱流式细胞术发现随机分组后甲基强的松龙组的 CD3+T 细胞、CD8+T 细胞和 NK 细胞明显低于对照组(p<0.05)。

结论

从这项提前关闭的试验中,我们发现短期早期使用皮质类固醇可能会抑制免疫细胞,从而延长 COVID-19 肺炎患者严重急性呼吸综合征冠状病毒 2 的脱落时间。

临床试验注册

ClinicalTrials.gov,NCT04273321。

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