{"title":"早期大剂量静脉注射维生素C治疗冠状病毒感染:一项双盲、随机、对照临床试验","authors":"Zohre Labbani-Motlagh, Shahideh Amini, Rasoul Aliannejad, Anahita Sadeghi, Gita Shafiee, Ramin Heshmat, Mohamadreza Jafary, Mona Talaschian, Maryam Akhtari, Ahmadreza Jamshidi, Mahdi Mahmoudi, Kourosh Sadeghi","doi":"10.4103/jrpp.jrpp_30_22","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Findings: </strong>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 (<i>P</i> = 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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":17158,"journal":{"name":"Journal of Research in Pharmacy Practice","volume":"11 2","pages":"64-72"},"PeriodicalIF":0.8000,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9b/33/JRPP-11-64.PMC9926917.pdf","citationCount":"1","resultStr":"{\"title\":\"High-dose Intravenous Vitamin C in Early Stages of Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Double-blind, Randomized, Controlled Clinical Trial.\",\"authors\":\"Zohre Labbani-Motlagh, Shahideh Amini, Rasoul Aliannejad, Anahita Sadeghi, Gita Shafiee, Ramin Heshmat, Mohamadreza Jafary, Mona Talaschian, Maryam Akhtari, Ahmadreza Jamshidi, Mahdi Mahmoudi, Kourosh Sadeghi\",\"doi\":\"10.4103/jrpp.jrpp_30_22\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Findings: </strong>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 (<i>P</i> = 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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":17158,\"journal\":{\"name\":\"Journal of Research in Pharmacy Practice\",\"volume\":\"11 2\",\"pages\":\"64-72\"},\"PeriodicalIF\":0.8000,\"publicationDate\":\"2022-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9b/33/JRPP-11-64.PMC9926917.pdf\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Research in Pharmacy Practice\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/jrpp.jrpp_30_22\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Research in Pharmacy Practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/jrpp.jrpp_30_22","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 1
摘要
目的:根据先前对败血症人群的研究,在损伤形成之前,高剂量服用维生素C可以预防损伤。本研究旨在评估高剂量维生素C在2019冠状病毒病(COVID-19)进展中的保护潜力。方法:采用双盲、安慰剂对照临床试验。根据世界卫生组织的定义,纳入疾病严重程度为中重度的患者,接受12 g/d维生素C(高剂量静脉注射维生素C [HDIVC])或安慰剂治疗4天。顺序器官衰竭评估(SOFA)评分作为主要结果,国家早期预警评分,临床改善顺序量表和细胞因子风暴生物标志物在第0,3和5天进行记录。在入组后第28天评估生存。结果:2020年4月5日至2020年11月19日,共入组74例患者(每组37例),所有患者均完成随访。治疗组SOFA评分在治疗前3天的增加较低(+0.026 vs +0.204),在治疗后2天的下降较高(-0.462 vs -0.036)。然而,这些差异没有达到显著水平(P分别= 0.57和0.12)。两组患者的其他临床和生物学改善指标、住院时间、重症监护病房住院天数均相同。治疗对28天死亡率没有影响。结论:在中重度COVID-19患者中,使用HDIVC +标准治疗与单独使用标准治疗相比,SOFA评分和28天死亡率无显著差异。
High-dose Intravenous Vitamin C in Early Stages of Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Double-blind, Randomized, Controlled Clinical Trial.
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 (P = 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.
期刊介绍:
The main focus of the journal will be on evidence-based drug-related medical researches (with clinical pharmacists’ intervention or documentation), particularly in the Eastern Mediterranean region. However, a wide range of closely related issues will be also covered. These will include clinical studies in the field of pharmaceutical care, reporting adverse drug reactions and human medical toxicology, pharmaco-epidemiology and toxico-epidemiology (poisoning epidemiology), social aspects of pharmacy practice, pharmacy education and economic evaluations of treatment protocols (e.g. cost-effectiveness studies). Local reports of medication utilization studies at hospital or pharmacy levels will only be considered for peer-review process only if they have a new and useful message for the international pharmacy practice professionals and readers.