Risks of convulsion and aseptic meningitis following measles-mumps-rubella vaccination in the United Kingdom
Risks of convulsion and aseptic meningitis following measles-mumps-rubella vaccination in the United Kingdom
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DOI：
10.1093/aje/kwk045
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发表时间：
2007-03-15
影响因子：
5
通讯作者：
Taylor, B.
中科院分区：
文献类型：
--
作者：
Miller, E.;Andrews, N.;Taylor, B.
1992年，在证明接种疫苗后15-35天无菌性脑膜炎风险增加后，英国撤回了含有浦部腮腺炎菌株的麻疹-腮腺炎-风疹（MMR）疫苗。在1998年引入替代MMR疫苗（Priorix; GlaxoSmithKline，伦敦，英国）后，建立了对无菌性脑膜炎和惊厥的主动监测，以评价与新疫苗相关的风险。在英格兰和威尔士，在服用160万剂Priorix（风险的95%置信上限：1：437，000）后，12-23个月的儿童中未发现实验室确诊的腮腺炎脑膜炎病例。95%置信上限排除了Urabe疫苗（1：143，000剂量）引起腮腺炎脑膜炎的风险。在一个地区住院病例数据库中，在12-23个月大的儿童中未发现无菌性脑膜炎病例，这些儿童接受了超过99，000剂Priorix（风险的95%置信上限：1：27，000）。相比之下，Urabe疫苗的观察风险为1：12，400。在接受Priorix治疗后的6- 11天内，发现惊厥的相对发生率升高（相对发病率= 6.26，95%置信区间：3.85，10.18）--与MMR疫苗麻疹成分的已知效应一致--但不是在15- 35天期间（相对发生率= 1.48，95%置信区间：0.88，2.50），与含Urabe的疫苗相同。本研究证明了主动上市后监测识别或排除在许可前试验中检测不到的罕见事件的能力。
Measles-mumps-rubella (MMR) vaccines containing the Urabe strain of mumps were withdrawn in the United Kingdom in 1992 following demonstration of an increased risk of aseptic meningitis 15-35 days after vaccination. Following introduction of a replacement MMR vaccine (Priorix; GlaxoSmithKline, London, United Kingdom) in 1998, active surveillance of aseptic meningitis and convulsion was established to evaluate the risk associated with the new vaccine. No laboratory-confirmed cases of mumps meningitis were detected among children aged 12-23 months after administration of 1.6 million doses of Priorix (upper 95% confidence limit of risk: 1:437,000) in England and Wales. The upper 95% confidence limit excluded the risk found for mumps meningitis with Urabe vaccines (1:143,000 doses). No cases of aseptic meningitis were detected among children aged 12-23 months, who had received over 99,000 doses of Priorix (upper 95% confidence limit of risk: 1:27,000), in a regional database of hospital-admitted cases. This compares with an observed risk of 1:12,400 for Urabe vaccines. An elevated relative incidence of convulsion was found in the 6- to 11-day period after receipt of Priorix (relative incidence = 6.26, 95% confidence interval: 3.85, 10.18)-consistent with the known effects of the measles component of MMR vaccine-but not in the 15- to 35-day period (relative incidence = 1.48, 95% confidence interval: 0.88, 2.50) as occurred with Urabe-containing vaccines. This study demonstrates the power of active postmarketing surveillance to identify or exclude events too rare to be detected in prelicensure trials.