Geier David A, Geier Mark R
Institute of Chronic Illnesses, Inc, 14 Redgate Ct, Silver Spring, MD, 20905, USA.
Immunol Res. 2017 Feb;65(1):46-54. doi: 10.1007/s12026-016-8815-9.
Gardasil is a quadrivalent human papillomavirus (HPV4) vaccine that was approved for use by the US Food and Drug Administration in June 2006. HPV4 vaccine is routinely recommended for administration to women in the USA who are 11-12 years old by the Advisory Committee on Immunization Practices. Previous studies suggest HPV4 vaccine administration was associated with autoimmune diseases. As a consequence, an epidemiological assessment of the vaccine adverse event reporting system database was undertaken for adverse event reports associated with vaccines administered from 2006 to 2014 to 6-39 year-old recipients with a listed US residence and a specified female gender. Cases with the serious autoimmune adverse event (SAAE) outcomes of gastroenteritis (odds ratio (OR) 4.627, 95 % confidence interval (CI) 1.892-12.389), rheumatoid arthritis (OR 5.629, 95 % CI 2.809-12.039), thrombocytopenia (OR 2.178, 95 % CI 1.222-3.885), systemic lupus erythematosus (OR 7.626, 95 % CI 3.385-19.366), vasculitis (OR 3.420, 95 % CI 1.211-10.408), alopecia (OR 8.894, 95 % CI 6.255-12.914), CNS demyelinating conditions (OR 1.585, 95 % CI 1.129-2.213), ovarian damage (OR 14.961, 95 % CI 6.728-39.199), or irritable bowel syndrome (OR 10.021, 95 % CI 3.725-33.749) were significantly more likely than controls to have received HPV4 vaccine (median onset of initial symptoms ranged from 3 to 37 days post-HPV4 vaccination). Cases with the outcome of Guillain-Barre syndrome (OR 0.839, 95 % CI 0.601-1.145) were no more likely than controls to have received HPV4 vaccine. In addition, cases with the known HPV4-related outcome of syncope were significantly more likely than controls to have received HPV4 vaccine (OR 5.342, 95 % CI 4.942-5.777). Cases with the general health outcomes of infection (OR 0.765, 95 % CI 0.428-1.312), conjunctivitis (OR 1.010, 95 % CI 0.480-2.016), diarrhea (OR 0.927, 95 % CI 0.809-1.059), or pneumonia (OR 0.785, 95 % CI 0.481-1.246) were no more likely than controls to have received HPV4 vaccine. Confirmatory epidemiological studies in other databases should be undertaken and long-term clinical consequences of HPV-linked SAAEs should be examined.
加德西是一种四价人乳头瘤病毒（HPV4）疫苗，于2006年6月获美国食品药品监督管理局批准使用。免疫实践咨询委员会常规建议，美国11至12岁的女性接种HPV4疫苗。此前的研究表明，接种HPV4疫苗与自身免疫性疾病有关。因此，对疫苗不良事件报告系统数据库进行了一项流行病学评估，以分析2006年至2014年期间向居住在美国且性别明确为女性的6至39岁疫苗接种者报告的不良事件。出现严重自身免疫不良事件（SAAE）结果的病例，如肠胃炎（优势比（OR）4.627，95%置信区间（CI）1.892 - 12.389）、类风湿性关节炎（OR 5.629，95% CI 2.809 - 12.039）、血小板减少症（OR 2.178，95% CI 1.222 - 3.885）、系统性红斑狼疮（OR 7.626，95% CI 3.385 - 19.366）、血管炎（OR 3.420，95% CI 1.211 - 10.408）、脱发（OR 8.894，95% CI 6.255 - 12.914）、中枢神经系统脱髓鞘疾病（OR 1.585，95% CI 1.129 - 2.213）、卵巢损伤（OR 14.961，95% CI 6.728 - 39.199）或肠易激综合征（OR 10.021，95% CI 3.725 - 33.749），比对照组更有可能接种了HPV4疫苗（初始症状的中位发病时间在接种HPV4疫苗后3至37天之间）。出现吉兰 - 巴雷综合征结果的病例（OR 0.839，95% CI 0.601 - 1.145）与对照组相比，接种HPV4疫苗的可能性并无差异。此外，出现已知与HPV4相关的晕厥结果的病例比对照组更有可能接种了HPV4疫苗（OR 5.342，95% CI 4.942 - 5.777）。出现感染（OR 0.765，95% CI 0.428 - 1.312）、结膜炎（OR 1.010，95% CI 0.480 - 2.016）、腹泻（OR 0.927，95% CI 0.809 - 1.059）或肺炎（OR 0.785，95% CI 0.481 - 1.246）等一般健康结果的病例与对照组相比接种HPV4疫苗的可能性并无差异。应在其他数据库中开展验证性流行病学研究，并研究与HPV相关的SAAEs的长期临床后果。
