Connecticut Children's Medical Center, Hartford, CT 06106, USA.
Ann Pharmacother. 2010 Mar;44(3):471-8. doi: 10.1345/aph.1M344. Epub 2010 Feb 11.
Macrolide antibiotics are often used to treat children with acute otitis media (AOM); however, the 2004 American Academy of Pediatrics (AAP) and American Academy of Family Physicians guidelines recommend against their use in patients without history of a type I allergic reaction to penicillins.
To evaluate via meta-analysis the comparative efficacy of amoxicillin or amoxicillin/clavulanate to that of macrolide antibiotics in the treatment of children with AOM.
A systematic literature search of MEDLINE, EMBASE, and International Pharmaceutical Abstracts was conducted from the earliest available date through September 2008. We used the following MeSH and key words: amoxicillin, amoxicillin/clavulanate, Augmentin, azithromycin, ceftriaxone, clarithromycin, macrolides, AND media, otitis media, and effusion. Included studies were randomized, blinded, and controlled trials evaluating guideline-recommended antibiotics (amoxicillin or amoxicillin/clavulanate) compared to macrolide antibiotics (azithromycin or clarithromycin) in AOM in children. The primary outcome assessed was clinical failure measured between days 10 and 16 after starting antibiotic therapy. Results are reported as relative risks (RRs) with 95% confidence intervals and were calculated using a random-effects model.
A total of 10 trials (N = 2766) evaluating children 6 months-15 years old were included in the meta-analysis. Upon meta-analysis, the use of macrolide antibiotics was associated with an increased risk of clinical failure (RR 1.31 [95% CI 1.07 to 1.60]; p = 0.008) corresponding to a number needed to harm of 32. Upon safety analysis, rates of any adverse reaction (RR 0.74 [95% CI 0.60 to 0.90]; p = 0.003) and diarrhea (RR 0.41 [95% CI 0.32 to 0.52]; p < 0.0001) were significantly lower in the macrolide group.
The meta-analysis suggests that patients treated with macrolides for AOM may be more likely to have clinical failures. As such, it supports the current AAP AOM recommendation that macrolides be reserved for patients who can not receive amoxicillin or amoxicillin/clavulanate.
大环内酯类抗生素常用于治疗急性中耳炎（AOM）患儿；然而，2004 年美国儿科学会（AAP）和美国家庭医师学会指南建议，对于无 I 型青霉素过敏史的患者，不使用此类抗生素。
通过荟萃分析评价阿莫西林或阿莫西林/克拉维酸治疗 AOM 患儿的疗效与大环内酯类抗生素的比较。
对 MEDLINE、EMBASE 和国际药学文摘进行了系统的文献检索，检索时间从最早可获得日期至 2008 年 9 月。我们使用了以下 MeSH 和关键词：阿莫西林、阿莫西林/克拉维酸、Augmentin、阿奇霉素、头孢曲松、克拉霉素、大环内酯类、和媒体、中耳炎、和渗出。纳入的研究是随机、盲法、对照试验，评估指南推荐的抗生素（阿莫西林或阿莫西林/克拉维酸）与 AOM 患儿的大环内酯类抗生素（阿奇霉素或克拉霉素）比较。主要结局评估是开始抗生素治疗后 10-16 天的临床失败。结果以相对风险（RR）表示，95%置信区间（CI），并使用随机效应模型计算。
共有 10 项试验（N = 2766）纳入了年龄 6 个月至 15 岁的儿童进行荟萃分析。荟萃分析结果显示，大环内酯类抗生素的使用与临床失败风险增加相关（RR 1.31 [95%CI 1.07 至 1.60]；p = 0.008），对应的需要治疗人数为 32。安全性分析结果显示，大环内酯类抗生素组的不良反应（RR 0.74 [95%CI 0.60 至 0.90]；p = 0.003）和腹泻（RR 0.41 [95%CI 0.32 至 0.52]；p < 0.0001）发生率显著降低。
荟萃分析表明，大环内酯类抗生素治疗 AOM 的患者更可能发生临床失败。因此，它支持目前 AAP 对 AOM 的建议，即大环内酯类抗生素应保留给不能使用阿莫西林或阿莫西林/克拉维酸的患者。
