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

被引:40
作者
Ni, Li [1 ,2 ]
Wen, Zheng [1 ,2 ]
Hu, Xiaowen [3 ]
Tang, Wei [4 ]
Wang, Haisheng [5 ]
Zhou, Ling [1 ,2 ]
Wu, Lujin [1 ,2 ]
Wang, Hong [1 ,2 ]
Xu, Chang [1 ,2 ]
Xu, Xizhen [1 ,2 ]
Xiao, Zhichao [1 ,2 ]
Li, Zongzhe [1 ,2 ]
Li, Chene [1 ,2 ]
Liu, Yujian [1 ,2 ]
Duan, Jialin [1 ,2 ]
Chen, Chen [1 ,2 ]
Li, Dan [1 ,2 ]
Zhang, Runhua [1 ,2 ]
Li, Jinliang [6 ]
Yi, Yongxiang [7 ,8 ]
Huang, Wei [1 ,2 ,9 ]
Chen, Yanyan [10 ]
Zhao, Jianping [11 ]
Zuo, Jianping [4 ]
Weng, Jianping [3 ]
Jiang, Hualiang [4 ,12 ,13 ]
Wang, Dao Wen [1 ,2 ]
机构
[1] Huazhong Univ Sci & Technol, Div Cardiol, Dept Internal Med, Tongji Hosp,Tongji Med Coll, Wuhan 430030, Peoples R China
[2] Huazhong Univ Sci & Technol, Hubei Key Lab Genet & Mol Mech Cardiol Disorders, Tongji Hosp, Tongji Med Coll, Wuhan 430030, Peoples R China
[3] Univ Sci & Technol China, Affiliated Hosp 1, Hefei 230026, Peoples R China
[4] Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, Shanghai 201203, Peoples R China
[5] Harbin Pharmaceut Grp Co Ltd, Harbin 150070, Peoples R China
[6] Sixth Hosp Harbin, Harbin 150036, Peoples R China
[7] Nanjing Univ Chinese Med, Second Hosp Nanjing, Nanjing 210003, Peoples R China
[8] Nanjing Univ Chinese Med, Affiliated Hosp, Nanjing 210003, Peoples R China
[9] Chinese Peoples Liberat Army Cent War Command Gen, Dept Cardiol, Wuhan 430010, Peoples R China
[10] Huazhong Univ Sci & Technol, Dept Informat Management, Tongji Hosp, Tongji Med Coll, Wuhan 430030, Peoples R China
[11] Huazhong Univ Sci & Technol, Div Resp, Dept Internal Med, Tongji Hosp,Tongji Med Coll, Wuhan 430030, Peoples R China
[12] ShanghaiTech Univ, Shanghai Inst Adv Immunochem Studies, Shanghai 201210, Peoples R China
[13] ShanghaiTech Univ, Sch Life Sci & Technol, Shanghai 201210, Peoples R China
基金
国家重点研发计划;
关键词
COVID-19; SARS-CoV-2; Shuanghuanglian oral liquid; clinical trial;
D O I
10.1007/s11684-021-0853-6
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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%, P = 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; P = 0.025) and day 14 (mean difference (95% CI), -74.21 (-133.35 to -15.08) HU; P = 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.
引用
收藏
页码:704 / 717
页数:14
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