Objective:To evaluate the efficacy and safety of Huashi Baidu Granules(HSBD)in treating patients with severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)Omicron variant.Methods:A single-center retrospective co...Objective:To evaluate the efficacy and safety of Huashi Baidu Granules(HSBD)in treating patients with severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)Omicron variant.Methods:A single-center retrospective cohort study was conducted during COVID-19 Omicron epidemic in the Mobile Cabin Hospital of Shanghai New International Expo Center from April 1st to May 23rd,2022.All COVID-19 patients with asymptomatic or mild infection were assigned to the treatment group(HSBD users)and the control group(non-HSBD users).After propensity score matching in a 1:1 ratio,496 HSBD users of treatment group were matched by propensity score to 496 non-HSBD users.Patients in the treatment group were administrated HSBD(5 g/bag)orally for 1 bag twice a day for 7 consecutive days.Patients in the control group received standard care and routine treatment.The primary outcomes were the negative conversion time of nucleic acid and negative conversion rate at day 7.Secondary outcomes included the hospitalized days,the time of the first nucleic acid negative conversion,and new-onset symptoms in asymptomatic patients.Adverse events(AEs)that occurred during the study were recorded.Further subgroup analysis was conducted in vaccinated(378 HSBD users and 390 non-HSBD users)and unvaccinated patients(118 HSBD users and 106 non-HSBD users).Results:The median negative conversion time of nucleic acid in the treatment group was significantly shortened than the control group[3 days(IQR:2-5 days)vs.5 days(IQR:4-6 days);P<0.01].The negative conversion rate of nucleic acid in the treatment group were significantly higher than those in the control group at day 7(91.73%vs.86.90%,P=0.014).Compared with the control group,the hospitalized days in the treatment group were significantly reduced[10 days(IQR:8-11 days)vs.11 days(IQR:10.25-12 days);P<0.01].The time of the first nucleic acid negative conversion had significant differences between the treatment and control groups[3 days(IQR:2-4 days)vs.5 days(IQR:4-6 days);P<0.01].The incidence of new-onset symptoms including cough,pharyngalgia,expectoration and fever in the treatment group were lower than the control group(P<0.05 or P<0.01).In the vaccinated patients,the median negative conversion time and hospitalized days were significantly shorter than the control group after HSDB treatment[3days(IQR:2-5days)vs.5 days(IQR:4-6 days),P<0.01;10 days(IQR:8-11 days)vs.11 days(IQR:10-12 days),P<0.01].In the unvaccinatedpatients,HSBD treatment efficiently shorten the median negative conversion time and hospitalized days[4 days(IQR:2-6 days)vs.5 days(IQR:4-7 days),P<0.01;10.5 days(IQR:8.75-11 days)vs.11.0 days(IQR:10.75-13 days);P<0.01].No serious AEs were reported during the study.Conclusion:HSBD treatment significantly shortened the negative conversion time of nuclear acid,the length of hospitalization,and the time of the first nucleic acid negative conversion in patients infectedwith SARS-COV-2Omicronvariant(Trial registry No.ChiCTR2200060472).展开更多
