PURPOSE:Despite withdrawal of RotaShield® and the development of second generation live attenuated rotavirus vaccines, concerns remain regarding the relationship between rotavirus vaccine and intussusception. Nevertheless, since there is no study in Korea, we reviewed data from cases at Severance Children's Hospital to determine the association between rotavirus vaccine and intussusception. MATERIALS AND METHODS:Patients coded as intussusception and following a prescription of RotaTeq® from 2007 to 2013 were reviewed. We calculated comparative incidence figures (CIFs) and 95% confidence intervals (CIs) to compare the risk of intussusception in Korea with the risk in the United States. Expected cases within the four-week post-vaccination window were calculated by applying rates of intussusception from data compiled by the Health Insurance Review and Assessment Service (for a five-year period) to numbers of vaccinations. RESULTS:In total, 10530 doses of pentavalent rotavirus vaccine were administered. A total of 65 intussusception cases were diagnosed, although only two cases occurred within four weeks after vaccination. This was compared to six cases within 999123 doses in United States from April 2008 to March 2013 (CIF, 31.63; CI, 31.33-31.93). When we adjusted incidence rate differences for both countries, the CIF decreased to 7.05 (CI, 6.72-7.40). When we compared our identified cases with the expected cases from our hospital, there was no increased intussusception occurring within four weeks of vaccination. CONCLUSION:We found no association between pentavalent rotavirus vaccine and intussusception. Therefore, rotavirus vaccination should be considered due to its benefits of preventing rotavirus-associated diseases.

译文

目的:尽管RotaShield®停药并开发了第二代减毒活的轮状病毒疫苗,但人们仍然担心轮状病毒疫苗与肠套叠之间的关系。但是,由于韩国尚未进行研究,我们审查了Severance儿童医院的病例数据,以确定轮状病毒疫苗与肠套叠之间的关联。
材料与方法:回顾性分析了2007年至2013年间按照RotaTeq®处方进行肠套叠的患者。我们计算了比较发病率数字(CIF)和95%置信区间(CIs),以比较韩国的肠套叠风险和美国的风险。疫苗接种后四个星期内的预期病例是根据健康保险审查与评估服务公司(五年期)收集的数据,将肠套叠率应用到疫苗接种数量上来计算的。
结果:总共接种了10530剂五价轮状病毒疫苗。尽管在接种疫苗后的四周内仅发生了2例,但总共诊断出了65例肠套叠病例。相比之下,2008年4月至2013年3月在美国有999123剂6例(CIF,31.63; CI,31.33-31.93)。当我们调整两国的发病率差异时,CIF降至7.05(CI,6.72-7.40)。当我们将确定的病例与医院的预期病例进行比较时,在接种疫苗后的四周内没有出现肠套叠增加的情况。
结论:我们发现五价轮状病毒疫苗与肠套叠之间无关联。因此,应考虑接种轮状病毒疫苗,因为它具有预防轮状病毒相关疾病的益处。

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