我国疫苗上市后主动监测模式的探讨

中国药物警戒 ›› 2016, Vol. 13 ›› Issue (11): 673-675.

我国疫苗上市后主动监测模式的探讨

张倩婷¹, 王亚丽², 曲毅^{3*, *}

1.贵州省药品评价中心,贵州贵阳 550004;
2.国家食品药品监督管理总局药品评价中心,北京 100045;
3.*
吉林省食品药品安全监测中心,吉林长春,130062

收稿日期:2016-12-05 修回日期:2016-12-05 出版日期:2016-11-20 发布日期:2016-12-05
作者简介:张倩婷,女,本科,药师,药物滥用监测与评价。

Discussion on Vaccine Active Surveillance in China

ZHANG Qian-ting¹, WANG Ya-li², QU Yi^{3, *}

1.Guizhou Province Center for Drug Reevaluation, Guizhou Guiyang 550004,China;
2.Center for Drug Reevaluation, CFDA, Beijing 100045,China;
3.Jilin Safety Monitoring Center for Food and Drug, Jilin Changchun 130062,China

Received:2016-12-05 Revised:2016-12-05 Online:2016-11-20 Published:2016-12-05
Contact: 曲毅,女,博士,主管药师,药物滥用和药械安全性监测。E-mail：18043008190@163.com

摘要/Abstract

摘要： 目的为进一步完善我国疫苗上市后不良反应监测模式提供思路和参考。方法通过介绍国外疫苗上市后主动监测模式,结合国内现状,找出我国疫苗上市后监测的差距。结果主动监测是疫苗上市后安全性监测的重要组成部分,通过主动监测不仅可以确认被动监测中产生的可疑信号,而且可以通过应用适当的流行病学方法来完成信号的假设检验。结论我国疫苗上市后主动监测尚处于起步阶段,应当结合我国国情,借鉴国际先进经验,利用现有的数据平台和信息化手段,与科研机构形成长期的合作伙伴关系,完善我国疫苗警戒体系。

关键词: 疫苗, 被动监测, 主动监测

Abstract: Objective To provide thoughts and references for improving vaccine post-marketing surveillance in China. Methods Through introducing the experiences of other countries and analyzing the situation in China, to find the gap between China and advanced countries in vaccine post-marketing surveillance. Results Active surveillance is one of the import methods of post-marketing safety monitoring of vaccine. Using active surveillance, it is not only to ascertain the potential signals detected from passive surveillance data, but also to verify the safety hypothesis by combining proper epidemiological study. Conclusion Vaccine active surveillance in China is still in its infancy. Vaccine pharmacovigilance system should be strengthened according to our own situation by using international advanced experience, utilizing existing data platform and information technique, and establishing long-term cooperation partnership with research institutions.

Key words: vaccine, passive surveillance, active surveillance

中图分类号:

张倩婷, 王亚丽, 曲毅. 我国疫苗上市后主动监测模式的探讨[J]. 中国药物警戒, 2016, 13(11): 673-675.

ZHANG Qian-ting, WANG Ya-li, QU Yi. Discussion on Vaccine Active Surveillance in China[J]. Chinese Journal of Pharmacovigilance, 2016, 13(11): 673-675.

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