文献简介

出版社:Journal Of Internal Medicine

作  者:Tseng HF ; Liu A ; Sy L ; Marcy SM ; Fireman B ; Weintraub E ; Baggs J ; Weinmann S ; Baxter R ; Nordin J ; Daley MF ; Jackson L ; Jacobsen SJ

编  号:10.1111/j.1365-2796.2011.02474.x

关键字:adult vaccination, case-centered method, herpes zoster vaccine, self-controlled case series, varicellazostervirus.

年  份:2012   点击量:739

文献摘要

Objectives

目的

The aim of this study was to examine a large cohort of adults who received the zoster vaccine for evidence of an increased risk of prespecified adverse events requiring medical attention.

这项研究的目的是调查一个大型接种带状疱疹疫苗的成人队列,以此作为预先设定的需要医疗护理的不良事件风险增加的证据

Design

设计

Two self-comparison approaches, including a case-centred approach and a self-controlled case series(SCCS)analysis were used.

采用了两种自我比较的方法:以案例为中心的方法和自身对照的案例系列研究(SCCS)方法。

Setting

背景

Eight managed-care organizations participating in the Vaccine Safety Datalink project in the United States.

八个管理式医疗保健组织都参与了美国的疫苗安全数据链项目。

Subjects

主体

A total of 193 083 adults aged 50 and older receiving a zoster vaccine from 1 January 2007 to 31 December 2008 were included.

200711日到20081231日期间接种带状疱疹疫苗的19308350岁以上的成人。

Main outcome measures

主要观察指标

Prespecified adverse events were identified by aggregated International Classification of Diseases, Ninth Revision (ICD-9) codes in auto-mated health plan datasets.

预先设定的不良反应由自动配对的健康计划数据集中国际疾病分类第九版(ICD-9)的聚合编码确定。

Results

结果

The risk of allergic reaction was significantly increased within 1–7 days of vaccination [relative risk = 2.13, 95% confidence interval (CI): 1.87–2.40 by case-centred method and relative rate =2.32, 95%  CI: 1.85–2.91 by SCCS].

过敏反应风险在接种疫苗后的1-7天内显著增加。[通过案例集中方法得出相对风险=2.1395% 置信区间(CI):1.87-2.40SCCS得出相对风险=2.3295% CI1.85-2.91]

 

No increased risk was found for the following adverse event groupings: cerebrovascular events; cardiovascular events; meningitis; encephalitis; and encephalopathy; and Ramsay-Hunt syndrome and Bell’s palsy.

下面不良事件组中未发现风险增加:脑血管事件,心血管事件,脑膜炎,脑炎,脑病,以及Ramsay-Hunt综合征和贝尔氏麻痹症。

 

Conclusions

结论

The results of this study support the findings from the pre licensure clinical trials, providing reassurance that the zoster vaccine is generally safe and well-tolerated with a small increased risk of allergic reactions in1–7 days after vaccination.

这项研究结果支持了之前的临床试验发现,并提供保证。带状疱疹疫苗通常是安全的并且耐受良好,在接种疫苗后的1-7天内出现过敏反应的风险小量会有小幅度增加。

  

Tseng HF et.al; Journal Of Internal Medicine ; 2012 May; Vol. 271 (5), pp