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【文献翻译】九价HPV疫苗的安全性

背景

1

九价HPV疫苗(9vHPV)于2014年被批准应用于9岁至26岁的女性和男性。本研究分析了批准上市后疫苗不良事件报告系统(Vaccine Adverse Event Reporting System, VAERS)中的监测报告。

The 9-valent human papillomavirus vaccine (9vHPV) was approved for females and males aged 9 to 26 years in 2014. We analyzed postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS).

方法

2

本研究旨在探讨术前辅助放疗或放化疗联合根治性手术对宫颈癌患者病理结果的影响。

To investigate the effect of preoperative radiotherapy or chemoradiotherapy combined with radical surgery on pathological outcomes in cervical cancer patients.

在VAERS数据中,我们搜索了美国九价HPV疫苗从2014年12月到2017年12月间的不良事件报告(adverse events, AEs)。通过计算报告率,并进行经验性的贝叶斯数据挖掘,以找出不对称的报告。医生对预先设定条件下的报告进行了回顾。

We searched VAERS data for US reports of adverse events (AEs) after 9vHPV from December 2014 through December 2017. We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reporting. Physicians reviewed reports for selected prespecified conditions.

结果

3

在九价HPV疫苗接种之后,VAERS收到7244份报告:其中女性31.2%,男性21.6%,47.2%未报告性别。总体而言,97.4%为非严重不良反应。头晕、晕厥、头痛和注射部位反应最为常见;最常见的不良事件报告在女性和男性之间的比例是相似的。对两份接种 九价HPV疫苗后死亡的报告进行了核实,尸检报告或死亡证明中没有任何信息表明死亡与疫苗接种有因果关系。本研究进行期间,共有约2800万份九价HPV疫苗投入使用,不良反应粗报告率为每百万次HPV剂量约259份,严重不良反应的报告率为7/10万。晕厥(一种已知的与人类乳头瘤病毒疫苗接种相关的不良反应)和几种疫苗接种错误(例如,在错误的年龄使用)超过了经验贝叶斯数据挖掘结果的统计阈值。

VAERS received 7244 reports after 9vHPV: 31.2% among females, 21.6% among males, and for 47.2%, sex was not reported. Overall, 97.4% of reports were nonserious. Dizziness, syncope, headache, and injection site reactions were most commonly reported; the most commonly reported AEs were similar between females and males. Two reports of death after 9vHPV were verified; no information in autopsy reports or death certificates suggested a causal relationship with vaccination. Approximately 28 million 9vHPV doses were distributed during the study period; crude AE reporting rates were 259 reports per million 9vHPV doses distributed for all reports and 7 per million doses distributed for serious reports. Syncope (a known AE associated with human papillomavirus vaccination) and several types of vaccine administration errors (eg, administered at wrong age) exceeded the statistical threshold for empirical Bayesian data mining findings.

结论

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目前尚未发现有临床意义的九价HPV疫苗新的或未曾预见的安全隐患或报告。九 价HPV疫苗的安全性与其上市前的数据及和四价HPV疫苗上市后的安全数据是一致的。

No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected. The safety profile of 9vHPV is consistent with data from prelicensure trials and from postmarketing safety data of its predecessor, the quadrivalent human papillomavirus vaccine.

参考文献

Shimabukuro T T, Su J R, Marquez P L, et al. Safety of the 9-valent human papillomavirus vaccine[J]. Pediatrics, 2019.

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本文系“守护女性宫颈健康”原创

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撰稿及编辑| 刘硕子

责任编辑 | 江星元

审稿 | 樊碧娆 江路

审核 | 陶霞

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