Rabie Al Shaimaa Ibrahim, Salah Hager, Said Amira S A, Shaaban Ahmed Hassan, Abdou Lamya Mohamed, Khalil Doaa Mahmoud, Kharaba Zelal, Afifi Hala, Sofy Mahmoud R, Youssef Eman M I, Bayoumy Eman S M, Hussein Raghda R S
Clinical Pharmacy Department, Fayium Oncology Center, Fayium 63511, Egypt.
Clinical Nutrition Department, Fayium Health Insurance Authority, Fayium 63511, Egypt.
Healthcare (Basel). 2023 Feb 17;11(4):607. doi: 10.3390/healthcare11040607.
There seem to currently be no therapeutic medications found for the severe coronavirus infection in 2019 (COVID-19). In light of this, it has been hypothesized that the immunomodulatory treatment known as tocilizumab can lessen the inflammatory response that occurs in the respiratory system, speed up the process of clinical benefit, lower the risk of death, and avert the need for ventilators. This randomized controlled trial (RCT) studied patients with a proven infection of SARS-CoV-2 and hyperinflammatory reactions. The inclusion criteria included fever (body temperature > 38 °C), pulmonary infiltrates, or supplemental oxygen. The patients received either conventional treatment with one dose of either tocilizumab (8 mg per kilogram of body weight) or conventional treatment only. The subjects were randomized to receive either treatment with a 1:1 ratio. A time-to-event test was conducted to determine the time to intubation or death. There was an insignificant difference between the investigated groups regarding the time to death, time to mechanical ventilation, and percentage of deaths. The conventional group's median (IQR) hospital length of stay was 4 (3-6) days, whereas the tocilizumab therapy group was 7 (4.75-10) days. There was a substantial difference in the mechanical ventilation rates in both groups, which were 17 (34%) and 28 (56%), respectively. In hospitalized patients with severe illness and COVID-19, tocilizumab was ineffective in preventing intubation or death. Trials must be larger, however, in order to exclude the potential benefits or harms.
目前似乎尚未发现针对2019年严重冠状病毒感染（COVID-19）的治疗药物。鉴于此，有人提出假设，名为托珠单抗的免疫调节治疗可以减轻呼吸系统发生的炎症反应，加速临床获益过程，降低死亡风险，并避免使用呼吸机的需求。这项随机对照试验（RCT）研究了确诊感染SARS-CoV-2且有高炎症反应的患者。纳入标准包括发热（体温>38°C）、肺部浸润或吸氧。患者接受单剂量托珠单抗（每公斤体重8毫克）的常规治疗或仅接受常规治疗。受试者以1:1的比例随机接受两种治疗。进行了一项事件发生时间测试，以确定插管或死亡的时间。在调查的组之间，关于死亡时间、机械通气时间和死亡百分比没有显著差异。常规组的中位（IQR）住院时间为4（3-6）天，而托珠单抗治疗组为7（4.75-10）天。两组的机械通气率有显著差异，分别为17（34%）和28（56%）。在患有重症和COVID-19的住院患者中，托珠单抗在预防插管或死亡方面无效。然而，试验必须更大规模，以便排除潜在的益处或危害。
