Lasserson T J, Cates C K, Jones A B, Steele E H, White J
St George's University of London, Community Health Sciences, Cranmer Terrace, Tooting, London, UK, SW17 ORE.
Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD005309. doi: 10.1002/14651858.CD005309.pub3.
The relative efficacy of fluticasone (FP) and beclomethasone (BDP) propelled with CFCs has been well established. The potency of HFA-BDP is thought to have been improved with new propellant and some studies suggest that it may equipotent at half the dose of CFC propelled-BDP. There is a need to revisit this question in the light of a potentially more potent new non-CFC propellant.
To determine the relative efficacy of FP and HFA-propelled BDP in chronic asthma.
The Cochrane Airways Group Specialised Register was searched using pre-specified terms. Searches were current as of January 2006.
Randomised controlled trials were eligible for inclusion in the review. We compared either CFC or HFA-propelled FP with HFA-propelled BDP. We made a distinction between HFA-BDP and HFA-BDP extra fine, which dispenses smaller particles of drug, leading to different, usually more peripheral distribution in the airways. Any inhaler device was considered, and there was no restriction on studies with or without spacers. We included studies which assessed HFA-BDP given via either pMDI, breath-actuated MDI, or DPI.
Two reviewers independently assessed studies for inclusion in the review. Data were extracted and entered in to RevMan 4.2 using standard meta-analytical techniques with predefined criteria for exploring statistical heterogeneity.
Eight studies (1260 participants) met the inclusion criteria of the review. One study was conducted in children. Study reporting quality was fair, but all studies were of short duration (three to twelve weeks). Only studies assessing HFA-BDP extra fine in comparison with FP were identified. Lung function was not significantly different between extra fine BDP and FP when compared at the same dose in parallel studies, change in FEV1: 0.04 litres (95% CI -0.03 to 0.11 litres; three studies, 659 adults); change in am PEF: -0.69 litres (95% CI -11.21 to 9.83 litres; two studies, 364 adults). Individual studies reported non-significant findings in symptom scores and quality of life questionnaires. There was no significant difference between FP and HFA-BDP in the risk of study withdrawal, dysphonia or when data were reported as any adverse event.
AUTHORS' CONCLUSIONS: There was no significant difference between FP and extra fine HFA-BDP on FEV(1) or peak flow at a dose ratio of 1:1. However, the number of studies and width of the confidence intervals in the analyses do not exclude a clinically meaningful difference between these two drugs. Difficulty in the successful manipulation of the devices studied may be a barrier to the widespread use of MDIs. One paediatric study was included in the review, so extrapolation of the findings of this review to children is limited. Further longer term studies in adults and children with moderate and severe asthma are required.
氟替卡松（FP）和含氯氟烃推进的倍氯米松（BDP）的相对疗效已得到充分证实。氢氟烷烃推进的倍氯米松（HFA-BDP）的效力被认为因新型推进剂而有所提高，一些研究表明，其效力可能在含氯氟烃推进的倍氯米松剂量减半时相当。鉴于一种可能效力更强的新型无氯氟烃推进剂，有必要重新审视这个问题。
确定FP和氢氟烷烃推进的BDP在慢性哮喘中的相对疗效。
使用预先设定的检索词检索Cochrane Airways Group专业注册库。检索截至2006年1月。
随机对照试验符合纳入本综述的条件。我们比较了含氯氟烃或氢氟烷烃推进的FP与氢氟烷烃推进的BDP。我们区分了HFA-BDP和HFA-BDP超细型，后者可喷出更小的药物颗粒，导致在气道中分布不同，通常更偏向周边。考虑使用任何吸入装置，对有无储物罐的研究均无限制。我们纳入了评估通过定量气雾剂（pMDI）、呼吸驱动定量气雾剂或干粉吸入器（DPI）给予HFA-BDP的研究。
两名综述作者独立评估纳入本综述的研究。使用标准的荟萃分析技术提取数据并录入RevMan 4.2，采用预定义标准探索统计异质性。
八项研究（1260名参与者）符合本综述的纳入标准。一项研究在儿童中进行。研究报告质量一般，但所有研究持续时间较短（3至12周）。仅识别出评估超细型BDP与FP比较的研究。在平行研究中，相同剂量下比较时，超细型BDP和FP之间的肺功能无显著差异，第一秒用力呼气容积（FEV1）变化：0.04升（95%可信区间-0.03至0.11升；三项研究，659名成年人）；上午呼气峰值流速（am PEF）变化：-0.69升（95%可信区间-11.21至9.83升；两项研究，364名成年人）。个别研究报告症状评分和生活质量问卷结果无显著差异。在研究退出风险、声音嘶哑或报告为任何不良事件的数据方面，FP和HFA-BDP之间无显著差异。
在剂量比为1:1时，FP和超细型HFA-BDP在FEV1或峰值流速方面无显著差异。然而，分析中的研究数量和可信区间宽度并未排除这两种药物之间存在具有临床意义的差异。所研究装置成功操作的难度可能是定量气雾剂广泛使用的障碍。本综述纳入了一项儿科研究，因此将本综述结果外推至儿童有限。需要对成人和中重度哮喘儿童进行进一步的长期研究。
