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2021年 第15卷 第3期

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《医学前沿（英文）》 >> 2021年 第15卷 第3期 doi: 10.1007/s11684-020-0824-3

Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial

. Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei 230001, China;.. Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230027, China;.. Intensive Care Unit, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei 230001, China;.. Drug Clinical Trail Institution, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, China;.. Department of Infectious Diseases, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, China;.. Department of Respiratory Medicine, the Second People’s Hospital of Fuyang, Fuyang 236000, China;.. Department of Respiratory Medicine, National Key Clinical Specialty, Branch of National Clinical Research Center for Respiratory Disease, Xiangya Hospital, Central South University, Xiangya Lung Cancer Center, Xiangya Hospital, Central South University, Hunan Provincial Clinical Research Center for Respiratory Diseases, Changsha 410000, China;.. Lu’an People’s Hospital Affiliated to Anhui Medical University, Lu’an 237005, China;.. Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of Bengbu Medical College, Clinical Research Center for Respiratory Disease (tumor) in Anhui Province, Bengbu 233004, China;.. Department of Respiratory Medicine, Anqing Hospital Affiliated to Anhui Medical University, Anqing 246000, China;.. The First Affiliated Hospital of Nanjing Medical University, Nanjing 210000, China;.. Department of Rheumatology and Immunology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei 230001, China;.. Department of Oncology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei 230001, China;.. Department of Endocrinology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei 230001, China;.. Department of Hematology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei 230001, China

收稿日期： 2021-01-30 录用日期： 2021-03-10 发布日期： 2021-03-10
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Tocilizumab has been reported to attenuate the “cytokine storm” in COVID-19 patients. We attempted to verify the effectiveness and safety of tocilizumab therapy in COVID-19 and identify patients most likely to benefit from this treatment. We conducted a randomized, controlled, open-label multicenter trial among COVID-19 patients. The patients were randomly assigned in a 1:1 ratio to receive either tocilizumab in addition to standard care or standard care alone. The cure rate, changes of oxygen saturation and interference, and inflammation biomarkers were observed. Thirty-three patients were randomized to the tocilizumab group, and 32 patients to the control group. The cure rate in the tocilizumab group was higher than that in the control group, but the difference was not statistically significant (94.12% vs. 87.10%, rate difference 95% CI −7.19%–21.23%, = 0.4133). The improvement in hypoxia for the tocilizumab group was higher from day 4 onward and statistically significant from day 12 ( = 0.0359). In moderate disease patients with bilateral pulmonary lesions, the hypoxia ameliorated earlier after tocilizumab treatment, and less patients (1/12, 8.33%) needed an increase of inhaled oxygen concentration compared with the controls (4/6, 66.67%; rate difference 95% CI −99.17% to −17.50%, = 0.0217). No severe adverse events occurred. More mild temporary adverse events were recorded in tocilizumab recipients (20/34, 58.82%) than the controls (4/31, 12.90%). Tocilizumab can improve hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative. For patients with bilateral pulmonary lesions and elevated IL-6 levels, tocilizumab could be recommended to improve outcome.

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