Odio C M, Kusmiesz H, Shelton S, Nelson J D
Pediatrics. 1985 May;75(5):819-26.
A total of 150 children with acute otitis media were randomly allocated to treatment with amoxicillin-potassium clavulanate (Augmentin) or with cefaclor. Each drug was given in a daily dosage of approximately 40 mg/kg in three divided doses for ten days. Tympanocentesis done before treatment yielded specimens that contained pneumococcus or Haemophilus sp or both in 67% of specimens. Viridans group streptococci were isolated from 10% of specimens and Branhamella catarrhalis from 6%. Patients were scheduled for follow-up examinations at midtreatment, end of therapy, and at 30, 60, and 90 days. Of the 150 children, 130 were evaluable. Five of 60 patients (8%) treated with cefaclor were considered therapeutic failures because of persistent purulent drainage and isolation of the original pathogen or suprainfection. There were no failures among patients treated with Augmentin (P = .019). Rates of relapse, recurrent acute otitis media with effusion, and persistent middle ear effusion were comparable in the two groups of patients. Diaper rash, or loose stools, or both were significantly more common in children treated with Augmentin (34%) than in those taking cefaclor (12%), but in no case was it necessary to discontinue medication because of these mild side effects (P = .002). Cefaclor therapy was discontinued in one patient because of severe abdominal pain and vomiting. In this study, treatment with Augmentin was superior to treatment with cefaclor in the acute phase of acute otitis media with effusion, but Augmentin produced more adverse effects. The rates of persistent middle ear effusion and recurrent acute otitis media with effusion were comparable with the two regimens.
总共150名急性中耳炎患儿被随机分配接受阿莫西林 - 克拉维酸钾（安灭菌）或头孢克洛治疗。每种药物的日剂量约为40mg/kg，分三次服用，共十天。治疗前进行的鼓膜穿刺术所获取的标本中，67%含有肺炎球菌或嗜血杆菌属或两者皆有。10%的标本分离出草绿色链球菌，6%分离出卡他布兰汉菌。患者计划在治疗中期、治疗结束时以及30天、60天和90天进行随访检查。150名儿童中，130名可进行评估。接受头孢克洛治疗的60名患者中有5名（8%）被视为治疗失败，原因是持续脓性引流以及原病原体分离或发生了二重感染。接受安灭菌治疗的患者中未出现治疗失败情况（P = 0.019）。两组患者的复发率、复发性急性中耳炎伴积液以及持续性中耳积液发生率相当。使用安灭菌治疗的儿童出现尿布疹或腹泻或两者皆有的情况（34%）明显多于服用头孢克洛的儿童（12%），但因这些轻微副作用而停药的情况在任何病例中都未出现（P = 0.002）。一名患者因严重腹痛和呕吐而停止使用头孢克洛治疗。在本研究中，在伴有积液的急性中耳炎急性期，安灭菌治疗优于头孢克洛治疗，但安灭菌产生的不良反应更多。两种治疗方案的持续性中耳积液发生率和复发性急性中耳炎伴积液发生率相当。
