Intranasal corticosteroids for nasal airway obstruction in children with moderate to severe adenoidal hypertrophy

 

Abstract

Background

This is an update of a Cochrane Review first published in The Cochrane Library in Issue 3, 2008.

Adenoidal hypertrophy is generally considered a common condition of childhood. When obstructive sleep apnoea or cardio-respiratory syndrome occurs, adenoidectomy is generally indicated. In less severe cases, non-surgical interventions may be considered, however few medical alternatives are currently available. Intranasal steroids may be used to reduce nasal airway obstruction.

Objectives

To assess the efficacy of intranasal corticosteroids for improving nasal airway obstruction in children with moderate to severe adenoidal hypertrophy.

Search methods

We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; ISI Web of Science; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the most recent search was 4 May 2010.

Selection criteria

Randomised controlled trials comparing intranasal corticosteroids with placebo, no intervention or other treatment in children aged 0 to 12 years with moderate to severe adenoidal hypertrophy.

Data collection and analysis

Two authors independently extracted data from the included trials and assessed trial quality. Meta-analysis was not applicable and we summarised data in a narrative format.

Main results

Six randomised trials involving a total of 394 patients were included. Five of the six trials demonstrated a significant efficacy of intranasal corticosteroids in improving nasal obstruction symptoms and in reducing adenoid size.

The first eight-week cross-over study showed that treatment with beclomethasone (336 mcg/day) yielded a greater improvement in mean symptom scores than placebo (-18.5 versus -8.5, P < 0.05) and a larger reduction in mean adenoid/choana ratio than placebo (right, -14% versus +0.4%, P = 0.002; left, -15% versus -2.0%, P = 0.0006) between week 0 and week 4. The second four-week cross-over study showed that the Nasal Obstruction Index decreased by at least 50% from baseline in 38% of patients treated with beclomethasone (400 mcg/day) between week 0 and week 2, whereas none of the patients treated with placebo had such improvement (P < 0.01). The third parallel-group trial showed that 77.7% of patients treated with mometasone (100 mcg/day) for 40 days demonstrated an improvement in nasal obstruction symptoms and a decrease in adenoid size, such that adenoidectomy could be avoided, whereas no significant improvement was observed in the placebo group. The fourth parallel-group trial showed that eight weeks of treatment with flunisolide (500 mcg/day) was associated with a larger reduction in adenoid size than isotonic saline solution (P < 0.05). The fifth parallel-group trial demonstrated that eight weeks of treatment with fluticasone (400 mcg/day) significantly reduced nasal obstruction symptoms and adenoid size, and adenoidectomy was avoided in 76% of these patients compared with 20% of the patients treated with normal saline (P < 0.05).

In contrast, one parallel-group trial did not find a significant improvement in nasal obstruction symptoms nor adenoid size after eight weeks of treatment with beclomethasone (200 mcg/day).

Authors' conclusions

Current evidence suggests that intranasal corticosteroids may significantly improve nasal obstruction symptoms in children with moderate to severe adenoidal hypertrophy, and this improvement may be associated with a reduction in adenoid size. The long-term efficacy of intranasal corticosteroids in these patients remains to be defined.

 

Plain language summary

Topical steroids for nasal airway obstruction in children with moderately to severely enlarged adenoids

Adenoidal hypertrophy is generally considered a common condition of childhood and represents one of the most frequent indications for surgery in children. In less severe cases, non-surgical interventions may be considered, however few medical alternatives are currently available. This review was conducted to assess the effectiveness of intranasal corticosteroids for improving nasal airway obstruction in children aged 0 to 12 years with moderate to severe adenoidal hypertrophy. Evidence derived from five of the six randomised controlled trials included in this review suggests that intranasal steroids may significantly improve symptoms of nasal obstruction in children with adenoidal hypertrophy and that this improvement may be associated with the reduction of adenoid size. One study did not find a significant improvement in nasal obstruction symptoms. Further large and high-quality randomised controlled trials are warranted.

 

摘要

背景

鼻內皮質類固醇對鼻道阻塞且中重度腺樣體肥大之兒童

腺樣體肥大通常被認為是兒童常見的疾病。當發生阻塞性睡眠呼吸暫停或心肺綜合徵時，通常建議病人施行腺樣體切除術。在不到嚴重的情況下，非手術的療法可能會考慮，但目前少有可行的療法。鼻內類固醇可能用於減少鼻道阻塞

目標

為了評估鼻內皮質類固醇改善鼻道阻塞且重度腺樣體肥大的兒童之療效

搜尋策略

我們的搜索包括了Cochrane耳，鼻，喉疾病組試驗註冊，登記的Cochrane中心對照試驗(中環)(Cochrane圖書館第2期，2007年)，雜誌(1951年至2007年)和醫學文摘庫(1974年至2007年)。所有搜索最初進行2007年5月和2008年4月更新

選擇標準

隨機對照試驗比較鼻內皮質類固醇與安慰劑或不干預或其他治療年齡0−12歲中重度腺樣體肥大之兒童

資料收集與分析

試驗數據有經過摘錄而試驗品質有經由兩位作者獨立地評估。後設分析並不適用，而數據經由總結的方式呈現

主要結論

五項隨機試驗，共包括349名患者，符合納入標準的試驗。所有試驗只有一項提及鼻內皮質類固醇在改善鼻塞的症狀和減少腺樣體大小有顯著成效。前八個星期的交叉研究表明，用beclomethasone治療(336微克/天)產生了較大的改善症狀的平均得分比安慰劑(跌百分之十八點五與 −8.5，P0.05)和較大的減少意味著腺樣/鼻孔率比服用安慰劑(右， −14％和0.4％，誤差 = 0.002;左， −15％和 −2.0％，誤差 = 0.0006)之間的週0和4週。第二個4週交叉研究表明，鼻塞指數下跌至少50％的基線38％的患者治療beclomethasone(400微克/天)每週之間0和2週，而沒有治療的患者與安慰劑有這樣的改善(P0.01)。第三個隨機，平行對照試驗表明，77.7％的患者治療糠(100微克/天)40天顯示出了改善鼻塞症狀和減少腺樣體大小，這樣，可避免腺樣體切除術，而沒有顯著觀察改善，安慰劑組。第四隨機，平行對照試驗表明，8週的治療flunisolide(500微克/天)是與一個啤酒減少腺樣大小大於等滲鹽溶液性(P0.05)。相反，一個隨機，平行對照試驗並沒有發現明顯改善鼻塞症狀，腺樣大小經過8週治療beclomethasone(200微克/天)

作者結論

有限之證據建議，鼻內皮質類固醇可能顯著改善中度至嚴重腺樣體肥大兒童之鼻呼吸道阻塞症狀，且此種改善情形可能與腺樣體大小之減少相關。鼻內皮質類固醇對於此等病患之長期作用仍有待定義

翻譯人

本摘要由國泰綜合醫院張馨仁翻譯

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

總結

腺樣體肥大一般而言被視為是兒童之常見病況，且其為兒童手術最為常見之適應症之一。對於較不嚴重之病例而言，其可能會考慮非手術性之干預措施，但是目前僅有極少數之醫藥替代選擇。茲進行本回顧，評估鼻內皮質類固醇對於改善中度至嚴重腺樣體肥大0−12歲兒童之鼻呼吸道阻塞的有效性。由收錄於本回顧中之5項隨機對照試驗所產生之有限證據建議，鼻內皮質類固醇可能顯著改善腺樣體肥大兒童之鼻阻塞症狀，且此種改善情形可能與腺樣體大小之減少相關。茲需要進一步之大規模及高品質的隨機對照試驗