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[JAMA最新论文]:输注维生素C对合并严重呼吸功能衰竭的脓毒症患者器官功能衰竭及炎症和血管损伤生物标志物的影响
2019年10月12日 时讯速递, 进展交流 暂无评论

Preliminary Communication Caring for the Critically Ill PatientOctober 1, 2019

Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial

Alpha A. Fowler III, Jonathon D. Truwit, R. Duncan Hite, et al

JAMA. 2019;322(13):1261-1270. doi:10.1001/jama.2019.11825

Importance 背景

Experimental data suggest that intravenous vitamin C may attenuate inflammation and vascular injury associated with sepsis and acute respiratory distress syndrome (ARDS).

试验数据提示,合并ARDS的脓毒症患者静脉输注维生素C能够减轻炎症反应和血管损伤。

Objective 目的

To determine the effect of intravenous vitamin C infusion on organ failure scores and biological markers of inflammation and vascular injury in patients with sepsis and ARDS.

确定合并ARDS的脓毒症患者静脉输注维生素C对于器官功能衰竭评分及炎症与血管损伤生物标志物的影响

Design, Setting, and Participants 试验设计、场景及研究对象

The CITRIS-ALI trial was a randomized, double-blind, placebo-controlled, multicenter trial conducted in 7 medical intensive care units in the United States, enrolling patients (N = 167) with sepsis and ARDS present for less than 24 hours. The study was conducted from September 2014 to November 2017, and final follow-up was January 2018.

CITRIS-ALI试验是一项随机、双盲、安慰剂对照、多中心临床试验,在美国7个内科ICU进行。入选脓毒症合并ARDS且发病不足24小时的患者(n = 167)。试验于2014年9月至2017年11月进行,最后随访至2018年1月。

Interventions 干预措施

Patients were randomly assigned to receive intravenous infusion of vitamin C (50 mg/kg in dextrose 5% in water, n = 84) or placebo (dextrose 5% in water only, n = 83) every 6 hours for 96 hours.

患者被随机分组,分别接受静脉输注维生素C (50 mg/kg溶于5%的葡萄糖溶液, n = 84) 或安慰剂 (5%葡萄糖溶液, n = 83),q6h,疗程96小时。

Main Outcomes and Measures 主要预后指标

The primary outcomes were change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 96 hours, and plasma biomarkers of inflammation (C-reactive protein levels) and vascular injury (thrombomodulin levels) measured at 0, 48, 96, and 168 hours.

主要预后终点为器官功能衰竭的变化,根据基线至96小时间修订后SOFA评分(评分范围0-20,分值越高提示器官功能障碍越严重)进行评估,同时,在0,48,96和168小时测定血浆炎症(C反应蛋白水平)及血管损伤(血栓调节蛋白水平)生物标志物。

Results 结果

Among 167 randomized patients (mean [SD] age, 54.8 years [16.7]; 90 men [54%]), 103 (62%) completed the study to day 60. There were no significant differences between the vitamin C and placebo groups in the primary end points of change in mean modified Sequential Organ Failure Assessment score from baseline to 96 hours (from 9.8 to 6.8 in the vitamin C group [3 points] and from 10.3 to 6.8 in the placebo group [3.5 points]; difference, −0.10; 95% CI, −1.23 to 1.03; P = .86) or in C-reactive protein levels (54.1 vs 46.1 μg/mL; difference, 7.94 μg/mL; 95% CI, −8.2 to 24.11; P = .33) and thrombomodulin levels (14.5 vs 13.8 ng/mL; difference, 0.69 ng/mL; 95% CI, −2.8 to 4.2; P = .70) at 168 hours.

在167名接受随机分组的患者(平均[SD]年龄, 54.8 岁 [16.7]; 90名男性 [54%])中,103名 (62%) 完成试验至第60天。维生素C组与安慰剂组主要预后终点即修订后SOFA评分从基线水平到96小时的变化没有显著差异(维生素C组从9.8分下降到6.8分 [3 分],安慰剂组从10.3分下降到6.8分[3.5 分]; 差异, −0.10; 95% CI, −1.23 to 1.03; P = .86),至168小时C-反应蛋白水平 (54.1 vs 46.1 μg/mL; 差异, 7.94 μg/mL; 95% CI, −8.2 to 24.11; P = .33) 和血栓调节蛋白水平 (14.5 vs 13.8 ng/mL; 差异, 0.69 ng/mL; 95% CI, −2.8 to 4.2; P = .70) 没有显著差异。

Conclusions and Relevance 结论与意义

In this preliminary study of patients with sepsis and ARDS, a 96-hour infusion of vitamin C compared with placebo did not significantly improve organ dysfunction scores or alter markers of inflammation and vascular injury. Further research is needed to evaluate the potential role of vitamin C for other outcomes in sepsis and ARDS.

在这项有关脓毒症合并ARDS的初步研究中,与安慰剂相比,维生素C输注96小时不能显著改善器官功能障碍评分,也不能改变炎症和血管损伤标志物。需要进一步研究评估维生素C对脓毒症和ARDS患者其他预后指标的可能影响。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT02106975

评论[仅代表个人观点]

  • 尽管这项研究早于针对感染性休克的鸡尾酒研究,而且是一项RCT,但是,仍然提出一个值得思考的问题,为何对于感染性休克和(或)ARDS这些临床综合征,一种药物治疗可能奏效?尤其是在各种复杂发病机制之间相互影响尚不清楚的时候。
  • 需要指出的是,目前正在进行多项有关包括维生素C在内的鸡尾酒疗法治疗感染性休克的RCT(有别于CITRIS-ALI研究),如果全部或大多数得到阴性结果,真的很意外吗?
  • 总是做这些结果注定为阴性的临床试验,尽管提供了所谓循证医学高级别证据,但是真的有益吗?

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