Fluticasone berbanding 'extrafine' HFA‐beclomethasone dipropionate untuk asma kronik dalam kalangan dewasa dan kanak‐kanak
Abstract
Background
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 extra‐fine HFA‐BDP may be equipotent at half the dose of CFC propelled‐BDP.
Objectives
To determine the relative efficacy of FP and HFA‐propelled extrafine BDP in chronic asthma.
Search methods
The Cochrane Airways Group Specialised Register was searched using pre‐specified terms. Searches were current as of January 2010.
Selection criteria
Randomised controlled trials were eligible for inclusion in the review. We compared either CFC or HFA‐propelled FP with HFA‐propelled extrafine BDP. We made a distinction between HFA‐BDP and HFA‐BDP extrafine, 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.
Data collection and analysis
Two review authors independently assessed studies for inclusion in the review. Data were extracted and entered in to RevMan 5 using standard meta‐analytical techniques with predefined criteria for exploring statistical heterogeneity.
Main results
Nine studies (1265 participants) met the inclusion criteria of the review. Two studies were conducted in children. Study reporting quality was fair, but all studies were of short duration (three to twelve weeks). Lung function was not significantly different between extrafine 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 FEV1 predicted: ‐2.18% (95% CI ‐4.62 to 0.26; three studies, 334 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 extrafine 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 extrafine HFA‐BDP on FEV1 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. Only two small paediatric studies were 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.
PICO
Ringkasan bahasa mudah
Fluticasone yang disedut berbanding 'extrafine' HFA‐beclomethasone dipropionate untuk asma kronik dalam kalangan dewasa dan kanak‐kanak
Peranti alat sedut yang diguna untuk menghantar steroid bagi asma secara umu terbahagi kepada tiga kategori. Yang menggunakan bahan pendorong untuk dispens steroid ke dalam saluran udara melalui mulut apabila kanister ditekan secara manual (penyedut dos terukur bertekanan ‐ pMDIs), yang menggunakan bahan pendorong untuk menghantar dos steroid yang dicetuskan oleh pernafasan pengguna (MDIs yang digerakkan oleh nafas), dan yang menghantar ubat sebagai serbuk kering (DPI). pMDI secara tradisi menggunakan bahan pendorong klorofluorokarbon (CFC), tetapi penyesuaian fasa penyedut CFC memberi implikasi besar bagi pembuatan ubat sedutan. Satu pendorong bukan CFC (hidrofluoroalkana‐134a (HFA) baharu telah diperkenalkan, dan ia diguna untuk mendorong beclomethasone (BDP). Sebelum ini fluticasone (FP) dianggap sekurang‐kurangnya sama berkesan seperti CFC‐BDP apabila diberi separuh dos. Ulasan kajian mendapati bahawa terdapat bukti yang terhad untuk menunjukkan BDP baharu dalam bentuk lebih halus adalah serupa dengan FP pada dos yang sama. Lebih banyak penyelidikan harus dilakukan dalam kalangan kanak‐kanak dan orang dengan asma yang lebih teruk untuk membantu menjawab persoalan tentang kesan relatif kedua‐dua steroid ini. Sesetengah orang mungkin tidak begitu arif menggunakan jenis alat sedut tertentu dan penemuan kajian mungkin hanya boleh diaplikasi kepada orang yang kompeten menggunakan alsat edut dos terukur (MDIs). Kajian‐kajian harus menimbang untuk memperkenalkan peruang di mana orang mendapatinya lebih mudah diguna.
