Burlacu Ruxandra, London Jonathan, Fleury Audrey, Sené Thomas, Diallo Abdourahmane, Meyssonnier Vanina, Zeller Valérie, Galland Joris, Huscenot Tessa, Rubenstein Emma, Trouiller Pierre, Amathieu Roland, Kutter Johannes, Blondeel David, Lejour Gabriel, Mouly Stéphane, Lidove Olivier, Wladimir Mauhin, Sène Damien
Department of Internal Medicine, Lariboisière Fernand Widal Hospital, AP-HP, University of Paris.
Department of Internal Medicine and Infectious Diseases, Diaconesses Croix-Saint Simon Hospital.
Medicine (Baltimore). 2021 May 28;100(21):e26023. doi: 10.1097/MD.0000000000026023.
To assess tocilizumab (TCZ) efficacy associated to standard of care (SOC) compared to SOC alone in severe coronavirus associated disease 2019 (COVID-19) patients. In a matched case-control study from 3 French Hospital COVID-19 Departments, 27 patients with severe COVID-19 treated with TCZ and SOC were matched for baseline epidemiological and clinical features and compared to 27 severe COVID-19 patients treated with SOC alone. Baseline characteristics of the study population were comparable between groups. Eleven patients (20%) died. TCZ was not associated with clinical improvement as compared to SOC regarding oxygen-free status (44% vs 63%) and death (18.5% vs 22%), despite a higher decrease of the C-reactive protein at Day 7 (10.7 vs 52 mg/L; P < 10-3). Compared to the 43 patients alive at the end-of follow-up, patients who died were older (78 vs 64 years; P < 10-3), with 82% of them older than 72 years vs only 23% of live patients (P < 10-3). Age (OR = 1.15; 95%CI = 1.04-1.3; P = .008) and age over 72 years (OR) = 14.85; 95%CI = 2.7-80; P = .002) were independently associated with mortality. TCZ in addition to SOC for severe COVID-19 patients did not reduce mortality, subsequent need for invasive mechanical ventilation nor did it shorten the time of oxygen support, despite better control of the inflammatory response. More powerful and randomized controlled trials are warranted to determine if TCZ is effective in the management of COVID-19.
评估在重症2019冠状病毒病(COVID-19)患者中,与单独使用标准治疗(SOC)相比,托珠单抗(TCZ)联合SOC的疗效。在一项来自法国3家医院COVID-19科室的配对病例对照研究中,27例接受TCZ和SOC治疗的重症COVID-19患者,根据基线流行病学和临床特征进行配对,并与27例单独接受SOC治疗的重症COVID-19患者进行比较。研究人群的基线特征在两组之间具有可比性。11例患者(20%)死亡。与SOC相比,TCZ在无吸氧状态(44%对63%)和死亡(18.5%对22%)方面并未带来临床改善,尽管第7天时C反应蛋白下降幅度更大(10.7对52mg/L;P<10-3)。与随访结束时存活的43例患者相比,死亡患者年龄更大(78对64岁;P<10-3),其中82%的死亡患者年龄超过72岁,而存活患者中这一比例仅为23%(P<10-3)。年龄(OR=1.15;95%CI=1.04-1.3;P=0.008)和72岁以上年龄(OR=14.85;95%CI=2.7-80;P=0.002)与死亡率独立相关。对于重症COVID-19患者,TCZ联合SOC并未降低死亡率、减少后续有创机械通气的需求,也未缩短吸氧支持时间,尽管炎症反应得到了更好控制。需要开展更有力的随机对照试验来确定TCZ在COVID-19治疗中是否有效。