Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial

Jia-bo WANG; Zhong-xia WANG; Jing JING; Peng ZHAO; Jing-hui DONG; Yong-feng ZHOU; Guang YANG; Ming NIU; Xu ZHAO; Tian-jun JIANG; Jing-feng BI; Zhe XU; Ping ZHANG; Dan WU; Zhao-fang BAI; Yu-ming GUO; Si-miao YU; Yong-qiang SUN; Zi-teng ZHANG; Xiao-yan ZHAN; Peng-yan LI; Jin-biao DING; Peng-fei ZHAO; Xue-ai SONG; Jian-yuan TANG; Dong-chu HE; Zhu CHEN; En-qiang QIN; Rui-lin WANG; Xiao-he XIAO

doi:10.1007/s11655-020-3426-7

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Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial

Original Article | Updated：2021-08-23

- Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial
- Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial
- Chinese Journal of Integrative Medicine 2020年26卷第9期页码：648-655
- Affiliations：
  
  1.China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing (100039), China
  2.Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing (100039), China
  3.Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing (100039), China
  4.National Clinical Research Center for Infectious Diseases, Beijing (100039), China
  5.Department of Radiology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing (100039), China
  6.Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing (100039), China
  7.Sichuan Evidence-Based Medicine Center of Traditional Chinese Medicine Affliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu (610075), China
  8.College of Life Science, Beijing University of Chinese Medicine, Beijing (100029), China
  9.Department of Integrated Treatment, General Hospital of Central Theater Command, Wuhan (430070), China
- Author bio：
  
  Prof. QIN En-qiang, E-mail:qeq2004@sina.com
  Prof. WANG Rui-lin, E-mail:wrl7905@163.com;
  Correspondence to: Prof. XIAO Xiao-he, E-mail:pharmacy302xxh@126.com;
- Funds：
  
  the National Administration of Traditional Chinese Medicine Project(2020ZYLCYJ05-1);the National Natural Science Foundation of China(81630100;81721002;81930110);China PLA Biosecurity Project(19SWAQ13);China PLA Emergency Project(BWS20J006);the Beijing Administration of Traditional Chinese Medicine Project(YJ2020-03;SYFY202011)
- DOI：10.1007/s11655-020-3426-7
  中图分类号：
- 纸质出版日期：2020-09-01，
  
  网络出版日期：2020-07-16，
  
  录用日期：2020-06-26
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Jia-bo WANG, Zhong-xia WANG, Jing JING, 等. Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(9):648-655.

Jia-bo WANG, Zhong-xia WANG, Jing JING, et al. Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(9):648-655.
Jia-bo WANG, Zhong-xia WANG, Jing JING, 等. Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(9):648-655. DOI： 10.1007/s11655-020-3426-7.

Jia-bo WANG, Zhong-xia WANG, Jing JING, et al. Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(9):648-655. DOI： 10.1007/s11655-020-3426-7.

摘要

Abstract

Objectives:

To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.

Methods:

A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized

controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation

50 μg twice daily; and lopinavir/ritonavir

400 and 100 mg twice daily

respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment

adverse events

time to fever resolution

ARDS development

and lung injury on newly diagnosed COVID-19 patients were assessed.

Results:

An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result

the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm

the testing arm exhibited a significant improvement in time to fever resolution (

=0.035)

and a significant reduction in the development of ARDS (

=0.048).

Conclusions:

Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT 04251871 at www.clinicaltrials.gov)

关键词

Keywords

COVID-19SARS-CoV-2acute respiratory distress syndromeChinese medicine

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