Medical Affairs, MSD K.K., Tokyo, Japan.
Biostatistics and Research Decision Sciences, MSD K.K., Tokyo, Japan.
Vaccine. 2018 May 3;36(19):2727-2732. doi: 10.1016/j.vaccine.2017.10.033. Epub 2017 Dec 11.
To estimate the trend in incidence of rotavirus gastroenteritis (RVGE) hospitalization among children aged <5 years in Japan during pre- and post-vaccine periods (2009-2011 and 2012-2015).
This retrospective observational study used a health insurance claims database (constructed by Japan Medical Data Center Co., Ltd.). Rotavirus vaccine became commercially available in 2011. We analyzed data of all children aged <5 years between January 2009 and December 2015. We estimated the incidence rate (IR) of RVGE hospitalization per 1000 person-years from 2009 to 2015 and incidence rate ratio (IRR) of post-vaccine years compared with the averaged pre-vaccine years. IRs and IRRs were also estimated by age group. Primary analysis was limited to the rotavirus season (January to June) of each year.
The IR was 6.3-9.3 in pre-vaccine years, 2.3 in 2014, and 3.0 in 2015; the decline was estimated to be 71% in 2014 and 61% in 2015 (p<0.01). By age group, reduction in hospitalizations began in 2013 among children <1 year old, followed by children aged 1 to <5 years in 2014. In the 2014 season, a 65% reduction in RVGE hospitalization was observed in children aged 36 to <60 months, although this age group was unlikely to be vaccinated.
A substantial decline of RVGE hospitalization in 2014 and its persistence was observed among children aged <5 years in Japan after introduction of rotavirus vaccine, although not included in the national immunization program. Indirect effects of rotavirus vaccination were suggested in the 2014 season.
估计日本<5 岁儿童轮状病毒胃肠炎(RVGE)住院发病率在疫苗接种前后(2009-2011 年和 2012-2015 年)的变化趋势。
这是一项回顾性观察性研究,使用了医疗保险索赔数据库(由日本医疗数据中心有限公司构建)。轮状病毒疫苗于 2011 年开始上市。我们分析了 2009 年 1 月至 2015 年 12 月期间所有<5 岁儿童的数据。我们估计了 2009 年至 2015 年每 1000 人年的 RVGE 住院发病率(IR),并比较了疫苗接种后年份与平均疫苗接种前年份的发病率比值(IRR)。按年龄组估计 IR 和 IRR。主要分析仅限于每年的轮状病毒季节(1 月至 6 月)。
疫苗接种前年份的 IR 为 6.3-9.3,2014 年为 2.3,2015 年为 3.0;估计 2014 年下降 71%,2015 年下降 61%(p<0.01)。按年龄组,2013 年<1 岁儿童住院人数开始减少,随后 2014 年 1-<5 岁儿童减少。2014 年季节,36-<60 个月儿童 RVGE 住院人数减少 65%,尽管该年龄组不太可能接种疫苗。
在日本,轮状病毒疫苗推出后,<5 岁儿童的 RVGE 住院人数在 2014 年大幅下降,并持续下降,尽管该疫苗未纳入国家免疫计划。2014 年季节提示轮状病毒疫苗具有间接效果。