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Journal of Traditional Chinese Medicine >

2026 , Vol. 46 >Issue 3: 652 - 665

DOI: https://doi.org/10.19852/j.cnki.jtcm.20260206.001

Original Articles

A multicenter randomized controlled trial and metabolomics exploration of Traditional Chinese Medicine pattern-based therapy for stable chronic obstructive pulmonary disease

  • DING Huanzhang ,
  • WANG Hui ,
  • YANG Qinjun ,
  • MA Xiao ,
  • WU Di ,
  • LI Qiao ,
  • ZHENG Caixia ,
  • LU Jiasheng ,
  • WU Chengming ,
  • HUANG Pingfu ,
  • CHEN Zhixiang ,
  • WANG Shihan ,
  • FENG Jihong ,
  • LIU Jian ,
  • SUN Dengdi ,
  • ZHU Jie ,
  • TONG Jiabing ,
  • GAO Yating ,
  • LI Zegeng
Expand
  • 1 Department of Respiratory Medicine, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230000, China
    2 Fuyang Medical School, Fuyang Normal University, Fuyang 236037, China
    3 College of Traditional Chinese Medicine, Anhui University of Chinese Medicine, Hefei 230000, China
    4 Anhui Provincial Key Laboratory for the Application and Transformation of Traditional Chinese Medicine in the Prevention and Treatment of Major Respiratory Diseases, Hefei 230000, China
    5 Department of Respiratory Medicine, Jieshou Hospital of Traditional Chinese Medicine, Jieshou 236500, China
    6 Department of Respiratory Medicine, Huaibei Hospital of Traditional Chinese Medicine, Huaibei 235000, China
    7 Department of Respiratory Medicine, Taihe Hospital of Traditional Chinese Medicine, Taihe 236600, China
    8 Department of Respiratory Medicine, Bozhou Hospital of Traditional Chinese Medicine, Bozhou 236000, China
    9 Department of Respiratory Medicine, Chuzhou Integrated Traditional Chinese and Western Medicine Hospital, Chuzhou 239000, China
    10 Department of Respiratory Medicine, Wuhu Hospital of Traditional Chinese Medicine, Wuhu 241000, China
    11 Department of Respiratory Medicine, Lu'an Hospital of Traditional Chinese Medicine, Lu'an 237000, China
    12 Department of Respiratory Medicine, Second Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin 300250, China
    13 School of Computer Science and Technology, Anhui University, Hefei 230601, China
First author contact:

DING Huanzhang and WANG Hui are co-first authors and contributed equally to this work

Prof. LI Zegeng, Department of Respiratory Medicine, the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230000, China; Anhui Provincial Key Laboratory for the Application and Transformation of Traditional Chinese Medicine in the Prevention and Treatment of Major Respiratory Diseases, Hefei 230000, China. ahzyfb@sina.com, Telephone: +86-13805516609

Received date: 2025-04-14

  Accepted date: 2025-08-11

  Online published: 2026-02-06

Supported by

National Natural Science Foundation of China-funded Project: Discussion of Molecular Mechanisms of Xin'an Guben Peiyuan Method Based on Inflammation Immune Network Regulation to Improve Chronic Obstructive Pulmonary Disease Patient Perception Through Formula Syndrome Correspondence(U20A20398);Natural Science Foundation of Anhui Province-funded Project: Experimental Study on Regulation of Immune Function in Chronic Obstructive Pulmonary Disease Rats with Phlegm Stasis Obstructing Lung Syndrome by Yiqi Huatan Quyu Formula Through Lung Gut Microbiota Imbalance(2208085QH264)

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Abstract

OBJECTIVE: To evaluate the efficacy of Traditional Chinese Medicine (TCM) pattern-based comprehensive therapy on stable chronic obstructive pulmonary disease (COPD) patients and its influence on metabolic profiles.

METHODS: In this multicenter trial, 270 participants from nine hospitals were randomly divided into a trial group and a control group at a 1∶2 ratio. The trial group received Tiotropium Bromide Powder for Inhalation (TBPI) plus one of three TCM granules [Shenqi Wenfei formula (参芪温肺方), Shenqi Buzhong formula (参芪补中方), or Shenqi Tiaoshen formula (参芪调肾方)], while the control group got only TBPI. The study had a 24-week treatment and 52-week follow-up. The main outcome was the frequency of acute COPD exacerbations. Secondary outcomes included related rates, scores on COPD assessment test (CAT) and modified medical research council (mMRC) dyspnea scale, 6-min walk test (6MWT) distance, and lung function, measured at weeks 0, 24, and 52. Serum samples for metabolomics were taken from the trial group before/after treatment and from healthy people.

RESULTS: A total of 256 out of 270 patients completed the study. The trial group had fewer acute exacerbations than the control group during 52-week follow-up (P <0.05). At 24 weeks, the trial group improved in CAT, mMRC, and 6MWT compared to the control (P <0.05), with mMRC and 6MWT improvements lasting at week 52. Lung function showed no significant group differences. Metabolomics found 32 different metabolites between healthy and pre-treatment patients, 17 reversing post-treatment. Bioinformatics showed pathway changes in pre-treatment patients reversed after treatment.

CONCLUSION: TCM pattern-based comprehensive therapy reduces acute exacerbation risk and improves quality of life, respiratory symptoms, and exercise tolerance in stable COPD patients, likely by modulating energy, protein, and amino acid metabolism pathways.

Key words： pulmonary disease, chronic obstructive; metabolomics; Traditional Chinese Medicine pattern; Shenqi Wenfei formula; Shenqi Buzhong formula; Shenqi Tiaoshen formula

Cite this article

DING Huanzhang , WANG Hui , YANG Qinjun , MA Xiao , WU Di , LI Qiao , ZHENG Caixia , LU Jiasheng , WU Chengming , HUANG Pingfu , CHEN Zhixiang , WANG Shihan , FENG Jihong , LIU Jian , SUN Dengdi , ZHU Jie , TONG Jiabing , GAO Yating , LI Zegeng . A multicenter randomized controlled trial and metabolomics exploration of Traditional Chinese Medicine pattern-based therapy for stable chronic obstructive pulmonary disease[J]. Journal of Traditional Chinese Medicine, 2026 , 46(3) : 652 -665 . DOI: 10.19852/j.cnki.jtcm.20260206.001

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