Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial.
Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial.
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DOI：
10.1016/s0140-6736(18)31490-9
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发表时间：
2018-08-18
期刊：
影响因子：
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通讯作者：
Butler CC
中科院分区：
文献类型：
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作者：
Francis NA;Cannings-John R;Waldron CA;Thomas-Jones E;Winfield T;Shepherd V;Harris D;Hood K;Fitzsimmons D;Roberts A;Powell C;Gal M;Butler CC
由于渗出性中耳炎而导致持续性听力损失的儿童通常通过手术干预进行治疗。一种安全、廉价和有效的治疗方法将增加治疗选择。动力不足，质量差的试验发现口服类固醇的短期益处。我们的目的是调查短期口服类固醇是否可以使患有持续性渗出性中耳炎和听力损失的儿童获得可接受的听力。在这项单独随机、平行、双盲、安慰剂对照试验中，我们招募了2 - 8岁的儿童，这些儿童的症状可归因于渗出性中耳炎至少3个月，并证实双侧听力损失。参与者来自英格兰和威尔士的20个耳鼻喉（ENT）、儿科听力学和视听前庭医学门诊部。通过使用计算机生成的随机排列区组大小，将参与者随机分配（1：1）到顺序编号的相同泼尼松龙（口服类固醇）或安慰剂包中，并按研究中心和儿童年龄分层。主要结局是5周时听力测定证实的可接受听力。所有的分析都是通过意向性治疗进行的。这项试验在ISRCTN注册处注册，编号为ISRCTN49798431。在2014年3月20日至2016年4月5日期间，对1018名儿童进行了筛查，其中389名进行了随机分配。200人被分配接受口服类固醇，189人接受安慰剂。口服类固醇组的183名儿童和安慰剂组的180名儿童在5周时进行了听力评估。口服类固醇组73名（40%）儿童和安慰剂组59名（33%）儿童的听力可接受（绝对差异7%[95%CI − 3至17]，需要治疗的人数14;校正比值比1.36 [95%CI 0.88 - 2.11]; p = 0.16）。没有证据表明两组之间的不良事件或生活质量指标存在任何显著差异。在有听力损失记录和可归因症状至少3个月的儿童中，渗出性中耳炎有很高的自然消退率。短期口服泼尼松龙对大多数2 - 8岁的持续性渗出性中耳炎儿童不是一种有效的治疗方法，但耐受性良好。每14个孩子中就有一个可能会提高听力，但生活质量不会提高。关于观察等待和其他干预措施的讨论将得到这一证据的支持。国家卫生研究所卫生技术评估方案。
Children with persistent hearing loss due to otitis media with effusion are commonly managed by surgical intervention. A safe, cheap, and effective medical treatment would enhance treatment options. Underpowered, poor-quality trials have found short-term benefit from oral steroids. We aimed to investigate whether a short course of oral steroids would achieve acceptable hearing in children with persistent otitis media with effusion and hearing loss. In this individually randomised, parallel, double-blinded, placebo-controlled trial we recruited children aged 2–8 years with symptoms attributable to otitis media with effusion for at least 3 months and with confirmed bilateral hearing loss. Participants were recruited from 20 ear, nose, and throat (ENT), paediatric audiology, and audiovestibular medicine outpatient departments in England and Wales. Participants were randomly allocated (1:1) to sequentially numbered identical prednisolone (oral steroid) or placebo packs by use of computer-generated random permuted block sizes stratified by site and child's age. The primary outcome was audiometry-confirmed acceptable hearing at 5 weeks. All analyses were by intention to treat. This trial is registered with the ISRCTN Registry, number ISRCTN49798431. Between March 20, 2014, and April 5, 2016, 1018 children were screened, of whom 389 were randomised. 200 were assigned to receive oral steroids and 189 to receive placebo. Hearing at 5 weeks was assessed in 183 children in the oral steroid group and in 180 in the placebo group. Acceptable hearing was observed in 73 (40%) children in the oral steroid group and in 59 (33%) in the placebo group (absolute difference 7% [95% CI −3 to 17], number needed to treat 14; adjusted odds ratio 1·36 [95% CI 0·88–2·11]; p=0·16). There was no evidence of any significant differences in adverse events or quality-of-life measures between the groups. Otitis media with effusion in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. A short course of oral prednisolone is not an effective treatment for most children aged 2–8 years with persistent otitis media with effusion, but is well tolerated. One in 14 children might achieve improved hearing but not quality of life. Discussions about watchful waiting and other interventions will be supported by this evidence. National Institute for Health Research (NIHR) Health Technology Assessment programme.