To observe the clinical efficacy and safety of budesonide/glycopyrrolate bromide/formoterol fumarate inhalation aerosol combined with theophylline sustained-release tablets in patients with severe chronic obstructive pulmonary disease (COPD) complicated by bronchiectasis (BE).

Patients with BE complicated with severe COPD admitted to our hospital were divided into control group and treatment group based on the treatment method. The control group received theophylline sustained-release tablets (oral, twice daily, 0.1 g per dose), while the treatment group received budesonide/glycopyrrolate/formoterol fumarate aerosol (oral inhalation, twice daily, two puffs per dose) combined with theophylline sustained-release tablets (oral, twice daily, 0.1 g per dose). Both groups were treated for 12 weeks. Inflammatory factor levels, pulmonary ventilation function indicators and clinical efficacy were compared between the two groups, and safety was evaluated.

A total of 133 patients were enrolled, including 71 in treatment group and 62 in control group. Propensity score matching (PSM) was performed at 1∶1 ratio, resulting in 50 patients in each group. After treatment, the total clinical effective rates in control group and treatment group were 80.00% (40 cases/50 cases) and 92.00% (46 cases /50 cases), respectively, with statistically significant difference (P<0.05). After treatment, the levels of C-reactive protein (CRP) in treatment group and control group were (13.85±2.43) and (27.54±3.71) mg·L^-1, respectively; tumor necrosis factor-alpha (TNF-α) levels were (50.54±4.28) and (59.37±4.61) pg·mL^-1, respectively; interleukin-6 (IL-6) levels were (42.30±4.71) and (56.42±5.24) pg·mL^-1, respectively; interleukin-8 (IL-8) levels were (15.71±2.63) and (17.88±3.11) pg·mL^-1, respectively; interleukin-18 (IL-18) levels were (59.42±6.25) and (78.62±7.09) pg·mL^-1, respectively. Differences in the above indicators between the two groups were statistically significant (all P<0.05). After treatment, the forced expiratory volume in 1 second (FEV₁) in treatment group and control group were (2.64±0.37) and (2.06±0.32) L, respectively; forced vital capacity (FVC) were (2.82±0.30) and (2.04±0.27) L, respectively; FEV₁/FVC were (65.68±5.94)% and (54.83±5.55)%, respectively. Differences in the above indicators between the two groups were statistically significant (all P<0.05). The main adverse drug reactions in treatment group were nausea, headache, rash and gastrointestinal discomfort; those in control group were nausea, insomnia, gastrointestinal discomfort and rash. The total incidence of adverse drug reactions was 10.00% in treatment group and 8.00% in control group, with no statistically significant difference (P>0.05).

For patients with BE combined with severe COPD, the regimen of budesonide/glycopyrronium bromide/formoterol fumarate inhalation aerosol combined with theophylline sustained-release tablets demonstrates favorable clinical advantages. It can effectively reduce inflammatory factors in patients and improve their ventilation function.