[NEJM论文]:氢化可的松与氟氢可的松治疗降低感染性休克患者90天病死率 | 中国病理生理学会危重病医学专业委员会
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Hydrocortisone plus Fludrocortisone for Adults with Septic Shock

Annane D, Renault A, Brun-Buisson C, et al

N Engl J Med. 2018 Mar 1; 378(9): 809-818.

doi: 10.1056/NEJMoa1705716.



Septic shock is characterized by dysregulation of the host response to infection, with circulatory, cellular, and metabolic abnormalities. We hypothesized that therapy with hydrocortisone plus fludrocortisone or with drotrecogin alfa (activated), which can modulate the host response, would improve the clinical outcomes of patients with septic shock.



In this multicenter, double-blind, randomized trial with a 2-by-2 factorial design, we evaluated the effect of hydrocortisone-plus-fludrocortisone therapy, drotrecogin alfa (activated), the combination of the three drugs, or their respective placebos. The primary outcome was 90-day all-cause mortality. Secondary outcomes included mortality at intensive care unit (ICU) discharge and hospital discharge and at day 28 and day 180 and the number of days alive and free of vasopressors, mechanical ventilation, or organ failure. After drotrecogin alfa (activated) was withdrawn from the market, the trial continued with a two-group parallel design. The analysis compared patients who received hydrocortisone plus fludrocortisone with those who did not (placebo group).



Among the 1241 patients included in the trial, the 90-day mortality was 43.0% (264 of 614 patients) in the hydrocortisone-plus-fludrocortisone group and 49.1% (308 of 627 patients) in the placebo group (P=0.03). The relative risk of death in the hydrocortisone-plus-fludrocortisone group was 0.88 (95% confidence interval, 0.78 to 0.99). Mortality was significantly lower in the hydrocortisone-plus-fludrocortisone group than in the placebo group at ICU discharge (35.4% vs. 41.0%, P=0.04), hospital discharge (39.0% vs. 45.3%, P=0.02), and day 180 (46.6% vs. 52.5%, P=0.04) but not at day 28 (33.7% and 38.9%, respectively; P=0.06). The number of vasopressor-free days to day 28 was significantly higher in the hydrocortisone-plus-fludrocortisone group than in the placebo group (17 vs. 15 days, P<0.001), as was the number of organ-failure-free days (14 vs. 12 days, P=0.003). The number of ventilator-free days was similar in the two groups (11 days in the hydrocortisone-plus-fludrocortisone group and 10 in the placebo group, P=0.07). The rate of serious adverse events did not differ significantly between the two groups, but hyperglycemia was more common in hydrocortisone-plus-fludrocortisone group.

在试验入选的1241名患者中,氢化可的松联合氟氢可的松组90天病死率为 43.0% (264/614),安慰剂组为 49.1% (308/627) (P=0.03)。氢化可的松联合氟氢可的松组死亡的相对危险度为 0.88 (95% 可信区间, 0.78 to 0.99)。与安慰剂组相比,氢化可的松联合氟氢可的松组的ICU病死率 (35.4% vs. 41.0%, P=0.04), 住院病死率 (39.0% vs. 45.3%, P=0.02), 和180天病死率 (46.6% vs. 52.5%, P=0.04) 显著降低,但28天病死率无差异(分别为33.7% 和 38.9%; P=0.06)。氢化可的松联合氟氢可的松组28天内无升压药物存活天数显著高于安慰剂组 (17 vs. 15 天, P<0.001),无器官功能衰竭存活天数也显著高于安慰剂组 (14 vs. 12 天, P=0.003)。两组患者无机械通气存活天数相似(氢化可的松联合氟氢可的松组11天,安慰剂组10天,P=0.07)。两组患者严重不良事件发生率无显著差异,但氢化可的松联合氟氢可的松组高血糖更常见。


In this trial involving patients with septic shock, 90-day all-cause mortality was lower among those who received hydrocortisone plus fludrocortisone than among those who received placebo. (Funded by Programme Hospitalier de Recherche Clinique 2007 of the French Ministry of Social Affairs and Health; APROCCHSS ClinicalTrials.gov number, NCT00625209 .).



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