Butler C C
Department of General Practice, University of Wales College of Medicine, Llanedeyrn Health Centre, Llanedeyrn, Cardiff, South Galmorgan, UK, CF3 7PN.
Cochrane Database Syst Rev. 2000(4):CD001935. doi: 10.1002/14651858.CD001935.
OME is common and may cause hearing loss with associated developmental delay. Treatment remains controversial. The effect of both systemic and intra-nasal steroids on effusions has been assessed by randomised controlled trials.
To examine evidence for or against treating children with hearing loss associated with OME with systemic or topical nasal steroids.
Searches were conducted in February 2000. We searched the Cochrane Controlled Trials Register using the terms 'otitis-media', 'otitis media with effusion', 'glue ear', or 'OME', and 'steroids', 'glucocorticoids, synthetic', 'glucocorticoids, topical', 'anti-inflammatory agents, steroidal'. EMBASE and MEDLINE were also searched for additional information.
Randomised controlled trials of oral and topical nasal steroids, either alone or in combination with another agent such as an antibiotic, were included.
publications in abstract form only since adequate appraisal was not possible; uncontrolled, non-randomised or retrospective studies; studies reporting outcomes with ears (rather than children) as the unit of analysis.
Data were extracted from the published reports by the two authors independently (CCB and JH van der V) using standardised data extraction forms and methodology. The methodological quality of the included studies were independently assessed by the two authors using the scheme described in the Cochrane Handbook. Dichotomous results were expressed as an odds ratio using a fixed effects model together with the 95% confidence intervals. Continuous data were analysed using the weighted mean difference in a fixed effects model. Tests for heterogeneity between studies were performed using a Mantel-Haenszel approach. In trials with a cross over design, post-crossover treatment data were not used.
No study prospectively documented hearing loss associated with OME prior to randomisation. Follow up was short term. No serious or lasting side effects were reported in the four studies that did mention side effects. Most comparisons involved small numbers of subjects. The odds ratio for OME persisting after short term follow up for children treated with oral steroids plus antibiotic compared to control plus antibiotic was 0.32 (95% CI 0.20 to 0.52). However there was significant heterogeneity between studies (p<0.01). Trends favoured steroids for most other comparisons, but confidence intervals included unity. There was no evidence of benefit for steroid treatment in the longer term, and no study assessed effect of steroid treatment on language development.
REVIEWER'S CONCLUSIONS: There is evidence that steroids combined with an antibiotic lead to a quicker resolution of OME in the short term. However, there is not evidence for long term benefit from treating hearing loss associated with OME with either oral or topical nasal steroids. These treatments are therefore not recommended at the present time. Future studies should document hearing loss associated with OME before the start of study treatment. Follow up should be longer and ideally include symptom, audiometry and developmental outcomes. Data should not be presented with ears as the unit of analysis.
分泌性中耳炎很常见，可能导致听力损失并伴有发育迟缓。其治疗仍存在争议。全身用和鼻内用类固醇对积液的影响已通过随机对照试验进行评估。
检验支持或反对用全身或局部鼻用类固醇治疗与分泌性中耳炎相关听力损失儿童的证据。
检索于2000年2月进行。我们使用“中耳炎”“分泌性中耳炎”“胶耳”或“OME”以及“类固醇”“合成糖皮质激素”“局部用糖皮质激素”“甾体抗炎药”等术语检索了Cochrane对照试验注册库。还检索了EMBASE和MEDLINE以获取更多信息。
纳入单独使用或与另一种药物（如抗生素）联合使用口服和局部鼻用类固醇的随机对照试验。
仅以摘要形式发表的文献，因为无法进行充分评估；非对照、非随机或回顾性研究；以耳（而非儿童）作为分析单位报告结果的研究。
两位作者（CCB和JH van der V）使用标准化数据提取表格和方法从已发表的报告中独立提取数据。两位作者使用Cochrane手册中描述的方案独立评估纳入研究的方法学质量。二分结果使用固定效应模型以比值比及95%置信区间表示。连续数据使用固定效应模型中的加权均数差值进行分析。使用Mantel-Haenszel方法进行研究间异质性检验。在交叉设计的试验中，不使用交叉后治疗数据。
没有研究在随机分组前前瞻性记录与分泌性中耳炎相关的听力损失。随访为短期。在确实提及副作用的四项研究中，未报告严重或持久的副作用。大多数比较涉及的受试者数量较少。与对照组加抗生素相比，口服类固醇加抗生素治疗的儿童在短期随访后分泌性中耳炎持续存在的比值比为0.32（95%CI 0.20至0.52）。然而，研究间存在显著异质性（p<0.01）。在大多数其他比较中，趋势有利于类固醇，但置信区间包含1。没有证据表明类固醇治疗在长期有益，也没有研究评估类固醇治疗对语言发育的影响。
有证据表明，类固醇与抗生素联合使用可在短期内使分泌性中耳炎更快消退。然而，没有证据表明口服或局部鼻用类固醇治疗与分泌性中耳炎相关的听力损失有长期益处。因此，目前不推荐这些治疗方法。未来的研究应在研究治疗开始前记录与分泌性中耳炎相关的听力损失。随访应更长，理想情况下应包括症状、听力测定和发育结局。数据不应以耳作为分析单位呈现。
