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[JAMA发表论文]:维生素C、皮质激素与维生素B1对感染性休克器官损伤的影响
2020年08月22日 时讯速递, 进展交流 暂无评论

Original Investigation August 18, 2020

Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial

Ari Moskowitz, David T. Huang, Peter C. Hou, et al

JAMA. 2020;324(7):642-650. doi:10.1001/jama.2020.11946

Abstract

Importance 背景

The combination of ascorbic acid, corticosteroids, and thiamine has been identified as a potential therapy for septic shock.

联合应用维生素C、皮质激素与维生素B1是针对感染性休克可能有效的治疗。

Objective 目的

To determine whether the combination of ascorbic acid, corticosteroids, and thiamine attenuates organ injury in patients with septic shock.

确定联合应用维生素C、皮质激素和维生素B1能否减轻感染性休克患者的器官损伤。

Design, Setting, and Participants 设计、场景与研究对象

Randomized, blinded, multicenter clinical trial of ascorbic acid, corticosteroids, and thiamine vs placebo for adult patients with septic shock. Two hundred five patients were enrolled between February 9, 2018, and October 27, 2019, at 14 centers in the United States. Follow-up continued until November 26, 2019.

针对成年感染性休克患者使用维生素C、皮质激素和维生素B1对比安慰剂的随机、设盲、多中心临床试验。2018年2月9日至2019年10月27日间在美国的14个中心共入选205名患者。随访持续到2019年11月26日。

Interventions 干预措施

Patients were randomly assigned to receive parenteral ascorbic acid (1500 mg), hydrocortisone (50 mg), and thiamine (100 mg) every 6 hours for 4 days (n = 103) or placebo in matching volumes at the same time points (n = 102).

患者被随机分为接受胃肠外维生素C (1500 mg),氢化可的松(50 mg) 和维生素B1 (100 mg) q6h,疗程4天 (n = 103) 或在相同时间使用相同容量的安慰剂(n = 102)。

Main Outcomes and Measures 主要结局指标

The primary outcome was change in the Sequential Organ Failure Assessment (SOFA) score (range, 0-24; 0 = best) between enrollment and 72 hours. Key secondary outcomes included kidney failure and 30-day mortality. Patients who received at least 1 dose of study drug were included in analyses.

主要预后指标为入选研究及72小时间SOFA评分的变化。关键的次要预后指标包括肾功能衰竭和30天病死率。接受至少1剂研究药物的患者纳入分析。

Results 结果

Among 205 randomized patients (mean age, 68 [SD, 15] years; 90 [44%] women), 200 (98%) received at least 1 dose of study drug, completed the trial, and were included in the analyses (101 with intervention and 99 with placebo group). Overall, there was no statistically significant interaction between time and treatment group with regard to SOFA score over the 72 hours after enrollment (mean SOFA score change from 9.1 to 4.4 [−4.7] points with intervention vs 9.2 to 5.1 [−4.1] points with placebo; adjusted mean difference, −0.8; 95% CI, −1.7 to 0.2; P = .12 for interaction). There was no statistically significant difference in the incidence of kidney failure (31.7% with intervention vs 27.3% with placebo; adjusted risk difference, 0.03; 95% CI, −0.1 to 0.2; P = .58) or in 30-day mortality (34.7% vs 29.3%, respectively; hazard ratio, 1.3; 95% CI, 0.8-2.2; P = .26). The most common serious adverse events were hyperglycemia (12 patients with intervention and 7 patients with placebo), hypernatremia (11 and 7 patients, respectively), and new hospital-acquired infection (13 and 12 patients, respectively).

共有205名患者接受随机分组(平均年龄, 68 [SD, 15] 岁; 90 名 [44%] 为女性),其中200名 (98%) 接受至少1剂研究药物,完成了试验,从而纳入统计分析(101 名干预组,99名对照组)。对于从入选至72小时的SOFA评分而言,时间与治疗分组间没有统计学显著的交互作用(干预组平均SOFA评分从 9.1 分到 4.4 分 [−4.7],安慰剂组从 9.2 分到 5.1 分 [−4.1];校正后平均差异,−0.8; 95% CI, −1.7 to 0.2; 交互作用 P = .12)。肾功能衰竭发生率(干预组31.7% vs 安慰剂组27.3%;校正后风险差异,0.03; 95% CI, −0.1 to 0.2; P = .58)或30天病死率(分别为34.7% vs 29.3%;风险比,1.3; 95% CI, 0.8-2.2; P = .26)没有统计学差异。最常见的严重不良事件为高血糖(干预组12名患者,安慰剂组7名患者),高钠血症(分别为11名和7名患者)及新发医院获得性感染(分别为13名和12名患者)。

Conclusions and Relevance 结论与意义

In patients with septic shock, the combination of ascorbic acid, corticosteroids, and thiamine, compared with placebo, did not result in a statistically significant reduction in SOFA score during the first 72 hours after enrollment. These data do not support routine use of this combination therapy for patients with septic shock.

对于感染性休克患者,与安慰剂相比,联合维生素C、皮质激素和维生素B1不能显著降低入选后最初72小时的SOFA评分。这些结果不支持对于感染性休克患者常规使用上述联合用药。

Trial Registration 研究注册

ClinicalTrials.gov Identifier: NCT03389555

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