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五价轮状病毒疫苗与肠套叠的关系:韩国某单一中心的一项回顾性研究

Relationship between Pentavalent Rotavirus Vaccine and Intussusception: A Retrospective Study at a Single Center in Korea.

作者信息

Kim Kyu Yeun, Kim Dong Soo

机构信息

Department of Pediatrics, Yonsei University College of Medicine, Severance Children's Hospital, Seoul, Korea.

出版信息

Yonsei Med J. 2017 May;58(3):631-636. doi: 10.3349/ymj.2017.58.3.631.

DOI:10.3349/ymj.2017.58.3.631
PMID:28332371
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5368151/
Abstract

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.

摘要

目的

尽管轮状病毒疫苗RotaShield®已退市且第二代减毒活轮状病毒疫苗已研发出来,但轮状病毒疫苗与肠套叠之间的关系仍受关注。然而,由于韩国尚无相关研究,我们回顾了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

对2007年至2013年编码为肠套叠且使用过Rotateq®的患者进行回顾。我们计算了比较发病率(CIF)和95%置信区间(CI),以比较韩国肠套叠风险与美国风险。通过将健康保险审查与评估服务机构(五年期间)汇编数据中的肠套叠发病率应用于疫苗接种数量,计算接种后四周内的预期病例数。

结果

共接种10530剂五价轮状病毒疫苗。共诊断出65例肠套叠病例,不过仅2例发生在接种疫苗后四周内。相比之下,2008年4月至2013年3月美国999123剂疫苗中有6例(CIF,31.63;CI,31.33 - 31.93)。当我们对两国发病率差异进行调整后,CIF降至7.05(CI,6.72 - 7.40)。当我们将所确定的病例与本院预期病例进行比较时,接种疫苗后四周内未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,鉴于其预防轮状病毒相关疾病的益处,应考虑接种轮状病毒疫苗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c67a/5368151/6ffb908a406c/ymj-58-631-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c67a/5368151/e652cca0d4b1/ymj-58-631-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c67a/5368151/6ffb908a406c/ymj-58-631-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c67a/5368151/e652cca0d4b1/ymj-58-631-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c67a/5368151/6ffb908a406c/ymj-58-631-g002.jpg

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本文引用的文献

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Intussusception risk after rotavirus vaccination in U.S. infants.美国婴儿接种轮状病毒疫苗后的肠套叠风险。
N Engl J Med. 2014 May 1;370(18):1766. doi: 10.1056/NEJMc1402790.
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Risk of intussusception after monovalent rotavirus vaccination.单价轮状病毒疫苗接种后的肠套叠风险。
N Engl J Med. 2014 Feb 6;370(6):513-9. doi: 10.1056/NEJMoa1311738. Epub 2014 Jan 14.
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Intussusception risk after rotavirus vaccination in U.S. infants.美国婴儿轮状病毒疫苗接种后的肠套叠风险。
轮状病毒疫苗:有效性、安全性和未来方向。
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N Engl J Med. 2014 Feb 6;370(6):503-12. doi: 10.1056/NEJMoa1303164. Epub 2014 Jan 14.
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Incidence of intussusception in Singaporean children aged less than 2 years: a hospital-based prospective study.新加坡 2 岁以下儿童肠套叠的发病率:一项基于医院的前瞻性研究。
BMC Pediatr. 2013 Oct 8;13:161. doi: 10.1186/1471-2431-13-161.
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Intussusception risk and disease prevention associated with rotavirus vaccines in Australia's National Immunization Program.澳大利亚国家免疫计划中轮状病毒疫苗相关的肠套叠风险和疾病预防。
Clin Infect Dis. 2013 Nov;57(10):1427-34. doi: 10.1093/cid/cit520. Epub 2013 Aug 26.
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Intussusception after rotavirus vaccines reported to US VAERS, 2006-2012.2006-2012 年美国 VAERS 报告的轮状病毒疫苗后肠套叠。
Pediatrics. 2013 Jun;131(6):1042-9. doi: 10.1542/peds.2012-2554. Epub 2013 May 13.
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Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized, double-blind, placebo-controlled, phase IV study.在韩国婴儿中,人轮状病毒疫苗(RIX4414)的免疫原性、反应原性和安全性:一项随机、双盲、安慰剂对照、四期研究。
Hum Vaccin Immunother. 2012 Jun;8(6):806-12. doi: 10.4161/hv.19853. Epub 2012 Jun 1.
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Postmarketing surveillance of intussusception following mass introduction of the attenuated human rotavirus vaccine in Mexico.在墨西哥大规模引入减毒人轮状病毒疫苗后对肠套叠进行的上市后监测。
Pediatr Infect Dis J. 2012 Jul;31(7):736-44. doi: 10.1097/INF.0b013e318253add3.
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Trends in intussusception hospitalizations among US infants before and after implementation of the rotavirus vaccination program, 2000-2009.2000-2009 年美国轮状病毒疫苗接种计划实施前后婴儿肠套叠住院趋势。
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