Gale J L, Thapa P B, Wassilak S G, Bobo J K, Mendelman P M, Foy H M
Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle 98195.
JAMA. 1994 Jan 5;271(1):37-41.
To evaluate the association between serious acute neurological illness and receipt of whole-cell pertussis vaccine, given as diphtheria-tetanus-pertussis (DTP) vaccine.
Population-based case-control study.
Outpatient and inpatient hospital settings, physician practices, and the general population in Washington and Oregon states.
A total of 424 confirmed cases of neurological illness were identified prospectively during a 12-month period by statewide active surveillance from the population of 218,000 children 1 to 24 months of age living in Washington and Oregon (estimated 368,000 DTP immunizations given). Each case child was matched to two population control children by birth date (+/- 5 days), gender, and county of birth. Written immunization records were used to determine whether illness occurred within 7 days of immunization in case children, or within 7 days of the same reference date in control children, thus qualifying as exposed.
Outpatient and inpatient cases of complex febrile seizures, seizures without fever, infantile spasms, and acute encephalitis/encephalopathy confirmed by an expert panel masked to immunization history.
The estimated odds ratio (OR) for onset of serious acute neurological illness within 7 days for young children exposed to DTP vaccine was 1.1 (95% confidence interval [CI], 0.6 to 2.0). When the analysis was restricted to children with encephalopathy or complicated seizures and adjusted for factors possibly affecting vaccine administration, the OR was 3.6 (95% CI, 0.8 to 15.2). Odds ratios for specific study diagnoses varied, but all CIs included 1. No elevated risk was observed for the largest group of illnesses studied, nonfebrile seizures (OR, 0.5; 95% CI, 0.2 to 1.5).
This study did not find any statistically significant increased risk of onset of serious acute neurological illness in the 7 days after DTP vaccine exposure for young children.
评估严重急性神经疾病与接种全细胞百日咳疫苗（以白喉-破伤风-百日咳疫苗[DTP]形式接种）之间的关联。
基于人群的病例对照研究。
华盛顿州和俄勒冈州的门诊和住院医院环境、医生诊所及普通人群。
在12个月期间，通过对华盛顿州和俄勒冈州218,000名1至24个月大儿童（估计接种了368,000剂DTP疫苗）进行全州范围的主动监测，前瞻性地确定了424例确诊的神经疾病病例。每个病例儿童按出生日期（±5天）、性别和出生县与两名对照儿童进行匹配。书面免疫记录用于确定病例儿童的疾病是否在接种疫苗后7天内发生，或对照儿童在相同参考日期后7天内发生，从而确定为暴露。
由对免疫史不知情的专家小组确诊的复杂热性惊厥、无热惊厥、婴儿痉挛症和急性脑炎/脑病的门诊和住院病例。
暴露于DTP疫苗的幼儿在7天内发生严重急性神经疾病的估计比值比（OR）为1.1（95%置信区间[CI]，0.6至2.0）。当分析仅限于患有脑病或复杂性惊厥的儿童并对可能影响疫苗接种的因素进行调整后，OR为3.6（95%CI，0.8至15.2）。特定研究诊断的比值比各不相同，但所有置信区间均包含1。在研究的最大一组疾病非热性惊厥中未观察到风险升高（OR，0.5；95%CI，0.2至1.5）。
本研究未发现幼儿在暴露于DTP疫苗后7天内发生严重急性神经疾病的风险有任何统计学上的显著增加。
