Kaleida P H, Bluestone C D, Rockette H E, Bass L W, Wolfson J H, Breck J M, Ubinger E B, Rohn D D
Pediatr Infect Dis J. 1987 Mar;6(3):265-71. doi: 10.1097/00006454-198703000-00013.
One hundred thirty-three infants and children with documented acute otitis media (OM) were randomized to receive the oral suspension of either amoxicillin-clavulanate potassium or cefaclor. Beta-lactamase-producing bacteria were found in 10.9 and 14.5% of subjects treated with amoxicillin-clavulanate potassium and cefaclor, respectively. Subjects were reexamined at 5, 10, 30, 60 and 90 days after the initiation of therapy and whenever signs/symptoms of acute otitis media recurred. All but two children had resolution of otalgia/otorrhea during the initial treatment period. The drug groups were not significantly different in the percentage of evaluable subjects with otitis media with effusion at each scheduled follow-up visit. Recurrence of acute OM/otorrhea [corrected] developed in a similar percentage of subjects in both treatment categories. Both subjects with and those without middle ear effusion at 10 days had approximately a 50% recurrence rate of subsequent middle ear disease. Adverse side effects/complaints, which occurred in significantly more children treated with amoxicillin-clavulanate potassium, were generally mild and primarily gastrointestinal.
133例确诊为急性中耳炎（OM）的婴幼儿被随机分为两组，分别接受阿莫西林克拉维酸钾口服混悬液或头孢克洛治疗。接受阿莫西林克拉维酸钾和头孢克洛治疗的受试者中，分别有10.9%和14.5%发现产β-内酰胺酶细菌。在治疗开始后的第5、10、30、60和90天以及急性中耳炎的体征/症状复发时对受试者进行复查。除两名儿童外，所有儿童在初始治疗期间耳痛/耳漏症状均得到缓解。在每次预定的随访中，药物组中耳积液性中耳炎可评估受试者的百分比无显著差异。两个治疗组中急性中耳炎/耳漏[校正后]复发的受试者比例相似。在第10天有中耳积液和无中耳积液的受试者随后中耳疾病的复发率均约为50%。阿莫西林克拉维酸钾治疗的儿童出现的不良副作用/主诉明显更多，一般较轻，主要为胃肠道反应。
