目的　探索头孢曲松单剂注射与口服阿莫西林 10d治疗儿童急性中耳炎是否具有相同的疗效 ,并比较此两种方案的安全性。方法　本研究为多中心、随机、对照、开放Ⅳ期临床实验。头孢曲松组 :头孢曲松 5 0mg/kg(总剂量不超过 1g)单次肌肉注射或静脉点滴。阿莫西林组 :阿莫西林40mg/(kg·d) ,每日 3次 ,口服 ,连续 10d。年龄在 1～ 12岁共 2 12例儿童。用药后两次复诊 ,观察症状、体征 ,耳镜检查 ,白细胞计数和分类 ,听力检测等。结果　给药后 10～ 14d ,头孢曲松组 10 6例中显效以上的为 10 3例 ,占 97 17% ,有效率高于阿莫西林组 10 6例中的 96例 ,占 90 5 7% ,(P <0 0 5 )。不良反应为丘疹样皮疹、荨麻疹、口角皮肤色素沉着 ,两组中各 2例 ,差异无显著意义。结论　对于急性中耳炎的儿童 ,单剂头孢曲松肌注或静脉滴注优于口服阿莫西林 10d ,两者安全性相同。头孢曲松在治疗儿童急性中耳炎、特别是在婴幼儿用药顺应性差时是一个很好的选择 Objective To explore whether ceftriaxone single injection and oral amoxicillin 10d treatment of children with acute otitis media have the same effect, and compare the safety of the two programs. Methods This study was a multicenter, randomized, controlled, open phase IV clinical trial. Ceftriaxone group: ceftriaxone 50mg / kg (total dose not exceeding 1g) single intramuscular injection or intravenous drip. Amoxicillin group: Amoxicillin 40mg / (kg · d), 3 times a day, orally for 10d. A total of 2 12 children aged 1 to 12 years old. Two referrals after treatment, observe the symptoms, signs, otoscopy, white blood cell count and classification, hearing test. Results 10 to 14 days after administration, 10 3 cases (97 17%) were significantly effective in 10 6 cases of ceftriaxone, 96 cases of which were 96 cases (96%), accounting for 90 5 7% , (P <0 0 5). Adverse reactions to papular rash, urticaria, pigmentation of the mouth skin, two in each two cases, no significant difference. Conclusion For children with acute otitis media, single intramuscular injection of ceftriaxone or intravenous drip is superior to oral amoxicillin 10d, both of the same safety. Ceftriaxone in the treatment of children with acute otitis media, especially in the poor compliance of infant medication is a good choice