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Corresponding author: xuyangpo, 957829492@qq.com

DOI: 10.12201/bmr.202608.00041

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  Abstract: 【】Objective: To evaluate the clinical efficacy of a self-formulated modified Shenling Baizhu Powder in patients with stable chronic obstructive pulmonary disease (COPD) classified as the lung-spleen qi deficiency type.Methods: A total of 220 patients with stable COPD and lung-spleen qi deficiency syndrome were randomly assigned to a control group (n = 110) and an observation group (n = 110) . Both groups continued conventional Western medicine maintenance therapy. The control group received a placebo, whereas the observation group received granules of a self-formulated modified Shenling Baizhu Powder. The treatment course lasted 12 weeks. Before and after the treatment, the COPD Assessment Test (CAT) score, 6-minute walk distance (6MWD), arterial blood gas parameters, and traditional Chinese medicine (TCM) syndrome scores were assessed, and the clinical efficacy was evaluated. Acute exacerbations during the study period were also recorded.Results: After treatment, the overall clinical response rate in the observation group was significantly higher than that in the control group 92.73% (102/110) vs. 80.00% (88/110), P<0.05. Both groups showed significant reductions in CAT scores and TCM syndrome scores compared with baseline (all P<0.05), with the observation group achieving significantly lower scores than the control group (all P<0.05). The 6-minute walk test (6MWT) distance increased significantly from baseline in both groups (P <0.05), and the observation group had a significantly greater increase than the control group (P< 0.05). PaCO? levels decreased significantly from baseline in both groups (P<0.05), and the observation group showed significantly lower PaCO? than the control group (P<0.05). PaO? levels increased significantly from baseline in both groups (P<0.05), and the observation group had significantly higher PaO? than the control group (P<0.05). Regarding acute exacerbations, during the entire study period, the number of patients experiencing acute exacerbations was lower in the observation group than in the control group, and the difference was statistically significant (P<0.05).Conclusion: The addition of self-formulated modified Shenling Baizhu Powder to conventional Western medicine maintenance therapy demonstrates favorable clinical efficacy for stable COPD patients with lung-spleen qi deficiency syndrome. It effectively improves daily exercise capacity and cardiopulmonary function, alleviates clinical symptoms, and significantly reduces the risk of acute exacerbation, warranting further clinical application and promotion.

  Key words: : COPD; syndrome of lung-spleen qi deficiency; modified Shenling Baizhu Powder; clinical effect

  Submit time: 21 August 2026

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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