Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Atlanta, GA, USA.
Vaccine. 2012 Feb 27;30(10):1841-6. doi: 10.1016/j.vaccine.2011.12.128. Epub 2012 Jan 9.
In 2002 CDC initiated the Anthrax Vaccination Program (AVP) to provide voluntary pre-exposure vaccination with Anthrax Vaccine Adsorbed (AVA) for persons at high risk of exposure to Bacillus anthracis spores. There has been concern that AVA could be associated with long term impairment of physical and/or mental health.
To ascertain whether physical and mental functional status, as measured by the SF-36v2 health survey (Medical Outcomes Trust, Boston, MA), of AVA recipients and controls changed differently over time.
We enrolled 437 exposed (received AVA) and 139 control subjects. The exposed group received AVA under then-current Advisory Committee on Immunization Practices (ACIP) recommendations. SF-36v2 surveys were completed at 0, 12, and 30 months. SF-36v2 physical and mental scores both range from 0 to 100 with an estimated national average of 50 points.
For physical scores, the average change from baseline was -0.53 for exposed vs. -0.67 for controls at 12 months (p=0.80) and -1.09 for exposed vs. -1.97 for controls at 30 months (p=0.23). For mental scores, the average change from baseline was -1.50 for exposed vs. -1.64 for controls at 12 months (p=0.86) and -2.11 for exposed vs. -0.24 for controls at 30 months (p=0.06). In multivariable analysis, the difference in mental score change between exposed vs. controls at 30 months was less pronounced (p=0.37) but other findings were similar to univariate analyses.
These results do not favor an association between receipt of AVA and an altered health related quality of life over a 30-month period.
2002 年,CDC 启动炭疽疫苗接种计划(AVP),为有高暴露风险的人群提供炭疽疫苗吸附剂(AVA)的预先暴露接种。人们一直担心 AVA 可能与身体和/或心理健康的长期损害有关。
确定 AVA 受种者和对照者的身体和精神功能状态(通过医疗结果信托公司的 SF-36v2 健康调查来衡量)是否随时间推移而不同。
我们招募了 437 名暴露者(接受 AVA)和 139 名对照者。暴露组根据当时的免疫实践咨询委员会(ACIP)建议接种 AVA。SF-36v2 调查在 0、12 和 30 个月时完成。SF-36v2 的身体和精神评分范围均为 0 至 100,估计全国平均得分为 50 分。
在身体评分方面,暴露组从基线的平均变化为-0.53,而对照组为-0.67(p=0.80),在 30 个月时暴露组为-1.09,而对照组为-1.97(p=0.23)。在精神评分方面,暴露组从基线的平均变化为-1.50,而对照组为-1.64(p=0.86),在 30 个月时暴露组为-2.11,而对照组为-0.24(p=0.06)。在多变量分析中,暴露组与对照组在 30 个月时的精神评分变化差异不明显(p=0.37),但其他发现与单变量分析相似。
这些结果不支持在 30 个月的时间内,接受 AVA 与健康相关的生活质量改变之间存在关联。