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

作     者：Dongsheng Wang Binqing Fu Zhen Peng Dongliang Yang Mingfeng Han Min Li Yun Yang Tianjun Yang Liangye Sun Wei Li Wei Shi Xin Yao Yan Ma Fei Xu Xiaojing Wang Jun Chen Daqing Xia Yubei Sun Lin Dong Jumei Wang Xiaoyu Zhu Min Zhang Yonggang Zhou Aijun Pan Xiaowen Hu Xiaodong Mei Haiming Wei Xiaoling Xu Dongsheng Wang;Binqing Fu;Zhen Peng;Dongliang Yang;Mingfeng Han;Min Li;Yun Yang;Tianjun Yang;Liangye Sun;Wei Li;Wei Shi;Xin Yao;Yan Ma;Fei Xu;Xiaojing Wang;Jun Chen;Daqing Xia;Yubei Sun;Lin Dong;Jumei Wang;Xiaoyu Zhu;Min Zhang;Yonggang Zhou;Aijun Pan;Xiaowen Hu;Xiaodong Mei;Haiming Wei;Xiaoling Xu

作者机构：Department of Pulmonary and Critical Care Medicinethe First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital)Hefei 230001China Division of Life Sciences and MedicineUniversity of Science and Technology of ChinaHefei 230027China Intensive Care Unitthe First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital)Hefei 230001China Drug Clinical Trail Institutionthe First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital)Division of Life Sciences and MedicineUniversity of Science and Technology of ChinaHefei 230001China Department of Infectious DiseasesUnion HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430000China Department of Respiratory Medicinethe Second People’s Hospital of FuyangFuyang 236000China Department of Respiratory MedicineNational Key Clinical SpecialtyBranch of National Clinical Research Center for Respiratory DiseaseXiangya HospitalCentral South UniversityXiangya Lung Cancer CenterXiangya HospitalCentral South UniversityHunan Provincial Clinical Research Center for Respiratory DiseasesChangsha 410000China Lu’an People’s Hospital Affiliated to Anhui Medical UniversityLu’an 237005China Department of Pulmonary and Critical Care Medicinethe First Affiliated Hospital of Bengbu Medical CollegeClinical Research Center for Respiratory Disease(tumor)in Anhui ProvinceBengbu 233004China Department of Respiratory MedicineAnqing Hospital Affiliated to Anhui Medical UniversityAnqing 246000China The First Affiliated Hospital of Nanjing Medical UniversityNanjing 210000China Department of Rheumatology and Immunologythe First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital)Hefei 230001China Department of Oncologythe First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital)Hefei 230001China Department of Endocrinologythe First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital)Hefei 230001China Department of Hematologythe First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital)Hefei 230001China 

出 版 物：《Frontiers of Medicine》 (医学前沿（英文版）)

年 卷 期：2021年第15卷第3期

页      面：486-494页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：This work was supported by the Department of Science and Technology of Anhui Province and Health Commission of Anhui Province(No.202004a07020001) the China National Center for Biotechnology Development(No.2020YFC0843800) 

主　　题：tocilizumab coronavirus disease 2019(COVID-19) cytokine storm 

摘      要：Tocilizumab has been reported to attenuate the“cytokine stormin COVID-19 *** attempted to verify the effectiveness and safety of tocilizumab therapy in COVID-19 and identify patients most likely to benefit from this *** conducted a randomized,controlled,open-label multicenter trial among COVID-19 *** patients were randomly assigned in a 1:1 ratio to receive either tocilizumab in addition to standard care or standard care *** cure rate,changes of oxygen saturation and interference,and inflammation biomarkers were ***-three patients were randomized to the tocilizumab group,and 32 patients to the control *** 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%,P=0.4133).The improvement in hypoxia for the tocilizumab group was higher from day 4 onward and statistically significant from day 12(P=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%,P=0.0217).No severe adverse events *** 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 *** patients with bilateral pulmonary lesions and elevated IL-6 levels,tocilizumab could be recommended to improve outcome.