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高剂量静脉注射维生素C用于严重急性呼吸综合征冠状病毒2感染早期:一项双盲、随机、对照临床试验。

High-dose Intravenous Vitamin C in Early Stages of Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Double-blind, Randomized, Controlled Clinical Trial.

作者信息

Labbani-Motlagh Zohre, Amini Shahideh, Aliannejad Rasoul, Sadeghi Anahita, Shafiee Gita, Heshmat Ramin, Jafary Mohamadreza, Talaschian Mona, Akhtari Maryam, Jamshidi Ahmadreza, Mahmoudi Mahdi, Sadeghi Kourosh

机构信息

Department of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.

Department of Pulmonary and Critical Care, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.

出版信息

J Res Pharm Pract. 2022 Dec 14;11(2):64-72. doi: 10.4103/jrpp.jrpp_30_22. eCollection 2022 Apr-Jun.

Abstract

OBJECTIVE

Based on previous studies in the sepsis population, Vitamin C could prevent injuries when administered in high doses and before the damage is established. This study aimed to evaluate the protective potentials of high-dose Vitamin C in the progression of coronavirus disease 2019 (COVID-19).

METHODS

A double-blind, placebo-controlled clinical trial was conducted. Patients with moderate-to-severe disease severity based on the World Health Organization definition were enrolled and received 12 g/d Vitamin C (high-dose intravenous Vitamin C [HDIVC]) or placebo for 4 days. Sequential Organ Failure Assessment (SOFA) score as a primary outcome, National Early Warning Score, Ordinal Scale of Clinical Improvement, and cytokine storm biomarkers were recorded on days 0, 3, and 5. Survival was also assessed on day 28 after enrollment.

FINDINGS

Seventy-four patients (37 patients in each group) were enrolled from April 5, 2020, to November 19, 2020, and all patients completed follow-up. A lower increase in SOFA score during the first 3 days of treatment (+0.026 vs. +0.204) and a higher decrease in this parameter in the last 2 days (-0.462 vs. -0.036) were observed in the treatment group. However, these differences did not reach a significance level ( = 0.57 and 0.12, respectively). Other indices of clinical and biological improvement, length of hospitalization, and intensive care unit admission days were the same between the two groups. Treatment did not affect the 28-day mortality.

CONCLUSION

Among patients with moderate-to-severe disease of COVID-19, the use of HDIVC plus standard care resulted in no significant difference in SOFA score or 28-day mortality compared to the standard care alone.

摘要

目的

基于先前对脓毒症患者的研究,大剂量维生素C在损伤确立之前给药可预防损伤。本研究旨在评估大剂量维生素C对2019冠状病毒病(COVID-19)进展的保护潜力。

方法

进行了一项双盲、安慰剂对照临床试验。纳入基于世界卫生组织定义的中重度疾病患者,给予12 g/d维生素C(大剂量静脉注射维生素C [HDIVC])或安慰剂,为期4天。在第0、3和5天记录序贯器官衰竭评估(SOFA)评分作为主要结局、国家早期预警评分、临床改善序数量表和细胞因子风暴生物标志物。还在入组后第28天评估生存率。

结果

2020年4月5日至2020年11月19日共纳入74例患者(每组37例),所有患者均完成随访。治疗组在治疗的前3天SOFA评分升高较低(+0.026对 +0.204),在最后2天该参数下降较高(-0.462对 -0.036)。然而,这些差异未达到显著水平(分别为 = 0.57和0.12)。两组之间临床和生物学改善的其他指标、住院时间和重症监护病房入住天数相同。治疗不影响28天死亡率。

结论

在COVID-19中重度疾病患者中,与单独的标准治疗相比,使用HDIVC加标准治疗在SOFA评分或28天死亡率方面无显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9194/9926917/c018ca3a6267/JRPP-11-64-g001.jpg

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