Infectious Diseases Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Italy.
Infectious Diseases Unit, Rimini-Forlì-Cesena Hospitals, Italy.
Clin Microbiol Infect. 2021 Jan;27(1):105-111. doi: 10.1016/j.cmi.2020.09.014. Epub 2020 Sep 22.
To assess the efficacy of corticosteroids in patients with coronavirus disease 2019 (COVID-19).
A multicentre observational study was performed from 22 February through 30 June 2020. We included consecutive adult patients with severe COVID-19, defined as respiratory rate ≥30 breath per minute, oxygen saturation ≤93% on ambient air or arterial partial pressure of oxygen to fraction of inspired oxygen ≤300 mm Hg. We excluded patients being treated with other immunomodulant drugs, receiving low-dose corticosteroids and receiving corticosteroids 72 hours after admission. The primary endpoint was 30-day mortality from hospital admission. The main exposure variable was corticosteroid therapy at a dose of ≥0.5 mg/kg of prednisone equivalents. It was introduced as binomial covariate in a logistic regression model for the primary endpoint and inverse probability of treatment weighting using the propensity score.
Of 1717 patients with COVID-19 evaluated, 513 were included in the study, and of these, 170 (33%) were treated with corticosteroids. During hospitalization, 166 patients (34%) met the criteria of the primary outcome (60/170, 35% in the corticosteroid group and 106/343, 31% in the noncorticosteroid group). At multivariable analysis corticosteroid treatment was not associated with lower 30-day mortality rate (adjusted odds ratio, 0.59; 95% confidence interval (CI), 0.20-1.74; p 0.33). After inverse probability of treatment weighting, corticosteroids were not associated with lower 30-day mortality (average treatment effect, 0.05; 95% CI, -0.02 to 0.09; p 0.12). However, subgroup analysis revealed that in patients with PO2/FiO2 < 200 mm Hg at admission (135 patients, 52 (38%) treated with corticosteroids), corticosteroid treatment was associated with a lower risk of 30-day mortality (23/52, 44% vs. 45/83, 54%; adjusted odds ratio, 0.20; 95% CI, 0.04-0.90; p 0.036).
The effect of corticosteroid treatment on mortality might be limited to critically ill COVID-19 patients.
评估皮质类固醇在 2019 年冠状病毒病(COVID-19)患者中的疗效。
这是一项多中心观察性研究,于 2020 年 2 月 22 日至 6 月 30 日进行。我们纳入了连续的成年重症 COVID-19 患者,定义为呼吸频率≥30 次/分钟,在大气氧或动脉血氧分压与吸入氧分数的比值≤93%或≤300 mmHg。我们排除了正在接受其他免疫调节剂治疗、接受低剂量皮质类固醇和入院后 72 小时内接受皮质类固醇治疗的患者。主要终点为入院后 30 天的死亡率。主要暴露变量是剂量≥0.5mg/kg 泼尼松等效物的皮质类固醇治疗。它作为二项协变量引入到主要终点的逻辑回归模型中,并使用倾向评分进行逆概率治疗加权。
在评估的 1717 例 COVID-19 患者中,513 例被纳入研究,其中 170 例(33%)接受了皮质类固醇治疗。在住院期间,166 例(34%)患者符合主要结局的标准(皮质类固醇组 60/170,35%;非皮质类固醇组 106/343,31%)。多变量分析显示皮质类固醇治疗与较低的 30 天死亡率无关(调整后的优势比,0.59;95%置信区间(CI),0.20-1.74;p=0.33)。在进行逆概率治疗加权后,皮质类固醇治疗与较低的 30 天死亡率无关(平均治疗效果,0.05;95%CI,-0.02 至 0.09;p=0.12)。然而,亚组分析显示,在入院时 PO2/FiO2<200 mmHg 的患者(135 例,52 例(38%)接受皮质类固醇治疗)中,皮质类固醇治疗与较低的 30 天死亡率相关(23/52,44% vs. 45/83,54%;调整后的优势比,0.20;95%CI,0.04-0.90;p=0.036)。
皮质类固醇治疗对死亡率的影响可能仅限于重症 COVID-19 患者。