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地塞米松治疗COVID-19伴中重度急性呼吸窘迫综合征患者可有效改善预后
作者:小柯机器人 发布时间:2020/9/8 21:26:43

巴西里约热内卢医院Luciano C. P. Azevedo团队研究了地塞米松对COVID-19伴中重度急性呼吸窘迫综合征患者存活天数和无呼吸机天数的影响。2020年9月2日,该研究发表在《美国医学会杂志》上。

COVID-19引起的急性呼吸窘迫综合征(ARDS)造成很多患者死亡,占用大量医疗资源。使用地塞米松可减轻这些患者的肺损伤。

为了确定静脉注射地塞米松是否会增加covid-19相关ARDS患者的无呼吸机天数,研究组在巴西的41个重症监护病房进行了一项多中心、随机、开放标签的临床试验。2020年4月17日至6月23日,研究组招募了299名COVID-19伴中重度ARDS的患者,将其随机分组,其中151名接受静脉注射地塞米松联合标准治疗,148名仅接受标准治疗。主要结局为治疗前28天无呼吸机天数,定义为存活且无机械通气。

299例患者的平均年龄为61岁,其中37%为女性,全部完成随访。地塞米松组患者在治疗的前28天中平均有6.6天无呼吸机,显著多于标准治疗组(4.0天)。治疗第7天,地塞米松组的序贯器官衰竭评估(SOFA)分数为6.1分,显著低于标准治疗组的7.5分。两组间预先确定的28天全因死亡率、前28天无ICU天数、机械通气时间等次要结局中均无显著差异。

地塞米松组中有33例(21.9%)患者继发感染,标准治疗组中有43例(29.1%);地塞米松组中有47例(31.1%)患者需胰岛素控制血糖,标准治疗组中有42例(28.3%);地塞米松组中有5例(3.3%)患者出现其他严重不良事件,安慰剂组中有9例(6.1%)。

总之,对于COVID-19伴中重度ARDS患者,静脉注射地塞米松联合标准治疗与单独使用标准治疗相比,可显著增加28天内的无呼吸机天数。

附:英文原文

Title: Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial

Author: Bruno M. Tomazini, Israel S. Maia, Alexandre B. Cavalcanti, Otavio Berwanger, Regis G. Rosa, Viviane C. Veiga, Alvaro Avezum, Renato D. Lopes, Flavia R. Bueno, Maria Vitoria A. O. Silva, Franca P. Baldassare, Eduardo L. V. Costa, Ricardo A. B. Moura, Michele O. Honorato, Andre N. Costa, Lucas P. Damiani, Thiago Lisboa, Letícia Kawano-Dourado, Fernando G. Zampieri, Guilherme B. Olivato, Cassia Righy, Cristina P. Amendola, Roberta M. L. Roepke, Daniela H. M. Freitas, Daniel N. Forte, Flávio G. R. Freitas, Caio C. F. Fernandes, Livia M. G. Melro, Gedealvares F. S. Junior, Douglas Costa Morais, Stevin Zung, Flávia R. Machado, Luciano C. P. Azevedo, for the COALITION COVID- Brazil III Investigators

Issue&Volume: 2020-09-02

Abstract: Importance  Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients.

Objective  To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19–associated ARDS.

Design, Setting, and Participants  Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients.

Interventions  Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n=151) or standard care alone (n=148).

Main Outcomes and Measures  The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days.

Results  A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P=.04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, 1.16; 95% CI, 1.94 to 0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events.

Conclusions and Relevance  Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days.

DOI: 10.1001/jama.2020.17021

Source: https://jamanetwork.com/journals/jama/fullarticle/2770277

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