Infectious Disease School, University of Modena and Reggio Emilia, Modena, Italy.
Rheumatology Unit, IRCCS Arcispedale Santa Maria Nuova, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, and University of Modena and Reggio Emilia PhD Program, Department of Surgical, Medical, Dental and Morphological Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Clin Exp Rheumatol. 2021 Sep-Oct;39(5):1119-1125. doi: 10.55563/clinexprheumatol/36rs0j. Epub 2021 Feb 26.
The results of the RECOVERY trial identified dexamethasone as the first pharmacological therapy that reduces mortality in patients with COVID-19. The aim of this paper is to conduct a systematic literature review on safety and efficacy of pulse glucocorticoid therapy for Severe Acute Respiratory Syndrome (SARS)-CoronaVirus (CoV), Middle East Respiratory Syndrome (MERS)-CoV or SARS-CoV-2 infections and describe a case-series of COVID-19 patients treated with off-label pulse doses of methylprednisolone.
We performed a systematic literature review on safety and efficacy of pulse therapy for betacoronaviridae infections as described in the protocol registered on PROSPERO (CRD42020190183). All consecutive patients admitted to Arcispedale Santa Maria Nuova di Reggio Emilia or Guastalla Hospital with COVID-19 between March 1st and April 30th, 2020 and treated with methylprednisolone 1 gram/day for at least three days were included in the case series. A retrospective review of available computed tomography (CT) scan and chest x-ray was performed independently by two radiologists blinded to clinical data, and discordances were resolved by consensus.
Twenty papers were included for SARS, but only two were comparative and were included in the primary endpoint analysis. Likewise, eleven papers were included for COVID-19, four of which were comparative and were considered for the primary outcome analysis. Included studies for both SARS and COVID-19 are mostly retrospective and highly heterogeneous, with lethality ranging from 0% to 100% and ICU admission rate ranging from 9% to 100%. Fourteen patients were included in our case series, 7 males and 7 females.
No randomised controlled trial is available yet for corticosteroids pulse-therapy defined as at least ≥500mg/day methylprednisolone in patients with emerging coronavirus pneumonia. Lethality among our cohort is high (4/14), but this finding should be interpreted with caution due to the fact that in our setting pulse-steroids were used in patients not eligible for other treatments because of comorbidities or as rescue therapy. The incidence of steroid-related adverse events seems low in our cohort. The quality of the evidence on glucocorticoid pulse-therapy in SARS, MERS and COVID-19 is poor. Randomised controlled trials are greatly needed.
RECOVERY 试验的结果表明，地塞米松是降低 COVID-19 患者死亡率的第一种药物治疗方法。本文旨在对 SARS-CoV、中东呼吸综合征冠状病毒（MERS-CoV）或 SARS-CoV-2 感染的脉冲糖皮质激素治疗的安全性和有效性进行系统文献回顾，并描述一系列 COVID-19 患者接受甲基强的松龙超说明书脉冲剂量治疗的病例系列。
我们按照 PROSPERO 上注册的方案（CRD42020190183）对贝塔冠状病毒感染的脉冲治疗的安全性和有效性进行了系统文献回顾。所有在 2020 年 3 月 1 日至 4 月 30 日期间因 COVID-19 入住雷焦艾米利亚省的 Arcispedale Santa Maria Nuova 或瓜斯塔拉医院，并接受至少 3 天甲基强的松龙 1 克/天治疗的连续患者均纳入病例系列。两名放射科医生对现有 CT 扫描和胸部 X 线进行了独立的回顾性评估，对临床数据进行了盲法，并通过共识解决了分歧。
有 20 篇关于 SARS 的论文被纳入，但只有 2 篇是比较性的，并被纳入主要终点分析。同样，有 11 篇关于 COVID-19 的论文被纳入，其中 4 篇是比较性的，并被考虑用于主要结果分析。纳入 SARS 和 COVID-19 的研究大多是回顾性的，高度异质性，死亡率从 0%到 100%不等，重症监护病房入住率从 9%到 100%不等。我们的病例系列纳入了 14 名患者，其中 7 名男性和 7 名女性。
目前尚无关于皮质类固醇脉冲治疗的随机对照试验，定义为至少≥500mg/天的甲基强的松龙用于新发冠状病毒性肺炎患者。我们队列的死亡率很高（4/14），但由于在我们的环境中，脉冲类固醇被用于因合并症或作为抢救治疗而不适合其他治疗的患者，因此这一发现应谨慎解释。我们队列中类固醇相关不良事件的发生率似乎较低。SARS、MERS 和 COVID-19 中糖皮质激素脉冲治疗的证据质量较差。非常需要随机对照试验。
