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.
在2007年1月1日到2008年12月31日期间接种带状疱疹疫苗的193083名50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=2.13，95% 置信区间（CI）：1.87-2.40，SCCS得出相对风险=2.32，95% CI：1.85-2.91]
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