Efficacy and Safety of Longyizhengqi Granule in Treatment of Mild COVID-19 Patients Caused by SARS-CoV-2 Omicron Variant: A Prospective Study

Miao Wang,1,* Jin Shi,2,* Kepei Zhang,1,* Jie Hong,2,* Xinwei Peng,2 Yu Tian,1 Wei Lu,3 Ke Li,2 Zengliang Wang,4 Feng Li,1 Zhijie Zhang,2 Guojiang Mei1 1Department of Internal Medicine of Traditional Chinese Medicine, Longhua Hospital, Shanghai University of Tradition...

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Main Authors: Wang M, Shi J, Zhang K, Hong J, Peng X, Tian Y, Lu W, Li K, Wang Z, Li F, Zhang Z, Mei G
Format: Article
Language:English
Published: Dove Medical Press 2023-03-01
Series:Infection and Drug Resistance
Subjects:
Online Access:https://www.dovepress.com/efficacy-and-safety-of-longyizhengqi-granule-in-treatment-of-mild-covi-peer-reviewed-fulltext-article-IDR
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author Wang M
Shi J
Zhang K
Hong J
Peng X
Tian Y
Lu W
Li K
Wang Z
Li F
Zhang Z
Mei G
author_facet Wang M
Shi J
Zhang K
Hong J
Peng X
Tian Y
Lu W
Li K
Wang Z
Li F
Zhang Z
Mei G
author_sort Wang M
collection DOAJ
description Miao Wang,1,&ast; Jin Shi,2,&ast; Kepei Zhang,1,&ast; Jie Hong,2,&ast; Xinwei Peng,2 Yu Tian,1 Wei Lu,3 Ke Li,2 Zengliang Wang,4 Feng Li,1 Zhijie Zhang,2 Guojiang Mei1 1Department of Internal Medicine of Traditional Chinese Medicine, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 2Department of Epidemiology and Health Statistics, Fudan University, Shanghai, People’s Republic of China; 3Department of Nursing, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 4Department of Epidemiology, School of Public Health, Shandong University, Jinan, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Zhijie Zhang, Department of Epidemiology and Health Statistics, School of Public Health, Fudan University, Xuhui District, School of Medicine Road, 130, Shanghai, People’s Republic of China, Tel +86-21-54237410, Email epistat@gmail.com; Guojiang Mei, Department of Internal Medicine of Traditional Chinese Medicine, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People’s Republic of China, Tel + 86-21-64385700, Email mgj_761014@sina.comPurpose: This study aimed to evaluate the clinical efficacy of Longyizhengqi granule, a traditional Chinese medicine, in patients with mild COVID-19.Patients and Methods: We conducted a prospective study including mild COVID-19 participants conducted at Mobile Cabin Hospital in Shanghai, China. Participants were assigned to receive Longyizhengqi granule or conventional treatment. The primary outcome was the time for nucleic acid to turn negative and the secondary outcomes are hospital stay and changes in cycle threshold (Ct) values for N gene and Orf gene. Multilevel random-intercept model was performed to analyze the effects of treatment.Results: A total of 3243 patients were included in this study (Longyizhengqi granule 667 patients; conventional treatment 2576 patients). Age (43.5 vs 42.1, p< 0.01) and vaccination doses (not vaccinated: 15.8% vs 21.7%, 1 dose: 3.5% vs 2.9%, 2 doses: 27.9% vs 25.6%, 3 doses: 52.8% vs 49.8%. p< 0.01) show statistical difference between Conventional treatment group and LYZQ granules group. The use of Longyizhengqi granule could significantly reduce the time for nucleic acid to turn negative (14.2 days vs 10.7 days, p< 0.01), shorten hospital stay (12.5 days vs 9.9 days, p< 0.01), and increase the changes in Ct value for N gene (8.44 vs 10.33, p< 0.01) and Orf gene (7.31 vs 8.44, p< 0.01) to approximately 1.5. Moreover, the difference in the changes of Ct values on the 4th, 6th, 8th, and 10th days seem to increase between two groups. No serious adverse events were reported.Conclusion: Longyizhengqi granule might be a promising drug for the treatment of mild COVID-19, and it might be beneficial to effectively shorten the negative transition time of nucleic acid, the total days of hospitalization, and increase the changes of Ct values. Long-term randomized controlled trials with follow-up evaluations are required to confirm its long-term efficacy.Keywords: COVID-19, Omicron variant, traditional Chinese medicine, prospective study
