Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial
Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial
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鼻球囊自动充气对初级护理中渗出性中耳炎儿童的影响：一项开放随机对照试验
DOI：
10.1503/cmaj.141608
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发表时间：
2015
影响因子：
14.6
通讯作者：
P. Little
中科院分区：
文献类型：
--
作者：
I. Williamson;J. Vennik;A. Harnden;M. Voysey;R. Perera;Sadie Kelly;G. Yao;J. Raftery;D. Mant;P. Little
背景：渗出性中耳炎是一种常见问题，缺乏循证的非手术治疗选择。我们评估了初级保健机构中鼻球囊装置治疗的临床效果。方法：我们在英国 43 个家庭诊所中进行了一项开放、务实的随机对照试验。近期有耳部症状和一侧或双耳有渗出液的中耳炎病史（经鼓室导抗测试证实）的 4-11 岁儿童被分配接受每天 3 次自动充气，持续 1-3 个月加常规护理或仅常规护理。 1 个月和 3 个月时中耳积液的清除情况由不知情的专家进行评估。结果：在纳入的 320 名儿童中，接受自动充气的儿童在 1 个月时（47.3% [62/131] vs. 35.6% [47/132]；调整后相对风险 [RR] 1.36，95% 置信区间 [CI] 0.99 至 1.88）和 3 个月时（49.6% [62/125]）更有可能具有正常的鼓室图。 v. 38.3% [46/120]；调整后的 RR 1.37，95% CI 1.03 至 1.83；需要治疗的人数 = 9)。自动通货膨胀使与耳朵相关的生活质量有了更大的改善（调整后的组间变化相对于基线的OMQ-14[与耳朵相关的生活质量测量]评分-0.42，95% CI -0.63至-0.22）。 1 个月时的依从性为 89%，3 个月时的依从性为 80%。不良事件轻微、罕见且组间具有可比性。解释：在初级保健中，对 4-11 岁患有渗出性中耳炎的儿童进行自动充气是可行的，并且可以有效清除渗出液、改善症状以及与耳朵相关的儿童和家长的生活质量。试用注册：ISRCTN，编号：55208702。
Background: Otitis media with effusion is a common problem that lacks an evidence-based nonsurgical treatment option. We assessed the clinical effectiveness of treatment with a nasal balloon device in a primary care setting. Methods: We conducted an open, pragmatic randomized controlled trial set in 43 family practices in the United Kingdom. Children aged 4–11 years with a recent history of ear symptoms and otitis media with effusion in 1 or both ears, confirmed by tympanometry, were allocated to receive either autoinflation 3 times daily for 1–3 months plus usual care or usual care alone. Clearance of middle-ear fluid at 1 and 3 months was assessed by experts masked to allocation. Results: Of 320 children enrolled, those receiving autoinflation were more likely than controls to have normal tympanograms at 1 month (47.3% [62/131] v. 35.6% [47/132]; adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88) and at 3 months (49.6% [62/125] v. 38.3% [46/120]; adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). Autoinflation produced greater improvements in ear-related quality of life (adjusted between-group difference in change from baseline in OMQ-14 [an ear-related measure of quality of life] score −0.42, 95% CI −0.63 to −0.22). Compliance was 89% at 1 month and 80% at 3 months. Adverse events were mild, infrequent and comparable between groups. Interpretation: Autoinflation in children aged 4–11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symptoms and ear-related child and parent quality of life. Trial registration: ISRCTN, No. 55208702.
学龄前儿童有渗出液的中耳炎。
DOI：
10.1288/00005537-198504000-00011
发表时间：
1985
期刊：
The Laryngoscope
影响因子：
--
作者：
Casselbrant,ML;Brostoff,LM;Cantekin,EI;Flaherty,MR;Doyle,WJ;Bluestone,CD;Fria,TJ
通讯作者：
Fria,TJ
新的神经元不会顶嘴。
影响因子：
16.2
作者：
Wadiche,JacquesI;Overstreet-Wadiche,Linda
通讯作者：
Overstreet-Wadiche,Linda