Straetemans Masja, Sanders Elisabeth A, Veenhoven Reinier H, Schilder Anne G, Damoiseaux Roger A, Zielhuis Gerhard A
Department of Epidemiology and Biostatistics, University Medical Center Nijmegen, Nijmegen, the Netherlands.
Pediatr Infect Dis J. 2003 Jun;22(6):515-24. doi: 10.1097/01.inf.0000069763.08122.1c.
Increasing resistance to antibiotics of the pathogens causing acute otitis media (AOM) emphasize the need for effective methods to prevent episodes of otitis media in young children.
To assess the effectiveness of pneumococcal vaccination for prevention of AOM in children age 12 years and younger.
Systematic review of 11 randomized controlled trials including 46 074 children in whom pneumococcal vaccination against AOM was compared with a control treatment. Vaccine effect was estimated as a rate ratio (RR): AOM episodes per child month in pneumococcal vaccination group divided by the AOM episodes per child-month in control group.
A moderate effect of pneumococcal polysaccharide vaccination was found in children 24 months of age and older [RR 0.78; 95% confidence interval (CI) 0.63 to 0.97]. Pneumococcal polysaccharide vaccine had little effect on prevention of AOM in children without previous documented episodes before vaccination (RR 0.92; 95% CI 0.85 to 0.99). Better efficacy was seen in those children with documented prior AOM before vaccination (RR 0.81; 95% CI 0.72 to 0.91). Pooled results of pneumococcal conjugate vaccine trials in infants vaccinated as early as 2 months of age and in toddlers attending day care showed only a small effect on prevention of AOM (RR 0.92; 95% CI 0.85 to 0.99).
Based on these results, a large scale pneumococcal vaccination program for a primary indication of preventing AOM in infancy is not indicated. The results of ongoing trials should provide more information whether the conjugate vaccine is effective in high risk (otitis-prone) children after 1 year of age.
引起急性中耳炎（AOM）的病原体对抗生素的耐药性不断增加，这凸显了需要有效的方法来预防幼儿中耳炎发作。
评估肺炎球菌疫苗接种对12岁及以下儿童预防AOM的有效性。
对11项随机对照试验进行系统评价，这些试验包括46074名儿童，将针对AOM的肺炎球菌疫苗接种与对照治疗进行比较。疫苗效果以率比（RR）估计：肺炎球菌疫苗接种组每个儿童月的AOM发作次数除以对照组每个儿童月的AOM发作次数。
在24个月及以上的儿童中发现肺炎球菌多糖疫苗有中等效果[RR 0.78；95%置信区间（CI）0.63至0.97]。肺炎球菌多糖疫苗对疫苗接种前无既往记录发作的儿童预防AOM几乎没有效果（RR 0.92；95%CI 0.85至0.99）。在疫苗接种前有既往AOM记录的儿童中观察到更好的疗效（RR 0.81；95%CI 0.72至0.91）。对最早在2个月大时接种疫苗的婴儿和参加日托的幼儿进行的肺炎球菌结合疫苗试验的汇总结果显示，对预防AOM只有很小的效果（RR 0.92；95%CI 0.85至0.99）。
基于这些结果，不建议开展大规模肺炎球菌疫苗接种计划作为预防婴儿期AOM的主要指征。正在进行的试验结果应能提供更多信息，以确定结合疫苗对1岁后高危（易患中耳炎）儿童是否有效。
