Institute for Health Research, Kaiser Permanente Colorado, Aurora.
Department of Epidemiology, Colorado School of Public Health, Aurora.
JAMA Pediatr. 2020 May 1;174(5):455-462. doi: 10.1001/jamapediatrics.2019.6324.
Because rotavirus infection is a hypothesized risk factor for type 1 diabetes, live attenuated rotavirus vaccination could increase or decrease the risk of type 1 diabetes in children.
To examine whether there is an association between rotavirus vaccination and incidence of type 1 diabetes in children aged 8 months to 11 years.
DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study of 386 937 children born between January 1, 2006, and December 31, 2014, was conducted in 7 US health care organizations of the Vaccine Safety Datalink. Eligible children were followed up until a diagnosis of type 1 diabetes, disenrollment, or December 31, 2017.
Rotavirus vaccination for children aged 2 to 8 months. Three exposure groups were created. The first group included children who received all recommended doses of rotavirus vaccine by 8 months of age (fully exposed to rotavirus vaccination). The second group had received some, but not all, recommended rotavirus vaccines (partially exposed to rotavirus vaccination). The third group did not receive any doses of rotavirus vaccines (unexposed to rotavirus vaccination).
Incidence of type 1 diabetes among children aged 8 months to 11 years. Type 1 diabetes was identified by International Classification of Diseases codes: 250.x1, 250.x3, or E10.xx in the outpatient setting. Cox proportional hazards regression models were used to analyze time to type 1 diabetes incidence from 8 months to 11 years. Hazard ratios and 95% CIs were calculated. Models were adjusted for sex, race/ethnicity, birth year, mother's age, birth weight, gestational age, number of well-child visits, and Vaccine Safety Datalink site.
In a cohort of 386 937 children (51.1% boys and 41.9% non-Hispanic white), 360 169 (93.1%) were fully exposed to rotavirus vaccination, 15 765 (4.1%) were partially exposed to rotavirus vaccination, and 11 003 (2.8%) were unexposed to rotavirus vaccination. Children were followed up a median of 5.4 years (interquartile range, 3.8-7.8 years). The total person-time follow-up in the cohort was 2 253 879 years. There were 464 cases of type 1 diabetes in the cohort, with an incidence rate of 20.6 cases per 100 000 person-years. Compared with children unexposed to rotavirus vaccination, the adjusted hazard ratio was 1.03 (95% CI, 0.62-1.72) for children fully exposed to rotavirus vaccination and 1.50 (95% CI, 0.81-2.77) for children partially exposed to rotavirus vaccination.
The findings of this study suggest that rotavirus vaccination does not appear to be associated with type 1 diabetes in children.
由于轮状病毒感染是 1 型糖尿病的一个假设风险因素，因此减毒活轮状病毒疫苗的接种可能会增加或降低儿童患 1 型糖尿病的风险。
研究轮状病毒疫苗接种与 8 个月至 11 岁儿童 1 型糖尿病发病之间是否存在关联。
设计、地点和参与者：对美国 7 家医疗保健机构的疫苗安全数据链接中的 386937 名 2006 年 1 月 1 日至 2014 年 12 月 31 日出生的儿童进行了一项回顾性队列研究。合格的儿童在随访期间直到被诊断为 1 型糖尿病、退出或 2017 年 12 月 31 日。
8 个月龄至 8 岁儿童接种轮状病毒疫苗。共创建了三个暴露组。第一组包括所有推荐剂量的轮状病毒疫苗均在 8 个月龄前接种（完全暴露于轮状病毒疫苗接种）的儿童。第二组接种了部分推荐剂量的轮状病毒疫苗（部分暴露于轮状病毒疫苗接种）。第三组未接种任何轮状病毒疫苗（未暴露于轮状病毒疫苗接种）。
8 个月至 11 岁儿童的 1 型糖尿病发病率。1 型糖尿病的诊断依据为国际疾病分类代码：250.x1、250.x3 或 250.x3 或 E10.xx 门诊。采用 Cox 比例风险回归模型分析从 8 个月至 11 岁的 1 型糖尿病发病时间。计算危险比和 95%CI。模型调整了性别、种族/民族、出生年份、母亲年龄、出生体重、胎龄、儿童就诊次数和疫苗安全数据链接站点。
在 386937 名儿童（51.1%为男孩，41.9%为非西班牙裔白人）的队列中，360169 名（93.1%）完全暴露于轮状病毒疫苗接种，15765 名（4.1%）部分暴露于轮状病毒疫苗接种，11003 名（2.8%）未暴露于轮状病毒疫苗接种。儿童平均随访中位数为 5.4 年（四分位间距，3.8-7.8 年）。队列的总随访人年为 2253879 年。队列中有 464 例 1 型糖尿病病例，发病率为 20.6/100000 人年。与未接种轮状病毒疫苗的儿童相比，完全接种轮状病毒疫苗的儿童的调整后危险比为 1.03（95%CI，0.62-1.72），部分接种轮状病毒疫苗的儿童为 1.50（95%CI，0.81-2.77）。
这项研究的结果表明，轮状病毒疫苗接种似乎与儿童 1 型糖尿病无关。
