Feldman W, Sutcliffe T, Dulberg C
Department of Pediatrics, University of Ottawa, Ont.
CMAJ. 1990 Jan 15;142(2):115-8.
Twice-daily trimethoprim-sulfamethoxazole has been shown to be effective in the treatment of acute otitis media except that caused by group A beta-streptococci. Amoxicillin-clavulanate potassium is effective in vitro against all bacterial pathogens causing acute otitis media and has been reported to be effective when given twice daily for urinary tract infections, acute otitis media and respiratory tract infections. To determine whether the in-vitro efficacy of amoxicillin-clavulanate carries over clinically, we conducted a prospective randomized double-blind trial in 219 children presenting at a pediatric walk-in clinic. Diagnosis and follow-up assessments were made by means of examination of the tympanic membrane and acoustic otoscopy. Of the 219 children 202 (101 in either group) were assessed by a specially trained nurse at a follow-up visit 12 to 16 (mean 14) days after treatment was begun. Cure was defined as absence of symptoms and normal results of both visual inspection of the tympanic membrane and acoustic reflectometry; improvement was defined as absence of symptoms and either normal appearance of the tympanic membrane or normal results of acoustic reflectometry; treatment failure was defined as abnormal appearance of the tympanic membrane along with an acoustic reflectometry reading of 5 units or more. There were no differences in age (mean 60 months), sex or proportion of subjects with unilateral versus bilateral disease between the two groups. The combined rate of cure an improvement was significantly higher with trimethoprim-sulfamethoxazole (93%) than with amoxicillin-clavulanate (82%) (p = 0.03). The rate of compliance (more than 80% of the drug taken) did not differ significantly between the two groups. Gastrointestinal side effects were more common with amoxicillin-clavulanate (p less than 0.0001). Our results suggest that for acute otitis media twice-daily trimethoprim-sulfamethoxazole is more effective clinically and produces fewer side effects than twice-daily amoxicillin-clavulanate.
每日两次服用甲氧苄啶-磺胺甲恶唑已被证明对治疗急性中耳炎有效，但由A组β溶血性链球菌引起的除外。阿莫西林-克拉维酸钾在体外对所有引起急性中耳炎的细菌病原体均有效，据报道，每日两次给药用于治疗尿路感染、急性中耳炎和呼吸道感染时有效。为了确定阿莫西林-克拉维酸钾的体外疗效是否能在临床上体现，我们对219名到儿科门诊就诊的儿童进行了一项前瞻性随机双盲试验。通过检查鼓膜和声学耳镜进行诊断和随访评估。在219名儿童中，202名（每组101名）在治疗开始后12至16天（平均14天）的随访中由一名经过专门培训的护士进行评估。治愈定义为无症状且鼓膜目视检查和声学反射测定结果均正常；改善定义为无症状且鼓膜外观正常或声学反射测定结果正常；治疗失败定义为鼓膜外观异常且声学反射测定读数为5个单位或更高。两组在年龄（平均60个月）、性别或单侧与双侧疾病患者比例方面无差异。甲氧苄啶-磺胺甲恶唑的治愈和改善合并率（93%）显著高于阿莫西林-克拉维酸钾（82%）（p = 0.03）。两组的依从率（服药超过80%）无显著差异。阿莫西林-克拉维酸钾的胃肠道副作用更常见（p小于0.0001）。我们的结果表明，对于急性中耳炎，每日两次服用甲氧苄啶-磺胺甲恶唑在临床上比每日两次服用阿莫西林-克拉维酸钾更有效且副作用更少。
