2009-2017 年美国疫苗不良事件报告系统（VAERS）中双价人乳头瘤病毒疫苗的安全性。
Safety of bivalent human papillomavirus vaccine in the US vaccine adverse event reporting system (VAERS), 2009-2017.
机构信息
Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, USA.
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, USA.
出版信息
Br J Clin Pharmacol. 2018 Dec;84(12):2928-2932. doi: 10.1111/bcp.13736. Epub 2018 Sep 21.
AIMS
Human papillomavirus (HPV) vaccines prevent infection with oncogenic virus types. We analysed reports to the US Vaccine Adverse Event Reporting System (VAERS) of adverse events (AE) following bivalent HPV vaccine (2vHPV).
METHODS
We conducted descriptive analysis of 2vHPV reports, reviewed individual reports, calculated crude AE reporting rates and conducted empirical Bayesian data mining.
RESULTS
Of 241 2vHPV reports, 158 were in females, 64 in males (2vHPV is approved for females only) and 19 with unknown sex; 95.8% were classified as nonserious. Dizziness, headache, nausea and injection site reactions were the most common symptoms. Crude AE reporting rates were 33.3 reports per 100 000 doses distributed overall, and 1.4 per 100 000 for serious reports. Empirical Bayesian data mining identified disproportional reporting for three types of medical errors; assessment indicated findings that were probably driven by inadvertent 2vHPV use in males.
CONCLUSIONS
We did not identify any new or unexpected safety concerns in our review of 2vHPV reports to VAERS.
目的
人乳头瘤病毒（HPV）疫苗可预防致癌病毒类型的感染。我们分析了美国疫苗不良事件报告系统（VAERS）中关于二价 HPV 疫苗（2vHPV）不良事件（AE）的报告。
方法
我们对 2vHPV 报告进行了描述性分析，回顾了个别报告，计算了 AE 的粗报告率，并进行了经验贝叶斯数据分析。
结果
在 241 份 2vHPV 报告中，158 份为女性，64 份为男性（2vHPV 仅批准用于女性），19 份为性别不明；95.8%为非严重报告。头晕、头痛、恶心和注射部位反应是最常见的症状。AE 的粗报告率为每 10 万剂分布 33.3 例，严重报告率为每 10 万剂 1.4 例。经验贝叶斯数据分析发现了三种医疗错误的报告比例异常；评估结果表明，这可能是由于男性无意中使用了 2vHPV 引起的。
结论
在对 VAERS 中 2vHPV 报告的审查中，我们没有发现任何新的或意外的安全问题。
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