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甲泼尼龙或地塞米松,哪一种是治疗住院 COVID-19 患者的更优皮质类固醇:一项三盲随机对照试验。

Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial.

机构信息

Thoracic and Vascular Surgery Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

BMC Infect Dis. 2021 Apr 10;21(1):337. doi: 10.1186/s12879-021-06045-3.

Abstract

BACKGROUND

Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients.

METHODS

In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8).

RESULTS

There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040).

CONCLUSION

In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone.

TRIAL REGISTRATION

The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1 ).

摘要

背景

虽然自 2019 年冠状病毒病(COVID-19)爆发以来已经过去了将近一年,并且已经有了有希望的疫苗报告,但我们仍需要很长时间才能使所有人都能获得这些措施。此外,COVID-19 治疗中最合适的皮质类固醇及其剂量仍不确定。我们进行了一项研究,以评估甲基强的松龙治疗与地塞米松治疗住院 COVID-19 患者的疗效。

方法

在这项前瞻性、三盲、随机对照试验中,我们于 2020 年 8 月至 11 月在伊朗设拉子招募了 86 名住院 COVID-19 患者。患者被随机分为两组,分别接受甲基强的松龙(2 mg/kg/天;干预组)或地塞米松(6 mg/天;对照组)治疗。根据从未感染(第 0 点)到死亡(第 8 点)的 9 分世界卫生组织等级量表评估数据。

结果

两组入院时无显著差异。然而,干预组在入院第 5 天(4.02 对 5.21,p=0.002)和第 10 天(2.90 对 4.71,p=0.001)的临床状况明显优于对照组。干预组和对照组之间的总体平均评分也有显著差异(分别为 3.909 对 4.873,p=0.004)。干预组和对照组的平均住院时间分别为 7.43±3.64 和 10.52±5.47 天(p=0.015)。与对照组相比,干预组需要呼吸机的患者比例显著降低(18.2%对 38.1%,p=0.040)。

结论

在住院缺氧 COVID-19 患者中,与地塞米松相比,甲基强的松龙的疗效更好。

试验注册

该试验在 IRCT.IR 进行注册(08/04/2020-No. IRCT20200204046369N1)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db94/8037929/35706f9f64eb/12879_2021_6045_Fig2_HTML.jpg

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