A Randomized Controlled Trial of Nebulized Gentamicin in Non–Cystic Fibrosis Bronchiectasis

Authors: Maeve P. Murray, John R. W. Govan, Catherine J. Doherty, et al.

Journal: Am J Respir Crit Care Med Vol 183. pp 491–499, 2011

報告者:孫文娟  呼吸治療師

指導者:鄭瑞駿  臨床組長

報告日期:2012年2月20日

Rationale: Bronchiectasis is a chronic debilitating disease with few evidence-based long-term treatments.

Objectives: A randomized controlled trial assessing the efficacy of nebulized gentamicin therapy over 1 year in patients with non–cystic fibrosis bronchiectasis.

Methods: Sixty-five patients were randomized to either twice-daily nebulized gentamicin, 80 mg, or nebulized 0.9% saline, for 12 months. All were reviewed at three-monthly intervals during treatment and at 3 months’ follow-up. Measurements and Main Results: At each review the following were assessed: quantitative and qualitative sputum bacteriology; sputum purulence and 24-hour volume; FEV1, FVC, and forced expiratory flow, mid expiratory phase; exercise capacity; Leicester Cough Questionnaire and St. George’s Respiratory Questionnaire; and exacerbation frequency. Fifty-seven patients completed the study. At the end of 12 months’ treatment, compared with the saline group, in the gentamicin group there was reduced sputum bacterial density with 30.8% eradication in those infected with Pseudomonas aeruginosa and 92.8% eradication in those infected with other pathogens; less sputum purulence (8.7% vs. 38.5%; P<0.0001); greater exercise capacity (510 [350–690]m vs. 415 [267.5–530]m; P=0.03); and fewer exacerbations (0 [0–1] vs. 1.5 [1–2]; P<0.0001) with increased time to first exacerbation (120 [87–161.5] d vs. 61.5 [20.7–122.7] d; P=0.02). The gentamicin group had greater improvements in Leicester Cough Questionnaire (81.4% vs. 20%; P<0.01) and St. George’s Respiratory Questionnaire (87.5%vs. 19.2%; P<0.004) score. No differences were seen in 24-hour sputum volume, FEV1, FVC, or forced expiratory flow, mid expiratory phase. No P. aeruginosa isolates developed resistance to gentamicin. At follow-up, all outcome measures were similar to baseline.

Conclusions: Regular, long-term nebulized gentamicin is of significant benefit in non–cystic fibrosis bronchiectasis but treatment needs to be continuous for its ongoing efficacy.