Black S, Shinefield H, Ray P, Lewis E, Chen R, Glasser J, Hadler S, Hardy J, Rhodes P, Swint E, Davis R, Thompson R, Mullooly J, Marcy M, Vadheim C, Ward J, Rastogi S, Wise R
Kaiser Permanente Vaccine Study Center, Oakland, CA, USA.
Pediatr Infect Dis J. 1997 May;16(5):500-3. doi: 10.1097/00006454-199705000-00009.
To assess the level of increased risk, if any, of hospitalizations for aseptic meningitis after Jeryl-Lynn mumps strain measles-mumps-rubella (MMR) vaccine in the Vaccine Safety Datalink population.
A possible increased risk of aseptic meningitis 8 to 14 days after receipt of MMR was observed in a preliminary screening analysis of automated data from the Vaccine Safety Datalink (VSD) project Year 2 analysis. To further evaluate this association a retrospective 10-year matched case-control study was undertaken in the four health maintenance organizations (HMOs) in the VSD project. Cases ascertained from a broad scan of the automated data were validated against a standard case definition. Two controls matched on age, sex, HMO and HMO membership were assigned per case.
The VSD project involves the cooperative collection of automated vaccination and medical outcome data from four large HMOs that currently have 500,000 children younger than 7 years of age under surveillance. Review of automated screening results from the first 2 years of data revealed a possible increased risk of aseptic meningitis 0 to 14 days after MMR with a relative risk of 3.61 (95% confidence interval, 1.0 to 13.1) although the total number of cases was small. Although the automated data had suggested a possible association of aseptic meningitis with MMR containing the Jeryl-Lynn strain of mumps, review of validated hospitalized cases during the observation period did not reveal evidence of an increased risk of aseptic meningitis after MMR containing the Jeryl-Lynn strain of mumps (odds ratio < 1.0 for all analyses).
Although it is recognized that hospitalized cases represent a minority of the total cases of aseptic meningitis, it is reassuring that in this evaluation no increased risk of aseptic meningitis after MMR vaccine was found.
评估在疫苗安全数据链人群中,接种杰里尔-林恩株麻疹-腮腺炎-风疹(MMR)疫苗后发生无菌性脑膜炎而住院的风险(如有)增加程度。
在疫苗安全数据链(VSD)项目第二年分析的自动数据初步筛查分析中,观察到接种MMR疫苗后8至14天发生无菌性脑膜炎的风险可能增加。为进一步评估这种关联,在VSD项目的四个健康维护组织(HMO)中进行了一项回顾性10年配对病例对照研究。通过对自动数据的广泛扫描确定的病例,根据标准病例定义进行验证。每个病例分配两名按年龄、性别、HMO和HMO成员资格匹配的对照。
VSD项目涉及从四个大型HMO合作收集自动疫苗接种和医疗结局数据,目前有50万名7岁以下儿童处于监测中。对前两年数据的自动筛查结果进行回顾发现,接种MMR疫苗后0至14天发生无菌性脑膜炎的风险可能增加,相对风险为3.61(95%置信区间,1.0至13.1),尽管病例总数较少。虽然自动数据提示无菌性脑膜炎可能与含杰里尔-林恩株腮腺炎的MMR有关,但对观察期内经验证的住院病例进行回顾时,未发现含杰里尔-林恩株腮腺炎的MMR接种后无菌性脑膜炎风险增加的证据(所有分析的比值比<1.0)。
虽然认识到住院病例仅占无菌性脑膜炎总病例的少数,但令人放心的是,在本次评估中未发现MMR疫苗接种后无菌性脑膜炎风险增加。