Remmington T, Jahnke N, Harkensee C
University of Liverpool, Institute of Child Health, Alder Hey Children's Hospital, Eaton Road, Liverpool, UK, L12 2AP.
Cochrane Database Syst Rev. 2007 Jul 18(3):CD005405. doi: 10.1002/14651858.CD005405.pub2.
Pseudomonas aeruginosa is the most common bacterial pathogen causing infection in the lungs of people with CF and appropriate antibiotic therapy is vital. Antibiotics for 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 the quality of life of 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 an exacerbation of respiratory tract infection; and (2) long-term treatment in 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 for information on relevant trials and checked reference lists of identified trials. Most recent search: March 2007.
Randomised or quasi-randomised controlled trials comparing any dose of oral anti-pseudomonal antibiotics, with other combinations of inhaled, oral or intravenous antibiotics, or with placebo or usual treatment for exacerbations and long-term treatment.
Two authors independently selected the trials, extracted data and assessed quality. We contacted trialists to obtain missing information.
We included four trials examining exacerbations (197 participants) and two trials examining long-term therapy (85 participants). We regarded the most important outcomes as quality of life and lung function. In our analysis, we were unable to identify any statistically significant difference between oral anti-pseudomonal antibiotics and other treatments for these outcome measures for either exacerbations or long-term treatment. One of the included trials reported significantly better lung function when treating an 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.
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 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 known effectiveness 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细菌病原体，恰当的抗生素治疗至关重要。用于病情加重期的抗生素通常通过静脉给药，而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，由于治疗方便且可避免住院，将有益于CF患者的生活质量。
确定口服抗铜绿假单胞菌抗生素疗法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）治疗呼吸道感染加重期；（2）慢性感染的长期治疗。
我们检索了Cochrane囊性纤维化和遗传疾病小组试验注册库，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手工检索确定的参考文献。我们联系了制药公司以获取相关试验的信息，并查阅了已确定试验的参考文献列表。最近一次检索时间为2007年3月。
比较任何剂量口服抗铜绿假单胞菌抗生素与其他吸入、口服或静脉抗生素组合，或与安慰剂或常规治疗用于病情加重期和长期治疗的随机或半随机对照试验。
两名作者独立选择试验、提取数据并评估质量。我们联系试验研究者以获取缺失信息。
我们纳入了四项考察病情加重期的试验（197名参与者）和两项考察长期治疗的试验（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。在我们的分析中，对于病情加重期或长期治疗，我们未能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有任何统计学显著差异。纳入的一项试验报告称，与静脉治疗相比，用环丙沙星治疗病情加重期时肺功能显著更好；然而，我们的分析并未证实这一发现。我们没有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发展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。
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铜绿假单胞菌慢性感染的病情加重期或长期治疗中比替代治疗更有效或效果更差。在有足够样本量的未来试验结果出来之前，治疗需要基于对当地菌株的已知有效性和个人偏好，从实际出发进行选择。
