Okamoto Keisuke, Morio Tomohiro, Nakamura Yoshikazu, Hataya Hiroshi, Mizuta Koichi, Mori Masaaki
Department of Pediatrics and Developmental Biology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.
Department of Public Health, Jichi Medical University, Shimotsuke, Japan.
Acta Paediatr. 2021 Apr;110(4):1299-1306. doi: 10.1111/apa.15641. Epub 2020 Nov 12.
Down syndrome has been considered an independent risk factor for respiratory syncytial virus (RSV) infection. Palivizumab, an anti-RSV humanised monoclonal antibody, was currently approved for all children with Down syndrome in Japan. To investigate the change in RSV-associated hospitalisation (RSVH) rates before and after the universal approval of palivizumab in Japan in 2013, we conducted a nationwide retrospective survey.
We conducted a nationwide, retrospective, questionnaire survey across paediatric institutions in Japan. The recruited children with Down syndrome were divided into two groups: those born April 2010 to March 2013 (2010-2012 cohort) and those born April 2013 to March 2016 (2013-2015 cohort).
Of the 664 institutions, 321 (48.3%) replied, and a total of 3929 children with Down syndrome were registered. The percentage of children who received palivizumab increased from 49.2% to 82.2%. The cumulative RSVH rate showed a decreased trend in the 2013-2015 cohort (OR, 0.83; 95%CI, 0.63-1.10), while the rate of these children (without CHD and born at a gestational age ≥ 36 weeks) was significantly decreased in the 2013-2015 cohort (OR, 0.56; 95%CI, 0.34-0.92).
The cumulative RSVH rate tended to be decreased after approval for all children with Down syndrome although the result was not significant.
唐氏综合征被认为是呼吸道合胞病毒（RSV）感染的独立危险因素。帕利珠单抗是一种抗RSV人源化单克隆抗体，目前在日本被批准用于所有唐氏综合征患儿。为了调查2013年帕利珠单抗在日本普遍获批前后RSV相关住院率（RSVH）的变化，我们进行了一项全国性的回顾性调查。
我们在日本的儿科机构中进行了一项全国性的回顾性问卷调查。招募的唐氏综合征患儿被分为两组：2010年4月至2013年3月出生的患儿（2010 - 2012队列）和2013年4月至2016年3月出生的患儿（2013 - 2015队列）。
在664家机构中，321家（48.3%）回复，共登记了3929例唐氏综合征患儿。接受帕利珠单抗治疗的患儿比例从49.2%增至82.2%。2013 - 2015队列中RSVH累积率呈下降趋势（比值比，0.83；95%置信区间，0.63 - 1.10），而在2013 - 2015队列中，这些患儿（无先天性心脏病且胎龄≥36周）的住院率显著下降（比值比，0.56；95%置信区间，0.34 - 0.92）。
尽管结果不显著，但在所有唐氏综合征患儿获批使用帕利珠单抗后，RSVH累积率有下降趋势。
