单剂量阿奇霉素与三日剂量阿奇霉素或单剂量头孢曲松治疗儿童非复杂性急性中耳炎的一项试点研究。
A pilot study of single-dose azithromycin versus three-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children.
作者信息
Arguedas Adriano, Loaiza Cecilia, Perez Alexandra, Gutierrez Alvaro, Herrera Marco Luis, Rothermel Constance D
机构信息
Instituto de Atención Pediátrica.
Laboratorio Centro de Investigaciones Clinicas;
出版信息
Curr Ther Res Clin Exp. 2003;64:16-29. doi: 10.1016/j.curtheres.2003.09.005.
BACKGROUND
The pharmacokinetic profile of azithromycin supports its use as single-dose therapy for uncomplicated acute otitis media (AOM) in children.
OBJECTIVE
This study was designed to (1) compare the safety of single-dose oral azithromycin, 3 daily doses of oral azithromycin, and a single dose of intramuscular ceftriaxone for the treatment of uncomplicated AOM in children, and (2) provide preliminary efficacy data to support initiation of a larger, comparative trial of single-dose azithromycin for the treatment of uncomplicated acute otitis media in children.
METHODS
In this single-center pilot study, children with uncomplicated AOM were randomly assigned to receive single-dose oral azithromycin (30 mg/kg), 3-day oral azithromycin (10 mg/kg once daily), or single-dose intramuscular ceftriaxone (50 mg/kg). Tympanocentesis was performed before administration of the first dose, and clinical response was assessed on days 14-15 and 28-30.
RESULTS
Between September 1995 and May 1997, 198 children (mean age, 2.5 years) were enrolled. All of the patients were evaluable for the safety and clinical intent-to-treat (ITT) analyses, and 98 were evaluable for the microbiologic ITT analysis. On day 14-15, rates of clinical success (cure or improvement) for the 3 treatment groups were: 62/64 (97%) for single-dose azithromycin, 60/63 (95%) for 3-day azithromycin, and 61/62 (98%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 61/65 (94%), 61/66 (92%), and 62/64 (97%). For the 98 microbiologically evaluable patients, clinical success rates at day 14-15 were 28/30 (93%) for single-dose azithromycin, 31/35 (89%) for 3-day azithromycin, and 33/33 (100%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 27/30 (90%), 30/35 (86%), and 32/33 (97%). Treatment-related adverse event rates for single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone were 10.6%, 9.1%, and 9.1%, respectively.
CONCLUSION
In this pilot study comparing single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone for the treatment of uncomplicated AOM in children, no differences were detected among the 3 regimens.
背景
阿奇霉素的药代动力学特征支持其作为儿童非复杂性急性中耳炎（AOM）单剂量治疗药物。
目的
本研究旨在（1）比较单剂量口服阿奇霉素、每日3次口服阿奇霉素以及单剂量肌内注射头孢曲松治疗儿童非复杂性AOM的安全性，（2）提供初步疗效数据，以支持开展一项更大规模的比较单剂量阿奇霉素治疗儿童非复杂性急性中耳炎的试验。
方法
在这项单中心试点研究中，将患有非复杂性AOM的儿童随机分配接受单剂量口服阿奇霉素（30mg/kg）、为期3天的口服阿奇霉素（每日10mg/kg）或单剂量肌内注射头孢曲松（50mg/kg）。在首次给药前进行鼓膜穿刺，并在第14 - 15天和第28 - 30天评估临床反应。
结果
1995年9月至1997年5月，共纳入198名儿童（平均年龄2.5岁）。所有患者均可进行安全性和临床意向性治疗（ITT）分析，98名患者可进行微生物学ITT分析。在第14 - 15天，3个治疗组的临床成功率（治愈或改善）分别为：单剂量阿奇霉素组62/64（97%），3天阿奇霉素组60/63（95%），单剂量头孢曲松组61/62（98%）。在第28 - 30天，相应的临床成功率分别为61/65（94%）、61/66（92%）和62/64（97%）。对于98名可进行微生物学评估的患者，在第14 - 15天，单剂量阿奇霉素组临床成功率为28/30（93%），3天阿奇霉素组为31/35（89%），单剂量头孢曲松组为33/33（100%）。在第28 - 30天，相应的临床成功率分别为27/30（90%）、30/35（86%）和32/33（97%）。单剂量阿奇霉素、3天阿奇霉素和单剂量头孢曲松的治疗相关不良事件发生率分别为10.6%、9.1%和9.1%。
结论
在这项比较单剂量阿奇霉素、3天阿奇霉素和单剂量头孢曲松治疗儿童非复杂性AOM的试点研究中，3种治疗方案之间未发现差异。
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