Advanced Search

Journal of Traditional Chinese Medicine >

2025 , Vol. 45 >Issue 6: 1395 - 1404

DOI: https://doi.org/10.19852/j.cnki.jtcm.2025.06.017

Original Articles

Dongtian Changchun ointment (洞天长春膏) for moderate-to-severe chronic obstructive pulmonary disease: a multicenter, prospective, open-label, randomized controlled trial

  • Yibao ZHANG ,
  • Feng CHEN ,
  • Meng SUN ,
  • Zhenwei WANG ,
  • Binqing TANG ,
  • Yechang QIAN ,
  • Wei JIA ,
  • Yufang BAO ,
  • Wenjie LI ,
  • Shanqun LI ,
  • Wei ZHANG
Expand
  • 1 Department of Pulmonary Diseases, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China
    2 Department of Respiratory Medicine, Yueyang Hospital of Integrated Traditional Chinese and Westem Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200083, China
    3 Department of Respiratory Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China
    4 Department of Respiratory Medicine, Shanghai Baoshan Hospital of Integrated Chinese and Western Medicine, Shanghai 201900, China
    5 Department of Respiratory Medicine, Shanghai TCM-integrated hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200082, China
    6 Department of Respiratory Medicine, Shanghai Pudong TCM Hospital, Shanghai 201299, China
    7 Department of Respiratory Medicine, Shanghai North Station Hospital, Shanghai 200070, China
    8 Department of Respiratory Medicine, Zhongshan Hospital Affiliated to Fudan University, Shanghai 200032, China
    9 Department of Pulmonary Diseases, Shuguang Hospital, Shanghai Institute of Infectious Diseases and Biosecurity, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China; Baoshan Famous Traditional Chinese Medicine Inheritance Studio, Shanghai Baoshan Hospital of Integrated Chinese and Western Medicine, Shanghai 201900, China; Institute of Infectious Diseases, Shanghai Institute of Traditional Chinese Medicine, Shanghai 201203, China
ZHANG Yibao and CHEN Feng are co-first authors and contributed equally to this work

Received date: 2024-11-22

  Accepted date: 2025-03-26

  Online published: 2025-11-24

Supported by

Shanghai Municipal Science and Technology Major Project: Clinical Research and Evaluation of TCM Diagnosis and Treatment of Sudden Acute Infectious Diseases(ZD2021CY001);National Key Research and Development Program of China: Research on the Establishment of Rehabilitation Systems and Strategies for Chronic Obstructive Pulmonary Disease and Clinical Applicability(2018YFC1313600);Shanghai Committee of Science and Technology Key Laboratory of Traditional Chinese Medicine Project(20DZ2272200);Shanghai Key Clinical Specialty Construction Project(shslczdzk05101);Cultivation and Construction Project for the Doctoral Program in Medical Technology

Fold

Abstract

OBJECTIVE: To evaluate the clinical efficacy and safety of Dongtian Changchun ointment (洞天长春膏, DTCO) for the treatment of patients with stable moderate-to-severe chronic obstructive pulmonary disease (COPD).

METHODS: This was a multicenter, prospective, open-label, randomized controlled trial. Patients with COPD who met the inclusion and exclusion criteria were randomly divided into a DTCO group and a control group in a 1∶1 ratio. Both groups were treated with Symbicort Turbuhaler (320 μg / 9 μg twice daily) for 48 weeks. The DTCO group was given additional DTCO (15 g twice daily) for the first 12 weeks. Outcome assessments were conducted at five time points: 0, 12, 24, 36, and 48 weeks. Primary outcome measures included frequency and duration of acute exacerbation of COPD (AECOPD). Secondary outcomes included St. George’s Breathing Questionnaire, pulmonary function, 6-min walk test, and modified Medical Research Council (mMRC) scores.

RESULTS: A total of 84 patients were randomly divided into the DTCO group (n = 42) and the control group (n = 42). The results showed that in the DTCO group, 23 patients had AECOPD for a total duration of 166 d compared with 31 patients in the control group for a total duration of 307 d. Compared with the control group, the DTCO group showed a significant reduction in the median (interquartile range) frequency and duration of AECOPD (P < 0.05). The incidence of AECOPD significantly reduced in the DTCO group to 0.539 [95% confidence interval (0.347, 0.836), P = 0.006]. In the DTCO group, a significant improvement in forced vital capacity was observed at 12 and 48 weeks (P < 0.05), and a reduction in mMRC was noted at 36 and 48 weeks (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups.

