Research Article: Clinical outcomes associated with Shenling Bufei Tongluo Decoction as add-on therapy in stable COPD patients with a frequent-exacerbator phenotype: a retrospective real-world cohort study
Abstract:
Acute exacerbations accelerate disease progression and increase mortality in chronic obstructive pulmonary disease (COPD). Patients with a frequent-exacerbator phenotype remain at persistently high risk despite conventional therapies, highlighting the need for effective adjunctive strategies. Shenling Bufei Tongluo Decoction (SLBTD) is used in routine clinical practice, but real-world evidence regarding its clinical outcomes in this high-risk population remains limited.
This retrospective real-world cohort study evaluated SLBTD add-on therapy in stable COPD patients with a frequent-exacerbator phenotype. Patients receiving SLBTD plus conventional management were compared with those receiving conventional management alone. Propensity score weighting was applied to balance baseline covariates. The primary outcome was first moderate-to-severe COPD exacerbation during a 1-year post-index observation period. Secondary outcomes included annualized exacerbation rates, hospitalization, symptoms, pulmonary function, traditional Chinese medicine (TCM) syndrome score, and recorded safety outcomes.
Among 528 eligible patients (176 SLBTD, 352 comparator), stabilized weighting achieved excellent covariate balance. Patients receiving SLBTD add-on therapy had a lower observed risk of first moderate-to-severe exacerbation [hazard ratio (HR), 0.68; 95% confidence interval (CI), 0.53–0.87; P = 0.002], a lower annualized exacerbation rate [rate ratio (RR), 0.71; P = 0.001], and fewer severe exacerbations requiring hospitalization [odds ratio (OR), 0.55; P = 0.014] than patients receiving conventional management alone. Patients receiving SLBTD also showed more favorable changes in COPD Assessment Test (CAT) score, modified Medical Research Council (mMRC) dyspnea grade, forced expiratory volume in 1 s (FEV 1 )% predicted, and TCM syndrome score (all P < 0.01). Sensitivity analyses using 30-day landmark, time-varying exposure, restricted-cohort, and severe-exacerbation-only definitions yielded consistent results. Recorded safety outcomes were comparable between groups.
In routine clinical practice, patients receiving SLBTD add-on therapy had a lower recorded exacerbation burden and more favorable symptom-related outcomes than those receiving conventional management alone, without an observed increase in recorded safety events. These findings should be interpreted as observational associations rather than evidence of causal efficacy.
Introduction:
Acute exacerbations accelerate disease progression and increase mortality in chronic obstructive pulmonary disease (COPD). Patients with a frequent-exacerbator phenotype remain at persistently high risk despite conventional therapies, highlighting the need for effective adjunctive strategies. Shenling Bufei Tongluo Decoction (SLBTD) is used in routine clinical practice, but real-world evidence regarding its clinical outcomes in this high-risk population remains limited.
Read more