Prescrire Int. 2002 Dec;11(62):177-8.
(1) In patients with cystic fibrosis, chronic bronchial infection with Pseudomonas aeruginosa is a major factor in the development of chronic respiratory failure and premature death. (2) Over the last two decades, such patients have commonly received long-term treatment with antibiotic aerosols (mainly tobramycin or colistin, in off-licence uses). (3) Tobramycin solution for nebulisation is the first antibiotic preparation to be licensed in the EU for this indication. (4) Comparative evaluation of antibiotic aerosol therapy for chronic bronchial infections due to P. aeruginosa includes two large trials of nebulised tobramycin. (5) A combined analysis of these two placebo-controlled trials, both lasting 20 weeks, showed that tobramycin aerosol delayed the deterioration of respiratory function and reduced the number of hospitalisations. However, an increase in P. aeruginosa resistance to tobramycin was reported. (6) The file on tobramycin includes no precise criteria for stopping treatment, and no data on the long-term impact of the observed increase in bacterial resistance. (7) The main adverse effects of tobramycin aerosol are tinnitus and voice changes. Deafness has also been reported. (8) The available assessment file does not show whether the risk-benefit ratio of tobramycin aerosol differs from that of other nebulised antibiotics used (off-licence) in this setting. However, tobramycin is the best-assessed nebulised antibiotic for this indication. (9) In practice, tobramycin solution for nebulisation may be considered the reference long-term treatment for chronic pulmonary infections due to P. aeruginosa in patients with cystic fibrosis. Assessment should continue, however, especially regarding the possible impact on mortality and the selection of resistant strains.
（1）在囊性纤维化患者中，铜绿假单胞菌引起的慢性支气管感染是慢性呼吸衰竭和过早死亡发生的主要因素。（2）在过去二十年中，此类患者通常接受抗生素气雾剂的长期治疗（主要是妥布霉素或多粘菌素，属超适应症用药）。（3）雾化用妥布霉素溶液是欧盟首个获此适应症许可的抗生素制剂。（4）针对铜绿假单胞菌引起的慢性支气管感染的抗生素气雾剂疗法的比较评估包括两项雾化妥布霉素的大型试验。（5）这两项均为期20周的安慰剂对照试验的综合分析表明，妥布霉素气雾剂延缓了呼吸功能的恶化并减少了住院次数。然而，有报告称铜绿假单胞菌对妥布霉素的耐药性有所增加。（6）妥布霉素的档案中没有停止治疗的精确标准，也没有关于观察到的细菌耐药性增加的长期影响的数据。（7）妥布霉素气雾剂的主要不良反应是耳鸣和声音改变。也有耳聋的报告。（8）现有的评估档案未表明妥布霉素气雾剂的风险效益比与在此情况下使用的其他雾化抗生素（超适应症用药）的风险效益比是否不同。然而，妥布霉素是对此适应症评估最佳的雾化抗生素。（9）在实践中，雾化用妥布霉素溶液可被视为囊性纤维化患者中由铜绿假单胞菌引起的慢性肺部感染的参考长期治疗方法。然而，评估仍应继续，特别是关于对死亡率的可能影响以及耐药菌株的选择。
