Welsh Emma J, Cates Christopher J
Population Health Sciences and Education, St George's, University of London, Cranmer Terrace, London, UK, SW17 0RE.
Cochrane Database Syst Rev. 2010 Sep 8;2010(9):CD008418. doi: 10.1002/14651858.CD008418.pub2.
Formoterol is a long-acting beta(2)-agonist but because it has a fast onset of action it can also be used as a relief medication.
To asses the efficacy and safety of formoterol as reliever therapy in comparison to short-acting beta(2)-agonists in adults and children with asthma.
We searched the Cochrane Airways Group Specialised Register and websites of clinical trial registers (for unpublished trial data), and we checked the Food and Drug Administration (FDA) submissions in relation to formoterol. The date of the most recent search was February 2010.
Randomised, parallel-arm trials of at least 12 weeks duration in patients of any age and severity of asthma. Studies randomised patients to any dose of as-needed formoterol versus short-acting beta(2)-agonist. Concomitant use of inhaled corticosteroids or other maintenance medication was allowed, as long as this was not part of the randomised treatment regimen.
Two authors independently selected trials for inclusion in the review. Outcome data were extracted by one author and checked by the second author. We sought unpublished data on primary outcomes.
This review includes eight studies conducted in 22,604 participants (mostly adults). Six studies compared formoterol as-needed to terbutaline whilst two studies compared formoterol with salbutamol as-needed. Background maintenance therapy varied across the trials. Asthma exacerbations and serious adverse events showed a direction of treatment effect favouring formoterol, of which one outcome reached statistical significance (exacerbations requiring a course of oral corticosteroids). In patients on short-acting beta(2)-agonists, 117 people out of 1000 had exacerbations requiring oral corticosteroids over 30 weeks, compared to 101 (95% CI 93 to 108) out of 1000 for patients on formoterol as-needed. In patients on maintenance inhaled corticosteroids there were also significantly fewer exacerbations requiring a course of oral corticosteroids on formoterol as-needed (Peto OR 0.75; 95% CI 0.62 to 0.91). There was one death per 1000 people on formoterol or on short-acting beta(2)-agonists.
AUTHORS' CONCLUSIONS: In adults, formoterol was similar to short-acting beta(2)-agonists when used as a reliever, and showed a reduction in the number of exacerbations requiring a course of oral corticosteroids. Clinicians should weigh the relatively modest benefits of formoterol as-needed against the benefits of single inhaler therapy and the potential danger of long-term use of long-acting beta(2)-agonists in some patients. We did not find evidence to recommend changes to guidelines that suggest that long-acting beta(2)-agonists should be given only to patients already taking inhaled corticosteroids.There was insufficient information reported from children in the included trials to come to any conclusion on the safety or efficacy of formoterol as relief medication for children with asthma.
福莫特罗是一种长效β₂受体激动剂，但因其起效迅速，也可作为缓解药物使用。
评估福莫特罗作为缓解疗法与短效β₂受体激动剂相比，在成人和儿童哮喘患者中的疗效和安全性。
我们检索了Cochrane Airways Group专业注册库以及临床试验注册网站（以获取未发表的试验数据），并查阅了美国食品药品监督管理局（FDA）与福莫特罗相关的提交资料。最近一次检索日期为2010年2月。
针对任何年龄和哮喘严重程度患者进行的至少为期12周的随机平行组试验。研究将患者随机分配至任何剂量的按需使用福莫特罗组与短效β₂受体激动剂组。允许同时使用吸入性糖皮质激素或其他维持药物，只要这不是随机治疗方案的一部分。
两位作者独立选择纳入综述的试验。结局数据由一位作者提取并由第二位作者核对。我们寻求关于主要结局的未发表数据。
本综述纳入了八项针对22604名参与者（大多数为成人）开展的研究。六项研究将按需使用的福莫特罗与特布他林进行比较，两项研究将按需使用的福莫特罗与沙丁胺醇进行比较。各试验中的背景维持治疗有所不同。哮喘加重和严重不良事件显示出治疗效果倾向于福莫特罗的趋势，其中一项结局达到统计学显著性（需要口服糖皮质激素疗程治疗的加重情况）。在使用短效β₂受体激动剂的患者中，每1000人中有117人在30周内出现需要口服糖皮质激素治疗的加重情况，而按需使用福莫特罗的患者中每1000人有101人（95%CI 为93至108）出现这种情况。在使用维持性吸入性糖皮质激素的患者中，按需使用福莫特罗时需要口服糖皮质激素疗程治疗的加重情况也显著更少（Peto比值比0.75；95%CI 为0.62至0.91）。使用福莫特罗或短效β₂受体激动剂的患者中，每1000人中有1人死亡。
在成人中，福莫特罗作为缓解药物使用时与短效β₂受体激动剂相似，并显示出需要口服糖皮质激素疗程治疗的加重情况数量有所减少。临床医生应权衡按需使用福莫特罗相对较小的益处与单一吸入器疗法的益处以及在某些患者中长期使用长效β₂受体激动剂的潜在风险。我们未找到证据支持对建议长效β₂受体激动剂仅应给予已在使用吸入性糖皮质激素患者的指南进行更改。纳入的试验中关于儿童的信息不足，无法就福莫特罗作为儿童哮喘缓解药物的安全性或疗效得出任何结论。
