Block Stan L, Cifaldi Mary, Gu Yihua, Paris Maria M
Kentucky Pediatric/Adult Research, Bardstown, 40004, USA.
Clin Ther. 2005 Jun;27(6):786-94. doi: 10.1016/j.clinthera.2005.06.012.
Short-course therapy for acute otitis media (AOM) improves adherence and may reduce secondary bacterial resistance.
In this multicenter, prospective, investigator-blinded study, patients between the ages of 6 months and 6 years with a clinical diagnosis of AOM were randomized to receive cefdinir oral suspension 7 mg/kg q12h for 5 days or azithromycin oral suspension 10 mg/kg once daily on day 1 and 5 mg/kg once daily on days 2 through 5. Clinical response was assessed at the end-of-therapy (EOT) visit (days 7-9) and the follow-up visit (days 20-25).
Three hundred fifty-seven patients were enrolled in the study. The treatment groups were similar at baseline with respect to demographic characteristics (mean [SD] age, 3.0 [1.7] years; 55% male), incidence of bilateral AOM (45%), and presenting signs and symptoms. The majority of evaluable children (77%) had previously received conjugated heptavalent pneumococcal vaccine (PCV7) against Streptococcus pneumoniae. At the EOT visit, clinical cure rates were comparable for cefdinir and azithromycin (87% [151/174] and 85% [149/176], respectively; 95% CI, -5.5 to 9.8). In addition, clinical cure rates at the EOT visit in the children who had been vaccinated with PCV7 were comparable between cefdinir and azithromycin (86% vs 83%; 95% CI, -6.5 to 11.8). No significant difference in clinical cure rates was observed at the follow-up visit (76% and 86%; 95% CI, -18.9 to 0.0). Parental satisfaction was similar between treatment groups with regard to ease of use, taste, compliance, health care resource utilization, and missed days of work and day-care. Both antibiotics were well tolerated; diarrhea and abnormal stools were the most common antibiotic-related adverse events (< or = 7% each).
Short courses (5 days) of therapy with cefdinir or azithromycin were comparable in these children with AOM based on clinical end points, parental preferences, and health care utilization.
急性中耳炎（AOM）的短程治疗可提高依从性，并可能降低继发细菌耐药性。
在这项多中心、前瞻性、研究者设盲的研究中，对临床诊断为AOM的6个月至6岁患者进行随机分组，分别接受头孢地尼口服混悬液7mg/kg，每12小时1次，共5天；或阿奇霉素口服混悬液，第1天10mg/kg，每日1次，第2至5天5mg/kg，每日1次。在治疗结束（EOT）访视（第7 - 9天）和随访访视（第20 - 25天）时评估临床反应。
357例患者纳入本研究。治疗组在基线时的人口统计学特征（平均[标准差]年龄，3.0[1.7]岁；55%为男性）、双侧AOM发生率（45%）以及出现的体征和症状方面相似。大多数可评估儿童（77%）此前已接种针对肺炎链球菌的七价结合肺炎球菌疫苗（PCV7）。在EOT访视时，头孢地尼和阿奇霉素的临床治愈率相当（分别为87%[151/174]和85%[149/176]；95%可信区间，-5.5至9.8）。此外，接种PCV7的儿童在EOT访视时，头孢地尼和阿奇霉素的临床治愈率相当（86%对83%；95%可信区间，-6.5至11.8）。随访访视时临床治愈率无显著差异（76%和86%；95%可信区间，-18.9至0.0）。治疗组在易用性、口感、依从性、卫生保健资源利用以及误工和日托缺课天数方面，家长满意度相似。两种抗生素耐受性均良好；腹泻和大便异常是最常见的抗生素相关不良事件（各<或 = 7%）。
基于临床终点、家长偏好和卫生保健利用情况，在这些AOM儿童中，头孢地尼或阿奇霉素的短程（5天）治疗效果相当。
Zotero 插件