Advanced Search

Journal of Traditional Chinese Medicine ›› 2026, Vol. 46 ›› Issue (5): 1248-1256.DOI: 10.19852/j.cnki.jtcm.2026.05.017

• Original Articles • Previous Articles     Next Articles

Bufei Huoxue capsules (补肺活血胶囊) enhance lung function in pneumoconiosis: a multicenter, randomized clinical trial

HUANG Limin1, CHEN Zidan1, XIAO Xiongbin2, CUI Ping3, SHI Weiwu4, PENG Lijun5, MAO Ling1()   

  1. 1 Department of Pneumoconiosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai 200433, China
    2 Department of Occupational Medicine, Hunan Prevention and Treatment Institute for Occupational Diseases, Changsha 410021, China
    3 Department of Pneumoconiosis, Occupational Disease Hospital, Shandong First Medical University, Jinan 250002, China
    4 Department of Occupational Medicine, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250001, China
    5 Department of Pneumoconiosis, Fourth Hospital of West China, Sichuan University, Chengdu 730311, China
  • Received:2025-04-12 Accepted:2025-12-22 Online:2026-10-15 Published:2026-10-09
  • Contact: Dr. MAO Ling, Department of Pneumoconiosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai 200433, China. maoling113@sina.com,Telephone: +86-13918501570
  • About author:First author contact:

    HUANG Linmin and CHEN Zidan have contributed equally to this work and share first authorship

  • Supported by:
    Open Research Fund of the Key Laboratory of Pneumoconiosis of the National Health Commission: Clinical Trial on the Accuracy of Remote Data Collection for Patients with Pneumoconiosis Using Technological Electrocardiogram Patches(NHC202308)

RichHTML

2

PDF

10

Supplement

1

Abstract:

OBJECTIVE: To clarify the efficacy and safety of Bufei Huoxue (BFHX) capsules (补肺活血胶囊) for the treatment of pneumoconiosis.

METHODS: This multicenter, double-blind, randomized, placebo-controlled trial enrolled patients with pneum-oconiosis from five centers between June 2020 and June 2023. Participants were randomized 1∶1 to receive oral BFHX capsules or matched placebo (4 capsules, thrice daily) for 24 weeks. The primary endpoint was the change from baseline in forced vital capacity percent predicted (FVC%) at 24 weeks. Secondary outcomes included changes in forced expiratory volume in 1 s percent predicted (FEV1%), 6-min walk test (6MWT) distance, COPD assessment test (CAT) score, Modified British Medical Research Council (mMRC) dyspnea scale score, and serum biomarkers at weeks 8 and 24. Safety was assessed through adverse events and laboratory analyses. Efficacy was evaluated in both the full analysis set (FAS) and per-protocol set (PPS), with blinding maintained throughout the trial.

RESULTS: In total, 162 patients were included in the study. For the primary outcome, the change from baseline in FVC% at 24 weeks was significantly greater in BFHX group than placebo group [BFHX-placebo least squares (LS): 5.65 ± 2.01, 95% confidence interval (CI) (1.68, 9.62), P = 0.0056]. A significant difference of FVC% was also observed at week 8 [BFHX-placebo LS: 3.50 ± 1.72, 95% CI(0.11, 6.90), P = 0.0434]. Significant improvements in secondary outcomes were also observed at week 24, including FEV1% [BFHX-placebo LS: 5.33 ± 2.51, 95% CI(0.37, 10.3), P = 0.0352], 6MWT distance [BFHX-placebo LS: 22.7 ± 8.76, 95% CI(5.40, 40.1), P = 0.0105], CAT score [BFHX-placebo LS: －2.14 ± 0.85, 95% CI(－3.82, －0.46), P = 0.0130], and mMRC score [BFHX-placebo LS: －0.34 ± 0.10, 95% CI(－0.54, －0.13), P = 0.0014]. The mMRC score also showed improvement at week 8 [BFHX-placebo LS: －0.25 ± 0.11, 95% CI(－0.47, －0.02), P = 0.0308]. Results were consistent in both the per-protocol and full analysis sets. No significant between-group differences were observed in laboratory safety parameters, inflammatory markers, or coagulation profiles (all P > 0.05). The overall safety profile was similar between the two groups.

CONCLUSIONS: BFHX capsules improved lung function, exercise tolerance, and respiratory symptoms in patients with pneumoconiosis. Therefore, this treatment can be safely and effectively used in patients with pneumoconiosis.

Key words: pneumoconiosis, randomized control trial, lung function, Bufei Huoxue capsules

Cite this article

HUANG Limin, CHEN Zidan, XIAO Xiongbin, CUI Ping, SHI Weiwu, PENG Lijun, MAO Ling. Bufei Huoxue capsules (补肺活血胶囊) enhance lung function in pneumoconiosis: a multicenter, randomized clinical trial[J]. Journal of Traditional Chinese Medicine, 2026, 46(5): 1248-1256.