NEJM:静脉维生素C治疗ICU中脓毒症成年患者

Abstract

BACKGROUND

Studies that have evaluated the use of intravenous vitamin C in adults with sepsis who were receiving vasopressor therapy in the intensive care unit (ICU) have shown mixed results with respect to the risk of death and organ dysfunction.

在重症监护室(ICU)接受血管加压药治疗的脓毒症成人患者中评价静脉注射维生素C的研究显示，在死亡和器官功能障碍风险方面的结果不一致。

METHODS

In this randomized, placebo-controlled trial, we assigned adults who had been in the ICU for no longer than 24 hours, who had proven or suspected infection as the main diagnosis, and who were receiving a vasopressor to receive an infusion of either vitamin C (at a dose of 50 mg per kilogram of body weight) or matched placebo administered every 6 hours for up to 96 hours. The primary outcome was a composite of death or persistent organ dysfunction (defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy) on day 28.

在这项随机、安慰剂对照试验中，我们分配了在ICU住院不超过24小时、确诊或疑似感染为主要诊断的成人，接受血管加压药以接受维生素C（剂量为50 mg/kg体重）或匹配安慰剂输注，每6小时给药一次，持续96小时。主要结局是第28天死亡或持续性器官功能障碍的复合终点（定义为使用血管加压药、有创机械通气或新的肾脏替代治疗）。

RESULTS

A total of 872 patients underwent randomization (435 to the vitamin C group and 437 to the control group). The primary outcome occurred in 191 of 429 patients (44.5%) in the vitamin C group and in 167 of 434 patients (38.5%) in the control group (risk ratio, 1.21; 95% confidence interval [CI], 1.04 to 1.40; P=0.01). At 28 days, death had occurred in 152 of 429 patients (35.4%) in the vitamin C group and in 137 of 434 patients (31.6%) in the placebo group (risk ratio, 1.17; 95% CI, 0.98 to 1.40) and persistent organ dysfunction in 39 of 429 patients (9.1%) and 30 of 434 patients (6.9%), respectively (risk ratio, 1.30; 95% CI, 0.83 to 2.05). Findings were similar in the two groups regarding organ-dysfunction scores, biomarkers, 6-month survival, health-related quality of life, stage 3 acute kidney injury, and hypoglycemic episodes. In the vitamin C group, one patient had a severe hypoglycemic episode and another had a serious anaphylaxis event.

共有872例患者接受了随机化（435例分配至维生素C组，437例分配至对照组）。维生素C组429例患者中有191例(44.5%)发生主要结局，对照组434例患者中有167例(38.5%)发生主要结局（风险比，1.21；95%置信区间[CI]，1.04～1.40；P = 0.01）。在28天时，维生素C组429例患者中的152例(35.4%)和安慰剂组434例患者中的137例(31.6%)发生死亡（风险比，1.17；95%CI，0.98-1.40），429例患者中的39例(9.1%)和434例患者中的30例(6.9%)分别发生持续性器官功能障碍（风险比，1.30；95%CI，0.83 to 2.05)。两组在器官功能障碍评分、生物标志物、6个月生存率、健康相关生活质量、3期急性肾损伤和低血糖发作方面的结果相似。在维生素C组中，1例患者发生重度低血糖发作，另1例发生严重过敏反应事件。

CONCLUSIONS

In adults with sepsis receiving vasopressor therapy in the ICU, those who received intravenous vitamin C had a higher risk of death or persistent organ dysfunction at 28 days than those who received placebo. (Funded by the Lotte and John Hecht Memorial Foundation; LOVIT ClinicalTrials.gov number, NCT03680274. opens in new tab.)

在ICU接受血管加压药治疗的脓毒症成人患者中，接受静脉注射维生素C的患者在28天时死亡或持续性器官功能障碍的风险高于接受安慰剂的患者。