Efficacy and safety of aerosol inhalation of ambroxol hydrochloride in the treatment of bronchiectasis:a multi-center,open-label,post-approval clinical studies
Objective To study the clinical effect and safety of aerosol inhalation of ambroxol hydrochloride in the treatment of bronchiectasis. Methods 183 patients with branchial dilatation were treated with aerosol inhalation of ambroxol hydrochloride. The scores of respiratory symptoms and signs (sputum character,sputum difficulty,sputum volume,cough symptom,sputum viscosity) and the scores of the EuroQol five-dimensional questionnaire (EQ-5D) before and after treatment were compared,and the clinical efficacy,safety during the treatment period,the duration and dosage of medication were analyzed. Results Before treatment,on the 4th day of treatment and at the end of treatment,the sputum characterization scores were (2.37±0.48),(1.45±0.80) and (0.69±0.81) points,the sputum difficulty scores were (2.19±0.39),(1.16±0.60) and (0.85±0.68) points,the sputum volume scores were (1.71±0.61),(1.00±0.72) and (0.63±0.71) points,the cough symptom scores were (1.97±0.54),(1.12±0.69) and (0.81±0.68) points,the sputum viscosity scores were (2.69±0.65),(1.67±0.82) and (0.97±0.84) points. On the 4th day of treatment and at the end of treatment,the scores of sputum character,sputum difficulty,sputum volume,cough symptom,and sputum viscosity of patients were lower than those before treatment,and the difference was statistically significant (P<0.05). At the end of treatment,the total score of (2.99±2.39) points was lower than (8.25±1.33) points before treatment,and the difference was statistically significant (P<0.05). EQ-5D score was (0.89±0.15) points before treatment and (0.95±0.12) points at the end of treatment;EQ-5D score at the end of treatment was higher than that before treatment,and the difference was statistically significant (P<0.05). Patients were clinically controlled in 56 cases (30.60％),apparently effective in 42 cases (22.95％),effective in 61 cases (33.33％),and ineffective in 24 cases (13.11％),with a total effective rate of 86.89％ (159/183). Among 183 patients with bronchiectasis,a total of 42 patients (22.95％) experienced 59 adverse events,18 patients (9.84％) experienced 18 adverse reactions,and 3 patients (1.64％) experienced 3 serious adverse events (fracture,bronchiectasis with aggravation of infection,hemoptysis). The incidence of adverse reactions was 10.38％ (19/183) and no serious adverse reactions occurred. The duration of drug administration in patients was up to (6.55±1.53) d,and the dosage was (37.86±8.99) ml. Conclusion Aerosol inhalation of ambroxol hydrochloride solution has obvious clinical effect on patients with bronchiectasis,and can also improve the quality of life of patients,and is safe and reliable.
Ambroxol hydrochlorideBronchiectasisPhlegmQuality of life
万方数据
维普
