Thomas C L, Simpson S, Butler C C, van der Voort J H
Cardiff University, Department of General Practice, Centre for Health Sciences Research, School of Medicine, 3rd Floor, Neuadd Meirionnydd, Heath Park, Cardiff, UK CF14 4XN.
Cochrane Database Syst Rev. 2006 Jul 19(3):CD001935. doi: 10.1002/14651858.CD001935.pub2.
Otitis media with effusion (OME) is common and may cause hearing loss with associated developmental delay. Treatment remains controversial.
To examine evidence for or against treating children with hearing loss associated with OME with systemic or topical intranasal steroids.
We searched the Cochrane Ear, Nose and Throat Disorders Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library Issue 4 2005, MEDLINE (1966 to 2006), EMBASE (1974 to 2006), and the CINAHL, LILACS, Zetoc, IndMED, SAMED, KoreaMed, MEDCARIB and Cambridge Scientific Abstracts databases in January 2006.
Randomised controlled trials of oral and topical intranasal steroids, either alone or in combination with another agent such as an antibiotic, were included.
publications in abstract form only; uncontrolled, non-randomised or retrospective studies; studies reporting outcomes with ears (rather than children).
Data were extracted from the published reports by the authors independently using standardised data extraction forms and methods. The methodological quality of the included studies was independently assessed by the authors as described in the Cochrane Handbook. Dichotomous results were expressed as an odds ratio using a fixed-effect model together with the 95% confidence intervals. Continuous data were analysed using the weighted mean difference in a fixed-effect model. Tests for heterogeneity between studies were performed using a Mantel-Haenszel approach. In trials with a cross-over design, post cross-over treatment data were not used.
No study prospectively documented hearing loss associated with OME prior to randomisation. Follow up was mainly short term. The odds ratio for OME persisting after short-term follow up in children treated with oral steroids compared to control was 0.22 (95% CI 0.08 to 0.63). 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 0.37 (95% CI 0.25 to 0.56). However, there was significant heterogeneity between studies included in the latter comparison (P < 0.01). Trends favoured steroids for most other comparisons, but confidence intervals included unity. There was no evidence of benefit for steroid treatment for OME or hearing loss associated with OME in the longer term.
AUTHORS' CONCLUSIONS: Both oral and topical intranasal steroids alone or in combination with an antibiotic lead to a quicker resolution of OME in the short term, however, there is no evidence of longer term benefit.
分泌性中耳炎(OME)很常见,可能导致听力损失并伴有发育迟缓。治疗方法仍存在争议。
研究支持或反对使用全身性或局部鼻内类固醇治疗与OME相关的听力损失儿童的证据。
我们检索了Cochrane耳、鼻、喉疾病组专业注册库、2005年第4期Cochrane图书馆中的Cochrane对照试验中央注册库(CENTRAL)、MEDLINE(1966年至2006年)、EMBASE(1974年至2006年),以及2006年1月的CINAHL、LILACS、Zetoc、IndMED、SAMED、KoreaMed、MEDCARIB和剑桥科学文摘数据库。
纳入单独使用口服和局部鼻内类固醇,或与另一种药物(如抗生素)联合使用的随机对照试验。
仅以摘要形式发表的文献;非对照、非随机或回顾性研究;报告耳部(而非儿童)结果的研究。
作者使用标准化的数据提取表格和方法,从已发表的报告中独立提取数据。作者按照Cochrane手册中的描述,对纳入研究的方法学质量进行独立评估。二分结果采用固定效应模型表示为比值比,并给出95%置信区间。连续数据使用固定效应模型中的加权平均差进行分析。采用Mantel-Haenszel方法对研究间的异质性进行检验。在交叉设计的试验中,不使用交叉治疗后的数据。
没有研究在随机分组前前瞻性记录与OME相关的听力损失情况。随访主要为短期。与对照组相比,口服类固醇治疗的儿童在短期随访后OME持续存在的比值比为0.22(95%CI 0.08至0.63)。与抗生素联合对照组相比,口服类固醇加抗生素治疗的儿童在短期随访后OME持续存在的比值比为0.37(95%CI 0.25至0.56)。然而,后一组比较中纳入的研究之间存在显著异质性(P<0.01)。在大多数其他比较中,趋势有利于类固醇治疗,但置信区间包含1。没有证据表明类固醇治疗对OME或与OME相关的听力损失有长期益处。
单独使用口服和局部鼻内类固醇,或与抗生素联合使用,在短期内可使OME更快消退,但没有证据表明有长期益处。