Department of Infectious Diseases, Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Department of Clinical Pharmacy, International Campus, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Int Immunopharmacol. 2022 Jun;107:108689. doi: 10.1016/j.intimp.2022.108689. Epub 2022 Mar 17.
This study was designed to compare the efficacy and safety of methylprednisolone and tocilizumab in the treatment of patients with severe COVID-19.
During a prospective cohort study, hospitalized patients with severe COVID-19 received intravenous methylprednisolone (250-500 mg daily up to three doses), weight-based tocilizumab (maximum 800 mg, one or two doses as daily interval) or dexamethasone (8 mg daily). The primary outcome was time to onset of clinical response. Secondary outcomes were improvement rate of oxygen saturation and CRP, need for ICU admission, duration of hospitalization and 28-day mortality. During study, adverse events of the treatments were recorded.
Although the difference was not statistically significant (p = 0.090), clinical response occurred faster in the tocilizumab group than other groups (10 vs. 16 days). Clinical response was detected in 74.19%, 81.25%, and 60% of patients in the methylprednisolone, tocilizumab, and dexamethasone groups respectively (p = 0.238). Based on the Cox regression analysis and considering dexamethasone as the reference group, HR (95% CI) of clinical response was 1.08 (0.65-1.79) and 1.46 (0.89-2.39) in the methylprednisolone and tocilizumab groups respectively. Improvement rate of oxygen saturation and CRP was not significantly different between the groups (p = 0.791 and p = 0.372 respectively). Also need for ICU admission and 28-day mortality was comparable between the groups (p = 0.176 and p = 0.143 respectively). Compared with methylprednisolone, tocilizumab caused more sleep disturbances (p = 0.019). Other adverse events were comparable among patients in the groups.
When or where access to tocilizumab is a problem, methylprednisolone may be considered as an alternative for the treatment of patients with severe COVID-19.
本研究旨在比较甲泼尼龙和托珠单抗治疗重症 COVID-19 患者的疗效和安全性。
在一项前瞻性队列研究中，住院的重症 COVID-19 患者接受静脉注射甲泼尼龙（250-500mg 每日，最多 3 剂）、托珠单抗（按体重给药，最大 800mg，每日间隔 1 或 2 剂）或地塞米松（8mg 每日）治疗。主要结局为临床应答开始时间。次要结局为氧饱和度和 CRP 改善率、需要入住 ICU、住院时间和 28 天死亡率。研究期间记录治疗的不良事件。
虽然差异无统计学意义（p=0.090），但托珠单抗组的临床应答发生更快（10 天与 16 天）。甲泼尼龙、托珠单抗和地塞米松组的患者中，临床应答分别为 74.19%、81.25%和 60%（p=0.238）。基于 Cox 回归分析，并以地塞米松为参考组，临床应答的 HR（95%CI）在甲泼尼龙组和托珠单抗组分别为 1.08（0.65-1.79）和 1.46（0.89-2.39）。各组之间氧饱和度和 CRP 的改善率无显著差异（p=0.791 和 p=0.372）。入住 ICU 需求和 28 天死亡率也相似（p=0.176 和 p=0.143）。与甲泼尼龙相比，托珠单抗导致更多的睡眠障碍（p=0.019）。各组患者的其他不良事件相似。
当托珠单抗无法获得或存在问题时，甲泼尼龙可考虑作为治疗重症 COVID-19 患者的替代药物。
