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比较不同剂量地塞米松治疗 COVID-19 的疗效和安全性:一项三臂随机临床试验。

Comparing efficacy and safety of different doses of dexamethasone in the treatment of COVID-19: a three-arm randomized clinical trial.

机构信息

Department of Clinical Pharmacy, International Campus, School of Pharmacy, Tehran University of Medical Sciences, P.O.Box: 14155/6451, 1417614411, Tehran, Iran.

Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Pharmacol Rep. 2022 Feb;74(1):229-240. doi: 10.1007/s43440-021-00341-0. Epub 2021 Nov 27.

DOI:10.1007/s43440-021-00341-0
PMID:34837648
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8627167/
Abstract

BACKGROUND AND OBJECTIVES

Corticosteroids are commonly used in the treatment of hospitalized patients with COVID-19. The goals of the present study were to compare the efficacy and safety of different doses of dexamethasone in the treatment of patients with a diagnosis of moderate to severe COVID-19.

METHODS

Hospitalized patients with a diagnosis of moderate to severe COVID-19 were assigned to intravenous low-dose (8 mg once daily), intermediate-dose (8 mg twice daily) or high-dose (8 mg thrice daily) dexamethasone for up to 10 days or until hospital discharge. Clinical response, 60-day survival and adverse effects were the main outcomes of the study.

RESULTS

In the competing risk survival analysis, patients in the low-dose group had a higher clinical response than the high-dose group when considering death as a competing risk (HR = 2.03, 95% CI: 1.23-3.33, p = 0.03). Also, the survival was significantly longer in the low-dose group than the high-dose group (HR = 0.36, 95% CI = 0.15-0.83, p = 0.02). Leukocytosis and hyperglycemia were the most common side effects of dexamethasone. Although the incidence was not significantly different between the groups, some adverse effects were numerically higher in the intermediate-dose and high-dose groups than in the low-dose group.

CONCLUSIONS

Higher doses of dexamethasone not only failed to improve efficacy but also resulted in an increase in the number of adverse events and worsen survival in hospitalized patients with moderate to severe COVID-19 compared to the low-dose dexamethasone. (IRCT20100228003449N31).

摘要

背景和目的

皮质类固醇在治疗住院的 COVID-19 患者中被广泛应用。本研究的目的是比较不同剂量地塞米松治疗中度至重度 COVID-19 患者的疗效和安全性。

方法

将诊断为中度至重度 COVID-19 的住院患者随机分为静脉注射低剂量(8mg 每日一次)、中剂量(8mg 每日两次)或高剂量(8mg 每日三次)地塞米松,疗程最长 10 天或直至出院。临床反应、60 天生存率和不良反应是本研究的主要结局。

结果

在竞争风险生存分析中,考虑死亡为竞争风险时,低剂量组的临床反应率高于高剂量组(HR=2.03,95%CI:1.23-3.33,p=0.03)。此外,低剂量组的生存率明显高于高剂量组(HR=0.36,95%CI=0.15-0.83,p=0.02)。白细胞增多和高血糖是地塞米松最常见的副作用。尽管组间发生率无显著差异,但中剂量和高剂量组的一些不良反应发生率高于低剂量组。

结论

与低剂量地塞米松相比,高剂量地塞米松不仅未能提高疗效,反而导致中度至重度 COVID-19 住院患者的不良反应发生率增加,生存状况恶化。(IRCT20100228003449N31)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cc5/8627167/ab26e6d72b5e/43440_2021_341_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cc5/8627167/656e05d61200/43440_2021_341_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cc5/8627167/ab26e6d72b5e/43440_2021_341_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cc5/8627167/656e05d61200/43440_2021_341_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7cc5/8627167/ab26e6d72b5e/43440_2021_341_Fig2_HTML.jpg

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