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褪黑素和维生素 C 治疗轻中度 COVID-19 的随机对照试验初步研究。

A Pilot of a Randomized Control Trial of Melatonin and Vitamin C for Mild-to-Moderate COVID-19.

机构信息

From Penn Medicine/Lancaster General Health Family Medicine Residency Program: (CF, DC, AM, DF, JR); Penn Medicine/Lancaster General Health Research Institute: (KB, TV).

出版信息

J Am Board Fam Med. 2022 Jul-Aug;35(4):695-707. doi: 10.3122/jabfm.2022.04.210529.

Abstract

UNLABELLED

This study aimed to help determine the effect of dietary supplements on symptom course and quality of life in patients with mild-to-moderate COVID-19 infection.

DESIGN

We modified the Wisconsin Upper Respiratory Symptom Survey (WURSS) to conduct a 3 arm, parallel, randomized, double-blind, placebo-controlled trial, enrolling patients with mild-to-moderate symptoms of COVID-19 infection. Patients took placebo ( = 34), vitamin C 1000 mg ( = 32), or melatonin 10 mg (n = 32) orally for 14 days.

OUTCOMES

Ninety Eight (98 out of 104 recruited; mean age = 52 years) patients completed the study. Outcomes were calculated as differences from baseline scores on each of 2 WURSS-derived surveys and analyzed using a spline regression analysis. Regarding symptom progression, those patients taking placebo and vitamin C progressed at the same rate. When compared with those taking placebo (coefficient = -1.09 (95% confidence interval [CI] = -1.39 to -0.8) the group taking melatonin had a faster resolution of symptoms (coefficient = -0.63 [95% CI -1.02 to -0.21] = ). By day 14 all 3 groups had reached plateau.Quality-of-life impact analysis demonstrated that the group taking vitamin C improved at the same rate as the group taking placebo (coefficient = -0.71 (95% CI = -1.11 to -0.3)). The group taking melatonin (coefficient = -1.16 (95% CI = -1.75 to - 0.57) < ) had a faster improvement in quality-of-life. By day 14 all 3 groups had reached plateau.

CONCLUSION

Vitamin C 1000 mg once daily has no effect on disease progression. Melatonin 10 mg daily may have a statistically significant effect but it is unclear if this represents a clinically significant benefit to those with mild-to-moderate symptoms of COVID-19 infection. Further study is warranted.

摘要

本研究旨在探讨膳食补充剂对轻中度 COVID-19 感染患者症状进程和生活质量的影响。

方法

我们修改了威斯康星上呼吸道症状调查(WURSS),开展了一项 3 臂、平行、随机、双盲、安慰剂对照试验,招募了轻中度 COVID-19 感染症状的患者。患者口服安慰剂(n=34)、维生素 C 1000mg(n=32)或褪黑素 10mg(n=32),疗程 14 天。

结果

98 例(104 例招募患者中的 98 例;平均年龄 52 岁)完成了研究。采用样条回归分析,根据 WURSS 衍生的 2 项调查的基线评分计算差值,作为结局指标。就症状进展而言,服用安慰剂和维生素 C 的患者进展速度相同。与服用安慰剂的患者相比(系数=-1.09(95%置信区间=-1.39 至-0.8),服用褪黑素的患者症状缓解更快(系数=-0.63(95%置信区间=-1.02 至-0.21)。至第 14 天,所有 3 组均达到平台期。生活质量影响分析显示,服用维生素 C 的患者与服用安慰剂的患者改善速度相同(系数=-0.71(95%置信区间=-1.11 至-0.3)。服用褪黑素的患者(系数=-1.16(95%置信区间=-1.75 至-0.57)<)生活质量改善更快。至第 14 天,所有 3 组均达到平台期。

结论

每日服用 1000mg 维生素 C 对疾病进展无影响。褪黑素 10mg 每日服用可能具有统计学显著效果,但尚不清楚这是否对轻中度 COVID-19 感染患者的症状有临床意义的益处。需要进一步研究。

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