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2021, Volume 15, Issue 5

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Frontiers of Medicine >> 2021, Volume 15, Issue 5 doi: 10.1007/s11684-021-0853-6

Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial

. Division of Cardiology, Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological Disorders, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.. The First Affiliated Hospital of University of Science and Technology of China, Hefei 230026, China.. State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.. Harbin Pharmaceutical Group Co., Ltd., Harbin 150070, China.. The Sixth Hospital of Harbin, Harbin 150036, China.. The Second Hospital of Nanjing and the Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210003, China.. Department of Cardiology, Chinese People’s Liberation Army Central War Command General Hospital, Wuhan 430010, China.. Department of Information Management, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.. Division of Respiratory, Department of Internal Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.. Shanghai Institute for Advanced Immunochemical Studies and School of Life Science and Technology, ShanghaiTech University, Shanghai 201210, China

Received: 2021-03-18 Accepted: 2021-04-27 Available online: 2021-04-27
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Abstract

We conducted a randomized, open-label, parallel-controlled, multicenter trial on the use of Shuanghuanglian (SHL), a traditional Chinese patent medicine, in treating cases of COVID-19. A total of 176 patients received SHL by three doses (56 in low dose, 61 in middle dose, and 59 in high dose) in addition to standard care. The control group was composed of 59 patients who received standard therapy alone. Treatment with SHL was not associated with a difference from standard care in the time to disease recovery. Patients with 14-day SHL treatment had significantly higher rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests than the patients from the control group (93.4% vs. 73.9%, =0.006). Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), −46.39 (−86.83 to −5.94) HU; =0.025) and day 14 (mean difference (95% CI), −74.21 (−133.35 to −15.08) HU; =0.014). No serious adverse events occurred in the SHL groups. This study illustrated that SHL in combination with standard care was safe and partially effective for the treatment of COVID-19.

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