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维生素 C 高剂量治疗 COVID-19 患者的安全性和有效性:一项随机、开放标签临床试验。

Safety and effectiveness of high-dose vitamin C in patients with COVID-19: a randomized open-label clinical trial.

机构信息

Department of Infectious Diseases, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Eur J Med Res. 2021 Feb 11;26(1):20. doi: 10.1186/s40001-021-00490-1.

Abstract

BACKGROUND

Vitamin C is an essential water-soluble nutrient that functions as a key antioxidant and has been proven to be effective for boosting immunity. In this study, we aimed to assess the efficacy of adding high-dose intravenous vitamin C (HDIVC) to the regimens for patients with severe COVID-19 disease.

METHODS

An open-label, randomized, and controlled trial was conducted on patients with severe COVID-19 infection. The case and control treatment groups each consisted of 30 patients. The control group received lopinavir/ritonavir and hydroxychloroquine and the case group received HDIVC (6 g daily) added to the same regimen.

RESULTS

There were no statistically significant differences between two groups with respect to age and gender, laboratory results, and underlying diseases. The mean body temperature was significantly lower in the case group on the 3rd day of hospitalization (p = 0.001). Peripheral capillary oxygen saturations (SpO) measured at the 3rd day of hospitalization was also higher in the case group receiving HDIVC (p = 0.014). The median length of hospitalization in the case group was significantly longer than the control group (8.5 days vs. 6.5 days) (p = 0.028). There was no significant difference in SpO levels at discharge time, the length of intensive care unit (ICU) stay, and mortality between the two groups.

CONCLUSIONS

We did not find significantly better outcomes in the group who were treated with HDIVC in addition to the main treatment regimen at discharge. Trial registration irct.ir (IRCT20200411047025N1), April 14, 2020.

摘要

背景

维生素 C 是一种必需的水溶性营养素,具有重要的抗氧化作用,已被证明能有效增强免疫力。在这项研究中,我们旨在评估在重症 COVID-19 患者的治疗方案中添加大剂量静脉注射维生素 C(HDIVC)的疗效。

方法

对重症 COVID-19 感染患者进行了一项开放标签、随机对照试验。病例组和对照组各 30 例。对照组接受洛匹那韦/利托那韦和羟氯喹,病例组接受 HDIVC(每日 6g)联合相同方案。

结果

两组在年龄、性别、实验室结果和基础疾病方面无统计学差异。病例组在住院第 3 天的平均体温明显较低(p=0.001)。接受 HDIVC 的病例组在住院第 3 天的外周毛细血管血氧饱和度(SpO)也更高(p=0.014)。病例组的中位住院时间明显长于对照组(8.5 天比 6.5 天)(p=0.028)。两组出院时 SpO 水平、重症监护病房(ICU)住院时间和死亡率无显著差异。

结论

我们没有发现在主要治疗方案中添加 HDIVC 的患者在出院时的结果有显著改善。试验注册 irct.ir(IRCT20200411047025N1),2020 年 4 月 14 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5faf/7879634/f76e2451a4c5/40001_2021_490_Fig1_HTML.jpg

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