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儿童疫苗与川崎病,疫苗安全数据链接,1996-2006 年。

Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006.

机构信息

Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta, GA, United States.

Immunization Safety Office, Division of Healthcare Quality and Promotion, Centers for Disease Control and Prevention, Atlanta, GA, United States.

出版信息

Vaccine. 2015 Jan 3;33(2):382-7. doi: 10.1016/j.vaccine.2014.10.044. Epub 2014 Nov 4.

DOI:10.1016/j.vaccine.2014.10.044
PMID:25444786
Abstract

BACKGROUND

Kawasaki disease is a childhood vascular disorder of unknown etiology. Concerns have been raised about vaccinations being a potential risk factor for Kawasaki disease.

METHODS

Data from the Vaccine Safety Datalink were collected on children aged 0-6 years at seven managed care organizations across the United States. Defining exposure as one of several time periods up to 42 days after vaccination, we conducted Poisson regressions controlling for age, sex, season, and managed care organization to determine if rates of physician-diagnosed and verified Kawasaki disease were elevated following vaccination compared to rates during all unexposed periods. We also performed case-crossover analyses to control for unmeasured confounding.

RESULTS

A total of 1,721,186 children aged 0-6 years from seven managed care organizations were followed for a combined 4,417,766 person-years. The rate of verified Kawasaki disease was significantly lower during the 1-42 days after vaccination (rate ratio=0.50, 95% CL=0.27-0.92) and 8-42 days after vaccination (rate ratio=0.45, 95% CL=0.22-0.90) compared to rates during unexposed periods. Breaking down the analysis by vaccination category did not identify a subset of vaccines which was solely responsible for this association. The case-crossover analyses revealed that children with Kawasaki disease had lower rates of vaccination in the 42 days prior to symptom onset for both physician-diagnosed Kawasaki disease (rate ratio=0.79, 95% CL=0.64-0.97) and verified Kawasaki disease (rate ratio=0.38, 95% CL=0.20-0.75).

CONCLUSIONS

Childhood vaccinations' studied did not increase the risk of Kawasaki disease; conversely, vaccination was associated with a transient decrease in Kawasaki disease incidence. Verifying and understanding this potential protective effect could yield clues to the underlying etiology of Kawasaki disease.

摘要

背景

川崎病是一种病因不明的儿童血管疾病。人们对疫苗接种成为川崎病潜在风险因素表示担忧。

方法

在美国七个管理式医疗组织中,收集了 0 至 6 岁儿童的数据。将暴露定义为接种疫苗后 42 天内的几个时间段之一,我们进行了泊松回归,控制年龄、性别、季节和管理式医疗组织,以确定与所有未暴露期相比,接种疫苗后医生诊断和确诊的川崎病发病率是否升高。我们还进行了病例交叉分析以控制未测量的混杂因素。

结果

来自七个管理式医疗组织的 1721186 名 0 至 6 岁儿童共随访 4417766 人年。与未暴露期相比,接种疫苗后 1-42 天(发病率比=0.50,95%可信区间=0.27-0.92)和 8-42 天(发病率比=0.45,95%可信区间=0.22-0.90)的确诊川崎病发生率显著降低。按疫苗类别细分分析并未发现某一类疫苗单独导致这种关联。病例交叉分析显示,在症状出现前的 42 天内,川崎病患儿的疫苗接种率较低,无论是医生诊断的川崎病(发病率比=0.79,95%可信区间=0.64-0.97)还是确诊的川崎病(发病率比=0.38,95%可信区间=0.20-0.75)。

结论

所研究的儿童疫苗接种并未增加川崎病的风险;相反,接种疫苗与川崎病发病率的短暂下降有关。验证和理解这种潜在的保护作用可能为川崎病的潜在病因提供线索。

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