Intervention Review

Azathioprine as an oral corticosteroid sparing agent for asthma

  1. Taraneh P Dean1,*,
  2. Ann Dewey1,
  3. Anna Bara2,
  4. Toby J Lasserson3,
  5. E. Haydn Walters4

Editorial Group: Cochrane Airways Group

Published Online: 8 JUL 2009

Assessed as up-to-date: 5 AUG 2010

DOI: 10.1002/14651858.CD003270.pub2

Database Title

Additional Information

How to Cite

Dean TP, Dewey A, Bara A, Lasserson TJ, Walters EH. Azathioprine as an oral corticosteroid sparing agent for asthma. Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD003270. DOI: 10.1002/14651858.CD003270.pub2.

Author Information

  1. 1

    University of Portsmouth, School of Health Sciences & Social Work, Portsmouth, Hampshire, UK

  2. 2

    Clinical Trials Unit, Medical Research Unit, London, UK

  3. 3

    The Cochrane Collaboration, Cochrane Editorial Unit, London, UK

  4. 4

    University of Tasmania, Menzies Research Institute, Hobart, Tasmania, Australia

*Taraneh P Dean, School of Health Sciences & Social Work, University of Portsmouth, James Watson (West), 2 King Richard 1st Road, Portsmouth, Hampshire, PO1 2FR, UK. tara.dean@port.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (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

For the majority of chronic asthmatics, symptoms are best controlled by using inhaled steroids. However, for a small group of asthmatics, symptoms can only be controlled by high doses of oral steroids. Continuous use of oral steroid is associated with severe side-effects, but it has been suggested that azathioprine, an immunosuppressive anti-metabolite, often used to reduce the immune response in chronic active hepatitis and severe rheumatoid arthritis, could be useful as an oral steroid sparing agent. There is a need to systematically evaluate the evidence regarding its use to reduce or eliminate oral corticosteroid usage.

Objectives

The objective of this review is to assess the efficacy of adding azathioprine in patients with stable asthma who are dependent on oral corticosteroids with the intention of eventually minimizing or eliminating the use of these steroids.

Search methods

Searches of the Cochrane Airways Group Specialised Register were undertaken with predefined search terms. Searches were current as of August 2010.

Selection criteria

Only studies with a randomised placebo-controlled design met the inclusion criteria for the review.

Data collection and analysis

Two authors independently assessed studies for suitability for inclusion in the review. Data were extracted and entered into Review Manager.

Main results

Two small trials recruiting 23 participants met the inclusion criteria for the review. Participants may have been suffering from comorbid lung disease. No data on oral steroid consumption were reported. No significant differences were observed in the studies for FEV1, FVC, PaO2 and symptoms. One study reported a statistically significant difference in SGaw, but the clinical importance of this is uncertain. Due to concerns over the small sample sizes and methodological shortcomings in terms of inadequate washout in one study, and methods used in outcome assessment for both studies, the findings of the studies are not generalisable to the issue of steroid tapering. An update search conducted in August 2010 did not identify any new studies for consideration in the review.

Authors' conclusions

Currently there is a clear lack of evidence to support the use of azathioprine in the treatment of chronic asthma as a steroid sparing-agent. Large, long-term studies with pre-defined steroid reducing protocols are required before recommendations for clinical practice can be made.

 

Plain language summary

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

Azathioprine as an oral corticosteroid sparing agent for asthma

Asthma can be treated with drugs that aim to reduce inflammation in the airways. Inhaled corticosteroids are frequently used, but occasionally individuals require oral steroids for adequate control. However, oral steroids are frequently associated with severe side-effects. Azathioprine has been suggested as a useful 'add-on' therapy to oral steroid treatment with the aim of reducing the dose requirement in such cases of severe asthma. The review found two small studies which did not provide adequate evidence as to whether azathioprine could be offered to reduce oral steroid treatment. There is a need for well-designed trials addressing this question before recommendations can be made.

 

摘要

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

背景

以azathioprine作為口服皮質類固醇治療氣喘的助減劑

大多數氣喘患者是使用吸入式類固醇來讓症狀得到最好的控制。然而，小數氣喘患者必須使用大劑量的口服類固醇才能控制症狀。連續使用口服類固醇會有嚴重的副作用，而曾有建議azathioprine(一種藉降低免疫反應常用於慢性活動性肝炎及嚴重類風濕性關節炎的免疫抑制抗代謝藥)可作為口服皮質類固醇的助減劑。對此須有系統性評估有關減少或免除使用類固醇的相關證據。

目標

本回顧的目的，是以需倚賴口服類固醇而情況穩定的氣喘病人為對象，評估其加入azathioprine治療在減少或免除使用類固醇的效果。

搜尋策略

以預設詞彙搜尋Cochrane Airways Group Specialised Register。搜尋日期至目前為2007年8月。

選擇標準

本回顧分析只納入有隨機安慰劑對照設計的研究。

資料收集與分析

兩位評論者獨立地評估研究是否適於納入回顧。摘錄的數據被輸入RevMan 4.2。

主要結論

僅有兩項共招募23名受試者的小規模試驗符合納入標準。參與者中有同時罹患其他肺病。口服類固醇的使用情況並無數據報導。在FEV1、FVC、PaO2及症狀等並無顯著差異。一項研究報導SGaw在統計學上有顯著差異，但其臨床意思並不確定。由於顧慮到試驗之個案數甚少，且在方法學上其中一項的藥物洗除期不足及兩項試驗在預後評估上有缺失，這些試驗的發現不能通用於減用類固醇的議題上。在2004年8月的最新搜尋並未找到可被考慮納入本評論的新試驗。

作者結論

在目前，以azathioprine作為類固醇助減劑來治療慢性氣喘仍是明顯缺乏證據的支持。在可以對臨床執業作出建議之前，必須先進行使用預設之類固醇減量療方之大規模且長期的研究。

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

沒有足夠的證據可判斷免疫抑制制azathioprine對療慢性氣喘是一種有效的類固醇助減劑。氣喘可藉由降低氣道發炎的藥物來治療。吸入性類固醇常被使用，但時有病人需要使用口服類固醇病情才能得到充分的控制。然而，口服類固醇常伴隨嚴重的副作用。Azathioprine曾被建議作為口服類固醇治療的「附加」治療以減少嚴重氣喘案例口服類固醇的使用量。本回顧搜尋到的兩項小規模試驗，並未提供足夠證據判定azathioprine能否減少口服類固醇。在可以提出建議之前，必須先行針對此一問題執行設計良好的臨床試驗。

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