机构地区:[1]Department of Pulmonary and Critical Care Medicine,Rujin Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai 200025,China [2]institute of Respiratory Diseases,School of Medicine,Shanghai Jiao Tong University,Shanghai 200025,China [3]Department of Emergency,Union Medical College Affiliated to Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430058,China [4]Department of Respiratory and Critical Care Medicine,Union Medical Collge Affiliated to Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430058,China [5]Department of Neurology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430030,China [6]Department of Respiratory and Critical Care Medicine,Renmin Hospital,Wuhan University,Wuhan,Hubei 430060,China [7]Department of Endocrinology,Union Medical Cllege Affiliated to Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430058,China [8]Department of Respiratory Medicine,Wuhan Bauhinia Hospital,Wuhan,Hubei 430062,China [9]Department of Respiratory Medicine,Guanggu Hospital District,The Third Hospital of Wuhan,Wuhan,Hubei 430074,China [10]Department of Respiratory and Crtical Care Medicin,Puren Hosptal,Wuhan University of Science and Technology,Wuhan,Hubei 430081,China [11]Department of Respiratory Medicine,The Third People's Hospital of Hubei Province,Wuhan,Hubei 430030,China [12]Department of Respiatory Medicine,The Sixth General Hospital of Hubei Province,Wuhan,Hubei 430015,China [13]Tuberculosis Department of Chengdu Public Health Clinical Medical Center,Chengdu,Sichuan 610066,China [14]Department of Neurology,Wuhan Red Cross Hospital,Wuhan,Hubei 430015,China [15]Department of Tuberculosis,Jinyintan Hospia,Wuhan,Hubei 430048,China [16]Department of Cardiology,The Third People's Hospital of Hubei Province,Wuhan,Hubei 430030,China.
出 处:《Chinese Medical Journal》2022年第13期1531-1538,共8页中华医学杂志(英文版)
基 金:Shanghai Top-Priority Clinical Key Disciplines Construction Project(No.2017ZZ02014);Shanghai Key Laboratory of Emergency Prevention,Diagnosis and Treatment of Respiratory Infectious Diseases(No.20dz2261100);Cultivation Project of Shanghai Major Infectious Disease Research Base(No.20dz2210500)。
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 daysvs. 12.0 days;hazard ratio [HR]: 1.877, 95% CI: 1.151-3.060,P=0.006), symptom of fever (median 3.0 daysvs. 12.0 days;HR: 18.990, 95% CI: 5.350-67.410,P<0.001), as well as hospitalization (median 12.5 daysvs. 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 daysvs. 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 significant
关 键 词:ARBIDOL Coronavirus disease 2019(COVID-19) Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)
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