Effectiveness and safety of Sanhan Huashi granules versus nirmatrelvir-ritonavir in adult patients with COVID-19:A randomized,open-label,multicenter trial

Xiaohui Zou ¹Kang Chang ¹Guohui Fan ²Huanwei Zheng ³Hezheng Shen ⁴Liang Tang ⁵Yingying Yang ⁶Yeming Wang ¹Linhua Zhao ⁷Hong Lv ⁸Xin Zhou ⁹Xiaoming Shen ¹⁰Liqiang Chen ¹¹Xiaolin Tong ¹²Bin Cao ¹for CAP-China network

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作者信息

1. National Center for Respiratory Medicine;State Key Laboratory of Respiratory Health and Multimorbidity;National Clinical Research Center for Respiratory Diseases;Institute of Respiratory Medicine,Chinese Academy of Medical Sciences;Laboratory of Clinical Microbiology and Infectious Diseases,Department of Pulmonary and Critical Care Medicine,Center of Respiratory Medicine,China-Japan Friendship Hospital,Beijing 100029,China
2. National Center for Respiratory Medicine;State Key Laboratory of Respiratory Health and Multimorbidity;National Clinical Research Center for Respiratory Diseases;Institute of Respiratory Medicine,Chinese Academy of Medical Sciences;Department of Clinical Research and Data Management Center of Respiratory Medicine,Center of Respiratory Medicine,China-Japan Friendship Hospital,Beijing 100029,China
3. Shijiazhuang Hospital of Traditional Chinese Medicine,Shijiazhuang 050051,China
4. Linyi Traditional Chinese Medicine Hospital,Linyi 276000,China
5. Wuxi Traditional Chinese Medicine Hospital,Wuxi 214071,China
6. National Center for Respiratory Medicine;State Key Laboratory of Respiratory Health and Multimorbidity;National Clinical Research Center for Respiratory Diseases;Institute of Respiratory Medicine,Chinese Academy of Medical Sciences;Department of Traditional Chinese Medicine for Pulmonary Diseases,Center of Respiratory Medicine,China-Japan Friendship Hospital,Beijing 100029,China
7. Institute of Metabolic Diseases,Guang'anmen Hospital of China,Academy of Chinese Medical Sciences,Beijing 100053,China
8. Taicang Traditional Chinese Medicine Hospital,Taicang 215400,China
9. The First Hospital of Qiqihar,Qiqihar 161005,China
10. The Second Affiliated Hospital of Jiaxing University,Jiaxing 314000,China
11. Huizhou First Hospital,Huizhou 516003,China
12. Institute of Metabolic Diseases,Guang'anmen Hospital of China,Academy of Chinese Medical Sciences,Beijing 100053,China;National Center for Integrated Traditional Chinese Medicine and Western Medicine,China-Japan Friendship Hospital,Beijing 100029,China
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Abstract

Sanhan Huashi granules(SHG)demonstrated therapeutic effects against coronavirus disease 2019(COVID-19)in observational studies.In order to compare the effectiveness and safety of SHG and nirma-trelvir-ritonavir in treating adults with mild-to-moderate COVID-19,we conducted a randomized,active-controlled,open-label,multi-center trial conducted between February and July in 2023.The patients were randomized in a 1∶1 ratio to the SHG group and the nirmatrelvir-ritonavir group.A total of 400 participants were randomized,among which 200 participants ultimately received SHG and 198 received nirmatrelvir-ritonavir.The primary outcome was time to sustained clinical recovery through day 28.SHG significantly shortened the median time to sustained clinical recovery compared to nirmatrelvir-riton-avir(6.0(95％CI,5.0 to 6.0)vs.8.0(95％Cl,6.0 to 9.0)d;P=0.001),particularly for individual symptoms including fever,sore throat,cough and fatigue.No participants in either group died and incidence of severe COVID-19 showed no difference between two groups.Participants who received nirmatrelvir-ritonavir demonstrated a higher rate of virus clearance on day 5 compared to those received SHG(46.4％(95％CI,39.1 to 53.7)vs.65.6％(95％CI,58.3 to 72.4);P＜0.001).Most adverse events were mild in both groups.In summary,SHG was superior to nirmatrelvir-ritonavir in shortening the time to sustained clinical recovery in participants with mild-to-moderate COVID-19,despite a lower virus clear-ance rate observed after 5 d of treatment(Chinese Clinical Trial Registry Identifier:ChiCTR2300067872).

Key words

Traditional Chinese medicine/COVID-19/Nirmatrelvir-Ritonavir/Sustained clinical recovery

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基金项目

Jiangsu Kanion Pharmaceutical Co.,Ltd()

Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine(ZYYCXTD-D-202208)

出版年

2024

科学通报(英文版)

中国科学院

科学通报(英文版)

CSTPCD

ISSN：1001-6538

参考文献量1

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