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spelling doaj.art-ebf380f08b664921a8b0b4f32bec52d92023-03-21T18:11:20ZengDove Medical PressInfection and Drug Resistance1178-69732023-03-01Volume 161611161882401Efficacy and Safety of Longyizhengqi Granule in Treatment of Mild COVID-19 Patients Caused by SARS-CoV-2 Omicron Variant: A Prospective StudyWang MShi JZhang KHong JPeng XTian YLu WLi KWang ZLi FZhang ZMei GMiao Wang,1,&ast; Jin Shi,2,&ast; Kepei Zhang,1,&ast; Jie Hong,2,&ast; Xinwei Peng,2 Yu Tian,1 Wei Lu,3 Ke Li,2 Zengliang Wang,4 Feng Li,1 Zhijie Zhang,2 Guojiang Mei1 1Department of Internal Medicine of Traditional Chinese Medicine, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 2Department of Epidemiology and Health Statistics, Fudan University, Shanghai, People’s Republic of China; 3Department of Nursing, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 4Department of Epidemiology, School of Public Health, Shandong University, Jinan, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Zhijie Zhang, Department of Epidemiology and Health Statistics, School of Public Health, Fudan University, Xuhui District, School of Medicine Road, 130, Shanghai, People’s Republic of China, Tel +86-21-54237410, Email epistat@gmail.com; Guojiang Mei, Department of Internal Medicine of Traditional Chinese Medicine, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People’s Republic of China, Tel + 86-21-64385700, Email mgj_761014@sina.comPurpose: This study aimed to evaluate the clinical efficacy of Longyizhengqi granule, a traditional Chinese medicine, in patients with mild COVID-19.Patients and Methods: We conducted a prospective study including mild COVID-19 participants conducted at Mobile Cabin Hospital in Shanghai, China. Participants were assigned to receive Longyizhengqi granule or conventional treatment. The primary outcome was the time for nucleic acid to turn negative and the secondary outcomes are hospital stay and changes in cycle threshold (Ct) values for N gene and Orf gene. Multilevel random-intercept model was performed to analyze the effects of treatment.Results: A total of 3243 patients were included in this study (Longyizhengqi granule 667 patients; conventional treatment 2576 patients). Age (43.5 vs 42.1, p< 0.01) and vaccination doses (not vaccinated: 15.8% vs 21.7%, 1 dose: 3.5% vs 2.9%, 2 doses: 27.9% vs 25.6%, 3 doses: 52.8% vs 49.8%. p< 0.01) show statistical difference between Conventional treatment group and LYZQ granules group. The use of Longyizhengqi granule could significantly reduce the time for nucleic acid to turn negative (14.2 days vs 10.7 days, p< 0.01), shorten hospital stay (12.5 days vs 9.9 days, p< 0.01), and increase the changes in Ct value for N gene (8.44 vs 10.33, p< 0.01) and Orf gene (7.31 vs 8.44, p< 0.01) to approximately 1.5. Moreover, the difference in the changes of Ct values on the 4th, 6th, 8th, and 10th days seem to increase between two groups. No serious adverse events were reported.Conclusion: Longyizhengqi granule might be a promising drug for the treatment of mild COVID-19, and it might be beneficial to effectively shorten the negative transition time of nucleic acid, the total days of hospitalization, and increase the changes of Ct values. Long-term randomized controlled trials with follow-up evaluations are required to confirm its long-term efficacy.Keywords: COVID-19, Omicron variant, traditional Chinese medicine, prospective studyhttps://www.dovepress.com/efficacy-and-safety-of-longyizhengqi-granule-in-treatment-of-mild-covi-peer-reviewed-fulltext-article-IDRcovid-19omicron varianttraditional chinese medicineprospective study
spellingShingle Wang M
Shi J
Zhang K
Hong J
Peng X
Tian Y
Lu W
Li K
Wang Z
Li F
Zhang Z
Mei G
Efficacy and Safety of Longyizhengqi Granule in Treatment of Mild COVID-19 Patients Caused by SARS-CoV-2 Omicron Variant: A Prospective Study
Infection and Drug Resistance
covid-19
omicron variant
traditional chinese medicine
prospective study
title Efficacy and Safety of Longyizhengqi Granule in Treatment of Mild COVID-19 Patients Caused by SARS-CoV-2 Omicron Variant: A Prospective Study
title_full Efficacy and Safety of Longyizhengqi Granule in Treatment of Mild COVID-19 Patients Caused by SARS-CoV-2 Omicron Variant: A Prospective Study
title_fullStr Efficacy and Safety of Longyizhengqi Granule in Treatment of Mild COVID-19 Patients Caused by SARS-CoV-2 Omicron Variant: A Prospective Study
title_full_unstemmed Efficacy and Safety of Longyizhengqi Granule in Treatment of Mild COVID-19 Patients Caused by SARS-CoV-2 Omicron Variant: A Prospective Study
title_short Efficacy and Safety of Longyizhengqi Granule in Treatment of Mild COVID-19 Patients Caused by SARS-CoV-2 Omicron Variant: A Prospective Study
title_sort efficacy and safety of longyizhengqi granule in treatment of mild covid 19 patients caused by sars cov 2 omicron variant a prospective study
topic covid-19
omicron variant
traditional chinese medicine
prospective study
url https://www.dovepress.com/efficacy-and-safety-of-longyizhengqi-granule-in-treatment-of-mild-covi-peer-reviewed-fulltext-article-IDR
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