France Eric K, Glanz Jason M, Xu Stanley, Davis Robert L, Black Steven B, Shinefield Henry R, Zangwill Kenneth M, Marcy S Michael, Mullooly John P, Jackson Lisa A, Chen Robert
Clinical Research Unit, Kaiser Permanente Colorado, Denver, USA.
Arch Pediatr Adolesc Med. 2004 Nov;158(11):1031-6. doi: 10.1001/archpedi.158.11.1031.
To our knowledge, there are no published population-based studies on the safety of the inactivated trivalent influenza vaccine among children.
To screen a large population of children for evidence of increased medical visits in the 2 weeks after influenza vaccination compared with 2 control periods. Secondary analyses included shorter risk periods and restricted age categories.
Self-control screening analysis. Children vaccinated from January 1, 1993, through December 31, 1999, were randomly divided into 2 equal groups. In group 1, risks of outpatient, emergency department, and inpatient visits during the 14 days after vaccination were compared with the risks of visits in 2 control periods. Significant plausible medically attended events identified in group 1 were then analyzed in group 2, using the same 2 control periods. Medically attended events significant in both groups were considered potentially associated with vaccination and were assessed by medical record review.
Five managed care organizations in the United States.
Children younger than 18 years who received an influenza vaccination in one of the managed care settings (N = 251 600).
Among vaccinated children seen for a medically attended event, the odds of the visit occurring in the 2 weeks after vaccination vs during 1 of the 2 control periods.
Study participants incurred 1165, 230, and 489 different diagnoses during the 14 days after vaccination according to the outpatient, emergency department, and inpatient data, respectively. Four diagnoses were positively associated with the vaccine in both groups 1 and 2: impetigo, dermatitis, uncomplicated diabetes mellitus, and ureteral disorder not otherwise specified. After medical record review, impetigo (9 cases) in children 6 to 23 months old remained significantly associated with vaccination.
This large screening safety study did not reveal any evidence of important medically attended events associated with pediatric influenza vaccination.
据我们所知，尚无关于儿童接种三价灭活流感疫苗安全性的基于人群的研究发表。
筛查大量儿童，以寻找与两个对照期相比，流感疫苗接种后2周内就诊次数增加的证据。二次分析包括更短的风险期和受限的年龄类别。
自我对照筛查分析。1993年1月1日至1999年12月31日期间接种疫苗的儿童被随机分为两组。在第1组中，将接种疫苗后14天内门诊、急诊科和住院就诊的风险与两个对照期的就诊风险进行比较。然后在第2组中分析第1组中确定的明显合理的就医事件，使用相同的两个对照期。两组中均具有显著意义的就医事件被认为可能与疫苗接种有关，并通过病历审查进行评估。
美国的五个管理式医疗组织。
在其中一个管理式医疗机构接种流感疫苗的18岁以下儿童（N = 251600）。
在因就医事件就诊的接种疫苗儿童中，接种疫苗后2周内就诊的几率与两个对照期之一内就诊的几率。
根据门诊、急诊科和住院数据，研究参与者在接种疫苗后的14天内分别出现了1165、230和489种不同诊断。第1组和第2组中均有四种诊断与疫苗呈正相关：脓疱病、皮炎、无并发症的糖尿病和未另作说明的输尿管疾病。经过病历审查，6至23个月大儿童的脓疱病（9例）仍与疫苗接种显著相关。
这项大规模筛查安全性研究未发现任何与儿童流感疫苗接种相关的重要就医事件的证据。
