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大剂量皮质类固醇脉冲疗法可提高 COVID-19 高危炎症反应患者的生存率。

High-dose corticosteroid pulse therapy increases the survival rate in COVID-19 patients at risk of hyper-inflammatory response.

机构信息

Infectious Diseases Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.

Grupo de investigación CTS 990: GEAPACECP, Universidad de Jaén, Jaén, Spain.

出版信息

PLoS One. 2021 Jan 28;16(1):e0243964. doi: 10.1371/journal.pone.0243964. eCollection 2021.

Abstract

OBJECTIVE

Test whether high dose corticosteroid pulse therapy (HDCPT) with either methylprednisolone or dexamethasone is associated with increased survival in COVID-19 patients at risk of hyper-inflammatory response. Provide some initial diagnostic criteria using laboratory markers to stratify these patients.

METHODS

This is a prospective observational study, 318 met the inclusion criteria. 64 patients (20.1%) were treated with HDCPT by using at least 1.5mg/kg/24h of methylprednisolone or dexamethasone equivalent. A multivariate Cox regression (controlling for co-morbidities and other therapies) was carried out to determine whether HDCPT (among other interventions) was associated with decreased mortality. We also carried out a 30-day time course analysis of laboratory markers between survivors and non-survivors, to identify potential markers for patient stratification.

RESULTS

HDCPT showed a statistically significant decrease in mortality (HR = 0.087 [95% CI 0.021-0.36]; P < 0.001). 30-day time course analysis of laboratory marker tests showed marked differences in pro-inflammatory markers between survivors and non-survivors. As diagnostic criteria to define the patients at risk of developing a COVID-19 hyper-inflammatory response, we propose the following parameters (IL-6 > = 40 pg/ml, and/or two of the following: C-reactive protein > = 100 mg/L, D-dimer > = 1000 ng/ml, ferritin > = 500 ng/ml and lactate dehydrogenase > = 300 U/L).

CONCLUSIONS

HDCPT can be an effective intervention to increase COVID-19 survival rates in patients at risk of developing a COVID-19 hyper-inflammatory response, laboratory marker tests can be used to stratify these patients who should be given HDCPT. This study is not a randomized clinical trial (RCT). Future RCTs should be carried out to confirm the efficacy of HDCPT to increase the survival rates of COVID-19.

摘要

目的

检验大剂量皮质类固醇脉冲疗法(HDCPT),无论是用甲泼尼龙还是地塞米松,是否能提高 COVID-19 高危炎症反应患者的生存率。提供一些使用实验室标志物进行初步诊断的标准,以对这些患者进行分层。

方法

这是一项前瞻性观察性研究,符合纳入标准的有 318 例患者。64 例(20.1%)患者接受了 HDCPT 治疗,使用至少 1.5mg/kg/24h 的甲泼尼龙或等效剂量的地塞米松。采用多变量 Cox 回归(控制合并症和其他治疗方法),以确定 HDCPT(以及其他干预措施)是否与降低死亡率相关。我们还对幸存者和非幸存者之间的实验室标志物进行了 30 天时间进程分析,以确定潜在的患者分层标志物。

结果

HDCPT 显著降低了死亡率(HR=0.087[95%CI 0.021-0.36];P<0.001)。实验室标志物检测的 30 天时间进程分析显示,幸存者和非幸存者之间促炎标志物存在显著差异。作为定义 COVID-19 高危炎症反应患者的诊断标准,我们提出以下参数(IL-6≥40pg/ml,和/或以下两项:C 反应蛋白≥100mg/L,D-二聚体≥1000ng/ml,铁蛋白≥500ng/ml,乳酸脱氢酶≥300U/L)。

结论

HDCPT 可作为增加 COVID-19 高危炎症反应患者生存率的有效干预措施,实验室标志物检测可用于分层这些应接受 HDCPT 治疗的患者。本研究并非随机临床试验(RCT)。应开展未来的 RCT 以确认 HDCPT 提高 COVID-19 生存率的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8de7/7842890/919591f87190/pone.0243964.g001.jpg

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