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托珠单抗治疗重症新型冠状病毒肺炎住院患者的疗效:一项病例对照队列研究。

Effect of Tocilizumab in Hospitalized Patients with Severe COVID-19 Pneumonia: A Case-Control Cohort Study.

作者信息

Rossi Benjamin, Nguyen Lee S, Zimmermann Philippe, Boucenna Faiza, Dubret Louis, Baucher Louise, Guillot Helene, Bouldouyre Marie-Anne, Allenbach Yves, Salem Joe-Elie, Barsoum Paul, Oufella Arezki, Gros Helene

机构信息

Department of Internal Medicine, Robert Ballanger Hospital, 93600 Aulnay-Sous-Bois, France.

Research & Innovation of CMC Ambroise Paré, 92200 Neuilly-Sur-Seine, France.

出版信息

Pharmaceuticals (Basel). 2020 Oct 17;13(10):317. doi: 10.3390/ph13100317.

DOI:10.3390/ph13100317
PMID:33080877
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7603074/
Abstract

Tocilizumab, an anti-interleukin-6 receptor, administrated during the right timeframe may be beneficial against coronavirus-disease-2019 (COVID-19) pneumonia. All patients admitted for severe COVID-19 pneumonia (SpO ≤ 96% despite O-support ≥ 6 L/min) without invasive mechanical ventilation were included in a retrospective cohort study in a primary care hospital. The treatment effect of a single-dose, 400 mg, of tocilizumab was assessed by comparing those who received tocilizumab to those who did not. Selection bias was mitigated using three statistical methods. Primary outcome measure was a composite of mortality and ventilation at day 28. A total of 246 patients were included (106 were treated with tocilizumab). Overall, 105 (42.7%) patients presented the primary outcome, with 71 (28.9%) deaths during the 28-day follow-up. Propensity-score-matched 84 pairs of comparable patients. In the matched cohort (n = 168), tocilizumab was associated with fewer primary outcomes than the control group (hazard ratio (HR) = 0.49 (95% confidence interval (95%CI) = 0.3-0.81), -value = 0.005). These results were similar in the overall cohort (n = 246), with Cox multivariable analysis yielding a protective association between tocilizumab and primary outcome (adjusted HR = 0.26 (95%CI = 0.135-0.51, = 0.0001), confirmed by inverse probability score weighting (IPSW) analysis ( < 0.0001). Analyses on mortality only, with 28 days of follow-up, yielded similar results. In this study, tocilizumab 400 mg in a single-dose was associated with improved survival without mechanical ventilation in patients with severe COVID-19.

摘要

托珠单抗是一种抗白细胞介素-6受体药物,在合适的时间范围内使用可能对2019冠状病毒病(COVID-19)肺炎有益。在一家基层医院开展的一项回顾性队列研究中,纳入了所有因重症COVID-19肺炎(尽管氧支持≥6升/分钟,但SpO₂≤96%)且未进行有创机械通气而入院的患者。通过比较接受托珠单抗治疗的患者和未接受治疗的患者,评估了单剂量400毫克托珠单抗的治疗效果。使用三种统计方法减轻了选择偏倚。主要结局指标是第28天的死亡率和通气情况的综合指标。共纳入246例患者(106例接受托珠单抗治疗)。总体而言,105例(42.7%)患者出现主要结局,在28天随访期间有71例(28.9%)死亡。倾向评分匹配了84对可比患者。在匹配队列(n = 168)中,托珠单抗组的主要结局比对照组少(风险比(HR)= 0.49(95%置信区间(95%CI)= 0.3 - 0.81),P值 = 0.005)。在总体队列(n = 246)中结果相似,Cox多变量分析显示托珠单抗与主要结局之间存在保护性关联(调整后HR = 0.26(95%CI = 0.135 - 0.51),P = 0.0001),逆概率评分加权(IPSW)分析也证实了这一点(P < 0.0001)。仅对死亡率进行分析,随访28天,结果相似。在本研究中,单剂量400毫克托珠单抗与重症COVID-19患者在无需机械通气情况下生存率的提高相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a286/7603074/63df855eb0f8/pharmaceuticals-13-00317-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a286/7603074/80aa52bfc27f/pharmaceuticals-13-00317-g001.jpg
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