Objective: To assess the effect and safety of Reyanning Mixture(RYN) in treating asymptomatic or mild severe acute respiratory syndrome coronavirus 2(SARS-Co V-2) infection in children and adolescents. Methods: This i...Objective: To assess the effect and safety of Reyanning Mixture(RYN) in treating asymptomatic or mild severe acute respiratory syndrome coronavirus 2(SARS-Co V-2) infection in children and adolescents. Methods: This is a prospective, open-label, randomized control ed trial. Patients aged 1–17 years and diagnosed with asymptomatic or mild coronavirus disease-2019(COVID-19) were assigned to an intervention group(RYN plus standard care) and a control group(standard care) according to a randomization list. The primary outcomes were SARS-Co V-2 negative conversion time. Secondary outcomes included negative conversion rate on days 3 and 7, hospital length of stay, symptom relief rate, new-onset symptoms of asymptomatic infected patients, and progressive disease rate. The cycle threshold(Ct) values of ORF1ab or N genes were also tested. Results: A total of 214 patients in the intervention group and 217 in the control group were analyzed. The SARS-CoV-2 negative conversion time was significantly shortened in the intervention group [5 days(interquartile range(IQR): 5–6) vs. 7 days(IQR: 6–7), P<0.01]. By days 3 and 7, the negative conversion rates were significantly higher in the intervention group(day 3: 32.7% vs. 21.2%, P=0.007;day 7: 75.2% vs. 60.8%, P=0.001). Ct values significantly increase on day 2 [ORF1ab gene: 35.62(IQR: 29.17–45.00) vs. 34.22(IQR: 28.41–39.41), P=0.03;N gene: 34.97(IQR: 28.50–45.00) vs. 33.51(IQR: 27.70–38.25), P=0.024] and day 3 [ORF1ab gene: 38.00(IQR: 32.72–45.00) vs. 35.81(IQR: 29.96–45.00), P=0.003;N gene: 37.16(IQR: 32.01–45.00) vs. 35.26(IQR: 29.09–45.00), P=0.01]. No significant difference was found in hospital length of stay between the two groups(P>0.05). Symptoms of cough were significantly improved(82.2% vs. 70.0%, P=0.02) and wheezing was significantly reduced(0.7% vs. 12.9%, P<0.01) in the intervention group compared with the control group. During the trial, no disease progression or serious adverse events were reported. Conclusion: Adding RYN to standard care may be a safe and effective treatment for children with asymptomatic and mild SARS-Co V-2 infection.(Registration No. Chi CTR2200060292)展开更多
Objective: To evaluate the effectiveness and safety of Baidu Jieduan Granules(BDJDG) to treat common type coronavirus disease 2019(COVID-19). Methods: This multicenter, retrospective, and observational clinical trial ...Objective: To evaluate the effectiveness and safety of Baidu Jieduan Granules(BDJDG) to treat common type coronavirus disease 2019(COVID-19). Methods: This multicenter, retrospective, and observational clinical trial included 230 common COVID-19 patients in Leishenshan, Huangshi, and Laohekou Hospitals in Wuhan from January 21 to March 26, 2020. The included patients were further divided into two subgroups according to the use of supplemental oxygen, mild and moderate groups. During the first 14 d of hospitalization, all patients were administered BDJDG combined with conventional Western medicine, and observed for continuous 28 d. Primary outcomes were disease progression rate and discharge rate. Secondary outcomes included negative conversion time of nucleic acid, hospitalization duration, clinical symptom subsidence time, and symptom regression rate. Results: A total of 230 common COVID-19 patients were analyzed(138 in moderate group and 92 in mild group). By day 28, the disease progression rate was 4.3% and the discharge rate was 95.7%. All mild cases recovered and were discharged from hospital. The median negative conversion time of nucleic acid of all 230 COVID-19 patients was 12 d [inter-quartile range(IQR) 3.5–17], the median hospitalization duration was 15 d(IQR 12–20). The median time to fever, cough, and fatigue recovery was 4 d(IQR 2–6), 8 d(IQR 5–12), and 8 d(IQR 5–11), respectively. The recovery rate of fever, cough, and fatigue was 94.6%, 90.5%, and 93.5%. The median time to clinical improvement was 12 d(IQR 10–17). Compared with the baseline, total leukocyte, neutrophil, lymphocyte, and platelet counts were all increased significantly on days 7 and 14(P<0.01). C-reactive protein markedly increased on day 3 and significantly decreased on days 7 and 14(P<0.01). No serious adverse events occurred during treatment. Conclusion: BDJDG may be effective and safe for treatment of common type COVID-19.(Registration No. ChiCTR2000030836)展开更多
