《新英格兰医学杂志》2018年3月1日378:797-808

在脓毒症休克患者中辅助糖皮质激素治疗

背景

糖皮质激素是否会降低脓毒症休克患者的死亡率尚不清楚。

方法

我们将进行机械通气的脓毒症休克患者随机分组，一组接受糖皮质激素（每日200mg的剂量），另一组接受安慰剂，持续7天、或直至死亡或从重症监护病房（ICU）转出，哪个时间点先达到就结束使用。主要终点为90天时的全因死亡。

结果

2013年3月至2017年4月，共计3800名患者进行了随机化分组。对3658名患者确认了主要终点情况（糖皮质激素组1832名、安慰剂组1826名）。90天时，糖皮质激素组511名（27.9%）患者死亡、安慰剂组526名（28.8%）死亡（比值比，0.95；95%置信区间[CI]，0.82-1.10；P=0.50）。在预先设定的6个亚组中，试验治疗的效果相近。糖皮质激素组患者比安慰剂组患者休克纠正更迅速（中位时间，3天[四分位值区间2-5天]对比4天[四分位值区间2-9天]；风险比，1.32；95%CI，1.23-1.41；P<0.001）。糖皮质激素组患者比安慰剂组患者初次使用机械通气的持续时间更短（中位值，6天[四分位值区间3-18天]对比7天[四分位值区间3-24天]；风险比，1.13；95%CI，1.05-1.22；P<0.001），但考虑到再次使用机械通气的情况，两组间存活天数、无机械通气天数没有明显差异，糖皮质激素组比安慰剂组接受输血的患者少（37.0%对比41.7%；比值比，0.82；95%CI，0.72-0.94；P=0.004）。就28天死亡率、休克复发率、ICU存活天数和转出ICU天数、住院存活天数和出院天数、再次使用机械通气、肾脏替代治疗率、败血症或真菌血症新发率而言，组间没有明显差异。

结论

在进行机械通气的脓毒症休克患者中，与安慰剂相比，持续输注糖皮质激素没有降低90天死亡率。

《桓兴医讯》南南和北北

Adjunctive Glucocorticoid Therapy in Patients with Septic Shock

Background

Whether hydrocortisone reduces mortality among patients with septic shock is unclear.

Methods

We randomly assigned patients with septic shock who were undergoing mechanical ventilation to receive hydrocortisone (at a dose of 200 mg per day) or placebo for 7 days or until death or discharge from the intensive care unit (ICU), whichever came first. The primary outcome was death from any cause at 90 days.

Results

From March 2013 through April 2017, a total of 3800 patients underwent randomization. Status with respect to the primary outcome was ascertained in 3658 patients (1832 of whom had been assigned to the hydrocortisone group and 1826 to the placebo group). At 90 days, 511 patients (27.9%) in the hydrocortisone group and 526 (28.8%) in the placebo group had died (odds ratio, 0.95; 95% confidence interval [CI], 0.82 to 1.10; P=0.50). The effect of the trial regimen was similar in six prespecified subgroups. Patients who had been assigned to receive hydrocortisone had faster resolution of shock than those assigned to the placebo group (median duration, 3 days [interquartile range, 2 to 5] vs. 4 days [interquartile range, 2 to 9]; hazard ratio, 1.32; 95% CI, 1.23 to 1.41; P<0.001). Patients in the hydrocortisone group had a shorter duration of the initial episode of mechanical ventilation than those in the placebo group (median, 6 days [interquartile range, 3 to 18] vs. 7 days [interquartile range, 3 to 24]; hazard ratio, 1.13; 95% CI, 1.05 to 1.22; P<0.001), but taking into account episodes of recurrence of ventilation, there were no significant differences in the number of days alive and free from mechanical ventilation. Fewer patients in the hydrocortisone group than in the placebo group received a blood transfusion (37.0% vs. 41.7%; odds ratio, 0.82; 95% CI, 0.72 to 0.94; P=0.004). There were no significant between-group differences with respect to mortality at 28 days, the rate of recurrence of shock, the number of days alive and out of the ICU, the number of days alive and out of the hospital, the recurrence of mechanical ventilation, the rate of renal-replacement therapy, and the incidence of new-onset bacteremia or fungemia.

Conclusions

Among patients with septic shock undergoing mechanical ventilation, a continuous infusion of hydrocortisone did not result in lower 90-day mortality than placebo. (Funded by the National Health and Medical Research Council of Australia and others; ADRENAL ClinicalTrials.gov number, NCT01448109.)

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