Division of Infectious Diseases, Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Spain.
Division of Infectious Diseases, Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Spain.
Int J Infect Dis. 2021 Jan;102:303-309. doi: 10.1016/j.ijid.2020.10.045. Epub 2020 Oct 25.
Tocilizumab (TCZ) is an interleukin-6 receptor antagonist, which has been used for the treatment of severe SARS-CoV-2 pneumonia (SSP), which aims to ameliorate the cytokine release syndrome (CRS) induced acute respiratory distress syndrome (ARDS). However, there are no consistent data about who might benefit most from it.
We administered TCZ on a compassionate-use basis to patients with SSP who were hospitalized (excluding intensive care and intubated cases) and who required oxygen support to have a saturation >93%. The primary endpoint was intubation or death after 24 h of its administration. Patients received at least one dose of 400 mg intravenous TCZ from March 8, 2020 to April 20, 2020.
A total of 207 patients were studied and 186 analyzed. The mean age was 65 years and 68% were male patients. A coexisting condition was present in 68% of cases. Prognostic factors of death were older age, higher IL-6, d-dimer and high-sensitivity C-reactive protein (HSCRP), lower total lymphocytes, and severe disease that requires additional oxygen support. The primary endpoint (intubation or death) was significantly worst (37% vs 13%, p < 0·001) in those receiving the drug when the oxygen support was high (FiO2 >0.5%).
TCZ is well tolerated in patients with SSP, but it has a limited effect on the evolution of cases with high oxygen support needs.
托珠单抗（TCZ）是一种白介素-6 受体拮抗剂，已被用于治疗严重的 SARS-CoV-2 肺炎（SSP），旨在改善细胞因子释放综合征（CRS）引起的急性呼吸窘迫综合征（ARDS）。然而，目前还没有关于谁最可能从中受益的一致数据。
我们在同情用药的基础上，对需要氧气支持以保持饱和度>93%的 SSP 住院患者（不包括重症监护和插管病例）使用 TCZ。主要终点是给药后 24 小时内插管或死亡。患者在 2020 年 3 月 8 日至 2020 年 4 月 20 日期间至少接受了一次 400mg 静脉 TCZ 治疗。
共研究了 207 例患者，其中 186 例进行了分析。平均年龄为 65 岁，68%为男性患者。68%的患者存在合并症。死亡的预后因素是年龄较大、IL-6、D-二聚体和高敏 C 反应蛋白（HSCRP）较高、总淋巴细胞计数较低以及需要额外氧气支持的严重疾病。主要终点（插管或死亡）在需要高氧气支持（FiO2>0.5%）的患者中明显更差（37% vs 13%，p<0.001）。
TCZ 在 SSP 患者中耐受良好，但对高氧气支持需求病例的病情演变影响有限。
