Block Stan L, Arrieta Antonio, Seibel Matthew, McLinn Samuel, Eppes Stephen, Murphy Mary J
Kentucky Pediatric Research, Bardstown, Kentucky.
Division of Infectious Disease, Children's Hospital of Orange County, Orange, California.
Curr Ther Res Clin Exp. 2003;64:30-42. doi: 10.1016/j.curtheres.2003.09.006.
The long half-life of azithromycin allows for single-dose oral therapy for acute otitis media (AOM).
This study was designed to compare the efficacy and tolerability of single-dose azithromycin with 10-day, twice-daily amoxicillin/clavulanate for the treatment of new-onset, uncomplicated AOM in children.
Children aged 6 months to 12 years with new-onset AOM were randomly assigned to receive either a single 30-mg/kg dose of azithromycin or standard-dose amoxicillin/clavulanate (45 mg/kg administered BID for 10 days) in a double-blind, double-placebo, multicenter clinical trial. The diagnosis of AOM was based on specific clinical signs and symptoms, and was confirmed by pneumatic otoscopy and acoustic reflectometry (level ≥3). Clinical response was assessed on days 12-16 and 28-32.
Mean (SD) age of children receiving azithromycin (n = 173) or amoxicillin/clavulanate (n = 173) was 2.7 (2.3) years and 3.4 (2.8) years, respectively, with 43% and 36% ≤2 years of age. Most (53.2%) of the children were boys, and most (51.2%) were white. Clinical success rates (intent-to-treat) for azithromycin and amoxicillin/clavulanate, respectively, were 87% and 88% (95% CI, -9.2 to 6.5) on day 12-16 and 75% and 75% (95% CI, -10.2 to 10.5) on day 28-32. The incidences of treatment-related adverse events for azithromycin and amoxicillin/clavulanate were 16.8% and 22.5%, respectively. Corresponding rates of diarrhea were 6.4% and 12.7%, respectively. Vomiting, which was generally mild, occurred in 7 children in each group. One azithromycin patient and 5 amoxicillin/clavulanate patients discontinued treatment because of adverse events. The compliance rate for azithromycin was significantly higher than that for amoxicillin/clavulanate (99% vs 83%; P<0.001).
In this trial comparing the efficacy of single-dose azithromycin (30 mg/kg) with twice-daily amoxicillin/clavulanate (45 mg/kg) for the treatment of new-onset, uncomplicated AOM, no differences were detected between the 2 regimens. Single-dose azithromycin was generally well tolerated and provides an alternative to conventional oral regimens for AOM.
阿奇霉素半衰期长，可用于急性中耳炎（AOM）的单剂量口服治疗。
本研究旨在比较单剂量阿奇霉素与10天每日两次阿莫西林/克拉维酸治疗儿童新发、非复杂性AOM的疗效和耐受性。
在一项双盲、双安慰剂、多中心临床试验中，将6个月至12岁新发AOM的儿童随机分配接受单剂量30mg/kg的阿奇霉素或标准剂量阿莫西林/克拉维酸（45mg/kg，每日两次，共10天）。AOM的诊断基于特定的临床体征和症状，并通过鼓气耳镜检查和声反射测量（水平≥3）得到证实。在第12 - 16天和第28 - 32天评估临床反应。
接受阿奇霉素（n = 173）或阿莫西林/克拉维酸（n = 173）治疗的儿童平均（标准差）年龄分别为2.7（2.3）岁和3.4（2.8）岁，43%和36%的儿童年龄≤2岁。大多数（53.2%）儿童为男孩，大多数（51. .2%）为白人。在第12 - 16天，阿奇霉素和阿莫西林/克拉维酸的临床成功率（意向性治疗）分别为87%和88%（95%CI，-9.2至6.5），在第28 - 32天分别为75%和75%（95%CI，-10.2至10.5）。阿奇霉素和阿莫西林/克拉维酸治疗相关不良事件的发生率分别为16.8%和22.5%。相应的腹泻发生率分别为6.4%和12.7%。呕吐一般较轻，每组各有7名儿童发生。1名阿奇霉素治疗患者和5名阿莫西林/克拉维酸治疗患者因不良事件停药。阿奇霉素的依从率显著高于阿莫西林/克拉维酸（99%对83%；P<0.001）。
在本试验中，比较单剂量阿奇霉素（30mg/kg）与每日两次阿莫西林/克拉维酸（45mg/kg）治疗新发、非复杂性AOM的疗效，两种治疗方案未发现差异。单剂量阿奇霉素耐受性一般良好，为AOM的传统口服治疗方案提供了一种替代选择。
