头孢曲松与阿莫西林治疗儿童急性中耳炎的疗效比较研究

Efficacy and safety of one dose ceftriaxone vs. ten-day oral amoxicillin for treatment of acute otitis media in children

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。

Objective To compare the efficacy and safety of a single ceftriaxone injection with 10-day oral amoxicillin in the treatment for children′s acute otitis media. Methods This study was a prospective, comparative, open randomized, multicenter trial. In the ceftriaxone group, a single dose sodium ceftriaxone (50 mg/kg, total dose <1 g) was injected. In the amoxicillin group, the oral amoxicillin [40 mg/(kg·d), tid] was used for 10 days. Totally 236 cases aged from 0.5 to 12 years were enrolled and 212 cases completed the study. These patients were followed up twice and clinical signs and symptomes were recorded, otoscopy, peripheral blood WBC count, hearing test (pure tone test )and tympanography were performed. Results In the ceftriaxone group,103/106 cases were cured or improved (97.17%), while in the amoxicillin group 96/106 cases were cured or improved ( 90.57%) (P<0.05). Ceftriaxone was significantly better than amoxicillin in the treatment. Totally 4 cases had side effects such as papular skin rash, urticaria around mouth, skin pigmentation, two cases in the ceftriaxone group and other two cases in the amoxicillin group. There was no significant difference between the 2 groups in side effects. Conclusion Ceftriaxone injection was significantly better than ten-day oral amoxicillin for treatment of acute otitis media in children. The single dose regimen with ceftriaxone seems to be a good choice for children, particularly for.