| Background:Bronchiectasis is a condition that causes permanent pathologic dilatation of the bronchial wall due to variant causes,resulting in recurrent purulent infection of the airway.N-acetylcysteine is a classic mucolytic agent that used for the treatment of many respiratory diseases.However,there are few clinical controlled trials have reported that long-term use of N-acetylcysteine in the therapy of bronchiectasis.Objective:The aim of this study is to investigate the efficacy of N-acetylcysteine on decrease the frequency of exacerbations and improve the quality of life in bronchiectasis patients in stable state.Methods:1.The BENE(Effect of N-acetylcysteine on Exacerbations of Bronchiectasis)study,a prospective,multiple center,randomized,controlled trial conducted in 5 three-top hospitals in the Shandong Province of China.We enrolled bronchiectasis patients of stable state that aged 18-80 years with a history of at last 2 exacerbations in the past year.Patients randomly assigned to receive N-acetylcysteine(one 600 mg tablet,twice daily)or control(receive on-demand treatment)for 12 months in a I:1 ratio.2.The primary outcome was rate of event-based exacerbations in the 12-month follow-up period.Secondary outcomes included time to first exacerbation,quality of life(COPD assessment test score,CAT score),24-hour sputum volume,lung function,inflammation indexes and adverse effect.3.After grouping for the patints,all the participants were followed for 1 year.Exacerbation rate was analysed with a Poisson regression model.Time to first exacerbation was analysed using the Cox proportional hazard method and presented with Kaplan-Meier plots.Results:1.Between Apr 1,2014,and Dec 31,2016,we screened 326 patients,of whom 161 were eligible for randomization(81 to N-acetylcysteine and 80 to control).2.After 1 year,we noted 106 acute exacerbations in the N-acetylcysteine group(1.31 exacerbations per patient-year)and 158 acute exacerbations in the conrol group.(1.98 exacerbations per patient-year;risk ratio 0.41,95%C1 0.17-0.66;p=0.0011).For the secondary outcome of our study,time to first exacerbation did not differ between groups(mean 140d vs 117d,p=0.0515)(log-rank),(HR=1.4195%CI 0.10-1.99).3.N-acetylcysteine produced a significant effect of improvement in CAT score of bronchiectasis patients(-3.79(5.40)vs(-1.44(6.19))(P=0.O11).Patients treated with N-acetylcysteine had greater changes from baseline in 24-hour sputum volume(-18.28(25.69)mL vs-6.48(22.88)mL)(P=0.003).N-acetylcysteine did not significantly improve the pulmonary function of the patients.Additionally,changes in inflammation indexes did not differ between the N-acetylcysteine and placebo groups.4.After treated with NAC,three patients experienced mild abnormality of liver function.Two patients had a rash,which was relieved by application of the hepatoprotective and anti-allergic agents.Odor was complained by 5 patients in NAC group during the treatment.Serious adverse events were not observed within the study period.Conclusion:Long-term use of N-acetylcysteine 600 mg twice daily can prevent exacerbations of bronchiectasis.It can also decrease expectoration and improve the quality of life in patients with bronchiectasis. |
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