Fluticasone versus placebo for chronic asthma in adults and children

 

Abstract

Background

Inhaled fluticasone propionate (FP) is a relatively new inhaled corticosteroid for the treatment of asthma.

Objectives

To assess efficacy and safety outcomes in studies that compared FP to placebo for treatment of chronic asthma.

Search methods

We searched the Cochrane Airways Group Specialised Register (January 2008), reference lists of articles, contacted trialists and searched abstracts of major respiratory society meetings (1997-2006).

Selection criteria

Randomised trials in children and adults comparing FP to placebo in the treatment of chronic asthma. Two reviewers independently assessed articles for inclusion and risk of bias.

Data collection and analysis

Two review authors extracted data. Quantitative analyses were undertaken using Review Manager software.

Main results

Eighty-six studies met the inclusion criteria, recruiting 16,160 participants. In non-oral steroid treated asthmatics with mild and moderate disease FP resulted in improvements from baseline compared with placebo across all dose ranges (100 to 1000 mcg/d) in FEV1 (between 0.1 to 0.43 litres); morning PEF (between 23 and 46 L/min); symptom scores (based on a standardised scale, between 0.44 and 0.7); reduction in rescue beta-2 agonist use (between 1 and 1.4 puffs/day). High dose FP increased the number of patients who could withdraw from prednisolone: FP 1000-1500 mcg/day Peto Odds Ratio 14.07 (95% CI 7.17 to 27.57). FP at all doses led to a greater likelihood of sore throat, hoarseness and oral Candidiasis.

Authors' conclusions

Doses of FP in the range 100-1000 mcg/day are effective. In most patients with mild-moderate asthma improvements with low dose FP are only a little less than those associated with high doses when compared with placebo. High dose FP appears to have worthwhile oral-corticosteroid reducing properties. FP use is accompanied by an increased likelihood of oropharyngeal side effects.

 

Plain language summary

Fluticasone versus placebo for chronic asthma in adults and children

Fluticasone is a well-established inhaled steroid for use a preventative agent in controlling asthma symptoms. This review found that it is highly effective even in low doses. The effect does appear to increase with higher doses, but these improvements are small. This drug is associated with symptoms such a thrush, sore throat and hoarseness and these get worse with higher doses. In people with severe asthma who need oral steroid tablets to control their asthma, it can reduce the dose of oral steroids they need and improve their asthma at the same time. However, high or very high doses are needed for this effect. The drug appears to work in children and adults.

 

摘要

背景

比較 Fluticasone 與安慰劑在治療成人及兒童之慢性氣喘的效應

吸入式 fluticasone propionate (FP)是一種用於治療氣喘頗新的吸入式類固醇。

目標

評估比較 FP 與安慰劑在治療慢性氣喘的效應及安全結果的研究。

搜尋策略

我們搜尋 Cochrane Airways Group Specialised Register (2008 年 1 月)、文章引用的文獻、聯繫試驗人員及搜尋重要的呼吸學會之會議摘要(1997 年至 2006 年)。

選擇標準

比較 FP 與安慰劑在治療成人及兒童之慢性氣喘的隨機試驗。兩位審查者獨立地評估文章的納入與否及偏誤的風險。

資料收集與分析

兩位審查者摘錄數據。定量分析乃使用 Review Manager 軟體。

主要結論

有 86 項研究符合納入標準，共納入 16,160 名參與者。在非口服類固醇治療之輕至中度氣喘患者中，在劑量範圍的各種劑量(100 至 1000 mcg/d)之 FP 與安慰劑相較在下列各項均較基線狀況有所改善： FEV1 (介於 0.1 至 0.43 L)；清晨 PEF (介於 23 至 46 L/min)；症狀評分(基於標準化尺規，介於 0.44 至 0.7)；減少使用乙型促效劑救援(介於 1 至 1.4 puffs/d)。高劑量 FP 增加停用 prednisolone 的病人數： FP 1000 至 1500 mcg/d Peto Odds Ratio 14.07 (95% CI 7.17 至 27.57)。各種劑量之 FP 均有較高的可能性引致喉痛、聲音嘶啞及口腔唸珠菌症。

作者結論

在 100 至 1000 mcg/d 劑量範圍的 FP 是有效的。在與安慰劑相較下，大多數輕至中度氣喘患者使用低劑量 FP 的進步僅稍低於使用高劑量 FP 者。高劑量 FP 呈現的價值在於減少口服皮質類固醇。 FP 的使用伴隨增加口咽副作用的可能性。

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

Fluticasone 是一種已被確定可作為控制氣喘症狀的預防性藥劑之吸入式類固醇。本回顧發現縱使它以低劑量使用時仍高度有效。在使用較高劑量時效應增加，但改善不多。本藥伴隨的症狀如鵝口瘡、喉痛及聲音嘶啞，而使用較高劑量時會更糟。在需口服類固醇控制病情的重度氣喘患者，本藥可減少所需口服類固醇的劑量及改善氣喘。然而，要有此一效應需要高或很高的劑量。本藥可作用於兒童及成人。