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 o...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 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.展开更多
Lung cancer is one of the most common human cancers and the number one cancer killer in the United States.In general,lung cancer includes small cell lung cancer(SCLC)and non-small cell lung cancer(NSCLC),but NSCLC acc...Lung cancer is one of the most common human cancers and the number one cancer killer in the United States.In general,lung cancer includes small cell lung cancer(SCLC)and non-small cell lung cancer(NSCLC),but NSCLC accounts for approximately 90%of lung cancer.The early diagnosis and therapy of lung cancer still presents a big challenge because validated screening tools,which can improve current early detection to reduce mortality from lung cancer,do not exist.Over the last decade,molecular genetic abnormalities have been described in NSCLC,including chromosomal aberrations,overexpression of oncogenes,and deletion and/or muta-tions in tumor suppressor genes.These molecular markers in NSCLC demonstrated close associations with the development of lung cancer such as Ras,the epidermal growth factor receptor(EGFR,or c-erbB-1),HER2(c-erbB-2),c-Met,and Bcl-2.Therefore,this information may be applied for early cancer detection,classification,novel targeted therapy,and prognosis in NSCLC.Recent clinical data have revealed that targeted therapy might be the second-line therapy as an alternative approach.Currently,the targeted therapies are mainly focused on two lung cancer pathways,the EGFR and the vascular endothelial growth factor(VEGF)pathways.Some clinical trials are very encouraging,but some of them are not.However,these trials have not identified a subgroup of NSCLC with biomarkers.Therefore,it is very important to select NSCLC patients with biomarkers to match targeted agents so that we can further identify effectiveness of targeted therapy in the future.展开更多
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)。
文摘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 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.
文摘Lung cancer is one of the most common human cancers and the number one cancer killer in the United States.In general,lung cancer includes small cell lung cancer(SCLC)and non-small cell lung cancer(NSCLC),but NSCLC accounts for approximately 90%of lung cancer.The early diagnosis and therapy of lung cancer still presents a big challenge because validated screening tools,which can improve current early detection to reduce mortality from lung cancer,do not exist.Over the last decade,molecular genetic abnormalities have been described in NSCLC,including chromosomal aberrations,overexpression of oncogenes,and deletion and/or muta-tions in tumor suppressor genes.These molecular markers in NSCLC demonstrated close associations with the development of lung cancer such as Ras,the epidermal growth factor receptor(EGFR,or c-erbB-1),HER2(c-erbB-2),c-Met,and Bcl-2.Therefore,this information may be applied for early cancer detection,classification,novel targeted therapy,and prognosis in NSCLC.Recent clinical data have revealed that targeted therapy might be the second-line therapy as an alternative approach.Currently,the targeted therapies are mainly focused on two lung cancer pathways,the EGFR and the vascular endothelial growth factor(VEGF)pathways.Some clinical trials are very encouraging,but some of them are not.However,these trials have not identified a subgroup of NSCLC with biomarkers.Therefore,it is very important to select NSCLC patients with biomarkers to match targeted agents so that we can further identify effectiveness of targeted therapy in the future.