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

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

机构地区：[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

出　　处：《Chinese Journal of Integrative Medicine》2020年第9期648-655,共8页中国结合医学杂志（英文版）

基　　金：the National Administration of Traditional Chinese Medicine Project(No.2020ZYLCYJ05-1);the National Natural Science Foundation of China(Nos.81630100,81721002,81930110);China PLA Biosecurity Project(No.19SWAQ13);China PLA Emergency Project(BWS20J006);the Beijing Administration of Traditional Chinese Medicine Project(Nos.YJ2020-03,SYFY202011)。

摘　　要：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(x g twice daily;and lopinavir/ritonavir,400 and 100 mg twice daily,respectively)and a testing therapy(control therapy plus Keguan-119.4 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(P=0.035),and a significant reduction in the development of ARDS(P=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：COVID-19 SARS-CoV-2 acute respiratory distress SYNDROME Chinese MEDICINE 

分 类 号：R563.1[医药卫生—呼吸系统]