美国埃默里大学医学院Jonathan E. Sevransky联合埃默里大学David W. Wright团队研究了维生素C、硫胺素和氢化可的松对脓毒症患者无呼吸机和无血管升压药天数的影响。2021年2月23日，该研究发表在《美国医学会杂志》上。
脓毒症是一种常见的综合征，发病率和死亡率都很高。维生素C、硫胺素和皮质类固醇的联合应用被认为是治疗脓毒症的一种潜在方法。
为了探讨维生素C、硫胺素和氢化可的松每6小时联合应用，与安慰剂相比，是否可增加脓毒症患者的无呼吸机和无血管升压药天数，研究组进行了一项多中心、随机、双盲、适应性样本量、安慰剂对照试验，2018年8月至2019年7月，在美国43家医院的急诊科或重症监护室共招募了501例脓毒症引起的呼吸和/或心血管功能障碍的成年患者。
将患者随机分组，其中252例接受静脉注射维生素C（1.5g）、硫胺素（100mg）和氢化可的松（50mg），每6小时一次；249例接受匹配的安慰剂治疗，持续96小时或直到从重症监护室出院或死亡。主要结局是随机分组后30天内连续无呼吸机和血管加压素天数。关键次要结局是30天死亡率。
501名参与者的平均年龄为62岁，女性占46%，黑人占30%，中位急性生理学和慢性健康评估II评分为27分，中位序贯器官衰竭评估评分为9分。干预组和对照组分别有33%和32%的人使用开放标签皮质类固醇。干预组中位无呼吸机和无血管升压药天数为25天，安慰剂组为26天，组间差异不显著。干预组30天死亡率为22%，安慰剂组为24%。
研究结果表明，对于脓毒症危重患者，与安慰剂相比，维生素C、硫胺素和氢化可的松联合治疗在30天内没有显著增加无呼吸机和血管加压素的天数。
附：英文原文
Title: Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial
Author: Jonathan E. Sevransky, Richard E. Rothman, David N. Hager, Gordon R. Bernard, Samuel M. Brown, Timothy G. Buchman, Laurence W. Busse, Craig M. Coopersmith, Christine DeWilde, E. Wesley Ely, Lindsay M. Eyzaguirre, Alpha A. Fowler, David F. Gaieski, Michelle N. Gong, Alex Hall, Jeremiah S. Hinson, Michael H. Hooper, Gabor D. Kelen, Akram Khan, Mark A. Levine, Roger J. Lewis, Chris J. Lindsell, Jessica S. Marlin, Anna McGlothlin, Brooks L. Moore, Katherine L. Nugent, Samuel Nwosu, Carmen C. Polito, Todd W. Rice, Erin P. Ricketts, Caroline C. Rudolph, Fred Sanfilippo, Kert Viele, Greg S. Martin, David W. Wright, VICTAS Investigators
Issue&Volume: 2021/02/23
Abstract:
Importance Sepsis is a common syndrome with substantial morbidity and mortality. A combination of vitamin C, thiamine, and corticosteroids has been proposed as a potential treatment for patients with sepsis.
Objective To determine whether a combination of vitamin C, thiamine, and hydrocortisone every 6 hours increases ventilator- and vasopressor-free days compared with placebo in patients with sepsis.
Design, Setting, and Participants Multicenter, randomized, double-blind, adaptive-sample-size, placebo-controlled trial conducted in adult patients with sepsis-induced respiratory and/or cardiovascular dysfunction. Participants were enrolled in the emergency departments or intensive care units at 43 hospitals in the United States between August 2018 and July 2019. After enrollment of 501 participants, funding was withheld, leading to an administrative termination of the trial. All study-related follow-up was completed by January 2020.
Interventions Participants were randomized to receive intravenous vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) every 6 hours (n=252) or matching placebo (n=249) for 96 hours or until discharge from the intensive care unit or death. Participants could be treated with open-label corticosteroids by the clinical team, with study hydrocortisone or matching placebo withheld if the total daily dose was greater or equal to the equivalent of 200 mg of hydrocortisone.
Main Outcomes and Measures The primary outcome was the number of consecutive ventilator- and vasopressor-free days in the first 30 days following the day of randomization. The key secondary outcome was 30-day mortality.
Results Among 501 participants randomized (median age, 62 [interquartile range {IQR}, 50-70] years; 46% female; 30% Black; median Acute Physiology and Chronic Health Evaluation II score, 27 [IQR, 20.8-33.0]; median Sequential Organ Failure Assessment score, 9 [IQR, 7-12]), all completed the trial. Open-label corticosteroids were prescribed to 33% and 32% of the intervention and control groups, respectively. Ventilator- and vasopressor-free days were a median of 25 days (IQR, 0-29 days) in the intervention group and 26 days (IQR, 0-28 days) in the placebo group, with a median difference of 1 day (95% CI, 4 to 2 days; P=.85). Thirty-day mortality was 22% in the intervention group and 24% in the placebo group.
Conclusions and Relevance Among critically ill patients with sepsis, treatment with vitamin C, thiamine, and hydrocortisone, compared with placebo, did not significantly increase ventilator- and vasopressor-free days within 30 days. However, the trial was terminated early for administrative reasons and may have been underpowered to detect a clinically important difference.
DOI: 10.1001/jama.2020.24505
Source: https://jamanetwork.com/journals/jama/article-abstract/2776688
JAMA-Journal of The American Medical Association：《美国医学会杂志》，创刊于1883年。隶属于美国医学协会，最新IF：157.335
官方网址：https://jamanetwork.com/
投稿链接：http://manuscripts.jama.com/cgi-bin/main.plex
本期文章：《美国医学会杂志》：Vol 325 No 8
