吸入型類固醇使用於兒童氣喘可能比Montelukast好
作者：Laurie Barclay, MD
出處：WebMD醫學新聞
December 9, 2009 — 根據一項線上發表於11月27日兒童疾病學誌（Archives of Disease in Childhood）廣泛性綜合分析的研究結果，吸入型類固醇（ICS）使用於兒童與青少年氣喘可能比montelukast（MONT）好。
智利Catolica de Pontificia大學醫學院的Jose A. Castro-Rodriguez醫師以及烏拉圭Armadas de las Fuerzas醫院中心的Montevideo Gustavo J. Rodrigo醫師寫到，氣喘是世界各地兒童最常見的慢性疾病。目前國際上所有的治療指引建議使用低劑量（beclomethasone 200-400 mcg[BDP]或相對應藥物）為偏好的控制治療，而白三烯素受體拮抗劑（LTRA）為替代療法，用於處理兒童（年齡介於5~11歲）以及青少年的持續性氣喘。這項系統性綜論的目的在於比較ICS相較於MONT（世界各地兒童最常使用的LTRA），以及與MONT加上ICS比較，使用於持續性氣喘學齡兒童與青少年的療效。
搜尋Medline、EMBASE與Central資料庫找出隨機分派、前瞻性的控制研究，這些研究發表於1996年到2009年11月之間。收納條件包括最少使用ICS 4週與MONT比較、或ICS與MONT加上ICS比較，且以需要全身性類固醇治療的氣喘急性發作（AEX）的主要試驗終點。次要試驗終點為肺功能、退出研究或因為AEX住院、症狀分數改變、不用使用緊急藥物天數、使用albuterol、不良反應與遵從性。
124篇研究中有18篇符合收納條件。在這18項研究中，總共收納了3,757位病患，13項研究比較ICS與MONT+ICS，2項研究比較ICS與MONT與ICS+MONT。
相較於接受MONT病患，那些接受ICS治療患者，發生AEX的風險顯著較低（相對風險[RR]為0.83；95%信賴區間[CI]為0.72-0.96；P=0.1）。根據後續分析，這些發現顯然與研究品質、贊助廠商與研究時間長短無關。接受ICS治療的兒童，相較於那些接受MONT治療者，在肺功能（最終一秒使力吐氣容積[FEV1]與預測值比較的百分比、試驗前後FEV1%改變值、晨間PEF）以及臨床參數（使用albuterol、症狀分數、免於使用緊急藥物的天數、以及因為AEX退出試驗）。
在兩項比較MONT作為ICS附加療法的研究中，相較於僅使用ICS，在主要與次要試驗終點上並無顯著差異。
這篇研究作者們寫到，罹患輕度持續性氣喘的學齡兒童與青少年，接受ICS治療，相較於MONT，發生AEX的機率較低，且肺功能及氣喘控制較佳。目前並沒有足夠數據證實，ICS加上MONT是否可以改善預後。
這項系統性綜論的限制為，主要預後分析僅根據7項研究（代表總體樣本數的65%），且無法根據不同相關因子進行研究分類。
這項系統性綜論並未接受贊助。Castro-Rodriguez醫師接受Merck Sharp與Dohme、GlaxoSmithKline與Grunenthal公司的演講與顧問費。Rodrigo醫師擔任Boehringer Ingelheim、GlaxoSmithKline、AstraZeneca、Dr. Esteve SA與Merck Sharp Dome贊助的科學會議及訓練講員。他也接受CYDEX有限公司以及Discovery實驗室的顧問費。
Inhaled Corticosteroids May Be Superior to Montelukast in Children With Asthma
By Laurie Barclay, MD
Medscape Medical News
December 9, 2009 — Inhaled corticosteroids (ICSs) may be superior to montelukast (MONT) in children and adolescents with asthma, according to the results of an extensive meta-analysis reported in the November 27 online issue of the Archives of Disease in Childhood.
"Asthma is one of the most common chronic diseases in children worldwide," write Jose A. Castro-Rodriguez, MD, PhD, from the School of Medicine, Pontificia Universidad Catolica de Chile, and Gustavo J. Rodrigo, MD, from Hospital Central de las Fuerzas Armadas in Montevideo, Uruguay. "All current international guidelines recommend the use of low-dose (200-400 mcg of beclomethasone [BDP] or equivalent) [ICS] as the preferred controller therapy, with leukotriene receptor antagonist (LTRA) as an alternative, for the management of persistent asthma in children (5-11 years of age) and adolescents.... The objective of this systematic review is to compare the efficacy of ICS vs. [MONT] (the most common LTRA use in children worldwide) and vs. MONT add-on to ICS in schoolchildren and adolescents with persistent asthma."
A search of Medline, Embase, and Central databases identified randomized, prospective, controlled trials published from January 1996 to November 2009. Inclusion criteria were a minimum of 4 weeks of ICS vs MONT and of ICS vs MONT+ICS, with primary outcome of asthma exacerbations requiring systemic corticosteroids (AEX). Secondary outcomes were pulmonary function, study withdrawal or hospitalization because of AEX, change in symptoms score, rescue-medication-free days, albuterol use, adverse effects, and adherence.
Inclusion criteria were met in 18 of 124 studies identified. Of these 18 studies, which enrolled a total of 3757 patients, 13 compared ICS vs MONT, 3 compared ICS vs MONT+ICS, and 2 compared ICS vs MONT vs ICS+MONT.
Compared with patients receiving MONT, those receiving an ICS had a significantly decreased risk for AEX (relative risk [RR], .83; 95% confidence interval [CI], .72 - .96; P = .01). This finding appeared to be independent of study quality, sponsorship, and study duration, based on post hoc analysis. Children treated with an ICS also fared better than those treated with MONT in terms of pulmonary function (final forced expiratory volume in 1 second [FEV1] % predicted, change from baseline FEV1 %, final morning PEF) and clinical parameters (albuterol use, symptom score, rescue medication-free days, and study withdrawals resulting from AEX).
In 2 studies comparing MONT as add-on therapy to ICS vs ICS alone, there was no significant difference in primary or secondary outcomes.
"Schoolchildren and adolescents with mild-persistent asthma treated with ICS had less AEX and better lung function and asthma control than with MONT," the review authors write. "There is insufficient data to determine if the addition of MONT to ICS improves outcome."
Limitations of this review are that the analysis of the main outcome was based on only 7 studies (representing 65% of the total sample) and that stratification of studies based on different relevant factors was not always possible.
This review received no funding. Dr. Castro-Rodriguez has received lecturing and consultancy fees from Merck Sharp & Dohme, GlaxoSmithKline, and Grunenthal. Dr. Rodrigo has participated as a lecturer and speaker in scientific meetings and courses under the sponsorship of Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Dr. Esteve SA, and Merck Sharp & Dome. He also received honoraria as consultant for CYDEX Inc and Discovery Laboratories.
Arch Dis Child. Published online November 27, 2009.