CONCLUSIONS: DTCO significantly reduced the frequency and duration of AECOPD in patients with moderate-to-severe COPD, and demonstrated satisfactory safety.

Key words： pulmonary disease, chronic obstructive; acute exacerbation; Dongtian Changchun ointment; randomized controlled trial

Cite this article

Yibao ZHANG , Feng CHEN , Meng SUN , Zhenwei WANG , Binqing TANG , Yechang QIAN , Wei JIA , Yufang BAO , Wenjie LI , Shanqun LI , Wei ZHANG . Dongtian Changchun ointment (洞天长春膏) for moderate-to-severe chronic obstructive pulmonary disease: a multicenter, prospective, open-label, randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2025 , 45(6) : 1395 -1404 . DOI: 10.19852/j.cnki.jtcm.2025.06.017

References

1. Christenson SA, Smith BM, Bafadhel M, Putcha N. Chronic obstructive pulmonary disease. Lancet 2022; 399: 2227-42.
2. Collins PF, Yang IA, Chang YC, Vaughan A. Nutritional support in chronic obstructive pulmonary disease (COPD): an evidence update. J Thorac Dis 2019; 11: S2230-7.
3. World Health Organization. The top 10 causes of death. online, 2024-08-07, cited 2024-12-22; 3 screens. Available from URL:. Available from URL: https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death.
4. Rothnie KJ, Mullerova H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2018; 198: 464-71.
5. Zhang X, Zhou Q, Wang S, Ma Q, Sun Y. Etiology of emergency visit and in-hospital outcomes of patients with COPD. Emerg Med Int 2022; 2022: 8247133.
6. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for prevention, diagnosis and management of COPD: 2023 Report online, 2022-11-15, cited 2024-2-23: 115. Available from URL: https://goldcopd.org/2023-gold-report-2/.
7. Plavec D, Vrbica ?. What is pre-COPD and do we know how to treat it? Expert Rev Respir Med 2024; 18: 349-54.
8. Cowan J, Mulpuru S, Abdallah SJ, et al. A randomized double-blind placebo-control feasibility trial of immunoglobulin treatment for prevention of recurrent acute exacerbations of COPD. Int J Chron Obstruct Pulmon Dis 2021; 16: 3275-84.
9. Cao X, Wang Y, Chen Y, et al. Advances in Traditional Chinese Medicine for the treatment of chronic obstructive pulmonary disease. J Ethnopharmacol 2023; 307: 116229.
10. Kong Q, Cao Y, Gao Z, et al. Efficacy and safety of modified Bushen Yiqi formulas (MBYF) as an add-on to formoterol and budesonide in the management of COPD: study protocol for a multicentre, double-blind, placebo-controlled, parallel-group, randomized clinical trial: FB-MBYF trial. Trials 2022; 23: 143.
11. Qi R, Zhang H, Li D, et al. The efficacy and safety of Xinjia Xuanbai Chengqi granules in acute exacerbation of COPD: a multicentre, randomised, double-blind, controlled trial. Evid Based Complement Alternat Med 2022; 2022: 7366320.
12. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010; 152: 726-32.
13. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for prevention, diagnosis and management of COPD: 2020 Report online, 2019-11-05, cited 2024-2-23: 31. Available from URL: https://goldcopd.org/gold-reports/.
14. Lung disease Professional Committee, Internal Medicine Branch, China Association of Traditional Chinese Medicine. The diagnostic criteria of TCM for chronic obstructive pulmonary disease (2011 edition). Zhong Yi Za Zhi 2012; 53: 177-8.
15. Julious SA. Sample sizes for clinical trials with normal data. Stat Med 2004; 23: 1921-86.
16. Zheng XY. guidelines for the clinical research of Chinese medicine new drugs. Beijing: China Medical Science and Technology Press, 2002: 15.
17. Whittaker H, Rubino A, Müllerová H, et al. Frequency and severity of exacerbations of COPD associated with future risk of exacerbations and mortality: a UK routine health care data study. Int J Chron Obstruct Pulmon Dis 2022; 17: 427-37.
