法国布雷顿诺医院Pierre-François Dequin团队研究了氢化可的松治疗重症社区获得性肺炎对患者预后的影响。相关论文于2023年3月21日发表在《新英格兰医学杂志》上。

糖皮质激素的抗炎和免疫调节作用是否会降低严重社区获得性肺炎患者的死亡率尚不清楚。

在这项临床3期、多中心、双盲、随机、对照试验中，研究组分配因严重社区获得性肺炎而进入重症监护室（ICU）的成年人接受静脉内氢化可的松（根据临床改善确定，每天200毫克，持续4或8天，随后分诊共8或14天）或接受安慰剂。所有患者接受标准治疗，包括抗生素和支持性护理。主要结局是28天死亡。

在第二次计划中期分析后停止试验时，共有800名患者接受了随机分组。研究组分析了795名患者的数据。截至第28天，氢化可的松组400名患者中有25名（6.2%）死亡，安慰剂组395名患者中47名（11.9%）死亡，绝对差异为-5.6个百分点，组间差异显著。

在基线未接受机械通气的患者中，氢化可的松组222例中有40例（18.0%）和安慰剂组220例中有65例（29.5%）进行了气管内插管（风险比为0.59）。氢化可的松组359例中的55例（15.3%）和安慰剂组344例中的86例（25.0%）在第28天开始此类治疗（风险比为0.59）。氢化可的松组患者在治疗的第一周每天接受更高剂量的胰岛素。

研究结果表明，在ICU治疗的严重社区获得性肺炎患者中，接受氢化可的松治疗的患者在第28天的死亡风险低于接受安慰剂治疗的患者。

附：英文原文

Title: Hydrocortisone in Severe Community-Acquired Pneumonia | NEJM

Author: Pierre-Franois Dequin, M.D., Ph.D.,, Ferhat Meziani, M.D., Ph.D.,, Jean-Pierre Quenot, M.D., Ph.D.,, Toufik Kamel, M.D.,, Jean-Damien Ricard, M.D., Ph.D.,, Julio Badie, M.D.,, Jean Reignier, M.D., Ph.D.,, Nicholas Heming, M.D., Ph.D.,, Gatan Plantefève, M.D.,, Bertrand Souweine, M.D., Ph.D.,, Guillaume Voiriot, M.D., Ph.D.,, Gwenhal Colin, M.D.,, Jean-Pierre Frat, M.D., Ph.D.,, Jean-Paul Mira, M.D., Ph.D.,, Nicolas Barbarot, M.D.,, Bruno Franois, M.D.,, Guillaume Louis, M.D.,, Sébastien Gibot, M.D., Ph.D.,, Christophe Guitton, M.D., Ph.D.,, Christophe Giacardi, M.D.,, Sami Hraiech, M.D., Ph.D.,, Sylvie Vimeux, M.D.,, Erwan L’Her, M.D., Ph.D.,, Henri Faure, M.D.,, Jean-Etienne Herbrecht, M.D.,, Camille Bouisse, M.D.,, Aurélie Joret, M.D.,, Nicolas Terzi, M.D., Ph.D.,, Arnaud Gacouin, M.D.,, Charlotte Quentin, M.D.,, Mercé Jourdain, M.D., Ph.D.,, Marie Leclerc, M.Sc.,, Carine Coffre, M.Sc.,, Hélène Bourgoin, Pharm.D.,, Céline Lengellé, Pharm.D.,, Caroline Caille-Fénérol, M.Sc.,, Bruno Giraudeau, Ph.D.,, and Amélie Le Gouge, M.Sc.

Issue&Volume: 2023-03-21

Abstract:

Background

Whether the antiinflammatory and immunomodulatory effects of glucocorticoids may decrease mortality among patients with severe community-acquired pneumonia is unclear.

Methods

In this phase 3, multicenter, double-blind, randomized, controlled trial, we assigned adults who had been admitted to the intensive care unit (ICU) for severe community-acquired pneumonia to receive intravenous hydrocortisone (200 mg daily for either 4 or 8 days as determined by clinical improvement, followed by tapering for a total of 8 or 14 days) or to receive placebo. All the patients received standard therapy, including antibiotics and supportive care. The primary outcome was death at 28 days.

Results

A total of 800 patients had undergone randomization when the trial was stopped after the second planned interim analysis. Data from 795 patients were analyzed. By day 28, death had occurred in 25 of 400 patients (6.2%; 95% confidence interval [CI], 3.9 to 8.6) in the hydrocortisone group and in 47 of 395 patients (11.9%; 95% CI, 8.7 to 15.1) in the placebo group (absolute difference, 5.6 percentage points; 95% CI, 9.6 to 1.7; P=0.006). Among the patients who were not undergoing mechanical ventilation at baseline, endotracheal intubation was performed in 40 of 222 (18.0%) in the hydrocortisone group and in 65 of 220 (29.5%) in the placebo group (hazard ratio, 0.59; 95% CI, 0.40 to 0.86). Among the patients who were not receiving vasopressors at baseline, such therapy was initiated by day 28 in 55 of 359 (15.3%) of the hydrocortisone group and in 86 of 344 (25.0%) in the placebo group (hazard ratio, 0.59; 95% CI, 0.43 to 0.82). The frequencies of hospital-acquired infections and gastrointestinal bleeding were similar in the two groups; patients in the hydrocortisone group received higher daily doses of insulin during the first week of treatment.

Conclusions

Among patients with severe community-acquired pneumonia being treated in the ICU, those who received hydrocortisone had a lower risk of death by day 28 than those who received placebo.

DOI: 10.1056/NEJMoa2215145

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2215145