糖皮质激素治疗重症 2019 冠状病毒病患者的有效性：一项随机对照试验方案。
Effectiveness of glucocorticoid therapy in patients with severe coronavirus disease 2019: protocol of a randomized controlled trial.
机构信息
Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing 400036, China.
出版信息
Chin Med J (Engl). 2020 May 5;133(9):1080-1086. doi: 10.1097/CM9.0000000000000791.
BACKGROUND
At the end of 2019, a novel coronavirus outbreak causative organism has been subsequently designated the 2019 novel coronavirus (2019-nCoV). The effectiveness of adjunctive glucocorticoid therapy in the management of 2019-nCoV-infected patients with severe lower respiratory tract infections is not clear, and warrants further investigation.
METHODS
The present study will be conducted as an open-labeled, randomized, controlled trial. We will enrol 48 subjects from Chongqing Public Health Medical Center. Each eligible subject will be assigned to an intervention group (methylprednisolone via intravenous injection at a dose of 1-2 mg/kg/day for 3 days) or a control group (no glucocorticoid use) randomly, at a 1:1 ratio. Subjects in both groups will be invited for 28 days of follow-up which will be scheduled at four consecutive visit points. We will use the clinical improvement rate as our primary endpoint. Secondary endpoints include the timing of clinical improvement after intervention, duration of mechanical ventilation, duration of hospitalization, overall incidence of adverse events, as well as rate of adverse events at each visit, and mortality at 2 and 4 weeks.
DISCUSSION
The present coronavirus outbreak is the third serious global coronavirus outbreak in the past two decades. Oral and parenteral glucocorticoids have been used in the management of severe respiratory symptoms in coronavirus-infected patients in the past. However, there remains no definitive evidence in the literature for or against the utilization of systemic glucocorticoids in seriously ill patients with coronavirus-related severe respiratory disease, or indeed in other types of severe respiratory disease. In this study, we hope to discover evidence either supporting or opposing the systemic therapeutic administration of glucocorticoids in patients with severe coronavirus disease 2019.
TRIAL REGISTRATION
ClinicalTrials.gov, ChiCTR2000029386, http://www.chictr.org.cn/showproj.aspx?proj=48777.
背景
2019 年底，一种新型冠状病毒爆发，随后被指定为 2019 年新型冠状病毒（2019-nCoV）。辅助糖皮质激素治疗 2019-nCoV 感染的严重下呼吸道感染患者的效果尚不清楚，需要进一步研究。
方法
本研究将作为一项开放标签、随机、对照试验进行。我们将从重庆市公共卫生医疗救治中心招募 48 名受试者。每个合格的受试者将被随机分配到干预组（静脉注射甲泼尼龙，剂量为 1-2mg/kg/天，连用 3 天）或对照组（不使用糖皮质激素），比例为 1:1。两组受试者均将受邀接受 28 天的随访，随访安排在连续 4 个访视点进行。我们将以临床改善率为主要终点。次要终点包括干预后临床改善的时间、机械通气时间、住院时间、总体不良事件发生率以及每个访视点的不良事件发生率和 2 周和 4 周的死亡率。
讨论
目前的冠状病毒爆发是过去 20 年中第三次严重的全球冠状病毒爆发。在过去，口服和静脉糖皮质激素已用于治疗冠状病毒感染患者的严重呼吸道症状。然而，目前文献中尚无明确的证据支持或反对在严重冠状病毒相关严重呼吸道疾病或其他类型的严重呼吸道疾病患者中使用全身糖皮质激素。在这项研究中，我们希望发现支持或反对全身治疗应用糖皮质激素治疗严重 2019 年冠状病毒病患者的证据。
试验注册
ClinicalTrials.gov，ChiCTR2000029386，http://www.chictr.org.cn/showproj.aspx?proj=48777。
Zotero 插件