Abstract: Objective To compare and analyze the efficacy and safety of different administration routes (aerosol inhalation and intravenous injection) of ambroxol hydrochloride in treating acute exacerbations of chronic bronchitis. Methods Patients with acute exacerbations of chronic bronchitis (n=120) were randomly assigned to two groups: observation group（n=60）and control group（n=60）.Two groups were treated with ambroxol hydrochloride by aerosol inhalation or intravenous injection respectively for 5~7 days. Clinical efficacy was measured by treatment outcomes and improvements of 5 symptom indicators: cough, sputum volume, sputum properties, expectoration difficulty and rales. Adverse events were also recorded. Results More overall improvements were observed in the observation group（96.7%） than in the control group（88.3%）(P<0.05). For the five symptom indicators, except for the treatment effect of cough, the observation group showed more significant improvements in the aspects of sputum volume(98.3%), sputum properties(100%), expectoration difficulty(98.3% ) and rales(98.3%) than those of the control group (88.3%、96.7%、85.0%、86.7%)( P<0.05). In the aspect of safety, adverse events were not observed in the observation group, meanwhile, 1 adverse effect was recorded in the control group(the incidence of adverse effects was 1.7%, P>0.05). Conclusion The result shows the better clinical effects of aerosol inhalation of ambroxol hydrochloride in the treatment of acute exacerbations of chronic bronchitis than those of the intravenous administration,especially in the improvements of sputum volume, sputum properties, expectoration difficulty and rales.

Key words: efficacy, aerosol inhalation, ambroxol hydrochloride, off-label use