Ojha Rohit P, Jackson Bradford E, Tota Joseph E, Offutt-Powell Tabatha N, Singh Karan P, Bae Sejong
Department of Epidemiology and Cancer Control; St. Jude Children's Research Hospital; Memphis, TN USA.
Division of Preventive Medicine; Department of Medicine; University of Alabama at Birmingham; Birmingham, AL USA.
Hum Vaccin Immunother. 2014;10(1):232-7. doi: 10.4161/hv.26292. Epub 2013 Sep 6.
Post-marketing surveillance studies provide conflicting evidence about whether Guillain-Barre syndrome occurs more frequently following quadrivalent human papillomavirus (HPV4) vaccination. We aimed to assess whether Guillain-Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among females and males aged 9 to 26 y in the United States. We used adverse event reports received by the United States Vaccine Adverse Event Reporting System (VAERS) between January 1, 2010 and December 31, 2012 to estimate overall, age-, and sex-specific proportional reporting ratios (PRRs) and corresponding Χ2 values for reports of Guillain-Barre syndrome between 5 and 42 d following HPV vaccination. Minimum criteria for a signal using this approach are 3 or more cases, PRR≥2, and Χ2≥4. Guillain-Barre syndrome was listed as an adverse event in 45 of 14,822 reports, of which 9 reports followed HPV4 vaccination and 36 reports followed all other vaccines. The overall, age-, and sex-specific PRR estimates were uniformly below 1. In addition, the overall, age-, and sex-specific Χ2 values were uniformly below 3. Our analysis of post-marketing surveillance data does not suggest that Guillain-Barre syndrome is reported more frequently following HPV4 vaccination than other vaccinations among vaccine-eligible females or males in the United States. Our findings may be useful when discussing the risks and benefits of HPV4 vaccination.
上市后监测研究提供了相互矛盾的证据，证明接种四价人乳头瘤病毒（HPV4）疫苗后格林-巴利综合征的发生频率是否更高。我们旨在评估在美国9至26岁的女性和男性中，接种HPV4疫苗后报告格林-巴利综合征的频率是否高于其他疫苗。我们使用了美国疫苗不良事件报告系统（VAERS）在2010年1月1日至2012年12月31日期间收到的不良事件报告，以估计HPV疫苗接种后5至42天内格林-巴利综合征报告的总体、年龄和性别特异性比例报告率（PRR）以及相应的Χ2值。使用这种方法确定信号的最低标准是3例或更多病例、PRR≥2且Χ2≥4。在14822份报告中，有45份将格林-巴利综合征列为不良事件，其中9份报告是在接种HPV4疫苗后出现的，36份报告是在接种所有其他疫苗后出现的。总体、年龄和性别特异性PRR估计值均低于1。此外，总体、年龄和性别特异性Χ2值均低于3。我们对上市后监测数据的分析表明，在美国符合疫苗接种条件的女性或男性中，接种HPV4疫苗后报告格林-巴利综合征的频率并不高于其他疫苗。我们的研究结果在讨论HPV4疫苗接种的风险和益处时可能会有所帮助。
