Abstract：
BACKGROUND: Current guidance suggests oral antibiotics can be considered for children with acute otitis media (AOM) and ear discharge, but there is an absence of evidence regarding the relative effectiveness of antibiotic-corticosteroid eardrops.
OBJECTIVE: To establish whether antibiotic-corticosteroid eardrops are non-inferior to oral antibiotics in children with AOM and ear discharge.
METHODS: Open randomized controlled non-inferiority trial set in Dutch primary care.
METHODS: Children were randomized to hydrocortisone-bacitracin-colistin eardrops (five drops, three times per day in the discharging ear(s)) or amoxicillin suspension (50 mg per kilogram of body weight per day, divided over three doses administered orally) for 7 days. The primary outcome was the proportion of children with resolution of ear pain and fever at day 3.
RESULTS: Between December 2017 and March 2023, 58 of the planned 350 children were recruited due to slow accrual for various reasons. Children assigned to eardrops (n = 26) had lower resolution rates of ear pain and fever at 3 days compared to those receiving oral antibiotics (n = 31): 42% vs 65%; adjusted risk difference 20.3%, 95% confidence interval -5.3% to 41.9%), longer parent-reported ear discharge (6 vs 3 days; P = .04), and slightly higher mean ear pain scores (Likert scale 0-6) over days 1-3 (2.1 vs 1.4, P = .02), but received fewer oral antibiotic courses in 3months (11 for 25 children vs 33 for 30 children), and had less GI upset and rash (12% vs 32% and 8% vs 16%, respectively).
CONCLUSIONS: Early termination stopped us from determining non-inferiority of antibiotic-corticosteroid eardrops. Our limited data, requiring confirmation, suggest that oral antibiotics may be more effective than antibiotic-corticosteroid eardrops in resolving symptoms and shortening the duration of ear discharge.
OBJECTIVE: To establish whether antibiotic-corticosteroid eardrops are non-inferior to oral antibiotics in children with AOM and ear discharge.
METHODS: Open randomized controlled non-inferiority trial set in Dutch primary care.
METHODS: Children were randomized to hydrocortisone-bacitracin-colistin eardrops (five drops, three times per day in the discharging ear(s)) or amoxicillin suspension (50 mg per kilogram of body weight per day, divided over three doses administered orally) for 7 days. The primary outcome was the proportion of children with resolution of ear pain and fever at day 3.
RESULTS: Between December 2017 and March 2023, 58 of the planned 350 children were recruited due to slow accrual for various reasons. Children assigned to eardrops (n = 26) had lower resolution rates of ear pain and fever at 3 days compared to those receiving oral antibiotics (n = 31): 42% vs 65%; adjusted risk difference 20.3%, 95% confidence interval -5.3% to 41.9%), longer parent-reported ear discharge (6 vs 3 days; P = .04), and slightly higher mean ear pain scores (Likert scale 0-6) over days 1-3 (2.1 vs 1.4, P = .02), but received fewer oral antibiotic courses in 3months (11 for 25 children vs 33 for 30 children), and had less GI upset and rash (12% vs 32% and 8% vs 16%, respectively).
CONCLUSIONS: Early termination stopped us from determining non-inferiority of antibiotic-corticosteroid eardrops. Our limited data, requiring confirmation, suggest that oral antibiotics may be more effective than antibiotic-corticosteroid eardrops in resolving symptoms and shortening the duration of ear discharge.
摘要：
背景：目前的指南建议，对于患有急性中耳炎（AOM）和耳部分泌物的儿童，可以考虑口服抗生素，但缺乏关于抗生素-皮质类固醇滴耳剂相对有效性的证据.
目的：确定在患有AOM和耳部分泌物的儿童中，抗生素-皮质类固醇滴耳剂是否不劣于口服抗生素。
方法：在荷兰初级保健中设置的开放随机对照非劣效性试验。
方法：儿童随机接受氢化可的松-杆菌肽-粘菌素滴耳剂（五滴，每天三次在排出的耳朵中）或阿莫西林悬浮液（每天每公斤体重50毫克，分三次口服给药）7天。主要结果是在第3天耳痛和发烧消退的儿童比例。
结果：在2017年12月至2023年3月之间，由于各种原因，计划中的350名儿童中有58名由于累积缓慢而被招募。与接受口服抗生素治疗的儿童（n=31）相比，接受耳塞治疗的儿童（n=26）在3天的耳痛和发烧缓解率较低：42％vs65％；调整后的风险差异20.3％，95%置信区间-5.3%至41.9%)，父母报告的耳朵放电时间更长（6天vs3天；P=.04），1-3天的平均耳痛评分（Likert量表0-6）略高（2.1vs1.4，P=.02），但在3个月内接受的口服抗生素疗程较少（25名儿童11例，30名儿童33例），胃肠道不适和皮疹较少(12%vs32%，8%vs16%，分别)。
结论：早期终止治疗使我们无法确定抗生素-皮质类固醇滴耳剂的非劣效性。我们有限的数据,需要确认,建议口服抗生素可能比抗生素-皮质类固醇滴耳剂更有效地缓解症状并缩短耳部分泌物的持续时间。
目的：确定在患有AOM和耳部分泌物的儿童中，抗生素-皮质类固醇滴耳剂是否不劣于口服抗生素。
方法：在荷兰初级保健中设置的开放随机对照非劣效性试验。
方法：儿童随机接受氢化可的松-杆菌肽-粘菌素滴耳剂（五滴，每天三次在排出的耳朵中）或阿莫西林悬浮液（每天每公斤体重50毫克，分三次口服给药）7天。主要结果是在第3天耳痛和发烧消退的儿童比例。
结果：在2017年12月至2023年3月之间，由于各种原因，计划中的350名儿童中有58名由于累积缓慢而被招募。与接受口服抗生素治疗的儿童（n=31）相比，接受耳塞治疗的儿童（n=26）在3天的耳痛和发烧缓解率较低：42％vs65％；调整后的风险差异20.3％，95%置信区间-5.3%至41.9%)，父母报告的耳朵放电时间更长（6天vs3天；P=.04），1-3天的平均耳痛评分（Likert量表0-6）略高（2.1vs1.4，P=.02），但在3个月内接受的口服抗生素疗程较少（25名儿童11例，30名儿童33例），胃肠道不适和皮疹较少(12%vs32%，8%vs16%，分别)。
结论：早期终止治疗使我们无法确定抗生素-皮质类固醇滴耳剂的非劣效性。我们有限的数据,需要确认,建议口服抗生素可能比抗生素-皮质类固醇滴耳剂更有效地缓解症状并缩短耳部分泌物的持续时间。
