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首页> 外文期刊>Vaccine >Ischemic cardiac events and other adverse events following ACAM2000 (R) smallpox vaccine in the Vaccine Adverse Event Reporting System
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Ischemic cardiac events and other adverse events following ACAM2000 (R) smallpox vaccine in the Vaccine Adverse Event Reporting System

机译：疫苗不良事件报告系统中的ACAM2000（R）天花疫苗接种后的缺血性心脏事件和其他不良事件

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Background: The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, used for monitoring the safety of all US licensed vaccines. In March 2008, ACAM2000 (R) replaced Dryvax (R) as the only licensed smallpox vaccine and is administered to all persons entering military service and certain civilian researchers. In 2011, routine data mining of VAERS identified a vaccine safety concern resulting in acute ischemic cardiac events (ICE) following ACAM2000 (R). Methods: During March 1, 2008 through June 30, 2013, we reviewed all serious reports received following ACAM2000 (R) and classified them by diagnostic category. We identified possible ICE cases by searching the Medical Dictionary for Regulatory Affairs (MedDRA (R)) terms for "myocardial ischaemia," "acute myocardial infarction," "myocardial infarction," and "ischaemia," and applied standardized surveillance case definitions. Results: VAERS received 1149 reports following ACAM2000 (R) administration; 169 (14.7%) were serious (resulting in permanent disability, hospitalization or prolongation of hospitalization, life-threatening illness or death), including one death. The two most frequent diagnostic categories for serious reports were cardiovascular and other infectious conditions. The MedDRA (R) search found 31 reports of possible ICE after receipt of ACAM2000 (R) vaccine. Of a total 30 possible ICE cases with demographic information, all but one was male; the age range was 20-45 years (median 32) and median interval to onset of symptoms was 12 days. On clinical review there were 16 cases of myocarditis/pericarditis and 15 ICE cases. Conclusions: Our review of the data mining signal did not substantiate the concerns about ICE after ACAM2000 (R). Our study also suggests that with current pre-vaccination screening, cardiac morbidity in generally healthy vaccinated populations remains uncommon
机译：背景：疫苗不良事件报告系统（VAERS）是一种被动报告系统，用于监视所有美国许可疫苗的安全性。 2008年3月，ACAM2000（R）替代了Dryvax（R），成为唯一获得许可的天花疫苗，并且对所有参军人员和某些平民研究人员进行管理。 2011年，VAERS的常规数据挖掘发现了疫苗安全性问题，导致在ACAM2000（R）之后发生急性缺血性心脏事件（ICE）。方法：在2008年3月1日至2013年6月30日之间，我们回顾了在ACAM2000（R）之后收到的所有严重报告，并按诊断类别对它们进行了分类。我们通过搜索《管理事务医学词典》（MedDRA（R））中的“心肌缺血，”，“急性心肌梗死”，“心肌梗死”和“缺血”来识别可能的ICE病例，并应用标准化的监测病例定义。结果：VAERS在ACAM2000（R）管理后收到1149份报告;严重（导致永久性残疾，住院或住院时间延长，危及生命的疾病或死亡）169例（14.7％），其中包括1例死亡。严重报告的两个最常见诊断类别是心血管疾病和其他感染性疾病。 MedDRA（R）搜索在收到ACAM2000（R）疫苗后发现了31份关于可能的ICE的报告。在总共30例具有人口统计学信息的ICE病例中，除1例外，其余均为男性。年龄范围为20-45岁（中位数32岁），症状发作的中位时间间隔为12天。在临床检查中，有16例心肌炎/心包炎和15例ICE病例。结论：我们对数据挖掘信号的评论并未证实ACAM2000（R）之后对ICE的担忧。我们的研究还表明，在当前的疫苗接种前筛查中，一般健康的接种人群中的心脏发病率仍然不常见

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