Intervention Review

Beclomethasone at different doses for chronic asthma

  1. Nick P Adams1,*,
  2. Janine C Bestall2,
  3. Paul Jones3

Editorial Group: Cochrane Airways Group

Published Online: 8 JUL 2009

Assessed as up-to-date: 22 JUL 1999

DOI: 10.1002/14651858.CD002879

Database Title

Additional Information

How to Cite

Adams NP, Bestall JC, Jones P. Beclomethasone at different doses for chronic asthma. Cochrane Database of Systematic Reviews 1999, Issue 4. Art. No.: CD002879. DOI: 10.1002/14651858.CD002879.

Author Information

  1. 1

    Worthing & Southlands NHS Trust, Respiratory Medicine, Worthing, UK

  2. 2

    St George's Hospital Medical School, Division of Physiological Medicine, London, UK

  3. 3

    St George's Hospital Medical School, Cardiovascular Medicine, London, UK

*Nick P Adams, Respiratory Medicine, Worthing & Southlands NHS Trust, Worthing, UK. Nick.Adams@wash.nhs.uk. nadams2002@btinternet.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 8 JUL 2009

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Beclomethasone dipropionate (BDP) is available in a wide range of daily doses for the treatment of long-term asthma.

Objectives

To assess the evidence for a dose response relationship for BDP in the treatment of long-term asthma.

Search methods

We searched the Cochrane Airways Group trial register, Cochrane Controlled Trials Register (The Cochrane Library issue 1 1999) and references lists of articles. Authors and Glaxo Wellcome UK were contacted to identify eligible studies. We also hand searched the proceeding from relevant respiratory society meetings, the British Journal of Clinical Research and the European Journal of Clinical Research for studies.

Selection criteria

Prospective, randomised trials comparing two or more daily doses of BDP in patients over the age of two years with long-term asthma.

Data collection and analysis

Trials were selected for inclusion and scored for quality by two reviewers. Data were extracted by one reviewer. Authors were contacted to clarify details of study design and retrieve missing data.

Main results

15 trials were included. Methodological quality was variable. Studies rarely gave a clear indication of the degree of asthma control at baseline. Less than two-fold to five-fold dose differences were assessed by different studies. The results are reported as weighted mean differences (WMD) with 95% confidence limits (95% CI). The number of trials (N) contributing to each outcome is stated. In non-oral steroid treated asthmatics a small advantage of BDP 800 mcg/d over 400 mcg/d was apparent for improvement in morning peak expiratory flow rate (PEFR) compared to baseline, WMD 11 L/min (95% CI 4 to 19 L/min) N=2; improvement in forced expired volume in one second (FEV1) compared to baseline, WMD 9 ml (95% CI 3 to 140) N=1; and reduction in night-time symptom score compared to baseline, WMD 0.13 (95% CI 0.04 to 0.22) N=1. Studies that assessed BDP 1000 v 500 mcg/d and BDP 1600 v 400 mcg/d demonstrated significant advantage of higher dose over lower dose for histamine bronchial hyper-responsiveness (BHR) and percentage improvement in FEV1 compared to baseline. No differences between higher and lower daily doses of BDP were apparent for daytime symptoms, withdrawals due to asthma exacerbation, oropharyngeal side effects or measures of hypothalamo-pituitary-adrenal (HPA) function. No difference in prednisolone sparing effect was apparent when comparing high dose and low dose BDP in oral corticosteroid (OCS) dependent patients.

Authors' conclusions

BDP appears to demonstrate a shallow dose response effect in long-term asthma for a small number of efficacy outcomes over range of daily doses from 400 mcg/d to 1600 mcg/d, although the clinical significance of the improvements afforded by higher doses is questionable.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Beclomethasone at different doses for chronic asthma

Inhaled steroids help control inflammation in the airways of the lung. There are numerous different preparations available, and we have assessed how varying the dose of beclomethasone (BDP) affects asthma in this review. There was a limited amount of evidence that 800mcg/d was superior to 400mcg/d in improving morning and evening peak flow. More research into the effects of different doses of BDP is required.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

不同劑量的beclomethasone對慢性氣喘的治療

Beclomethasone dipropionate(BDP)用來治療長期氣喘的每日劑量範圍很大。

目標

評估與BDP治療長期氣喘的劑量反應關係的相關證據。

搜尋策略

搜尋Cochrane Airways Group trial register、Cochrane Controlled Trials Register(The Cochrane Library issue 1 1999)和研究文章的參考資料清單。另外聯絡作者和英國Glaxo Wellcome藥廠找出更多合適的研究。我們也人工搜尋相關呼吸學會的會議紀錄、英國臨床試驗期刊和歐洲臨床試驗期刊等。

選擇標準

針對兩歲以上的長期氣喘患者，比較BDP的兩種或多種每日劑量的前瞻性隨機試驗。

資料收集與分析

兩位審查員選擇欲納入的研究，並評定其研究品質。一位審查員擷取數據。聯絡作者確認研究設計的詳細內容，並補充缺失的資料。

主要結論

納入十一個試驗、共1614位受試者。方法學品質有很大的差異。大部分研究並未詳細說明－研究開始時氣喘控制的程度。不同的研究使用的劑量不同，差異小於2到5倍。結果以加權平均差(WMD)及 95%信賴區間(95% CI)表示。並說明各項結果的納入研究數目(N)。 非口服類固醇治療的氣喘患者中，在清晨尖峰吐氣流速(PEFR)(與基準線相比)方面，BDP 800 mcg/日治療組稍微優於400 mcg/日治療組，加權平均差11公升/分鐘(95%信賴區間4到19公升/分鐘)，N = 2；第1秒用力吐氣量(FEV1)(與基準線相比)也有改善，加權平均差9毫升(95%信賴區間3到140)，N = 1；另外，夜間症狀分數減少(與基準線相比)，加權平均差0.13 (95%信賴區間0.04到0.22)，N = 1。 其它研究比較BDP 1000和500 mcg/日，以及BDP1600 和400mcg/日，結果證實：在組織胺支氣管過度反應(bronchial hyperresponsiveness, BHR)和FEV1的改善百分比(與基準線相比)方面，高劑量明顯優於低劑量。至於在日間症狀、因氣喘發作而退出試驗的比例、口咽副作用、或下視丘腦下垂體腎上腺功能(hypothalamopituitaryadrenal, HPA)測量值等各方面，高、低劑量治療組間則沒有明顯的差別。針對口服類固醇依賴的患者，高、低劑量的BDP對於減少prednisolone的使用(prednisolone sparing effect)方面沒有明顯的差異。

作者結論

對於長期氣喘患者的少數幾項治療效果，當BDP的使用劑量在每日400 mcg到1600 mcg之間時，似乎顯示有一點劑量反應效果。但是，較高劑量的BDP所提供的臨床改善意義還有待商榷。

翻譯人

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

總結

無總結

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