Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.
Hum Vaccin Immunother. 2021 Apr 3;17(4):1235-1238. doi: 10.1080/21645515.2020.1809265. Epub 2020 Sep 22.
Down syndrome (DS) is an independent risk factor for severe respiratory syncytial virus (RSV) infection. Palivizumab - passive immunization for RSV - is the only pharmacological measure for preventing severe disease. In most countries, palivizumab is indicated in young children with congenital heart disease, premature birth, and chronic lung disease. In Japan, since 2013, children with DS, but without such "standard" risk factors, have been able to receive insurance-covered palivizumab prophylaxis, but its effectiveness of policy is unknown. From a nationwide database, we extracted data of children with DS who hospitalized for RSV-related lower respiratory infections (LRTIs), from April 2010 to January 2019. Using an interrupted time-series design, we analyzed data from before and after the introduction of the universal palivizumab prophylaxis program for DS children in Japan. As a result, we identified a total of 152 RSV-related LRTIs in 147 children hospitalized with DS. With time-series analysis, we did not observe a significant change in both level (-1.07, = .11) and slope (0.26 per 12 months, = .30), before and after 2013. In summary, the expansion of the palivizumab prophylaxis program to all children with DS in Japan was not associated with a reduction in RSV-related hospitalization in these children.
唐氏综合征（DS）是严重呼吸道合胞病毒（RSV）感染的独立危险因素。帕利珠单抗 - RSV 的被动免疫 - 是预防严重疾病的唯一药物措施。在大多数国家，帕利珠单抗适用于患有先天性心脏病、早产和慢性肺部疾病的幼儿。在日本，自 2013 年以来，患有 DS 但没有此类“标准”危险因素的儿童能够接受保险覆盖的帕利珠单抗预防，但该政策的效果尚不清楚。我们从 2010 年 4 月至 2019 年 1 月从全国性数据库中提取了因 RSV 相关下呼吸道感染（LRTIs）住院的 DS 儿童的数据。使用中断时间序列设计，我们分析了日本为 DS 儿童引入普遍帕利珠单抗预防计划前后的数据。结果，我们共确定了 147 名患有 DS 的儿童因 RSV 相关 LRTIs 住院的 152 例。通过时间序列分析，我们在 2013 年之前和之后都没有观察到水平（-1.07， =.11）和斜率（每 12 个月 0.26， =.30）的显著变化。总之，日本将帕利珠单抗预防计划扩大到所有患有 DS 的儿童，与这些儿童因 RSV 相关住院的减少无关。
