Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.
Analysis Group, Inc., Boston, MA, USA.
BMC Infect Dis. 2022 Mar 26;22(1):294. doi: 10.1186/s12879-022-07275-9.
Acute otitis media (AOM) is a leading cause of office visits and antibiotic prescriptions in children. Pneumococcal conjugate vaccines were introduced in the USA in 2000 (7-valent, PCV7) and 2010 (13-valent, PCV13). Expanded valency PCVs are currently under development. To describe the impact of PCVs and quantify the residual burden of AOM, this study estimated annual incidence rates (IRs) of AOM and AOM-related complications and surgical procedures in children < 18 years in the USA before and after the introduction of PCV7 and PCV13.
AOM episodes were identified in the IBM MarketScan Commercial and Medicaid databases using diagnosis codes (ICD-9-CM: 382.x; ICD-10-CM: H66.xx and H67.xx). Annual IRs were calculated as the number of episodes per 1000 person-years (PYs) for all children < 18 years and by age group (< 2, 2-4, and 5-17 years). National estimates of annual AOM IRs were extrapolated using Census Bureau data. Interrupted time series analyses were used to assess immediate and gradual changes in monthly AOM IRs, controlling for seasonality.
In the commercially insured population, AOM IRs declined between the pre-PCV7 period (1998-1999) and the late PCV13 period (2014-2018) from 1170.1 to 768.8 episodes per 1000 PY for children < 2 years, from 547.4 to 410.3 episodes per 1000 PY in children 2-4 years, and from 115.6 to 91.8 episodes per 1000 PY in children 5-17 years. The interrupted time series analyses indicated significant immediate or gradual decreases in the early PCV7 period (2001-2005), and gradual increases in the late PCV7 period (2006-2009) in children < 2 years; however, crude IRs trended downward in all time periods. In older children, IRs decreased in the early PCV7 and early PCV13 period (2011-2013), but gradually increased in the late PCV7 period. IRs of AOM-related surgical procedures decreased, and IRs of AOM-related complications increased during the study timeframe.
AOM disease burden remains high in children of all ages despite overall reductions in AOM IRs during 1998-2018 following the introduction of PCV7 and PCV13. The impact of investigational PCVs on the disease burden of AOM will likely depend on AOM etiology and circulating pneumococcal serotypes.
急性中耳炎（AOM）是导致儿童就诊和抗生素处方的主要原因。肺炎球菌结合疫苗于 2000 年（7 价，PCV7）和 2010 年（13 价，PCV13）在美国推出。目前正在开发扩展价 PCV。为了描述 PCV 的影响并量化 AOM 的残留负担，本研究在美国 PCV7 和 PCV13 推出前后，估计了 18 岁以下儿童的 AOM 和与 AOM 相关的并发症和手术的年度发病率（IR）。
使用诊断代码（ICD-9-CM：382.x；ICD-10-CM：H66.xx 和 H67.xx）在 IBM MarketScan 商业和医疗补助数据库中识别 AOM 发作。所有<18 岁的儿童每年的发病率（IR）以每 1000 人年（PY）的发作数计算，按年龄组（<2、2-4 和 5-17 岁）进行计算。使用人口普查局的数据推断全国 AOM 发病率的年度估计数。使用中断时间序列分析来评估每月 AOM IR 的即时和渐进变化，同时控制季节性。
在商业保险人群中，与 PCV7 前时期（1998-1999 年）相比，AOM IR 在 PCV13 后期（2014-2018 年）下降，<2 岁儿童每 1000PY 减少 1170.1 至 768.8 例，2-4 岁儿童每 1000PY 减少 547.4 至 410.3 例，5-17 岁儿童每 1000PY 减少 115.6 至 91.8 例。中断时间序列分析表明，在 PCV7 早期（2001-2005 年）和 PCV7 后期（2006-2009 年）均存在显著的即时或渐进性下降，但所有时期的原始 IR 均呈下降趋势。在较大的儿童中，IR 在 PCV7 早期和 PCV13 早期（2011-2013 年）下降，但在 PCV7 后期逐渐增加。与 AOM 相关的手术发病率下降，与 AOM 相关的并发症发病率在研究期间增加。
尽管自 1998 年至 2018 年 PCV7 和 PCV13 推出后，AOM 的发病率总体下降，但所有年龄段的儿童的 AOM 疾病负担仍然很高。研究性 PCV 对 AOM 疾病负担的影响可能取决于 AOM 的病因和循环肺炎球菌血清型。
