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典型文献
A trial of arbidol hydrochloride in adults with COVID-19
文献摘要:
Background::To date, there is no effective medicine to treat coronavirus disease 2019 (COVID-19), and the antiviral efficacy of arbidol in the treatment for COVID-19 remained equivocal and controversial. The purpose of this study was to evaluate the efficacy and safety of arbidol tablets in the treatment of COVID-19.Methods::This was a prospective, open-label, controlled and multicenter investigator-initiated trial involving adult patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Patients were stratified 1:2 to either standard-of-care (SOC) or SOC plus arbidol tablets (oral administration of 200 mg per time, three times a day for 14 days). The primary endpoint was negative conversion of SARS-CoV-2 within the first week. The rates and 95% confidential intervals were calculated for each variable.Results::A total of 99 patients with laboratory-confirmed SARS-CoV-2 infection were enrolled; 66 were assigned to the SOC plus arbidol tablets group, and 33 to the SOC group. The negative conversion rate of SARS-CoV-2 within the first week in patients receiving arbidol tablets was significantly higher than that of the SOC group (70.3% [45/64] vs. 42.4% [14/33]; difference of conversion rate 27.9%; 95% confidence interval [CI], 7.7%-48.1%; P = 0.008). Compared to those in the SOC group, patients receiving arbidol tablets had a shorter duration of clinical recovery (median 7.0 days vs. 12.0 days; hazard ratio [HR]: 1.877, 95% CI: 1.151-3.060, P = 0.006), symptom of fever (median 3.0 days vs. 12.0 days; HR: 18.990, 95% CI: 5.350-67.410, P < 0.001), as well as hospitalization (median 12.5 days vs. 20.0 days; P < 0.001). Moreover, the addition of arbidol tablets to SOC led to more rapid normalization of declined blood lymphocytes (median 10.0 days vs. 14.5 days; P > 0.05). The most common adverse event in the arbidol tablets group was the elevation of transaminase (5/200, 2.5%), and no one withdrew from the study due to adverse events or disease progression. Conclusions::SOC plus arbidol tablets significantly increase the negative conversion rate of SARS-CoV-2 within the first week and accelerate the recovery of COVID-19 patients. During the treatment with arbidol tablets, we find no significant serious adverse events.Trial registration::Chinese Clinical Trial Registry, NCT04260594, NCT04260594&draw=2&rank=1
文献关键词:
Arbidol;Coronavirus disease 2019 (COVID-19);Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
作者姓名:
Zhao Jingya;Zhang Jinnong;Jin Yang;Tang Zhouping;Hu Ke;Sun Hui;Shi Mengmeng;Yang Qingyuan;Gu Peiyu;Guo Hongrong;Li Qi;Zhang Haiying;Li Chenghong;Yang Ming;Xiong Nian;Dong Xuan;Xu Juanjuan;Lin Fan;Wang Tao;Yang Chao;Huang Bo;Zhang Jingyi;Chen Shi;He Qiong;Zhou Min;Qu Jieming
作者机构:
Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China;Institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China;Department of Emergency, Union Medical College Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430058, China;Department of Respiratory and Critical Care Medicine, Union Medical College Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430058, China;Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China;Department of Respiratory and Critical Care Medicine, Renmin Hospital, Wuhan University, Wuhan, Hubei 430060, China;Department of Endocrinology, Union Medical College Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430058, China;Department of Respiratory Medicine, Wuhan Bauhinia Hospital, Wuhan, Hubei 430062, China;Department of Respiratory Medicine, Guanggu Hospital District, The Third Hospital of Wuhan, Wuhan, Hubei 430074, China;Department of Respiratory and Critical Care Medicine, Puren Hospital, Wuhan University of Science and Technology, Wuhan, Hubei 430081, China;Department of Respiratory Medicine, The Third People’s Hospital of Hubei Province, Wuhan, Hubei 430030, China;Department of Respiratory Medicine, The Sixth General Hospital of Hubei Province, Wuhan, Hubei 430015, China;Tuberculosis Department of Chengdu Public Health Clinical Medical Center, Chengdu, Sichuan 610066, China;Department of Neurology, Wuhan Red Cross Hospital, Wuhan, Hubei 430015, China;Department of Tuberculosis, Jinyintan Hospital, Wuhan, Hubei 430048, China;Department of Cardiology, The Third People’s Hospital of Hubei Province, Wuhan, Hubei 430030, China
引用格式:
[1]Zhao Jingya;Zhang Jinnong;Jin Yang;Tang Zhouping;Hu Ke;Sun Hui;Shi Mengmeng;Yang Qingyuan;Gu Peiyu;Guo Hongrong;Li Qi;Zhang Haiying;Li Chenghong;Yang Ming;Xiong Nian;Dong Xuan;Xu Juanjuan;Lin Fan;Wang Tao;Yang Chao;Huang Bo;Zhang Jingyi;Chen Shi;He Qiong;Zhou Min;Qu Jieming-.A trial of arbidol hydrochloride in adults with COVID-19)[J].中华医学杂志(英文版),2022(13):1531-1538
A类:
arbidol,NCT04260594,Arbidol
B类:
trial,hydrochloride,adults,Background,To,date,there,effective,medicine,coronavirus,disease,antiviral,efficacy,treatment,remained,equivocal,controversial,purpose,this,study,was,evaluate,safety,tablets,Methods,This,prospective,open,label,controlled,multicenter,investigator,initiated,involving,patients,confirmed,severe,acute,respiratory,syndrome,SARS,CoV,infection,Patients,were,stratified,either,standard,care,SOC,plus,oral,administration,per,three,times,days,primary,endpoint,negative,conversion,within,first,week,rates,confidential,intervals,calculated,each,variable,Results,total,laboratory,enrolled,assigned,group,receiving,significantly,higher,than,that,difference,confidence,Compared,those,had,shorter,duration,clinical,recovery,median,hazard,symptom,fever,well,hospitalization,Moreover,addition,more,rapid,normalization,declined,blood,lymphocytes,most,common,adverse,elevation,transaminase,one,withdrew,from,due,events,progression,Conclusions,increase,accelerate,During,find,serious,Trial,registration,Chinese,Clinical,Registry,draw,rank,Coronavirus,Severe
AB值:
0.43867
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