基金Supported by Traditional Chinese Medicine Emergency Project on Novel Coronavirus-Infected Pneumonia of State Administration of Traditional Chinese Medicine (No. 2022ZYLCYJ05-4)Shanghai Key Clinical Specialty Project (No. shslczdzk04401)+1 种基金National Traditional Chinese Medicine Emergency Medical Rescue Base Construction Project [No. ZY(2021-2023)-0101-01]National Traditional Chinese Medicine Multidisciplinary Cross Innovation Team Project (No. ZYYCXTD-D-202203)
文摘Objective:To evaluate the efficacy and safety of Huashi Baidu Granules(HSBD)in treating patients with severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)Omicron variant.Methods:A single-center retrospective cohort study was conducted during COVID-19 Omicron epidemic in the Mobile Cabin Hospital of Shanghai New International Expo Center from April 1st to May 23rd,2022.All COVID-19 patients with asymptomatic or mild infection were assigned to the treatment group(HSBD users)and the control group(non-HSBD users).After propensity score matching in a 1:1 ratio,496 HSBD users of treatment group were matched by propensity score to 496 non-HSBD users.Patients in the treatment group were administrated HSBD(5 g/bag)orally for 1 bag twice a day for 7 consecutive days.Patients in the control group received standard care and routine treatment.The primary outcomes were the negative conversion time of nucleic acid and negative conversion rate at day 7.Secondary outcomes included the hospitalized days,the time of the first nucleic acid negative conversion,and new-onset symptoms in asymptomatic patients.Adverse events(AEs)that occurred during the study were recorded.Further subgroup analysis was conducted in vaccinated(378 HSBD users and 390 non-HSBD users)and unvaccinated patients(118 HSBD users and 106 non-HSBD users).Results:The median negative conversion time of nucleic acid in the treatment group was significantly shortened than the control group[3 days(IQR:2-5 days)vs.5 days(IQR:4-6 days);P<0.01].The negative conversion rate of nucleic acid in the treatment group were significantly higher than those in the control group at day 7(91.73%vs.86.90%,P=0.014).Compared with the control group,the hospitalized days in the treatment group were significantly reduced[10 days(IQR:8-11 days)vs.11 days(IQR:10.25-12 days);P<0.01].The time of the first nucleic acid negative conversion had significant differences between the treatment and control groups[3 days(IQR:2-4 days)vs.5 days(IQR:4-6 days);P<0.01].The incidence of new-onset symptoms including cough,pharyngalgia,expectoration and fever in the treatment group were lower than the control group(P<0.05 or P<0.01).In the vaccinated patients,the median negative conversion time and hospitalized days were significantly shorter than the control group after HSDB treatment[3days(IQR:2-5days)vs.5 days(IQR:4-6 days),P<0.01;10 days(IQR:8-11 days)vs.11 days(IQR:10-12 days),P<0.01].In the unvaccinatedpatients,HSBD treatment efficiently shorten the median negative conversion time and hospitalized days[4 days(IQR:2-6 days)vs.5 days(IQR:4-7 days),P<0.01;10.5 days(IQR:8.75-11 days)vs.11.0 days(IQR:10.75-13 days);P<0.01].No serious AEs were reported during the study.Conclusion:HSBD treatment significantly shortened the negative conversion time of nuclear acid,the length of hospitalization,and the time of the first nucleic acid negative conversion in patients infectedwith SARS-COV-2Omicronvariant(Trial registry No.ChiCTR2200060472).
