Kassim Priya, Eslick Guy D
The Whiteley-Martin Research Centre, Discipline of Surgery, The University of Sydney, Nepean Hospital, Penrith, New South Wales, Australia.
The Whiteley-Martin Research Centre, Discipline of Surgery, The University of Sydney, Nepean Hospital, Penrith, New South Wales, Australia.
Vaccine. 2017 Jul 24;35(33):4276-4286. doi: 10.1016/j.vaccine.2017.05.064. Epub 2017 Jun 22.
International post-licensure studies on rotavirus vaccines have identified an increased risk of intussusception in infants after administration. The first developed rotavirus vaccine (Rotashield (RRV-TV)) was suspended post-licensure in 1999 after an association with intussusception was found. The currently available second-generation rotavirus vaccines (Rotateq (RV5) and Rotarix (RV1)), are recommended as a routine vaccine by the World Health Organisation (WHO). Post-licensure studies of these vaccines have shown a smaller but temporal increased risk for developing intussusception.
A meta-analysis was performed to summarise available evidence and to give an overall risk of developing intussusception from case-control and cohort studies for all rotavirus vaccines that have been manufactured up to date. A search was conducted on MEDLINE, PubMed, EMBASE and Google Scholar up to May 2017. Eligible studies assessed the relationship between the rotavirus vaccine administration and subsequent development of intussusception both after receiving the first dose and after receiving all doses combined. Data was extracted on study characteristics, methods and outcomes. Results were pooled using the random-effect model.
Six cohort studies involving 4506265 total first doses and five case-control studies involving a total sample of 9643 children were included in this analysis. The cohort data revealed that there was an associated increased risk of intussusception after the first 7days post first dose of the vaccine (RR:3.71, 95% CI:1.08-12.69) and after receiving all doses of the rotavirus vaccine (RR:3.47, 95% CI:1.23-9.78). Similarly, the case-control data found an increased risk of intussusception following the first dose (OR: 8.45, 95% CI: 4.08-17.50) and following all doses (OR: 1.59, 95% CI: 1.11-2.27).
Findings of this meta-analysis suggest that the rotavirus vaccine is associated with an increased risk on the development of intussusception, principally seen after administration of the first dose of vaccine.
轮状病毒疫苗的国际上市后研究发现，婴儿接种后发生肠套叠的风险增加。首个研发的轮状病毒疫苗（Rotashield，RRV-TV）在1999年发现与肠套叠有关联后被暂停上市。目前可用的第二代轮状病毒疫苗（Rotateq，RV5和Rotarix，RV1）被世界卫生组织（WHO）推荐为常规疫苗。这些疫苗的上市后研究显示，发生肠套叠的风险虽较小但呈阶段性增加。
进行一项荟萃分析，以总结现有证据，并给出截至目前生产的所有轮状病毒疫苗在病例对照研究和队列研究中发生肠套叠的总体风险。截至2017年5月，在MEDLINE、PubMed、EMBASE和谷歌学术上进行了检索。符合条件的研究评估了接种轮状病毒疫苗与首次接种后及所有剂量接种后随后发生肠套叠之间的关系。提取了有关研究特征、方法和结果的数据。使用随机效应模型汇总结果。
本分析纳入了6项队列研究（共涉及4506265剂首剂疫苗）和5项病例对照研究（共涉及9643名儿童样本）。队列数据显示，在首剂疫苗接种后的前7天（RR：3.71，95%CI：1.08 - 12.69）以及接种所有剂量的轮状病毒疫苗后（RR：3.47，95%CI：1.23 - 9.78），肠套叠的发生风险增加。同样，病例对照数据发现，首次接种后（OR：8.45，95%CI：4.08 - 17.50）和所有剂量接种后（OR：1.59，95%CI：1.11 - 2.27）肠套叠的发生风险增加。
这项荟萃分析的结果表明，轮状病毒疫苗与肠套叠发生风险增加有关，主要见于首次接种疫苗后。
