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COVID-19 患者大剂量皮质类固醇给药没有临床获益:一项随机临床试验的初步报告。

No clinical benefit of high dose corticosteroid administration in patients with COVID-19: A preliminary report of a randomized clinical trial.

机构信息

Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Eur J Pharmacol. 2021 Apr 15;897:173947. doi: 10.1016/j.ejphar.2021.173947. Epub 2021 Feb 16.

Abstract

The aim of this study was to evaluate the clinical effects of dexamethasone administration in patients with mild to moderate acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19). The study included 50 patients who were randomly assigned to the dexamethasone group or control group. Dexamethasone was administered at a dose of 20 mg/day from day 1-5 and then at 10 mg/day from day 6-10. The need for invasive mechanical ventilation, death rate, duration of clinical improvement, length of hospital stay, and radiological changes in the computed tomography scan were assessed. The results revealed that 92% and 96% of patients in the dexamethasone and control groups, respectively, required noninvasive ventilation (P = 0.500). Among them, 52% and 44% of patients in the dexamethasone and control groups, respectively, required invasive mechanical ventilation (P = 0.389). At the end of the study, 64% of patients in the dexamethasone group and 60% of patients in the control group died (P = 0.500); the remaining patients were discharged from the hospital during the 28-day follow-up period. The median length of hospital stay was 11 days in the dexamethasone group and 6 days in the control group (P = 0.036) and the median length of hospital stay was 7 days in the dexamethasone group and 3 days in the control group (P < 0.001). No significant differences were observed in the other outcomes. This study showed that corticosteroid administration had no clinical benefit in patients with COVID-19-induced mild to moderate ARDS.

摘要

本研究旨在评估地塞米松治疗 2019 冠状病毒病(COVID-19)所致轻度至中度急性呼吸窘迫综合征(ARDS)患者的临床效果。研究纳入了 50 例患者,他们被随机分为地塞米松组或对照组。地塞米松的剂量为 20mg/天,从第 1-5 天开始,然后从第 6-10 天开始剂量为 10mg/天。评估了需要有创机械通气、死亡率、临床改善持续时间、住院时间以及计算机断层扫描的影像学变化。结果显示,地塞米松组和对照组分别有 92%和 96%的患者需要无创通气(P=0.500)。其中,地塞米松组和对照组分别有 52%和 44%的患者需要有创机械通气(P=0.389)。研究结束时,地塞米松组 64%的患者和对照组 60%的患者死亡(P=0.500);其余患者在 28 天随访期间出院。地塞米松组的中位住院时间为 11 天,对照组为 6 天(P=0.036),地塞米松组的中位住院时间为 7 天,对照组为 3 天(P<0.001)。其他结果无显著差异。本研究表明,皮质类固醇治疗 COVID-19 引起的轻度至中度 ARDS 患者无临床获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ff9/7885705/9266fea50200/gr1_lrg.jpg

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