Department of Otorhinolaryngology, University Medical Centre Utrecht, Netherlands.
BMJ. 2011 Sep 6;343:d5154. doi: 10.1136/bmj.d5154.
To assess the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections.
Open randomised controlled trial.
11 general hospitals and two academic centres.
111 children aged 1-6 with recurrent upper respiratory tract infections selected for adenoidectomy.
A strategy of immediate adenoidectomy with or without myringotomy or a strategy of initial watchful waiting. Main outcome measure Primary outcome measure: number of upper respiratory tract infections per person year calculated from data obtained during the total follow-up (maximum 24 months).
days with upper respiratory tract infection per person year, middle ear complaints with fever in episodes and days, days with fever, prevalence of upper respiratory tract infections, and health related quality of life.
During the median follow-up of 24 months, there were 7.91 episodes of upper respiratory tract infections per person year in the adenoidectomy group and 7.84 in the watchful waiting group (difference in incidence rate 0.07, 95% confidence interval -0.70 to 0.85). No relevant differences were found for days of upper respiratory tract infections and middle ear complaints with fever in episodes and days, nor for health related quality of life. The prevalence of upper respiratory tract infections decreased over time in both groups. Children in the adenoidectomy group had significantly more days with fever than the children in the watchful waiting group. Two children had complications related to surgery.
In children selected for adenoidectomy for recurrent upper respiratory tract infections, a strategy of immediate surgery confers no clinical benefits over a strategy of initial watchful waiting. Trial registration Dutch Trial Register NTR968: ISRCTN03720485.
评估腺样体切除术治疗复发性上呼吸道感染的疗效。
开放性随机对照试验。
11 家综合医院和 2 家学术中心。
111 例年龄 1-6 岁、经选择行腺样体切除术的复发性上呼吸道感染患儿。
立即行腺样体切除术加或不加鼓膜切开术的策略，或初始观察等待的策略。主要观察指标：从总随访期（最长 24 个月）获得的数据计算出每人每年的上呼吸道感染次数。
每人每年的上呼吸道感染天数、伴有发热的中耳炎发作次数和天数、发热天数、上呼吸道感染发生率以及健康相关生活质量。
在 24 个月的中位随访期内，腺样体切除术组每人每年发生 7.91 次上呼吸道感染，而观察等待组为 7.84 次（发生率差异 0.07，95%置信区间 -0.70 至 0.85）。两组间上呼吸道感染天数和伴有发热的中耳炎发作次数和天数以及健康相关生活质量均无显著差异。两组的上呼吸道感染发生率均随时间下降。腺样体切除术组发热天数显著多于观察等待组。有 2 例患儿发生与手术相关的并发症。
对于因复发性上呼吸道感染而选择行腺样体切除术的患儿，立即手术策略并不优于初始观察等待策略。
荷兰试验注册处 NTR968：ISRCTN03720485。
