Williamson Ian, Benge Sarah, Barton Sheila, Petrou Stavros, Letley Louise, Fasey Nicky, Haggard Mark, Little Paul
Primary Medical Care, University of Southampton, Aldermoor Health Centre, Southampton SO16 5ST.
BMJ. 2009 Dec 16;339:b4984. doi: 10.1136/bmj.b4984.
To determine the clinical effectiveness of topical intranasal corticosteroids in children with bilateral otitis media with effusion.
Double blind randomised placebo controlled trial.
76 Medical Research Council General Practice Research Framework practices throughout the United Kingdom, between 2004 and 2007.
217 children aged 4-11 years who had at least one practice recorded episode of otitis media or a related ear problem in the previous 12 months, and with bilateral otitis media with effusion confirmed by a research nurse using otoscopy plus micro-tympanometry (B/B or B/C2, modified Jerger types).
Mometasone furoate 50 microg or placebo spray given once daily into each nostril for three months.
Proportions of children cured of bilateral otitis media with effusion assessed with tympanometry (C1 or A type) at one month (primary end point), three months, and nine months; adverse events; three month diary symptoms. Results 41% (39/96) of the topical steroid group and 45% (44/98) of the placebo group were cured in one or both ears at one month (difference favouring placebo 4.3% (95% confidence interval -9.3% to 18.1%). Poisson regression was done with adjustment for four pre-specified covariates (clinical severity, P=0.003; atopy, P=0.67; age, P=0.92; season, P=0.71). The adjusted relative risk at one month was 0.97 (95% confidence interval 0.74 to 1.26). At three months, 58% of the topical steroid group and 52% of the placebo group were cured (relative risk 1.23, 0.84 to 1.80). Diary symptoms did not differ between the two groups, and no significant harms were reported.
Topical steroids are unlikely to be an effective treatment for otitis media with effusion in general practice. High rates of natural resolution occurred by 1-3 months.
Current Controlled Trials ISRCTN38988331; National Research Register NO575123823; MREC 03/11/073.
确定鼻内局部使用皮质类固醇激素治疗双侧中耳积液患儿的临床疗效。
双盲随机安慰剂对照试验。
2004年至2007年期间，英国76家医学研究委员会全科医学研究框架机构。
217名4至11岁的儿童，他们在过去12个月中至少有一次全科医学记录的中耳炎发作或相关耳部问题，且经研究护士使用耳镜检查加微型鼓室测压法（B/B或B/C2，改良耶格类型）确诊为双侧中耳积液。
糠酸莫米松50微克或安慰剂喷雾剂，每天每个鼻孔喷一次，持续三个月。
在1个月（主要终点）、3个月和9个月时，通过鼓室测压法（C1或A型）评估双侧中耳积液治愈患儿的比例；不良事件；三个月的日记症状。结果：局部使用类固醇激素组41%（39/96）的患儿和安慰剂组45%（44/98）的患儿在1个月时单耳或双耳治愈（倾向于安慰剂的差异为4.3%（95%置信区间-9.3%至18.1%））。采用泊松回归，并对四个预先指定的协变量进行调整（临床严重程度，P=0.003；特应性，P=0.67；年龄，P=0.92；季节，P=0.71）。1个月时调整后的相对风险为0.97（95%置信区间0.74至1.26）。3个月时，局部使用类固醇激素组58%的患儿和安慰剂组52%的患儿治愈（相对风险1.23，0.84至1.80）。两组的日记症状无差异，且未报告有显著危害。
在全科医疗中，局部使用类固醇激素不太可能是治疗中耳积液的有效方法。1至3个月内自然缓解率较高。
当前对照试验ISRCTN38988331；国家研究注册NO575123823；医学研究伦理委员会03/ /073。
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