基金the National Traditional Chinese Medicine Multidisciplinary Innovation Team Project(No.ZYYCXTD-D-202203)National Traditional Chinese Medicine Emergency Medical Rescue Base Construction(No.ZY(2021-2023)-0101-01)+1 种基金World Federation of Chinese Medicine Societies Project(No.SZL-2022YI010)Emergency Tackle Project on COVID-19 Omicron Infection of Shanghai University of Traditional Chinese Medicine(No.2022YJ-03)。
文摘Objective: To assess the effect and safety of Reyanning Mixture(RYN) in treating asymptomatic or mild severe acute respiratory syndrome coronavirus 2(SARS-Co V-2) infection in children and adolescents. Methods: This is a prospective, open-label, randomized control ed trial. Patients aged 1–17 years and diagnosed with asymptomatic or mild coronavirus disease-2019(COVID-19) were assigned to an intervention group(RYN plus standard care) and a control group(standard care) according to a randomization list. The primary outcomes were SARS-Co V-2 negative conversion time. Secondary outcomes included negative conversion rate on days 3 and 7, hospital length of stay, symptom relief rate, new-onset symptoms of asymptomatic infected patients, and progressive disease rate. The cycle threshold(Ct) values of ORF1ab or N genes were also tested. Results: A total of 214 patients in the intervention group and 217 in the control group were analyzed. The SARS-CoV-2 negative conversion time was significantly shortened in the intervention group [5 days(interquartile range(IQR): 5–6) vs. 7 days(IQR: 6–7), P<0.01]. By days 3 and 7, the negative conversion rates were significantly higher in the intervention group(day 3: 32.7% vs. 21.2%, P=0.007;day 7: 75.2% vs. 60.8%, P=0.001). Ct values significantly increase on day 2 [ORF1ab gene: 35.62(IQR: 29.17–45.00) vs. 34.22(IQR: 28.41–39.41), P=0.03;N gene: 34.97(IQR: 28.50–45.00) vs. 33.51(IQR: 27.70–38.25), P=0.024] and day 3 [ORF1ab gene: 38.00(IQR: 32.72–45.00) vs. 35.81(IQR: 29.96–45.00), P=0.003;N gene: 37.16(IQR: 32.01–45.00) vs. 35.26(IQR: 29.09–45.00), P=0.01]. No significant difference was found in hospital length of stay between the two groups(P>0.05). Symptoms of cough were significantly improved(82.2% vs. 70.0%, P=0.02) and wheezing was significantly reduced(0.7% vs. 12.9%, P<0.01) in the intervention group compared with the control group. During the trial, no disease progression or serious adverse events were reported. Conclusion: Adding RYN to standard care may be a safe and effective treatment for children with asymptomatic and mild SARS-Co V-2 infection.(Registration No. Chi CTR2200060292)
基金Supported by the National Key Research and Development Program Project (No.2018YFC1705900)the Emergency Committee of the World Federation of Chinese Medicine Societies and Shanghai Society of Traditional Chinese Medicine and Shanghai Society of Traditional Chinese Medicine, Novel Coronavirus Pneumonia Emergency Tackling Key Project (No.SJZLJZ.N01)。
文摘Objective: To evaluate the effectiveness and safety of Baidu Jieduan Granules(BDJDG) to treat common type coronavirus disease 2019(COVID-19). Methods: This multicenter, retrospective, and observational clinical trial included 230 common COVID-19 patients in Leishenshan, Huangshi, and Laohekou Hospitals in Wuhan from January 21 to March 26, 2020. The included patients were further divided into two subgroups according to the use of supplemental oxygen, mild and moderate groups. During the first 14 d of hospitalization, all patients were administered BDJDG combined with conventional Western medicine, and observed for continuous 28 d. Primary outcomes were disease progression rate and discharge rate. Secondary outcomes included negative conversion time of nucleic acid, hospitalization duration, clinical symptom subsidence time, and symptom regression rate. Results: A total of 230 common COVID-19 patients were analyzed(138 in moderate group and 92 in mild group). By day 28, the disease progression rate was 4.3% and the discharge rate was 95.7%. All mild cases recovered and were discharged from hospital. The median negative conversion time of nucleic acid of all 230 COVID-19 patients was 12 d [inter-quartile range(IQR) 3.5–17], the median hospitalization duration was 15 d(IQR 12–20). The median time to fever, cough, and fatigue recovery was 4 d(IQR 2–6), 8 d(IQR 5–12), and 8 d(IQR 5–11), respectively. The recovery rate of fever, cough, and fatigue was 94.6%, 90.5%, and 93.5%. The median time to clinical improvement was 12 d(IQR 10–17). Compared with the baseline, total leukocyte, neutrophil, lymphocyte, and platelet counts were all increased significantly on days 7 and 14(P<0.01). C-reactive protein markedly increased on day 3 and significantly decreased on days 7 and 14(P<0.01). No serious adverse events occurred during treatment. Conclusion: BDJDG may be effective and safe for treatment of common type COVID-19.(Registration No. ChiCTR2000030836)
