Effect of N-acetylcysteine on exacerbations of bronchiectasis (BENE): a randomized controlled trial.

BACKGROUND: N-acetylcysteine is a classic mucolytic agent. This study aimed to investigate the efficacy of N-acetylcysteine on reducing the risk of exacerbations in bronchiectasis patients. METHODS: A prospective, randomized, controlled trial was conducted between April 1, 2014 and December 31, 2016 in five general hospitals in Shandong Province, China. Adult bronchiectasis patients with at least two exacerbations in the past year were potentially eligible. Patients were randomly assigned to receive oral N-acetylcysteine (600 mg, twice daily, 12 months) or on-demand treatment. RESULTS: A total of 161 patients were eligible for randomization (81 to the N-acetylcysteine group and 80 to the control group). During the 12-month follow-up, the incidence of exacerbations in the N-acetylcysteine group was significantly lower than that in the control group (1.31 vs. 1.98 exacerbations per patient-year; risk ratio, 0.41; 95% CI, 0.17-0.66; P = 0.0011). The median number of exacerbations in the N-acetylcysteine group was 1 (0.5-2), compared with 2 (1-2) in the control group (U = - 2.95, P = 0.003). A total of 24.7% of the N-acetylcysteine group patients and 11.3% of the control group patients remained exacerbation-free throughout the 12-month follow-up (χ2 = 4.924, P = 0.026). Compared with the control group, the volume of 24-h sputum in the N-acetylcysteine group was significantly reduced (t = - 3.091, P = 0.002). Additionally, the N-acetylcysteine group showed a significant improvement in the quality of life. No severe adverse events were reported in the intervention group. CONCLUSION: The long-term use of N-acetylcysteine is able to reduce the risk of exacerbations for bronchiectasis patients in Shandong Province, China. The results of this study should be verified in a larger randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02088216) (Registered date: March 5, 2014).

A Prospective Trial of Nebulized Amikacin in the Treatment of Bronchiectasis Exacerbation.

BACKGROUND: Pseudomonas aeruginosa is the most common pathogenic bacteria in bronchiectasis (BE) patients. The availability and security of nebulized amikacin treatment are unknown. OBJECTIVE: The purpose of this study was to explore the efficiency and adverse effects of nebulized amikacin treatment for 2 weeks, administered as intravenous therapy during exacerbation of BE patients infected with P. aeruginosa. METHODS: A total of 143 patients with exacerbation of BE were screened between January 2013 and March 2016 at five tertiary hospitals in Shandong Province, China. The BE patients were diagnosed by high-resolution computed tomography scans, and all of them were confirmed to be infected with P. aeruginosa after sputum culture test. Seventy-four patients were assigned to the intervention group and received amikacin nebulization (0.2 g) treatment twice daily for 2 weeks along with intravenous antibiotic therapy. Sixty-nine patients were assigned to the control group and received standard antibiotic therapy alone. The primary outcome was the rate of bacterial eradication from the sputum, and the secondary outcomes were drug resistance and adverse effects. RESULTS: The bacterial eradication rate of sputum in the intervention group (51.4%) was significantly higher compared to that in the control group (23.2%) (χ2 = 14.211, p = 0.030). Drug sensitivity testing showed that there were 5 drug-resistant cases in the intervention group and 7 in the control group, which was not significantly different. Three patients dropped out of the trial due to adverse effects. None of the patients hat renal injury. CONCLUSIONS: Nebulized amikacin treatment is a safe treatment for exacerbation of BE and significantly increases the bacterial eradication rate of sputum.