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咽部轻度感染或扁桃体轻度肥大的儿童行扁桃体切除术的效果评估:开放性随机对照试验

Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: Open, randomised controlled trial
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摘要 对有咽部轻度感染或扁桃体轻度肥大症状的儿童行扁桃体切除术的效果予以评估。设计:本文采用开放性随机对照试验设计。机构:300例受试者选自荷兰的21个综合医院和3个医学中心,年龄为2-8岁,均需要施行扁桃体切除术。试验分组:扁桃体切除术组与观察等待组。主要观察指标:发热、咽部感染。 Objective: To assess the effectiveness of adenotonsillecto-my in children with mild symptoms of throat infections or adenotonsillar hypertrophy. Design: Open, randomised controlled trial. Setting: 21 general hospitals and three a-cademic centres in the Netherlands. Participants: 300 children aged 2-8 years requiring adenotonsillectomy. Intervention: Adenotonsillectomy compared with watchful waiting. Main outcome measures: Episodes of fever, throat infections, upper respiratory tract infections, and health related quality of life. Results: During the median follow up period of 22 months, children in the adenotonsillectomy group had 2. 97 episodes of fever per person year compared with 3. 18 in the watchful waiting group (difference -0. 21, 95% confidence interval - 0. 54 to 0. 12) - , 0. 56 throat infections per person year compared with 0. 77 ( -0.21, -0.36 to -0.06), and 5.47 upper respiratory tract infections per person year compared with 6. 00 ( -0.53, -0.97 to -0.08) . No clinically relevant differences were found for health related quality of life. Adenotonsillectomy was more effective in children with a history of three to six throat infections than in those with none to two. 12 children had surgery related complications. Conclusion: Adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy has no major clinical benefits over watchful waiting.
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