van Kempen Muriel J P, Vermeiren Judith S, Vaneechoutte Mario, Claeys Geert, Veenhoven Reinier H, Rijkers Ger T, Sanders Elisabeth A M, Dhooge Ingeborg J
Department of Otorhinolaryngology, Ghent University Hospital, Belgium.
Int J Pediatr Otorhinolaryngol. 2006 Feb;70(2):275-85. doi: 10.1016/j.ijporl.2005.06.022. Epub 2005 Sep 2.
Based on two clinical trials in healthy infants the American Academy of Pediatrics (AAP) advices immunization with a 7-valent pneumococcal conjugate vaccine in children with recurrent acute otitis media (AOM).
To study the efficacy of a 7-valent pneumococcal conjugate vaccine on acute otitis media recurrences, its immunogenicity and impact on nasopharyngeal Streptococcus pneumoniae carriage in children with a history of frequent acute otitis media.
In this double-blind, randomized study, 74 Belgian children, aged 1-7 years, with at least 2 clinically diagnosed episodes of acute otitis media in the previous year were enrolled. Children were immunized with either a 7-valent pneumococcal conjugate vaccine followed by a 23-valent pneumococcal polysaccharide booster or a control hepatitis A vaccine. Total follow-up was 26 months.
Despite adequate serum IgG responses to all conjugate vaccine pneumococcal serotypes, no reduction of acute otitis media episodes was observed in the pneumococcal vaccine group as compared to the control group (rate ratio: 1.16; 95% CI: 0.69-1.96). Overall nasopharyngeal pneumococcal carriage remained stable. However, a transient shift from conjugate vaccine related S. pneumoniae serogroups to non-vaccine related serogroups was noted following conjugate vaccination.
Clinically no protective effect of pneumococcal conjugate vaccination on acute otitis media recurrences was found in children with a history of frequent AOM.
基于两项针对健康婴儿的临床试验，美国儿科学会（AAP）建议对复发性急性中耳炎（AOM）患儿接种7价肺炎球菌结合疫苗。
研究7价肺炎球菌结合疫苗对急性中耳炎复发的疗效、免疫原性以及对有频繁急性中耳炎病史儿童鼻咽部肺炎链球菌携带情况的影响。
在这项双盲、随机研究中，纳入了74名年龄在1至7岁、前一年至少有2次临床诊断为急性中耳炎发作的比利时儿童。儿童分别接种7价肺炎球菌结合疫苗，随后接种23价肺炎球菌多糖加强疫苗，或接种对照甲型肝炎疫苗。总随访时间为26个月。
尽管对所有结合疫苗肺炎球菌血清型有足够的血清IgG反应，但与对照组相比，肺炎球菌疫苗组的急性中耳炎发作次数未减少（率比：1.16；95%置信区间：0.69 - 1.96）。总体鼻咽部肺炎球菌携带情况保持稳定。然而，接种结合疫苗后，发现从与结合疫苗相关的肺炎链球菌血清群暂时转变为与非疫苗相关的血清群。
在有频繁AOM病史的儿童中，肺炎球菌结合疫苗接种对急性中耳炎复发临床上未发现有保护作用。
