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

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

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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).

Traditional Chinese medicineCOVID-19Nirmatrelvir-RitonavirSustained clinical recovery

Xiaohui Zou、Kang Chang、Guohui Fan、Huanwei Zheng、Hezheng Shen、Liang Tang、Yingying Yang、Yeming Wang、Linhua Zhao、Hong Lv、Xin Zhou、Xiaoming Shen、Liqiang Chen、Xiaolin Tong、Bin Cao、for CAP-China network

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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

Department of Clinical Research and Data Management Center of Respiratory Medicine,Center of Respiratory Medicine,China-Japan Friendship Hospital,Beijing 100029,China

Shijiazhuang Hospital of Traditional Chinese Medicine,Shijiazhuang 050051,China

Linyi Traditional Chinese Medicine Hospital,Linyi 276000,China

Wuxi Traditional Chinese Medicine Hospital,Wuxi 214071,China

Department of Traditional Chinese Medicine for Pulmonary Diseases,Center of Respiratory Medicine,China-Japan Friendship Hospital,Beijing 100029,China

Institute of Metabolic Diseases,Guang'anmen Hospital of China,Academy of Chinese Medical Sciences,Beijing 100053,China

Taicang Traditional Chinese Medicine Hospital,Taicang 215400,China

The First Hospital of Qiqihar,Qiqihar 161005,China

The Second Affiliated Hospital of Jiaxing University,Jiaxing 314000,China

Huizhou First Hospital,Huizhou 516003,China

National Center for Integrated Traditional Chinese Medicine and Western Medicine,China-Japan Friendship Hospital,Beijing 100029,China

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Jiangsu Kanion Pharmaceutical Co.,LtdInnovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine

ZYYCXTD-D-202208

2024

10.1016/j.scib.2024.04.040

科学通报(英文版)
中国科学院

科学通报(英文版)

CSTPCD
ISSN：1001-6538
年,卷(期)：2024.69(12)
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