Abstract:

Objective: To observe the clinical efficacy of Guben Kechuan Granules combined with budesonide-glycopyrronium-formoterol inhalation aerosol in elderly stable-stage chronic obstructive pulmonary disease (COPD) patients with spleen-kidney deficiency pattern, and its influence on the risk of acute exacerbation. Methods: This was a prospective randomized controlled study. A total of 80 elderly patients with stable COPD treated in the medical consortium of Linping District Hospital of Traditional Chinese Medicine in Hangzhou from July 2024 to January 2025 were enrolled. Patients were divided into observation group and control group by random number table method, with 40 cases in each group. The control group received budesonide-glycopyrronium-formoterol inhalation aerosol, while the observation group was additionally given Guben Kechuan Granules on the basis of the control group. Both groups were treated for 12 weeks. Traditional Chinese Medicine (TCM) syndrome score, COPD assessment test (CAT) score, pulmonary function indicators (forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), FEV₁ percentage of predicted value (FEV₁%pred)), serum interleukin-17 (IL-17) and IL-23 levels were compared between the two groups before and after treatment. Adverse reactions were recorded during treatment. Patients were followed-up for 12 months after treatment completion to record the occurrence of acute exacerbations. Results: There were no statistically significant differences in baseline general data and observation indicators between the two groups before treatment. After treatment, the TCM syndrome scores of the control group and observation group were 16.00±2.64 and 14.05±3.19, and the CAT scores were 12.03±2.68 and 10.40±2.52, respectively. Both scores decreased compared with baseline, and were significantly lower in the observation group (t=2.965, P=0.004; t=2.795, P=0.007). After treatment, FEV₁ were (1.37±0.29) L and (1.58±0.31) L; FVC were (2.08±0.51) L and (2.39±0.55) L; FEV₁%pred were (58.41±4.83) % and (62.39±5.09) % for the control and observation group. All pulmonary-function parameters increased after treatment and were significantly higher in the observation group (t=-3.277, P=0.009; t=-2.605, P=0.011; t=-5.390, P<0.001). Post-treatment serum IL-17 were (45.42±4.21) pg/ml and (42.20±4.38) pg/ml; IL-23 were (239.05±28.11) pg/ml and (221.48±27.54) pg/ml for the control and observation group. Both inflammatory biomarkers decreased after treatment and were significantly lower in the observation group (t=3.351, P=0.001; t=2.902, P=0.005). During treatment, the incidence of adverse reactions was 2.5% (1/40) in the control group and 5.0% (2/40) in the observation group, without statistical difference (Fisher’s exact test, P=1.000). Within the 12-month follow-up period, the incidence of acute exacerbations in the observation group was 12.5% (5/40), which was lower than 35.0% (14/40) in the control group (χ²=5.590, P=0.018). Conclusion: Adding Guben Kechuan Granules to budesonide-glycopyrronium-formoterol inhalation therapy can further improve clinical symptoms, pulmonary function and partial inflammatory markers in elderly stable-COPD patients with Spleen-Kidney Deficiency Pattern, and may reduce the risk of acute exacerbations within 12-month follow-up with satisfactory safety profile.

Key words: Aged, Pulmonary disease, chronic obstructive, Medicine, Chinese traditional, Therapeutic uses, Randomized controlled trial