Adenoidectomy versus chemoprophylaxis and placebo for recurrent acute otitis media in children aged under 2 years: randomised controlled trial
Adenoidectomy versus chemoprophylaxis and placebo for recurrent acute otitis media in children aged under 2 years: randomised controlled trial
复制标题
腺样体切除术与化学预防和安慰剂治疗 2 岁以下儿童复发性急性中耳炎：随机对照试验
作者：
P. Koivunen;M. Uhari;J. Luotonen;A. Kristo;Risto Raski;T. Pokka;O. Alho
摘要目的评价腺样体切除术与长期药物预防和安慰剂治疗对10个月~ 2岁儿童急性中耳炎复发的预防作用。设计随机、双盲、对照试验。设置欧卢大学医院，芬兰的第三中心。研究对象180例年龄10个月~ 2岁的复发性急性中耳炎患儿。干预腺样体切除术，磺胺呋唑（磺胺异恶唑）50 mg/kg体重，每天一次，持续6个月或安慰剂。随访两年，记录急性中耳炎的所有症状和发作情况。主要结果测量随访期间干预失败（两个月内发作两次或六个月内发作三次或持续性积液），急性中耳炎发作次数，因感染而就诊的次数，抗生素处方数，以及呼吸道感染症状的天数。结果与安慰剂相比，腺样体切除术组和化学预防组在前6个月和其余24个月随访期间的干预失败率相似（6个月时，风险差异分别为10%（95%置信区间-9%至29%）和18%（-2%至38%））。两组在急性中耳炎发作次数、就诊次数、抗生素处方和呼吸道感染症状天数方面没有显著差异。结论腺样体切除术作为10 ~ 24月龄儿童复发性急性中耳炎的首选手术治疗，对预防复发并不有效。不能推荐作为主要预防方法。
Abstract Objective To evaluate the efficacy of adenoidectomy compared with long term chemoprophylaxis and placebo in the prevention of recurrent acute otitis media in children aged between 10 months and 2 years. Design Randomised, double blind, controlled trial. Setting Oulu University Hospital, a tertiary centre in Finland. Participants 180 children aged 10 months to 2 years with recurrent acute otitis media. Intervention Adenoidectomy, sulfafurazole (sulphisoxazole) 50 mg/kg body weight, given once a day for six months or placebo. Follow up lasted for two years, during which time all symptoms and episodes of acute otitis media were recorded. Main outcome measures Intervention failure (two episodes in two months or three in six months or persistent effusion) during follow up, number of episodes of acute otitis media, number of visits to a doctor because of any infection, and antibiotic prescriptions Number of prescriptions, and days with symptoms of respiratory infection. Results Compared with placebo, interventions failed during both the first six months and the rest of the follow up period of 24 months similarly in the adenoidectomy and chemoprophylaxis groups (at six months the differences in risk were 10% (95% confidence interval −9% to 29%) and 18% (−2% to 38%), respectively). No significant differences were observed between the groups in the numbers of episodes of acute otitis media, visits to a doctor, antibiotic prescriptions, and days with symptoms of respiratory infection. Conclusions Adenoidectomy, as the first surgical treatment of children aged 10 to 24 months with recurrent acute otitis media, is not effective in preventing further episodes. It cannot be recommended as the primary method of prophylaxis.