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 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)
