Perera Rafael, Glasziou Paul P, Heneghan Carl J, McLellan Julie, Williamson Ian
Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, UK, OX2 6GG.
Cochrane Database Syst Rev. 2013 May 31;2013(5):CD006285. doi: 10.1002/14651858.CD006285.pub2.
This is an update of a Cochrane review first published in The Cochrane Library in Issue 4, 2006.Otitis media with effusion (OME) or 'glue ear' is an accumulation of fluid in the middle ear, in the absence of acute inflammation or infection. It is the commonest cause of acquired hearing loss in childhood and the usual reason for insertion of 'grommets'. Potential treatments include decongestants, mucolytics, steroids, antihistamines and antibiotics. Autoinflation devices have been proposed as a simple mechanical means of improving 'glue ear'.
To assess the effectiveness of autoinflation compared with no treatment in children and adults with otitis media with effusion.
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 12 April 2013.
We selected randomised controlled trials that compared any form of autoinflation to no autoinflation in individuals with 'glue ear'.
Two review authors independently assessed studies for inclusion, assessed risk of bias and extracted data from included studies.
Eight studies, with a total of 702 participants, met the inclusion criteria. Overall, the studies were predominantly assessed as being at low or unclear risk of bias; unclear risk was mainly due lack of information. There was no evidence of selective reporting.Pooled estimates favoured the intervention, but did not show a significant effect on tympanometry (type C2 and B) at less than one month, nor at more than one month. Similarly, there were no significant changes for discrete pure-tone audiometry and non-discrete audiometry. Pooled estimates favoured, but not significantly, the intervention for the composite measure of tympanogram or audiometry at less than one month; at more than one month the result became significant (RRI 1.74, 95% CI 1.22 to 2.50). Subgroup analysis based on the type of intervention showed a significant effect using a Politzer device under one month (RRI 7.07, 95% CI 3.70 to 13.51) and over one month (RRI 2.25, 95% CI 1.67 to 3.04).None of the studies demonstrated a significant difference in the incidence of side effects between interventions.
AUTHORS' CONCLUSIONS: All of the studies were small, of limited treatment duration and had short follow-up. However, because of the low cost and absence of adverse effects it is reasonable to consider autoinflation whilst awaiting natural resolution of otitis media with effusion. Primary care could prove a beneficial place to evaluate such interventions and there is ongoing research in this area. Further research should also consider the duration of treatment, the long-term impact on developmental outcomes in children and additional quality of life outcome measures for children and families.
这是对首次发表于《Cochrane系统评价》2006年第4期的一篇Cochrane综述的更新。中耳积液(OME)或“胶耳”是指中耳内有液体积聚,而无急性炎症或感染。它是儿童后天性听力损失最常见的原因,也是插入“通气管”的常见原因。潜在的治疗方法包括减充血剂、黏液溶解剂、类固醇、抗组胺药和抗生素。自我膨胀装置已被提议作为改善“胶耳”的一种简单机械方法。
评估自我膨胀疗法与不治疗相比,对患有中耳积液的儿童和成人的有效性。
我们检索了Cochrane耳、鼻、喉疾病组试验注册库;Cochrane对照试验中央注册库(CENTRAL);PubMed;EMBASE;CINAHL;科学引文索引;BIOSIS预评文摘;剑桥科学文摘;国际临床试验注册平台及其他已发表和未发表试验的来源。最近一次检索日期为2013年4月12日。
我们选择了将任何形式的自我膨胀疗法与不进行自我膨胀疗法相比较的针对“胶耳”患者的随机对照试验。
两位综述作者独立评估纳入研究,评估偏倚风险并从纳入研究中提取数据。
八项研究,共702名参与者,符合纳入标准。总体而言,这些研究主要被评估为偏倚风险低或不明确;不明确的风险主要是由于信息不足。没有选择性报告的证据。汇总估计值支持干预措施,但在不到一个月和超过一个月时,对鼓室图(C2型和B型)均未显示出显著效果。同样,离散纯音听力测定和非离散听力测定也没有显著变化。汇总估计值在不到一个月时支持干预措施,但对鼓室图或听力测定的综合指标无显著影响;超过一个月时结果变得显著(相对风险增加1.74,95%置信区间1.22至2.50)。基于干预类型的亚组分析显示,使用波利策尔装置在一个月内(相对风险增加7.07,95%置信区间3.70至13.51)和超过一个月时(相对风险增加2.25,95%置信区间1.67至3.04)有显著效果。没有研究表明干预措施之间副作用发生率有显著差异。
所有研究规模较小,治疗持续时间有限且随访时间短。然而,由于成本低且无不良反应,在等待中耳积液自然消退期间,考虑自我膨胀疗法是合理的。初级保健可能是评估此类干预措施的有益场所,并且该领域正在进行研究。进一步的研究还应考虑治疗持续时间、对儿童发育结果的长期影响以及针对儿童和家庭的额外生活质量结果指标。