法国在肺炎球菌结合疫苗时代儿童和成人侵袭性肺炎球菌病的发病率：来自 17 年全国前瞻性监测研究数据的中断时间序列分析。
Invasive pneumococcal disease incidence in children and adults in France during the pneumococcal conjugate vaccine era: an interrupted time-series analysis of data from a 17-year national prospective surveillance study.
机构信息
Public health France, the French National Public Health agency, Saint Maurice, France; Association Clinique et Thérapeutique Infantile du Val-de-Marne, Créteil, France; Groupe de Pathologie Infectieuse Pédiatrique, Paris, France; Department of General Paediatrics, Infectious Diseases and Internal Medicine, Assistance Publique-Hôpitaux de Paris, Hôpital Robert Debré, Paris, France; Unité d'épidémiologie clinique, Épidémiologie clinique, évaluation économique appliquées aux populations vulnérables, unité mixte de recherche 1123, Assistance publique des hôpitaux de Paris, Hôpital Robert Debré, Institut National de la Santé et de la Recherche Médicale, Paris, France.
National Reference Centre for Pneumococci, Centre Hospitalier Intercommunal de Créteil, Créteil, France.
出版信息
Lancet Infect Dis. 2021 Jan;21(1):137-147. doi: 10.1016/S1473-3099(20)30165-1. Epub 2020 Jul 20.
BACKGROUND
The long-term benefits of pneumococcal conjugate vaccines (PCVs) remain unknown because of serotype replacement. We aimed to estimate the effect of PCV implementation on invasive pneumococcal disease incidence in France.
METHODS
We did a quasi-experimental interrupted time-series analysis using data from a French national prospective surveillance system. We included all invasive pneumococcal disease cases in children and adults from more than 250 participating hospitals between Jan 1, 2001, and Dec 31, 2017. The primary outcome was incidence of invasive pneumococcal disease (meningitis and non-meningitis) over time, analysed by segmented regression with autoregressive error. Isolates were serotyped by latex agglutination with antiserum samples.
FINDINGS
We included 75 903 patients with invasive pneumococcal disease, including 4302 (5·7%) children younger than 2 years and 37 534 (49·4%) adults aged 65 years or older. Before PCV7 implementation, the estimated monthly incidence of invasive pneumococcal disease was 0·78 cases per 100 000 inhabitants, which did not change significantly up to May, 2010. PCV13 implementation in 2010 was followed by a significant decrease in the incidence of invasive pneumococcal disease (-1·5% per month, 95% CI -2·2 to -0·8), reaching an estimated monthly incidence of 0·52 cases per 100 000 inhabitants in December, 2014. From January, 2015, the incidence rebounded (1·8% per month, 95% CI 1·0 to 2·6), reaching an estimated monthly incidence of 0·73 cases per 100 000 inhabitants in December, 2017. The estimated monthly incidence increased from 0·93 cases per 100 000 in December, 2014, to 1·73 cases per 100 000 in December, 2017, for children younger than 2 years, and from 1·54 cases per 100 000 in December, 2014, to 2·08 cases per 100 000 in December, 2017, for adults aged 65 years or older. The main non-PCV13 serotypes involved in the increase were 24F in young children and 12F, 22F, 9N, and 8 in adults aged 65 years or older.
INTERPRETATION
PCV13 implementation led to a major reduction in the incidence of invasive pneumococcal disease. However, a rebound in cases among children and adults since 2015, driven by several emerging non-PCV13 serotypes, jeopardises the long-term PCV benefits. These findings, if confirmed in the coming years, should be considered in the development of next-generation PCVs and might guide policy makers in the selection of future pneumococcal vaccines.
FUNDING
Foundation for Medical Research; Pfizer, BioMérieux, Sanofi for the Regional Observatory of Pneumococci.
背景
由于血清型替代，肺炎球菌结合疫苗（PCV）的长期获益仍不清楚。本研究旨在评估 PCV 实施对法国侵袭性肺炎球菌病发病率的影响。
方法
我们使用来自法国全国前瞻性监测系统的数据，进行了一项准实验性中断时间序列分析。我们纳入了 2001 年 1 月 1 日至 2017 年 12 月 31 日期间，250 多家参与医院的 25 岁以上儿童和成人侵袭性肺炎球菌病（脑膜炎和非脑膜炎）患者的所有病例。主要结局是通过自回归误差的分段回归分析随时间推移的侵袭性肺炎球菌病发病率。通过乳胶凝集试验用抗血清样本对分离株进行血清型分型。
结果
我们纳入了 75903 例侵袭性肺炎球菌病患者，包括 4302 例（5.7%）年龄<2 岁的儿童和 37534 例（49.4%）年龄≥65 岁的成年人。在 PCV7 实施之前，侵袭性肺炎球菌病的估计每月发病率为 0.78 例/10 万居民，直至 2010 年 5 月，发病率无显著变化。2010 年 PCV13 实施后，侵袭性肺炎球菌病的发病率显著下降（每月下降 1.5%，95%CI -2.2 至-0.8），2014 年 12 月估计每月发病率为 0.52 例/10 万居民。自 2015 年 1 月起，发病率出现反弹（每月增加 1.8%，95%CI 1.0 至 2.6），2017 年 12 月估计每月发病率为 0.73 例/10 万居民。2014 年 12 月，年龄<2 岁的儿童的估计每月发病率从 0.93 例/10 万居民增加到 1.73 例/10 万居民，年龄≥65 岁的成年人从 1.54 例/10 万居民增加到 2.08 例/10 万居民。发病率反弹的主要非 PCV13 血清型为 24F 型（在幼儿中）、12F、22F、9N 和 8 型（在年龄≥65 岁的成年人中）。
解释
PCV13 实施后，侵袭性肺炎球菌病的发病率显著降低。然而，自 2015 年以来，儿童和成年人的病例出现反弹，这主要由几种新出现的非 PCV13 血清型驱动，危及 PCV 的长期获益。如果未来几年的研究结果证实了这一点，那么这些发现应在下一代 PCV 的开发中得到考虑，并可能为政策制定者在选择未来的肺炎球菌疫苗方面提供指导。
资助
医学研究基金会；辉瑞、生物梅里埃、赛诺菲，用于肺炎球菌观察站。
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