Remmington Tracey, Jahnke Nikki, Harkensee Christian
Department of Women's and Children's Health, University of Liverpool, Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool, UK, L12 2AP.
Cochrane Database Syst Rev. 2013 Oct 29(10):CD005405. doi: 10.1002/14651858.CD005405.pub3.
Pseudomonas aeruginosa is the most common bacterial pathogen causing lung infections in people with CF and appropriate antibiotic therapy is vital. Antibiotics for pulmonary exacerbations are usually given intravenously, and for long-term treatment, via a nebuliser. Oral anti-pseudomonal antibiotics with the same efficacy and safety as intravenous or nebulised antibiotics would benefit people with CF due to ease of treatment and avoidance of hospitalisation.
To determine the benefit or harm of oral anti-pseudomonal antibiotic therapy for people with CF, colonised with Pseudomonas aeruginosa, in the:1. treatment of a pulmonary exacerbation; and 2. long-term treatment of chronic infection.
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.We contacted pharmaceutical companies and checked reference lists of identified trials.Date of last search: 28 June 2013.
Randomised or quasi-randomised controlled trials comparing any dose of oral anti-pseudomonal antibiotics, to other combinations of inhaled, oral or intravenous antibiotics, or to placebo or usual treatment for pulmonary exacerbations and long-term treatment.
Two authors independently selected the trials, extracted data and assessed quality. We contacted trial authors to obtain missing information.
We included three trials examining pulmonary exacerbations (171 participants) and two trials examining long-term therapy (85 participants). We regarded the most important outcomes as quality of life and lung function. The analysis did not identify any statistically significant difference between oral anti-pseudomonal antibiotics and other treatments for these outcome measures for either pulmonary exacerbations or long-term treatment. One of the included trials reported significantly better lung function when treating a pulmonary exacerbation with ciprofloxacin when compared with intravenous treatment; however, our analysis did not confirm this finding. We found no evidence of difference between oral anti-pseudomonal antibiotics and other treatments regarding adverse events or development of antibiotic resistance, but trials were not adequately powered to detect this. None of the studies had a low risk of bias from blinding which may have an impact particularly on subjective outcomes such as quality of life. The risk of bias for other criteria could not be clearly stated across the studies.
AUTHORS' CONCLUSIONS: We found no conclusive evidence that an oral anti-pseudomonal antibiotic regimen is more or less effective than an alternative treatment for either pulmonary exacerbations or long-term treatment of chronic infection with P. aeruginosa. Until results of adequately-powered future trials are available, treatment needs to be selected on a pragmatic basis, based upon any available non-RCT evidence, the clinical circumstances of the individual, the known effectiveness of drugs against local strains and upon individual preference.
铜绿假单胞菌是囊性纤维化(CF)患者肺部感染最常见的病原菌,恰当的抗生素治疗至关重要。肺部病情加重时抗生素通常通过静脉给药,长期治疗则通过雾化器给药。与静脉或雾化抗生素具有相同疗效和安全性的口服抗铜绿假单胞菌抗生素,因其治疗方便且可避免住院,将使CF患者受益。
确定口服抗铜绿假单胞菌抗生素治疗对定植有铜绿假单胞菌的CF患者在以下方面的益处或危害:1. 治疗肺部病情加重;2. 慢性感染的长期治疗。
我们检索了Cochrane囊性纤维化和遗传性疾病研究组试验注册库,其中包括通过全面电子数据库检索、相关期刊手工检索以及会议论文摘要集检索所识别的参考文献。我们联系了制药公司并查阅了已识别试验的参考文献列表。最后检索日期:2013年6月28日。
比较任何剂量口服抗铜绿假单胞菌抗生素与吸入、口服或静脉使用抗生素的其他组合,或与安慰剂或常规治疗用于肺部病情加重和长期治疗的随机或半随机对照试验。
两位作者独立选择试验、提取数据并评估质量。我们联系试验作者以获取缺失信息。
我们纳入了三项研究肺部病情加重的试验(171名参与者)和两项研究长期治疗的试验(85名参与者)。我们将生活质量和肺功能视为最重要的结局指标。分析未发现口服抗铜绿假单胞菌抗生素与其他治疗在这些结局指标上对于肺部病情加重或长期治疗存在任何统计学上的显著差异。纳入的一项试验报告称,与静脉治疗相比,用环丙沙星治疗肺部病情加重时肺功能明显更好;然而,我们的分析未证实这一发现。我们未发现口服抗铜绿假单胞菌抗生素与其他治疗在不良事件或抗生素耐药性产生方面存在差异的证据,但试验的样本量不足以检测到这一点。没有一项研究在盲法方面存在低偏倚风险,这可能对诸如生活质量等主观结局产生特别影响。在各项研究中,其他标准的偏倚风险无法明确说明。
我们没有确凿证据表明,口服抗铜绿假单胞菌抗生素方案在治疗肺部病情加重或铜绿假单胞菌慢性感染的长期治疗中比替代治疗更有效或效果更差。在获得未来样本量充足的试验结果之前,需要根据任何可用的非随机对照试验证据、个体的临床情况、药物对当地菌株的已知有效性以及个人偏好,从实际出发选择治疗方法。