Griffin Glenn, Flynn Cheryl A
Quinte West Medical Centre, 80 Catherine Street, Trenton, Ontario, Canada, ON K8V 6N8.
Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD003423. doi: 10.1002/14651858.CD003423.pub3.
This is an update of a Cochrane Review first published in The Cochrane Library in Issue 4, 2006.Otitis media with effusion (OME) is common and may cause hearing loss with associated developmental delay. Treatment remains controversial. The effectiveness of antihistamines, decongestants and antihistamine/decongestant combinations in promoting the resolution of effusions has been assessed by randomized controlled trials.
The objective of this review was to determine whether antihistamine, decongestant or combination therapy is effective in treating children who present with OME.
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Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the most recent search was 1 February 2011, following a previous search in 2006.
Randomized controlled trials (RCTs) using antihistamines, decongestants or antihistamine/decongestant combinations as treatment for OME in children. We excluded trials that randomized on the basis of acute otitis media (AOM) even though OME was also studied in follow up.
Two authors independently extracted data from the published reports using standardized data extraction forms and methods. The two authors assessed the methodological quality of the included studies independently. We expressed dichotomous results as a risk ratio with 95% confidence intervals using a fixed-effect model when homogeneous and a random-effects model when heterogeneous. Nearly all outcomes analyzed were homogeneous. We discussed continuous results qualitatively. We conducted statistical analysis using RevMan 5.1 software.
Sixteen studies (1880 participants) were included in the review. No statistical or clinical benefit was found for any of the interventions or outcomes studied. However, treated study subjects experienced 11% more side effects than untreated subjects (number needed to treat to harm = 9).
AUTHORS' CONCLUSIONS: The pooled data demonstrate no benefit and some harm from the use of antihistamines or decongestants alone or in combination in the management of OME, therefore we recommend against their use.
这是对一篇Cochrane系统评价的更新，该评价首次发表于《Cochrane图书馆》2006年第4期。中耳积液（OME）很常见，可能导致听力损失及相关发育迟缓。治疗方法仍存在争议。随机对照试验已评估了抗组胺药、减充血剂以及抗组胺药/减充血剂联合使用在促进积液消退方面的有效性。
本系统评价的目的是确定抗组胺药、减充血剂或联合治疗对患有OME的儿童是否有效。
我们检索了Cochrane耳、鼻、喉疾病组试验注册库；Cochrane对照试验中心注册库（CENTRAL）；PubMed；EMBASE；CINAHL；科学引文索引；BIOSIS预评文摘；剑桥科学文摘；国际标准随机对照试验编号注册库以及其他已发表和未发表试验的来源。在2006年进行上次检索之后，最近一次检索日期为2011年2月1日。
使用抗组胺药、减充血剂或抗组胺药/减充血剂联合治疗儿童OME的随机对照试验（RCT）。我们排除了基于急性中耳炎（AOM）进行随机分组的试验，即使在随访中也对OME进行了研究。
两位作者使用标准化数据提取表格和方法，独立从已发表报告中提取数据。两位作者独立评估纳入研究的方法学质量。当结果具有同质性时，我们使用固定效应模型将二分结果表示为风险比及95%置信区间；当结果具有异质性时，则使用随机效应模型。几乎所有分析的结果都是同质的。我们对连续性结果进行了定性讨论。我们使用RevMan 5.1软件进行统计分析。
本系统评价纳入了16项研究（1880名参与者）。在所研究的任何干预措施或结果中均未发现统计学或临床益处。然而，接受治疗的研究对象比未接受治疗的对象出现副作用的比例高11%（伤害所需治疗人数 = 9）。
汇总数据表明，单独或联合使用抗组胺药或减充血剂治疗OME既无益处，还存在一些危害，因此我们不建议使用。
