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氢化可的松治疗COVID-19重症患者不能改善第21天治疗失败率
作者:小柯机器人 发布时间:2020/9/8 21:36:27

法国布列塔尼医院Pierre-François Dequin团队探讨了氢化可的松治疗COVID-19重症患者对21天死亡或呼吸支持的影响。2020年9月2日,该研究发表在《美国医学会杂志》上。

COVID-19与严重肺损伤有关。皮质类固醇是一种可能的治疗选择。

为了探讨氢化可的松对重症SARS-CoV-2感染和急性呼吸衰竭患者21天治疗失败的影响,研究组在法国进行了一项多中心、随机、双盲、序贯试验,计划每50例患者进行一次中期分析。2020年3月7日至6月1日,研究组招募了149名ICU收治的covid-19相关急性呼吸衰竭患者,将其随机分组,其中76例接受低剂量氢化可的松治疗,73例接受安慰剂治疗。第21天治疗失败的主要结局定义为死亡或持续依赖机械通气或高流量氧疗。

149名患者的平均年龄为62.2岁,30.2%为女性,机械通气占81.2%。共有148名患者(99.3%)完成了试验,69例治疗失败,其中氢化可的松组中有11人死亡,安慰剂组中有20人死亡。氢化可的松组中有32例(42.1%)患者出现21天治疗失败的主要结局,安慰剂组中有37例(50.7%),差异不显著。两组间预先指定的次要结局间均无统计学差异,且均未发生治疗相关的严重不良事件。

研究结果表明,与安慰剂相比,低剂量氢化可的松治疗重症covid-19并不能改善第21天治疗失败率。

附:英文原文

Title: Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support Among Critically Ill Patients With COVID-19: A Randomized Clinical Trial

Author: Pierre-Franois Dequin, Nicholas Heming, Ferhat Meziani, Gatan Plantefève, Guillaume Voiriot, Julio Badié, Bruno Franois, Cécile Aubron, Jean-Damien Ricard, Stephan Ehrmann, Youenn Jouan, Antoine Guillon, Marie Leclerc, Carine Coffre, Hélène Bourgoin, Céline Lengellé, Caroline Caille-Fénérol, Elsa Tavernier, Sarah Zohar, Bruno Giraudeau, Djillali Annane, Amélie Le Gouge, for the CAPE COVID Trial Group and the CRICS-TriGGERSep Network

Issue&Volume: 2020-09-02

Abstract: Importance  Coronavirus disease 2019 (COVID-19) is associated with severe lung damage. Corticosteroids are a possible therapeutic option.

Objective  To determine the effect of hydrocortisone on treatment failure on day 21 in critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute respiratory failure.

Design, Setting, and Participants  Multicenter randomized double-blind sequential trial conducted in France, with interim analyses planned every 50 patients. Patients admitted to the intensive care unit (ICU) for COVID-19–related acute respiratory failure were enrolled from March 7 to June 1, 2020, with last follow-up on June 29, 2020. The study intended to enroll 290 patients but was stopped early following the recommendation of the data and safety monitoring board.

Interventions  Patients were randomized to receive low-dose hydrocortisone (n=76) or placebo (n=73).

Main Outcomes and Measures  The primary outcome, treatment failure on day 21, was defined as death or persistent dependency on mechanical ventilation or high-flow oxygen therapy. Prespecified secondary outcomes included the need for tracheal intubation (among patients not intubated at baseline); cumulative incidences (until day 21) of prone position sessions, extracorporeal membrane oxygenation, and inhaled nitric oxide; Pao2:Fio2 ratio measured daily from day 1 to day 7, then on days 14 and 21; and the proportion of patients with secondary infections during their ICU stay.

Results  The study was stopped after 149 patients (mean age, 62.2 years; 30.2% women; 81.2% mechanically ventilated) were enrolled. One hundred forty-eight patients (99.3%) completed the study, and there were 69 treatment failure events, including 11 deaths in the hydrocortisone group and 20 deaths in the placebo group. The primary outcome, treatment failure on day 21, occurred in 32 of 76 patients (42.1%) in the hydrocortisone group compared with 37 of 73 (50.7%) in the placebo group (difference of proportions, –8.6% [95.48% CI, –24.9% to 7.7%]; P=.29). Of the 4 prespecified secondary outcomes, none showed a significant difference. No serious adverse events were related to the study treatment.

Conclusions and Relevance  In this study of critically ill patients with COVID-19 and acute respiratory failure, low-dose hydrocortisone, compared with placebo, did not significantly reduce treatment failure (defined as death or persistent respiratory support) at day 21. However, the study was stopped early and likely was underpowered to find a statistically and clinically important difference in the primary outcome.

DOI: 10.1001/jama.2020.16761

Source: https://jamanetwork.com/journals/jama/fullarticle/2770276

期刊信息

JAMA-Journal of The American Medical Association:《美国医学会杂志》,创刊于1883年。隶属于美国医学协会,最新IF:51.273
官方网址:https://jamanetwork.com/
投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex