Beclomethasone versus budesonide for chronic asthma

 

Abstract

Background

Beclomethasone dipropionate (BDP) and budesonide (BUD) are used widely in the treatment of chronic asthma. The two drugs have different in vitro pharmacokinetic characteristics. It is unclear whether this translates into clinically significant differences in efficacy or safety when treating children and adults with chronic asthma.

Objectives

To assess clinical outcomes in studies which have compared inhaled BDP and BUD in the treatment of chronic asthma.

Search methods

We searched the Cochrane Airways Group Trial Register (1999) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997-1999).

Selection criteria

Prospective, randomised trials comparing BDP to BUD in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and methodological quality.

Data collection and analysis

One reviewer extracted data; authors were contacted to clarify missing information. Quantitative analyses where undertaken using Review Manager 4.0.3 with MetaView 3.1.

Main results

24 studies met the criteria for inclusion (1174 participants). Methodological quality was variable. A meta-analysis of crossover studies did not demonstrate a significant difference between BDP and BUD for FEV1, morning PEF, evening PEF, asthma symptoms or rescue beta2 agonist use, over a dose range of 400 to 1000 mcg/d. The majority of crossover trials had significant design flaws related to a lack of washout and/or failure to exclude carryover effects so the results must be viewed with caution. A single crossover study with adequate washout showed that BUD 400 mcg/d delivered via Turbohaler dry powder inhaler (DPI) may be more effective than BDP 400 mcg/d delivered via Rotahaler DPI in reducing histamine bronchial hyper-responsiveness: Weighted Mean Difference (WMD) 0.43 log10 PC20 FEV1 (95% Confidence Intervals (CI) 0.05, 0.81 log10 PC20 FEV1). A meta-analysis of two parallel group, dose down-titration studies (231 patients) showed that less BUD delivered via a Turbohaler DPI was required to maintain control in adults asthmatics compared to BDP delivered via metered dose inhaler with or without a spacer: WMD 444 mcg/d (95% CI 332, 556 mcg/d).

Authors' conclusions

There is limited high quality randomised controlled trial data comparing the relative efficacy of BDP and BUD. Current guidelines (BTS 1997; GINA 1995; NHLBI 1997) assume BDP and BUD to have equal efficacy, such that for each defined level of asthma severity, the recommended doses BDP and BUD are the same. Although there is some data to suggest that BUD via Turbohaler is more effective than BDP via either Rotahaler or MDI (with and without spacer), these comparisons are confounded by use of different delivery devices, and are not sufficient to warrant a change in guideline recommendations.

 

Plain language summary

The effects of beclomethasone or budesonide for chronic asthma

Beclomethasone and budesonide are commonly used to treat people with asthma in the long-term. Despite the large amount of research which has been conducted with these two steroids, very little can be concluded as to how effective they are, because the quality of the research to date has not been strong enough. The available research does not therefore provide a clear answer as to whether beclomethasone or budesonide are better for treating asthma.

 

摘要

背景

比較beclomethasone與budesonide對慢性氣喘的治療

Beclomethasone dipropionate(BDP)及budesonide(BUD)被廣泛地用於治療慢性氣喘。此兩種藥有不同的離體藥物動力學特性，但不知這些特性導致在治療兒童或成人慢性氣喘時是否療效及安全性呈現臨床上有意義的差別。

目標

評估比較吸入式BDP及BUD治療慢性氣喘臨床結果之研究。

搜尋策略

我們搜尋Cochrane Airways Group Trial Register(1999)及論文的參考文獻。我們聯繫其他研究的試驗人員及商品製造商，亦搜尋主要呼吸學會會議之摘要(1997 – 1999)。

選擇標準

比較BDP及NUD治療慢性氣喘之前瞻性隨機試驗。兩位審查者獨立地評估文章是否適合納入及其方法學品質。

資料收集與分析

一名審查者摘取數據，並與作者聯繫釐清不合的資料。使用Review Manager 4.0.3及MetaView 3.1進行量性分析

主要結論

共有24項研究(1174名受試者)符合納入標準。方法學品質頗為懸殊。一項針對交叉研究的綜合分析並未顯示BDP與BUD在FEV1、清晨PEF、夜間PEF、氣喘症狀或以其他2型促效劑救援有任差異，這些研究所使用的劑量介於400至1000 mcg/d之間。大多數交叉試驗因有缺乏廓清期及/或不能排除carryover效應等重大的設計錯誤，故對其結果必須審慎評估。某一單項交叉研究則有充分的廓清期，此研究顯示採用Turbohaler乾粉吸入器(dry powder inhaler, DPI)吸入BUD 400 mcg/d比採用Rotahaler dpi吸入BDP 400 mcg/d較能降低組織胺支氣管過度反應(histamine bronchial hyperresponsiveness)：權重平均差(WMD)0.43 log 10 PC20 FEV1(95%信賴區間[CI]0.05, 0.81 log10 PC20 FEV1)。一項涉及量平行組劑量下調(downtitration，共231名受試者)的研究顯示採用Turbohaler DPI吸入BUD維持控制所需的劑量低於使用metered dose吸入器(MDI)吸入BDP(無論是否有用spacer)：WMD 444 mcg/d(95% CI332, 556 mcg/d)。

作者結論

比較BDP及BUD相對效益的高品質隨機控制試驗非常有限。目前的指引(VTS 1997; GINA 1995; NHLBI 1997)均假定BDP及BUD具相同效益，因而對於某一設定嚴重度的氣喘，BDP及BUD的建議劑量均相同。雖然有些數據顯示採用Turbohaler吸入BUD較採用Rotahaler或MDI(有或無spacer)吸入BDP更為有效。由於這些比較乃使用不同的送藥設計而受到干擾，致不足以將指引的推薦內容有所改變。

翻譯人

本摘要由中國醫藥大學附設醫院陳祖裕翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

Beclomethasone及budesonide均被廣泛地使用於治療成人及兒童的氣喘。兩類藥物似是同樣有效。Beclomethasone及budesonide常被氣喘患者長期使用。雖然使用這兩種類固醇所進行的研究數量甚大，但因至今研究的品質仍不夠好，故甚少研究能提出結論陳述這兩種藥物有多大效果。因此，beclomethasone與budesonide何者在治療氣喘的效益較佳，現在的研究並不能提供明確答案。