Incidence rates of AOM cases.

BackgroundAcute otitis media (AOM) is a common childhood disease frequently caused by Streptococcus pneumoniae. Pneumococcal conjugate vaccines (PCV7, PCV10, PCV13) can reduce the risk of AOM but may also shift AOM etiology and serotype distribution. The aim of this study was to review estimates from published literature of the burden of AOM in Europe after widespread use of PCVs over the past 10 years, focusing on incidence, etiology, serotype distribution and antibiotic resistance of Streptococcus pneumoniae, and economic burden.MethodsThis systematic review included published literature from 31 European countries, for children aged ≤5 years, published after 2011. Searches were conducted using PubMed, Embase, Google, and three disease conference websites. Risk of bias was assessed with ISPOR-AMCP-NPC, ECOBIAS or ROBIS, depending on the type of study.ResultsIn total, 107 relevant records were identified, which revealed wide variation in study methodology and reporting, thus limiting comparisons across outcomes. No homogenous trends were identified in incidence rates across countries, or in detection of S. pneumoniae as a cause of AOM over time. There were indications of a reduction in hospitalization rates (decreases between 24.5–38.8% points, depending on country, PCV type and time since PCV introduction) and antibiotic resistance (decreases between 14–24%, depending on country), following the widespread use of PCVs over time. The last two trends imply a potential decrease in economic burden, though this was not possible to confirm with the identified cost data. There was also evidence of an increase in serotype distributions towards non-vaccine serotypes in all of the countries where non-PCV serotype data were available, as well as limited data of increased antibiotic resistance within non-vaccine serotypes.ConclusionsThough some factors point to a reduction in AOM burden in Europe, the burden still remains high, residual burden from uncovered serotypes is present and it is difficult to provide comprehensive, accurate and up-to-date estimates of said burden from the published literature. This could be improved by standardised methodology, reporting and wider use of surveillance systems.

研究背景：急性中耳炎（Acute otitis media, AOM）是一类常见儿童疾病，其致病诱因多为肺炎链球菌（Streptococcus pneumoniae）。肺炎球菌结合疫苗（Pneumococcal conjugate vaccines, PCV7、PCV10、PCV13）可降低急性中耳炎的发病风险，但也可能改变该病的病原学特征与血清型分布格局。本研究旨在回顾近10年来欧洲广泛接种肺炎球菌结合疫苗后，已发表文献中关于急性中耳炎疾病负担的评估结果，重点关注肺炎链球菌的发病率、病原学特征、血清型分布、抗生素耐药性，以及疾病带来的经济负担。
研究方法：本系统综述纳入了2011年后发表的、针对31个欧洲国家≤5岁儿童的相关已发表文献。检索数据库与平台包括PubMed、Embase、Google，以及3个疾病领域会议官方网站。根据研究类型的不同，分别采用ISPOR-AMCP-NPC、ECOBIAS或ROBIS工具对研究的偏倚风险进行评估。
研究结果：最终共检索到107篇符合要求的相关文献。分析显示，不同研究的方法学设计与报告规范存在显著差异，这限制了不同结局指标间的横向比较。各国急性中耳炎的发病率、随时间推移肺炎链球菌作为AOM致病菌的检出率均未呈现统一的变化趋势。随着肺炎球菌结合疫苗的广泛应用，部分国家的急性中耳炎住院率（降幅为24.5%~38.8%，具体数值因国家、疫苗类型及疫苗引入后的时间而异）与抗生素耐药率（降幅为14%~24%，具体数值因国家而异）呈现下降趋势。上述两项变化提示疾病的经济负担可能有所降低，但现有可获取的成本数据无法证实这一推测。此外，在所有可获取非疫苗血清型数据的国家中，均观察到血清型分布向非PCV覆盖血清型偏移的现象；同时存在有限证据表明，非疫苗血清型的抗生素耐药性有所上升。
研究结论：尽管部分指标指向欧洲急性中耳炎的疾病负担有所降低，但整体负担仍处于较高水平，未被疫苗覆盖的血清型仍带来了残留疾病负担，且现有已发表文献难以提供全面、准确且与时俱进的急性中耳炎疾病负担估算结果。通过标准化的研究方法、报告规范，以及更广泛地应用疾病监测系统，可改善这一现状。