人乳头状瘤病毒疫苗上市后不良反应监测概况

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (7): 439-442.

• 安全性评价与合理用药 • 上一篇下一篇

人乳头状瘤病毒疫苗上市后不良反应监测概况

王亚丽

国家食品药品监督管理总局药品评价中心,北京100045

收稿日期:2017-08-16 修回日期:2017-08-16 出版日期:2017-07-20 发布日期:2017-08-16
作者简介:王亚丽,女,博士,副主任药师,药品不良反应监测与评价。

The Post-Marketing Surveillance of Human Papilloma Virus Vaccine

WANG Ya-li

Center for drug reevaluation, CFDA, Beijing 100045, China

Received:2017-08-16 Revised:2017-08-16 Online:2017-07-20 Published:2017-08-16

摘要/Abstract

摘要： 目的为我国人乳头瘤病毒疫苗上市后的安全性监测提供参考。方法总结了其他国家人乳头瘤病毒疫苗上市后安全监测情况,特别是被动监测系统的监测状况,以及当前关注的安全性热点。结果与结论人乳头瘤病毒疫苗是预防宫颈癌的主要方法之一,国际上多个国家已将人乳头瘤病毒疫苗纳入国家免疫规划中。目前的监测数据提示,接种人乳头瘤病毒疫苗后常见的不良反应是轻微的、不严重的,但与自身免疫性疾病、早期卵巢功能不良等疾病的因果关联性尚有待进一步证实。

关键词: 人乳头瘤病毒疫苗, 上市后安全性监测, 自身免疫性疾病, 早期卵巢功能不良

Abstract: Objective To provide information for the post-marketing surveillance ofhuman papilloma virus (HPV) vaccine in China. Methods The data of HPV vaccine of post-market surveillance from other countries, especially of passive surveillance system, and the hotspots of safety issues were summarized in the paper. Results and Conclusion HPV vaccine is one of the most import methods to againstcervical cancer and has been introduced in the national immunization programme of many countries. Based on the surveillance data, the most common adverse events following vaccination are slight and unserious. However the causality association between HPV vaccine and autoimmune diseases and primary ovarian failure should be evaluated based on more studies.

Key words: human papilloma virus vaccine, post-marketing surveillance, autoimmune diseases, primary ovarian failure

中图分类号:

R994.11

王亚丽. 人乳头状瘤病毒疫苗上市后不良反应监测概况[J]. 中国药物警戒, 2017, 14(7): 439-442.

WANG Ya-li. The Post-Marketing Surveillance of Human Papilloma Virus Vaccine[J]. Chinese Journal of Pharmacovigilance, 2017, 14(7): 439-442.

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人乳头状瘤病毒疫苗上市后不良反应监测概况

The Post-Marketing Surveillance of Human Papilloma Virus Vaccine

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