Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID-19 patients: results from a randomised controlled clinical trial.
Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID-19 patients: results from a randomised controlled clinical trial.
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DOI：
10.1183/13993003.02808-2020
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发表时间：
2020-12
期刊：
影响因子：
--
通讯作者：
Rostamian A
中科院分区：
文献类型：
--
作者：
Edalatifard M;Akhtari M;Salehi M;Naderi Z;Jamshidi A;Mostafaei S;Najafizadeh SR;Farhadi E;Jalili N;Esfahani M;Rahimi B;Kazemzadeh H;Mahmoodi Aliabadi M;Ghazanfari T;Sattarian M;Ebrahimi Louyeh H;Raeeskarami SR;Jamalimoghadamsiahkali S;Khajavirad N;Mahmoudi M;Rostamian A
目前尚无针对严重COVID-19的确定治疗药物。这表明甲基强的松龙作为一种免疫抑制治疗，可以减轻COVID-19患者呼吸系统的炎症。我们进行了一项单盲、随机对照临床试验，涉及伊朗确诊为COVID-19的重症住院患者，这些患者处于疾病的早期肺部阶段。通过区组随机化方法，将患者以1：1的比例随机分配至接受甲基强的松龙脉冲（静脉注射，250 mg·d-1，持续3天）的标准治疗或仅接受标准治疗。 研究终点是临床改善或死亡的时间，以先发生者为准。在意向治疗（ITT）人群中进行主要和安全性分析。2020年4月20日至2020年6月20日，68名符合条件的患者接受了随机分组（每组34名患者）。在标准治疗组中，6名患者在治疗前由主治医生接受皮质类固醇，并从总体分析中排除。甲泼尼龙组改善患者的百分比高于标准治疗组（94.1%对57.1%），甲泼尼龙组的死亡率显著低于标准治疗组（5.9%对42.9%; p<0.001）。我们证明，与标准治疗组相比，甲基强的松龙组患者的生存时间显著延长（对数秩检验：p<0.001;风险比0.293，95%CI 0.154-0.556）。甲基强的松龙组2例（5.8%）和标准治疗组2例（7.1%）在治疗开始至研究结束期间出现严重不良事件。我们的研究结果表明，甲基强的松龙脉冲可能是一种有效的治疗药物，用于住院的严重COVID-19患者在肺部阶段。这项研究表明，在疾病的早期肺部阶段开始时，甲基强的松龙脉冲给药可降低死亡率，并改善COVID-19患者的肺部受累、氧饱和度和炎症标志物。https://bit.ly/3hik4JB
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−1 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% versus 57.1%) and the mortality rate was significantly lower in the methylprednisolone group (5.9% versus 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. This study showed that methylprednisolone pulse administration at the beginning of the early pulmonary phase of illness decreased the mortality rate and improved pulmonary involvement, oxygen saturation and inflammatory markers in COVID-19 patients https://bit.ly/3hik4JB
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影响因子：
6.1
作者：
Liu, Kui;Fang, Yuan-Yuan;Liu, Hui-Guo
通讯作者：
Liu, Hui-Guo
DOI：
10.1038/nrmicro.2016.81
发表时间：
2016-08
期刊：
Nature reviews. Microbiology
影响因子：
--
作者：
de Wit E;van Doremalen N;Falzarano D;Munster VJ
通讯作者：
Munster VJ
影响因子：
8.8
作者：
Liu, Fang;Li, Lin;Zhou, Xiang
通讯作者：
Zhou, Xiang
DOI：
10.1016/j.jclinepi.2010.03.004
发表时间：
2010-01-01
期刊：
Open medicine : a peer-reviewed, independent, open-access journal
影响因子：
--
作者：
Schulz, Kenneth F;Altman, Douglas G;Moher, David
通讯作者：
Moher, David
影响因子：
168.9
作者：
Huang, Chaolin;Wang, Yeming;Cao, Bin
通讯作者：
Cao, Bin