18. MacLeod M, Papi A, Contoli M, et al. Chronic obstructive pulmonary disease exacerbation fundamentals: diagnosis, treatment, prevention and disease impact. Respirology 2021; 26: 532-51.
19. Shi WZ, Yuan WA. Influence of placebo on clinical trials of new Traditional Chinese Medicine and relevant suggestions. Drug Evaluation Research 2022; 45: 817-21.
20. Meng XL, He YT, Mao RL, et al. Application of St George's respiratory questionnaire, CAT and mMRC in chronic obstructive pulmonary disease. Fudan Journal (Medical Edition) 2022; 49: 862-8.
21. Gernhold L, Neurohr C, Tsitouras K, Lutz N, Briese S, Ghiani A. Hypercapnia and lung function parameters in chronic obstructive pulmonary disease. BMC Pulm Med 2024; 24: 345.
22. Aktan R, ?zalevli S, Yakut H, ?zgen Alpaydin A. The effects of inspiratory muscle warm-up prior to inspiratory muscle training during pulmonary rehabilitation in subjects with chronic obstructive pulmonary disease: a randomized trial. Physiother Theory Pract 2024; In press.
23. Phillips DB, James MD, Elbehairy AF, et al. Reduced exercise tolerance in mild chronic obstructive pulmonary disease: the contribution of combined abnormalities of diffusing capacity for carbon monoxide and ventilatory efficiency. Respirology 2021; 26: 786-95.
24. Bourbeau J, Bhutani M, Hernandez P, et al. 2023 Canadian thoracic society guideline on pharmacotherapy in patients with stable COPD. Chest 2023; 164: 1159-83.
25. Stallberg B, Lisspers K, Larsson K, et al. Predicting hospitalization due to COPD exacerbations in Swedish primary care patients using machine learning - based on the ARCTIC study. Int J Chron Obstruct Pulmon Dis 2021; 16: 677-88.
26. Wang C, Xu J, Yang L, et al. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China pulmonary health [CPH] study): a national cross-sectional study. Lancet 2018; 391: 1706-17.
27. Dal Negro RW, Wedzicha JA, Iversen M, et al. Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study. Eur Respir J 2017; 50: 1700711.
28. Peng L, Bie M, Cai H, Tang Y. To explore the medication rules of Professor Chen Xinyu's ointment based on the ancient and modern medical record cloud platform. Xian Dai Zhong Xi Yi Jie He Za Zhi 2022; 31: 2724-31.
29. Chinese Society of Traditional Chinese Medicine (CSTCM). Clinical application guideline of Traditional Chinese Medicine pulmonary rehabilitation therapyfor chronic obstructive pulmonary disease. Zhong Yi Za Zhi 2021; 62: 2018-24.
30. Xu YS, Huang CS. Discussion on the pathogenesis evolution of chronic obstructive pulmonary disease and lts complications based on the theory of five viscera correlation. Guangzhou Zhong Yi Yao Da Xue Xue Bao 2024; 41: 1335-40.
31. The Taiping Huimin Heji Bureau (Song dynasty). Tai Ping Hui Min He Ji Ju Fang. Beijing: People's Medical Publishing House, 2021: 135.
32. Vogelmeier CF, Criner GJ, Martinez FJ, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease 2017 report. GOLD executive summary. Am J Respir Crit Care Med 2017; 195: 557-82.
33. Brightling C, Greening N. Airway inflammation in COPD: progress to precision medicine. Eur Respir J 2019; 54: 1900651.
34. Chu X, Liu XJ, Qiu JM, Zeng XL, Bao HR, Shu J. Effects of astragalus and codonopsis pilosula polysaccharides on alveolar macrophage phagocytosis and inflammation in chronic obstructive pulmonary disease mice exposed to PM2.5. Environ Toxicol Pharmacol 2016; 48: 76-84.
35. Huang L, Lyu Q, Zheng W, Yang Q, Cao G. Traditional application and modern pharmacological research of Eucommia ulmoides Oliv. Chin Med 2021; 16: 73.
36. Yang QJ, Yin DD, Wang H, et al. Uncovering the action mechanism of Shenqi Tiaoshen formula in the treatment of chronic obstructive pulmonary disease through network pharmacology, molecular docking, and experimental verification. J Tradit Chin Med 2024; 44: 770-3.
Options
Outlines

/

〈 〉