Unit of Infectious Diseases, Hospital Universitario "12 de Octubre", Instituto de Investigación Sanitaria Hospital "12 de Octubre" (imas12), Madrid, Spain.
Department of Internal Medicine, Hospital Universitario "12 de Octubre", Instituto de Investigación Sanitaria Hospital "12 de Octubre" (imas12), Madrid, Spain.
J Med Virol. 2021 Feb;93(2):831-842. doi: 10.1002/jmv.26308. Epub 2020 Jul 27.
Coronavirus disease 2019 (COVID-19) can lead to a massive cytokine release. The use of the anti-interleukin-6 receptor monoclonal antibody tocilizumab (TCZ) has been proposed in this hyperinflammatory phase, although supporting evidence is limited. We retrospectively analyzed 88 consecutive patients with COVID-19 pneumonia that received at least one dose of intravenous TCZ in our institution between 16 and 27 March 2020. Clinical status from day 0 (first TCZ dose) through day 14 was assessed by a 6-point ordinal scale. The primary outcome was clinical improvement (hospital discharge and/or a decrease of ≥2 points on the 6-point scale) by day 7. Secondary outcomes included clinical improvement by day 14 and dynamics of vital signs and laboratory values. Rates of clinical improvement by days 7 and 14 were 44.3% (39/88) and 73.9% (65/88). Previous or concomitant receipt of subcutaneous interferon-β (adjusted odds ratio [aOR]: 0.23; 95% confidence interval [CI]: 0.06-0.94; P = .041) and serum lactate dehydrogenase more than 450 U/L at day 0 (aOR: 0.25; 95% CI: 0.06-0.99; P = .048) were negatively associated with clinical improvement by day 7. All-cause mortality was 6.8% (6/88). Body temperature and respiratory and cardiac rates significantly decreased by day 1 compared to day 0. Lymphocyte count and pulse oximetry oxygen saturation/FiO ratio increased by days 3 and 5, whereas C-reactive protein levels dropped by day 2. There were no TCZ-attributable adverse events. In this observational single-center study, TCZ appeared to be useful and safe as immunomodulatory therapy for severe COVID-19 pneumonia.
新型冠状病毒病（COVID-19）可导致大量细胞因子释放。在这种炎症过度活跃的阶段，已提出使用抗白细胞介素-6 受体单克隆抗体托珠单抗（TCZ），但其支持证据有限。我们回顾性分析了 2020 年 3 月 16 日至 27 日期间，在我院接受至少一剂静脉 TCZ 治疗的 88 例连续 COVID-19 肺炎患者。通过 6 分等级量表评估从第 0 天（首次 TCZ 剂量）到第 14 天的临床状态。主要结局是第 7 天临床改善（出院和/或 6 分等级量表下降≥2 分）。次要结局包括第 14 天的临床改善以及生命体征和实验室值的动态变化。第 7 天和第 14 天的临床改善率分别为 44.3%（39/88）和 73.9%（65/88）。第 0 天有或同时有皮下干扰素-β（调整后的优势比[aOR]：0.23；95%置信区间[CI]：0.06-0.94；P=0.041）和血清乳酸脱氢酶>450 U/L（aOR：0.25；95%CI：0.06-0.99；P=0.048）与第 7 天临床改善呈负相关。全因死亡率为 6.8%（6/88）。与第 0 天相比，第 1 天的体温、呼吸和心率均显著下降。淋巴细胞计数和脉搏血氧饱和度/FiO 比值在第 3 天和第 5 天增加，而 C 反应蛋白水平在第 2 天下降。没有 TCZ 相关的不良事件。在这项观察性单中心研究中，TCZ 似乎是一种有用且安全的免疫调节治疗药物，可用于治疗严重 COVID-19 肺炎。
