Advanced Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.
These two authors contributed equally as first authors.
Eur Respir J. 2020 Dec 24;56(6). doi: 10.1183/13993003.02808-2020. Print 2020 Dec.
There are no determined treatment agents for severe COVID-19. It is suggested that methylprednisolone, as an immunosuppressive treatment, can reduce the inflammation of the respiratory system in COVID-19 patients.
We conducted a single-blind, randomised controlled clinical trial involving severe hospitalised patients with confirmed COVID-19 at the early pulmonary phase of the illness in Iran. The patients were randomly allocated in a 1:1 ratio by the block randomisation method to receive standard care with methylprednisolone pulse (intravenous injection, 250 mg·day for 3 days) or standard care alone. The study end-point was the time of clinical improvement or death, whichever came first. Primary and safety analysis was done in the intention-to-treat (ITT) population.
68 eligible patients underwent randomisation (34 patients in each group) from April 20, 2020 to June 20, 2020. In the standard care group, six patients received corticosteroids by the attending physician before the treatment and were excluded from the overall analysis. The percentage of improved patients was higher in the methylprednisolone group than in the standard care group (94.1% 57.1%) and the mortality rate was significantly lower in the methylprednisolone group (5.9% 42.9%; p<0.001). We demonstrated that patients in the methylprednisolone group had a significantly increased survival time compared with patients in the standard care group (log-rank test: p<0.001; hazard ratio 0.293, 95% CI 0.154-0.556). Two patients (5.8%) in the methylprednisolone group and two patients (7.1%) in the standard care group showed severe adverse events between initiation of treatment and the end of the study.
Our results suggest that methylprednisolone pulse could be an efficient therapeutic agent for hospitalised severe COVID-19 patients at the pulmonary phase.
目前尚无针对重症 COVID-19 的确定治疗药物。有研究表明，甲泼尼龙作为一种免疫抑制剂，可以减轻 COVID-19 患者的呼吸系统炎症。
我们在伊朗进行了一项单盲、随机对照临床试验，纳入了处于疾病肺部早期阶段的确诊 COVID-19 住院重症患者。采用区组随机分组方法，以 1:1 的比例将患者随机分配至接受标准治疗加甲泼尼龙冲击治疗（静脉注射，250mg·d，连续 3 天）或单独接受标准治疗。研究终点为临床改善或死亡的时间，以先出现者为准。主要分析和安全性分析均采用意向治疗（ITT）人群。
2020 年 4 月 20 日至 6 月 20 日，68 例符合条件的患者进行了随机分组（每组 34 例）。在标准治疗组中，6 例患者在治疗前接受了医生给予的皮质类固醇治疗，因此被排除在总体分析之外。与标准治疗组相比，甲泼尼龙组的患者改善率更高（94.1%比 57.1%），死亡率更低（5.9%比 42.9%；p<0.001）。我们表明，与标准治疗组相比，甲泼尼龙组的患者生存时间显著增加（对数秩检验：p<0.001；风险比 0.293，95%CI 0.154-0.556）。甲泼尼龙组有 2 例患者（5.8%）和标准治疗组有 2 例患者（7.1%）在治疗开始至研究结束期间出现严重不良事件。
我们的结果表明，甲泼尼龙冲击可能是肺部发病阶段住院重症 COVID-19 患者的一种有效治疗药物。
