Barros Camila Miriam Suemi Sato, Freire Raissa Soares, Frota Elisângela, Rezende Santos Anna Gabriela, Farias Maria Eduarda Leão, Rodrigues Maria Gabriela Almeida, Silva Bernardo Maia, Prado Jeronimo Christiane Maria, Netto Rebeca Linhares Abreu, Silva Borba Mayla Gabriela, Baía-da-Silva Djane, Brito-Sousa José Diego, Xavier Mariana Simão, Araújo-Alexandre Marcia Almeida, Sampaio Vanderson Souza, Melo Gisely Cardoso, Arêas Guilherme Tinoco, Hajjar Ludhmila Abrahão, Monteiro Wuelton Marcelo, Gomes Naveca Felipe, Costa Fábio Trindade Maranhão, Val Fernando Fonseca Almeida, Lacerda Marcus Vinícius Guimarães
Instituto de Pesquisa Clínica Carlos Borborema, Fundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.
Front Med (Lausanne). 2021 Nov 30;8:758405. doi: 10.3389/fmed.2021.758405. eCollection 2021.
The use of corticosteroids may help control the cytokine storm occurring in acute respiratory failure due to the severe form of COVID-19. We evaluated the postacute effect of corticosteroids used during the acute phase, such as impairment in pulmonary function parameters, on day 120 (D120)-follow-up, in participants who survived over 28 days. This is a parallel, double-blind, randomized, placebo-controlled phase IIb clinical trial carried out between April 18 and October 9, 2020, conducted in hospitalized patients with clinical-radiological suspicion of COVID-19, aged 18 years or older, with SpO ≤ 94% on room air or requiring supplementary oxygen, or under invasive mechanical ventilation (IMV) in a referral center in Manaus, Western Brazilian Amazon. Intravenous methylprednisolone (MP) (0.5 mg/kg) was given two times daily for 5 days to these patients. The primary outcome used for this study was pulmonary function testing at day 120 follow-up visit. Out of the total of surviving patients at day 28 ( = 246) from the Metcovid study, a total of 118 underwent satisfactory pulmonary function testing (62 in the placebo arm and 56 in the MP arm). The supportive treatment was similar between the placebo and MP groups (seven [11%] vs. four [7%]; = 0.45). At hospital admission, IL-6 levels were higher in the MP group ( < 0.01). Also, the need for ICU ( = 0.06), need for IMV ( = 0.07), and creatine kinase ( = 0.05) on admission also tended to be higher in this group. In the univariate analysis, forced expiratory volume on 1st second of exhalation (FEV1) and forced vital capacity (FVC) at D120 follow-up were significantly higher in patients in the MP arm, being this last parameter also significantly higher in the multivariate analysis independently of IMV and IL-6 levels on admission. The use of steroids for at least 5 days in severe COVID-19 was associated with a higher FVC, which suggests that hospitalized COVID-19 patients might benefit from the use of MP in its use in the long-term, with less pulmonary restrictive functions, attributed to fibrosis. ClinicalTrials.gov, Identifier: NCT04343729.
使用皮质类固醇可能有助于控制因重症新型冠状病毒肺炎（COVID-19）导致的急性呼吸衰竭中出现的细胞因子风暴。我们评估了急性期使用皮质类固醇对存活超过28天的参与者在第120天（D120）随访时的急性后期影响，如肺功能参数受损情况。这是一项平行、双盲、随机、安慰剂对照的IIb期临床试验，于2020年4月18日至10月9日在巴西西部亚马逊州玛瑙斯的一家转诊中心进行，研究对象为临床影像学怀疑患有COVID-19、年龄18岁及以上、在室内空气环境下SpO₂≤94%或需要补充氧气或接受有创机械通气（IMV）的住院患者。这些患者每天静脉注射两次甲泼尼龙（MP）（0.5 mg/kg），持续5天。本研究使用的主要结局指标是第120天随访时的肺功能测试。在METCovid研究第28天存活的患者总数（n = 246）中，共有118例患者接受了满意的肺功能测试（安慰剂组62例，MP组56例）。安慰剂组和MP组的支持性治疗相似（7例[11%]对4例[7%]；P = 0.45）。入院时，MP组的白细胞介素-6水平较高（P < 0.01）。此外，该组入院时入住重症监护病房（ICU）的需求（P = 0.06）、接受IMV的需求（P = 0.07）和肌酸激酶水平（P = 0.05）也往往更高。在单因素分析中，MP组患者在D120随访时的第1秒用力呼气量（FEV₁）和用力肺活量（FVC）显著更高，在多因素分析中，这一最后参数也显著更高，且独立于入院时的IMV和白细胞介素-6水平。在重症COVID-19中使用类固醇至少5天与更高的FVC相关，这表明住院的COVID-19患者长期使用MP可能有益，肺限制性功能因纤维化而降低。ClinicalTrials.gov标识符：NCT04343729。
