作者：Laurie Barclay, MD
出處：WebMD醫學新聞
January 22, 2009 —根據1月22日新英格蘭醫學期刊中一篇隨機雙盲安慰劑控制試驗結果，對於病毒感染引起的學齡前孩童輕到中度哮喘，口服prednisolone在縮短住院天數或改善其他結果方面並未優於安慰劑。
英國Leicester大學的Jayachandran Panickar醫師等人寫道，10個月大到6歲的學齡前孩童，常會因為上呼吸道病毒感染而引起哮喘；哮喘的學齡前孩童住院時，短期口服prednisolone被廣為使用來治療，但是有關其用於此年齡層病患之效果的證據各異。
本研究中，英國三家醫院的700名年紀在10至60個月、因為病毒感染而發生哮喘的孩童，被隨機指派接受5天的口服 prednisolone (10-24個月的小孩每天一次、每次10 mg，大於24個月的小孩則是每天一次、每次20 mg)或者安慰劑，總共有687個小孩納入治療意向分析，343名是prednisolone組，344 名是安慰劑組。研究的主要終點是住院期間，次級終點是學齡前呼吸道評估量表(PRAM)分數、使用albuterol這個藥物的情況，以及7天的症狀分數。
安慰劑組與prednisolone組在住院天數方面並無顯著差異(13.9小時與11.0 小時；幾何平均比值(ratio of geometric means)為0.90; 95%信心區間為0.77 - 1.05)，簽住院與准予出院的間隔、任何次級結果或者不良反應件數也都沒有顯著差異。
研究作者寫道，在病毒感染引起輕微到中度哮喘而住院的學齡前孩童中，口服prednisolone效果並未優於安慰劑。
研究限制包括，多數參與者並無傳統遺傳性氣喘對短期使用皮質類固醇有反應之證據；缺乏血中免疫球蛋白E值之資料；缺乏父母拒絕小孩參與研究這一部份的臨床資料；無法排除兩組之間住院期間的些微差異；無法進行聚合酶連鎖反應分析、免疫螢光抗體法或者病毒培養以確認與上呼吸道感染有關的病毒株。
研究作者結論表示，我們發現，不論是醫師或者病患評估，並無證據支持短期口服皮質類固醇治療可顯著縮短住院天數，或者顯著減少症狀的嚴重度，我們的結果認為，口服prednisolone不應常規給予病毒引起之急性輕微到中度哮喘學齡前孩童。
在一篇編輯評論中，英國皇家Brompton醫院、國家心臟與肺臟研究中心大英帝國醫學院的Andrew Bush醫師指出，prednisolone只可以在住院重症時給予這些學齡前孩童，且不應使用間歇性高劑量吸入式皮質類固醇。
Bush醫師寫道，也須對治療組中的所有學齡前孩童進行追蹤，看哪些人會有持續的、遺傳的、多種因素引發的哮喘(真正的氣喘)；應回溯分析資料，以確認那些真正氣喘的學齡前孩童在發作時是否有治療反應，是否不同於那些症狀短暫的小孩；我個人認為不會有差別。
Asthma UK 的資金支持本研究，三名研究作者宣稱與AstraZeneca UK、Novartis、Profile Pharma、Boehringer、Roche、Forest Laboratories、Boots Healthcare和/或GlaxoSmithKline等藥廠有各種的財務關係；其他研究作者宣稱沒有相關資金上的往來。Bush醫師接受Pharmaxis的資助。
Oral Prednisolone May Not Be Helpful for Acute Virus-Induced Wheezing in Children
By Laurie Barclay, MD
Medscape Medical News
January 22, 2009 — Oral prednisolone is not superior to placebo in shortening hospitalization or improving other outcomes in preschool children with mild to moderate wheezing associated with a virus infection, according to the results of a randomized, double-blind, placebo-controlled trial reported in the January 22 issue of the New England Journal of Medicine.
"Attacks of wheezing induced by upper respiratory viral infections are common in preschool children between the ages of 10 months and 6 years," write Jayachandran Panickar, MD, MRCPCH, from University of Leicester, in Leicester, United Kingdom, and colleagues. "A short course of oral prednisolone is widely used to treat preschool children with wheezing who present to a hospital, but there is conflicting evidence regarding its efficacy in this age group."
In this study, 700 children aged 10 to 60 months who presented to 3 hospitals in England with an attack of wheezing associated with a virus infection were randomly assigned to a 5-day course of oral prednisolone (10 mg once a day for children aged 10 to 24 months and 20 mg once a day for older children) or placebo. Of 687 children included in the intent-to-treat analysis, 343 were in the prednisolone group and 344 in the placebo group. The main endpoint of the study was the duration of hospitalization, and secondary endpoints were the Preschool Respiratory Assessment Measure (PRAM) score, albuterol use, and a 7-day symptom score.
The placebo group and the prednisolone group were not significantly different in the duration of hospitalization (13.9 vs 11.0 hours; ratio of geometric means, 0.90; 95% confidence interval, 0.77 - 1.05), in the interval between hospital admission and signoff for discharge by a clinician, or in any of the secondary outcomes or the number of adverse events.
"In preschool children presenting to a hospital with mild-to-moderate wheezing associated with a viral infection, oral prednisolone was not superior to placebo," the study authors write.
Limitations of this study were no evidence of classic atopic asthma responsive to a short course of oral corticosteroids in most participants; lack of blood immunoglobulin E levels; lack of clinical data from the substantial proportion of children whose parents declined participation; inability to rule out a small difference in duration of hospitalization between the 2 study groups; and failure to perform polymerase-chain-reaction analysis, immunofluorescence, or viral cultures to identify viruses associated with upper respiratory tract infections.
"We found no evidence that a short course of an oral corticosteroid significantly shortened the duration of hospitalization or significantly reduced markers of the severity of symptoms, as assessed by either physicians or parents," the study authors conclude. "Our results suggest that oral prednisolone should not be routinely given to preschool children presenting to the hospital with acute, mild-to-moderate virus-induced wheezing."
In an accompanying editorial, Andrew Bush, MD, from the Imperial School of Medicine at the National Heart and Lung Institute and the Royal Brompton Hospital, London, United Kingdom, notes that prednisolone should be administered to preschoolers only when they are severely ill in the hospital and that intermittent, high-dose inhaled corticosteroids should not be used.
"Also needed is follow-up of all preschool children enrolled in therapeutic trials to see who will go on to have persistent, atopic, multitrigger wheezing (true asthma)," Dr. Bush writes. "The data from the studies should be analyzed retrospectively to determine whether the response to treatment for acute episodes in preschoolers in whom true asthma develops differs from that in patients in whom symptoms subsequently regress. My suspicion is that there will be no difference."
A grant from Asthma UK supported this study. Three of the study authors have disclosed various financial relationships with AstraZeneca UK, Novartis, Profile Pharma, Boehringer, Roche, Forest Laboratories, Boots Healthcare, and/or GlaxoSmithKline. The remaining study authors have disclosed no relevant financial relationships. Dr. Bush has received grant support from Pharmaxis.
N Engl J Med. 2009;360:329-338, 409-410. |
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