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维生素 A 补充对住院 COVID-19 患者结局严重程度的影响:一项初步随机临床试验。

Effect of vitamin A supplementation on the outcome severity of COVID-19 in hospitalized patients: A pilot randomized clinical trial.

机构信息

Gastroenterologist, Liver and gastrointestinal diseases research center, Tabriz University of Medical Sciences, Tabriz, Iran.

Pulmonologist, Tuberculosis and Lung Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

Nutr Health. 2024 Sep;30(3):549-554. doi: 10.1177/02601060221129144. Epub 2022 Oct 7.

DOI:10.1177/02601060221129144
PMID:36205099
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9548486/
Abstract

INTRODUCTION

Vitamin A is one of the vitamins that is suggested as adjuvant therapy in viral infections due to its immune enhancing role. In the present clinical trial, we intended to assess the effect of vitamin A supplementation on Coronavirus disease-2019 (COVID-19) in hospitalized patients.

METHODS

The present pilot randomized controlled clinical trial was conducted on 30 hospitalized patients with COVID-19. Patients in the intervention group received 50000 IU/day intramuscular vitamin A for a maximum of two weeks. Patients in the control group continued their common treatment protocols. All participants were followed up until discharge from the hospital or death. The primary outcome of the study was time to achieve clinical response based on the six classes of an ordinal scale. Time to clinical response was calculated based on the days needed to improve two scores on the scale or patient's discharge.

RESULTS

The time to clinical response was not significantly different between the two groups (7.23 ± 2.14 vs. 6.75 ± 1.85 days, respectively, p = 0.48). There was no significant difference between the groups regarding clinical response (hazard ratio: 1.76 [95% CI: 0.73, 4.26]). There were no significant differences between groups regarding the need for mechanical ventilation, duration of hospitalization, or death in the hospital.

CONCLUSION

The results of this pilot clinical trial showed no benefit of vitamin A compared with the common treatment on outcome severity in hospitalized patients with COVID-19. Although the results are negative, there is still a great need for future clinical studies to provide a higher level of evidence.

摘要

介绍

维生素 A 是一种被建议作为病毒感染辅助治疗的维生素,因为它具有增强免疫的作用。在本临床试验中,我们旨在评估维生素 A 补充对住院 COVID-19 患者的影响。

方法

本前瞻性随机对照临床试验纳入了 30 名 COVID-19 住院患者。干预组患者接受 50000IU/天肌内注射维生素 A,最多持续两周。对照组患者继续接受常规治疗方案。所有参与者均随访至出院或死亡。本研究的主要结局是根据等级量表的六个等级达到临床反应的时间。临床反应时间根据需要提高两个等级所需的天数或患者出院计算。

结果

两组间临床反应时间无显著差异(分别为 7.23±2.14 天和 6.75±1.85 天,p=0.48)。两组间临床反应无显著差异(危险比:1.76[95%CI:0.73, 4.26])。两组间机械通气需求、住院时间或住院死亡无显著差异。

结论

本初步临床试验结果显示,与常规治疗相比,维生素 A 对 COVID-19 住院患者的结局严重程度无获益。尽管结果为阴性,但仍需要进一步的临床研究提供更高水平的证据。