SOC Reumatologia, Azienda USL-IRCCS, Reggio Emilia, Italy
Unità di Reumatologia, Università degli Studi di Modena e Reggio Emilia, Modena, Italy.
Eur Respir J. 2022 Oct 20;60(4). doi: 10.1183/13993003.00025-2022. Print 2022 Oct.
Pulse glucocorticoid therapy is used in hyperinflammation related to coronavirus disease 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia.
In this multicentre, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with COVID-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for three consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need for supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival.
Overall, 112 (75.4%) out of 151 patients in the pulse methylprednisolone arm and 111 (75.2%) of 150 in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups (15 days, 95% CI 13.0-17.0 days and 16 days, 95% CI 13.8-18.2 days, respectively; hazard ratio (HR) 0.92, 95% CI 0.71-1.20; p=0.528). No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to intensive care unit with orotracheal intubation or death (20.0% 16.1%; HR 1.26, 95% CI 0.74-2.16; p=0.176) or overall mortality (10.0% 12.2%; HR 0.83, 95% CI 0.42-1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups.
Methylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia.
脉冲糖皮质激素疗法用于与 2019 年冠状病毒病（COVID-19）相关的过度炎症。我们评估了在 COVID-19 肺炎中除标准治疗外，额外给予脉冲静脉内甲泼尼龙的疗效和安全性。
在这项多中心、随机、双盲、安慰剂对照试验中，将 304 名住院 COVID-19 肺炎患者随机分为三组，分别接受 1g 静脉内甲泼尼龙连续 3 天治疗，或接受标准地塞米松加安慰剂治疗。主要结局是患者住院时间，计算为随机分组至出院且无需补充氧气的时间间隔。主要次要结局是免于有创通气和总体生存率。
总体而言，151 名接受脉冲甲泼尼龙组的患者中有 112 名（75.4%）和 150 名接受安慰剂组的患者中有 111 名（75.2%）在随机分组后 30 天内无需吸氧出院。两组中位出院时间相似（15 天，95%CI 13.0-17.0 天和 16 天，95%CI 13.8-18.2 天，风险比（HR）0.92，95%CI 0.71-1.20；p=0.528）。在入住重症监护病房行有创通气或死亡（20.0% 16.1%；HR 1.26，95%CI 0.74-2.16；p=0.176）或总体死亡率（10.0% 12.2%；HR 0.83，95%CI 0.42-1.64；p=0.584）方面，脉冲甲泼尼龙组与安慰剂组之间没有观察到显著差异。两组严重不良事件的发生频率相似。
在 COVID-19 肺炎患者中，除地塞米松外，给予甲泼尼龙脉冲治疗没有益处。
