Pakistan journal of pharmaceutical sciences · 2026
Adverse reactions and safety of nebulized budesonide in elderly patients with inflammatory airway diseases.
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Meng Weifeng, Fu Lingfei, Huang Hui
Аннотация
BACKGROUND: Budesonide suspension is a first-line inhaled corticosteroid for elderly patients with inflammatory airway diseases, but existing research lacks targeted safety data for the very elderly (≥80 years), systematic analysis of adverse reaction (ADR) temporal distribution and quantitative evidence for modifiable clinical risk factors.
OBJECTIVE: To investigate the safety profile, ADR temporal patterns and independent modifiable risk factors of nebulized budesonide suspension in elderly patients, with a focus on ≥80 years.
METHODS: A retrospective analysis of 128 elderly patients (39 ≥80 years) treated with budesonide suspension (2 ml:1 mg) from January 2023 to June 2025 was conducted. ADRs were identified via medical record cross-check and verified by an expert team, with causality assessed using the WHO-UMC system. ADR incidence, type and temporal distribution were observed; univariate and multivariate logistic regression analyses were used to screen independent risk factors.
RESULTS: The overall incidence of mild ADRs was 17.97%, with local ADRs (78.26%, predominantly oropharyngeal candidiasis) and systemic ADRs (21.74%). ADRs peaked at 8-14 days (39.13%). Age ≥80 years (OR=3.245, p=0.030), treatment duration >14 days (OR=2.897, p=0.048) and inadequate mouth rinsing (OR=4.126, p=0.008) were independent risk factors. ADR incidence was higher in patients with ≥3 underlying diseases (25.00% vs. 11.76%).
CONCLUSION: Nebulized budesonide suspension is well tolerated in elderly patients, with no severe ADRs. This study clarifies temporal patterns of ADRs and identifies inadequate mouth rinsing as a key modifiable risk factor, providing targeted safety data for the very elderly. Standardized mouth rinsing and short-course medication are recommended for high-risk groups to reduce ADR risk. Notably, this study is limited by its single-center, retrospective design, which may introduce selection and information bias and the findings require validation in prospective multi-center studies with larger sample sizes.
OBJECTIVE: To investigate the safety profile, ADR temporal patterns and independent modifiable risk factors of nebulized budesonide suspension in elderly patients, with a focus on ≥80 years.
METHODS: A retrospective analysis of 128 elderly patients (39 ≥80 years) treated with budesonide suspension (2 ml:1 mg) from January 2023 to June 2025 was conducted. ADRs were identified via medical record cross-check and verified by an expert team, with causality assessed using the WHO-UMC system. ADR incidence, type and temporal distribution were observed; univariate and multivariate logistic regression analyses were used to screen independent risk factors.
RESULTS: The overall incidence of mild ADRs was 17.97%, with local ADRs (78.26%, predominantly oropharyngeal candidiasis) and systemic ADRs (21.74%). ADRs peaked at 8-14 days (39.13%). Age ≥80 years (OR=3.245, p=0.030), treatment duration >14 days (OR=2.897, p=0.048) and inadequate mouth rinsing (OR=4.126, p=0.008) were independent risk factors. ADR incidence was higher in patients with ≥3 underlying diseases (25.00% vs. 11.76%).
CONCLUSION: Nebulized budesonide suspension is well tolerated in elderly patients, with no severe ADRs. This study clarifies temporal patterns of ADRs and identifies inadequate mouth rinsing as a key modifiable risk factor, providing targeted safety data for the very elderly. Standardized mouth rinsing and short-course medication are recommended for high-risk groups to reduce ADR risk. Notably, this study is limited by its single-center, retrospective design, which may introduce selection and information bias and the findings require validation in prospective multi-center studies with larger sample sizes.