Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, China; Peking University International Hospital, Beijing, China.
Department of Tuberculosis, Wuhan Pulmonary Hospital, Wuhan, 430030, China.
Biomed Pharmacother. 2021 Jan;133:110825. doi: 10.1016/j.biopha.2020.110825. Epub 2020 Sep 30.
Since December 2019, COVID-19 has spread to almost every corner of the world. In theory, tocilizumab and favipiravir are considered to be reliable drugs for the treatment of COVID-19 with elevated IL-6. We aimed to assess the efficacy and safety of tocilizumab combined with favipiravir in patients with COVID-19.
This was a multicenter trial in adults with COVID-19. Patients were randomly assigned (3:1:1) to a 14-day combination of favipiravir combined with tocilizumab (combination group), favipiravir, and tocilizumab. The primary outcome was the cumulative lung lesion remission rate (lung CT examination indicated absorption of lung inflammation).
Between Feb 2 and March 15, 2020, 26 patients were recruited; 14 were randomly assigned to the combination group, 7 were assigned to the favipiravir group and 5 were assigned to the tocilizumab group. The cumulative lung lesion remission rate at day 14 was significantly higher in combination group as compared with favipiravir group (P = 0.019, HR 2.66 95 % CI [1.08-6.53]). And there was also a significant difference between tocilizumab and favipivavir (P = 0.034, HR 3.16, 95 % CI 0.62-16.10). In addition, there was no significant difference between the combination group and the tocilizumab group (P = 0.575, HR 1.28 95 %CI 0.39-4.23). Furthermore, combined therapy can also significantly relieve clinical symptoms and help blood routine to return to normal. No serious adverse events were reported.
Tocilizumab combined with or without favipiravir can effectively improve the pulmonary inflammation of COVID-19 patients and inhibit the deterioration of the disease.
自 2019 年 12 月以来，COVID-19 已蔓延至世界几乎每一个角落。理论上，托珠单抗和法匹拉韦被认为是治疗 COVID-19 伴有升高的白细胞介素-6 的可靠药物。我们旨在评估托珠单抗联合法匹拉韦治疗 COVID-19 的疗效和安全性。
这是一项多中心成人 COVID-19 患者试验。患者被随机分配（3:1:1）接受 14 天的法匹拉韦联合托珠单抗（联合组）、法匹拉韦和托珠单抗治疗。主要结局是累积肺部病变缓解率（肺部 CT 检查显示肺部炎症吸收）。
2020 年 2 月 2 日至 3 月 15 日期间，共招募了 26 名患者；14 名患者被随机分配到联合组，7 名患者分配到法匹拉韦组，5 名患者分配到托珠单抗组。联合组在第 14 天的累积肺部病变缓解率显著高于法匹拉韦组（P=0.019，HR 2.66[95%CI 1.08-6.53]）。而且，托珠单抗与法匹拉韦之间也有显著差异（P=0.034，HR 3.16，95%CI 0.62-16.10）。此外，联合组与托珠单抗组之间无显著差异（P=0.575，HR 1.28，95%CI 0.39-4.23）。此外，联合治疗还可以显著缓解临床症状，有助于血象恢复正常。未报告严重不良事件。
托珠单抗联合或不联合法匹拉韦均可有效改善 COVID-19 患者肺部炎症，抑制病情恶化。
