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Efficacy and safety of oral melatonin in patients with severe COVID-19: a randomized controlled trial

机译:口服褪黑激素在重症 COVID-19 患者中的疗效和安全性:一项随机对照试验

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摘要

Abstract Patients with COVID-19 have shown melatonin deficiency. We evaluated the efficacy and safety of administration oral melatonin in patients with COVID-19-induced pneumonia. Patients were randomly assigned in a 1:1 ratio to receive melatonin plus standard treatment or standard treatment alone. The primary outcomes were mortality rate and requirement of IMV. The clinical status of patients was recorded at baseline and every day over hospitalization based on seven-category ordinal scale from 1 (discharged) to 7 (death). A total of 226 patients (109 in the melatonin group and 117 in the control group) were enrolled (median age; in melatonin group: 54.60?±?11.51, in control group: 54.69?±?13.40). The mortality rate was 67 in the melatonin group and 94 in the control group (OR; 7.75, 95 CI, 3.27–18.35, P?
机译:摘要 COVID-19 患者表现出褪黑激素缺乏症。我们评估了口服褪黑激素在COVID-19诱导的肺炎患者中的疗效和安全性。患者以 1:1 的比例随机分配接受褪黑激素加标准治疗或单独接受标准治疗。主要结局是死亡率和IMV需求。根据从 1(出院)到 7(死亡)的七类顺序量表,记录患者在基线和住院期间每天的临床状态。共纳入226例患者(褪黑激素组109例,对照组117例)(中位年龄;褪黑激素组:54.60?±?11.51,对照组:54.69?±?13.40)。褪黑激素组的死亡率为67%,对照组的死亡率为94%(OR;7.75,95%CI,3.27-18.35,P?0.001)。褪黑激素组的IMV需求率为51.4%,对照组为70.9%,OR为2.31(95%CI,1.34-4.00,P?0.001)。褪黑激素组出院的中位天数为15天(13-17),对照组为21天(14-24天)(OR;5.00,95%CI,0.15-9.84,P?=?0.026)。褪黑激素组的临床状态≥改善时间为12天(9-13),对照组为16天(10-19)(OR;3.92,95%CI,1.69-6.14,P?=?0.038)。褪黑激素显著改善了重症 COVID-19 肺炎患者的临床状态,并具有安全性。

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