Jacobsson S, Fogh A, Larsson P, Lomborg S
Ear-Nose-Throat Department, Mölndal Hospital, Sweden.
Eur J Clin Microbiol Infect Dis. 1993 May;12(5):319-24. doi: 10.1007/BF01964426.
A total of 311 children who had recurrent otitis media or who had experienced failure of initial treatment of acute otitis media with phenoxymethylpenicillin, amoxicillin, ampicillin esters or cefaclor were entered into a single-blind study in two parallel groups in order to compare the clinical efficacy and safety of amoxicillin/clavulanate suspension given b.i.d. or t.i.d. for seven days. The patients were examined prior to the start of treatment, at an early follow-up visit 9 to 12 days after the start of treatment and at a late follow-up visit about three weeks later. Specimens for bacteriological culture were taken from the nasopharynx at entry, at the early follow-up visit, and at the late follow-up visit if there were symptoms of otitis. Both treatment groups showed a similar response, 90% or more of the patients being cured or showing improvement at the time of the early follow-up visit. The initial nasopharyngeal cultures showed growth of Haemophilus influenzae in 53% of the patients, Moraxella catarrhalis in 43% and Streptococcus pneumoniae in 39%. After treatment, cultures showed elimination of the initial pathogens in 30% of patients in both groups and recolonization in 23% in both groups. Haemophilus influenzae was the bacteria most frequently found in the nasopharynx at the first follow-up visit. Adverse effects, which consisted mostly of gastrointestinal and dermatological reactions, tended to be more common in the b.i.d. group but the difference was not statistically significant.
共有311名患有复发性中耳炎或初次使用苯氧甲基青霉素、阿莫西林、氨苄西林酯或头孢克洛治疗急性中耳炎失败的儿童被纳入一项单盲研究，分为两个平行组，以比较bid或tid给药7天的阿莫西林/克拉维酸混悬液的临床疗效和安全性。在治疗开始前、治疗开始后9至12天的早期随访以及约三周后的晚期随访时对患者进行检查。在入组时、早期随访时以及晚期随访（如果有中耳炎症状）时从鼻咽部采集细菌培养标本。两个治疗组的反应相似，90%或更多的患者在早期随访时治愈或病情改善。最初的鼻咽部培养显示，53%的患者有流感嗜血杆菌生长，43%有卡他莫拉菌生长，39%有肺炎链球菌生长。治疗后，两个组中30%的患者培养显示最初的病原体被清除，两个组中23%的患者出现重新定植。流感嗜血杆菌是首次随访时在鼻咽部最常发现的细菌。不良反应主要包括胃肠道和皮肤反应，bid组往往更常见，但差异无统计学意义。
