Research on the Effectiveness and Safety of Bronchial Thermoplasty in Patients with Chronic Obstructive Pulmonary Disease

Abstract

Abstract Objective To investigate the clinical efficacy and safety of bronchial thermoplasty (BT) in treating chronic obstructive pulmonary disease (COPD) patients. Methods Clinical data of 57 COPD patients were randomized into control (n = 29, conventional inhalation drug) or observation group (n = 28, convention inhalation drug plus BT). Primary outcomes were differences in clinical symptom changes, pulmonary function-related indicators, 6-min walk test (6MWT), COPD assessment test (CAT) score, Modified Medical Research Council (mMRC) and acute exacerbation incidence from baseline to average of 3 and 12 months. Safety was assessed by adverse events. Results FVC, FEV1 and FEV1% predicted value in both groups improved to varying degrees post-treatment compared with those pre-treatment (P < 0.05), except for FEV1/FVC. Observation group showed greater increase amplitudes of FEV1 (Ftime × between groups = 21.713, P < 0.001) and FEV1% predicted value (Ftime × between groups = 31.216, P < 0.001) than control groups, with no significant difference in FVC variation trend (Ftime × between groups = 1.705, P = 0.193). mMRC, 6MWT and CAT scores of both groups post-treatment improved to varying degrees (Ps < 0.05), but the improving amplitudes of mMRC (Ftime × between groups=3.947, P = 0.025), 6MWT (Ftime × between groups༝16.988, P < 0.001) and CAT score (Ftime × between groups༝16.741, P < 0.001) in observation group were greater than control groups. According to COPD acute exacerbation risk assessment, the proportion of high-risk COPD patients with acute exacerbation in control and observation groups at 1 year post-treatment (100% vs 65%, 100% vs 28.6%), inpatient proportion (100% vs 62.1%; 100% vs 28.6%), COPD acute exacerbation number [3.0 (2.50, 5.0) vs 1.0 (1.0, 2.50); 3.0(3.0, 4.0) vs 0 (0, 1.0)] and hospitalization number [2.0 (2.0, 3.0) vs 1.0 (0, 2.0); 2.0 (2.0, 3.0) vs 0 (0, 1.0)] were significantly lower than those pre-treatment (P < 0.05). Besides, data of observation group were significantly lower than control group (P < 0.05). Conclusion Combined BT treatment better improves lung function and life quality of COPD patients than conventional medical treatment, and reduce the COPD exacerbation risk without serious adverse events.