Gao Jie, Zhang Wenjing, Ding Yaru, Peng Xinru, Wang Jing, Li Yuting, Gao Jing, Cheng Jie, Zhou Wei, Zhang Shuxiang
Department of Respiratory Medicine, First Clinical Medical College, Ningxia Medical University, Yinchuan, China.
Department of Respiratory and Critical Care Medicine, General Hospital of Ningxia Medical University, Yinchuan, China.
Front Pharmacol. 2025 Jul 24;16:1571372. doi: 10.3389/fphar.2025.1571372. eCollection 2025.
To evaluate the therapeutic efficacy of different doses of tocilizumab (TCZ) in patients with severe or critical COVID-19.
In this single-center retrospective cohort study conducted from January 2023 to January 2024, 56 hospitalized patients with severe or critical COVID-19 who received TCZ were included. Patients were categorized into three groups based on the number of TCZ doses administered: one dose (n = 16), two doses (n = 32), and three doses (n = 8). The primary outcomes were in-hospital mortality and 30-day mortality following the first dose. Secondary outcomes included changes in inflammatory marker levels, length of hospital stay, duration of mechanical ventilation, and incidence of complications during hospitalization.
After adjusting for potential confounders, there were no statistically significant differences in 30-day mortality (one dose vs. two doses HR 0.39; 95% CI, 0.15-1.04; P = 0.060 and one dose vs. three doses HR 0.27; 95% CI, 0.06-1.07; P = 0.067) or in-hospital mortality (one dose vs. two doses HR 0.65; 95% CI, 0.35-1.25; P = 0.090 and one dose vs. three doses HR 0.70; 95% CI, 0.40-1.50; P = 0.300) among the three groups. However, all groups showed a favorable response in inflammatory markers. Interleukin-6 (IL-6) levels initially increased after TCZ administration but subsequently declined in a fluctuating pattern. C-reactive protein (CRP) levels decreased consistently across all groups, while procalcitonin showed a modest decline. The number of TCZ doses had no significant impact on length of hospital stay, duration of mechanical ventilation, or the incidence of complications such as respiratory failure requiring mechanical ventilation, heart failure, secondary infections, thrombotic/embolic events, transaminase elevation, neutropenia, GI perforation/Haemorrhage, or acute kidney injury.
Administering additional doses of TCZ beyond the initial dose was not associated with further reductions in mortality or improvements in other major clinical outcomes in patients with severe or critical COVID-19.
评估不同剂量的托珠单抗（TCZ）对重症或危重症新型冠状病毒肺炎（COVID-19）患者的治疗效果。
在这项于2023年1月至2024年1月进行的单中心回顾性队列研究中，纳入了56例接受TCZ治疗的住院重症或危重症COVID-19患者。根据给予的TCZ剂量数量将患者分为三组：一剂组（n = 16）、两剂组（n = 32）和三剂组（n = 8）。主要结局为首次给药后的院内死亡率和30天死亡率。次要结局包括炎症标志物水平变化、住院时间、机械通气时间以及住院期间并发症的发生率。
在对潜在混杂因素进行调整后，三组患者的30天死亡率（一剂组与两剂组，风险比[HR] 0.39；95%置信区间[CI]，0.15 - 1.04；P = 0.060；一剂组与三剂组，HR 0.27；95% CI，0.06 - 1.07；P = 0.067）或院内死亡率（一剂组与两剂组，HR 0.65；95% CI，0.35 - 1.25；P = 0.090；一剂组与三剂组，HR 0.70；95% CI，0.40 - 1.50；P = 0.300）无统计学显著差异。然而，所有组在炎症标志物方面均显示出良好反应。白细胞介素-6（IL-6）水平在给予TCZ后最初升高，但随后呈波动下降。所有组的C反应蛋白（CRP）水平持续下降，而降钙素原呈适度下降。TCZ剂量数量对住院时间、机械通气时间或并发症发生率（如需要机械通气的呼吸衰竭、心力衰竭、继发感染、血栓形成/栓塞事件、转氨酶升高、中性粒细胞减少、胃肠道穿孔/出血或急性肾损伤）无显著影响。
对于重症或危重症COVID-19患者，在初始剂量之外额外给予TCZ剂量与死亡率的进一步降低或其他主要临床结局的改善无关。
