Ryan G, Mukhopadhyay S, Singh M
Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
Cochrane Database Syst Rev. 2003(3):CD001021. doi: 10.1002/14651858.CD001021.
Persistent infection by Pseudomonas aeruginosa contributes to lung damage, resulting in illness and death in people with cystic fibrosis (CF). Nebulised antibiotics are commonly used to treat this infection.
To examine the evidence that nebulised anti-pseudomonal antibiotic treatment in people with CF reduces frequency of exacerbations of infection, improves lung function, quality of life and survival. To examine adverse effects of nebulised anti-pseudomonal antibiotic treatment.
Trials were identified from the Cochrane Cystic Fibrosis and Genetic Disorders Group clinical trials register. Companies that marketed nebulised anti-pseudomonal antibiotics were contacted for information on unpublished trials. Most recent search of the Group's trials register: August 2002.
Trials were selected if, nebulised anti-pseudomonal antibiotics treatment was used for four weeks or more in people with CF, allocation to treatment was randomised or quasi-randomised, and there was a placebo or a no placebo control group or another nebulised antibiotic comparison.
For the first version of this review, two reviewers independently selected and judged the quality of, the trials to be included in the review. One reviewer extracted data from these trials and performed all tasks for the updated version of the review.
Out of 33 trials identified, there were 11, with 873 participants, that met the inclusion criteria. Ten trials with 758 participants compared a nebulised anti-pseudomonal antibiotic with placebo or usual treatment. One of these trials accounted for 68% of the total participants and seven of these trials used a cross-over design. Tobramycin was studied in four trials and follow up ranged from 1 to 32 months. Lung function, measured as forced expired volume in one second (FEV1) was better in the treated group than in control group in nine of these. Resistance to antibiotics increased more in the antibiotic treated group than in placebo group. Tinnitus and voice alteration were more frequent with tobramycin than placebo. One short-term trial of one month, with 115 participants, compared tobramycin and colistin, and showed a trend towards greater improvement in FEV1 in the tobramycin group.
REVIEWER'S CONCLUSIONS: Nebulised anti-pseudomonal antibiotic treatment improves lung function. However, more evidence, from longer duration trials, is needed to determine if this benefit is maintained as well as to determine the significance of development of antibiotic resistant organisms. There is insufficient evidence for recommendations about type of drug and dose regimens.
铜绿假单胞菌的持续感染会导致肺部损伤，从而致使囊性纤维化（CF）患者发病甚至死亡。雾化抗生素常用于治疗这种感染。
检验雾化抗铜绿假单胞菌抗生素治疗CF患者可降低感染加重频率、改善肺功能、生活质量及生存率的证据。检验雾化抗铜绿假单胞菌抗生素治疗的不良反应。
从Cochrane囊性纤维化和遗传疾病组临床试验注册库中识别试验。联系销售雾化抗铜绿假单胞菌抗生素的公司以获取未发表试验的信息。该组试验注册库的最新检索时间为2002年8月。
若符合以下条件则入选试验：在CF患者中使用雾化抗铜绿假单胞菌抗生素治疗四周或更长时间；治疗分配为随机或半随机；有安慰剂或无安慰剂对照组或另一种雾化抗生素对照。
对于本综述的第一版，两名综述作者独立选择并判断纳入综述的试验质量。一名综述作者从这些试验中提取数据并完成综述更新版的所有任务。
在识别出的33项试验中，有11项（共873名参与者）符合纳入标准。10项试验（共758名参与者）将雾化抗铜绿假单胞菌抗生素与安慰剂或常规治疗进行了比较。其中一项试验占总参与者的68%，这些试验中有7项采用交叉设计。四项试验研究了妥布霉素，随访时间为1至32个月。其中九项试验中，治疗组一秒用力呼气容积（FEV1）所测量的肺功能优于对照组。抗生素治疗组的抗生素耐药性增加幅度大于安慰剂组。与安慰剂相比，妥布霉素导致耳鸣和声音改变更为常见。一项为期一个月、有115名参与者的短期试验比较了妥布霉素和黏菌素，结果显示妥布霉素组FEV1改善趋势更明显。
雾化抗铜绿假单胞菌抗生素治疗可改善肺功能。然而，需要来自更长疗程试验的更多证据来确定这种益处是否能持续，以及确定抗生素耐药菌产生的意义。关于药物类型和剂量方案的推荐，证据不足。
