河北省三种脊髓灰质炎疫苗安全性监测分析

doi:10.3969/j.issn.1006-3110.2020.11.005

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摘要目的比较河北省二价脊髓灰质炎(脊灰)减毒活疫苗(bivalent oral polio attenuated live vaccine, bOPV)、脊灰灭活疫苗(Salk株)(inactivvated poliomyelitis vaccine made from Salk strains, IPV-Salk)和脊灰灭活疫苗(Sabin株)(inactivated poliomyelitis vaccine made from Sabin strains , IPV-Sabin )接种后疑似预防接种异常反应(adverse events following immunization,AEFI)的发生特征,评价脊灰疫苗的安全性。方法通过疑似AEFI信息管理系统收集河北省2016年5月1日—2018年4月30日脊灰疫苗接种后AEFI个案,比较分析三种脊灰疫苗接种后AEFI的报告发生情况。结果 bOPV、IPV-Salk和IPV-Sabin的AEFI报告发生率分别为13.53 / 10万剂、40.50/10万剂和63.70 / 10万剂。bOPV与IPV-Salk、bOPV与IPV-Sabin、IPV-Salk与IPV-Sabin的AEFI报告发生率(χ²= 360.355, P＜0.001,χ²= 360.247, P＜0.001, χ²= 34.895, P＜0.001)和一般反应报告发生率(χ²= 373.009, P＜0.001, χ²= 564.795, P＜0.001, χ²= 35.382,P＜0.001)差异均有统计学意义,由高到低依次为:IPV-Sabin、IPV-Salk和bOPV;异常反应报告发生率(χ²= 3.077,P=0.079, χ²_C= 1.165,P=0.281, χ²_C= 0,P=1)差异均无统计学意义。三种脊灰疫苗的AEFI中均以一般反应为主,年龄主要集中在≤1岁组,主要发生在接种后1 d内。结论河北省三种脊灰疫苗总体安全性良好,但仍需加强脊灰疫苗安全性监测。

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	孙丽
	许晓萌
	王晶辉
	丛艳丽
	王亚菲
	王易寒
	李静
	张振国

关键词 ：疑似预防接种异常反应, 脊髓灰质炎减毒活疫苗, 脊髓灰质炎灭活疫苗

Abstract：Objective To compare occurrence features of suspected adverse events following immunization (AEFI) of bivalent oral polio attenuated live vaccine (bOPV), inactivated poliomyelitis vaccine made from Salk strains (IPV-Salk) andinactivated poliomyelitis vaccine made from Sabin strains (IPV-Sabin) in Hebei province, and to evaluate the safety of poliomyelitis vaccines.Methods We collected reported AEFI cases related to vaccination of poliomyelitis vaccines in Hebei province from May 1, 2016 to April 30, 2018 through suspected AEFI information management system, and then compared and analyzed the incidence of reported AEFI cases related to vaccination of the three types of poliomyelitis vaccines. Results The incidence rates of AEFI of bOPV, IPV-Salk and IPV-Sabin were 13.53/100,000 doses, 40.50/100,000 doses, and 63.70/100,000 doses, respectively. Statistically significant differences in the incidence rates of AEFI (χ²=360.355, P<0.001; χ²=360.247, P<0.001; χ²=34.895, P<0.001) and common adverse reaction reported (χ²=373.009, P<0.001; χ²=564.795, P<0.001; χ²=35.382, P<0.001) were seen between bOPV and IPV-Salk,betweenbOPV and IPV-Sabin, and between IPV-Salk and IPV-Sabin. The order from high to low was IPV-Sabin, IPV-Salk and bOPV. No statistically significant differences were found in the incidence rates of reported rare adverse reaction between bOPV and IPV-Salk (χ²=3.077, P=0.079), bOPV and IPV-Sabin (χ²_c= 1.165, P=0.281), and IPV-Salk and IPV-Sabin (χ²_c=0, P=1). Most of the reported AEFI cases caused by the three types of poliomyelitis vaccines were common adverse reactions, were children aged ≤1 year, and occurred within 1 day after vaccination. Conclusions The three types of poliomyelitis vaccines in Hebei province are safe, but the work of monitoring safety of poliomyelitis vaccines still needs to be strengthened.

Key words： adverse events following immunization poliomyelitis attenuated live vaccine inactivated poliomyelitis vaccine

收稿日期: 2020-01-06

R186

基金资助:河北省2020年度医学科学研究课题(20200693)

通讯作者: 张振国,E-mail:hbepi@hotmail.com。

作者简介: 孙丽(1981-),女,硕士,副主任医师,研究方向:疑似预防接种异常反应监测与处置。许晓萌为本文共同第一作者。

引用本文:

孙丽, 许晓萌, 王晶辉, 丛艳丽, 王亚菲, 王易寒, 李静, 张振国. 河北省三种脊髓灰质炎疫苗安全性监测分析[J]. 实用预防医学, 2020, 27(11): 1299-1303. SUN Li, XU Xiao-meng, WANG Jing-hui, CONG Yan-li, WANG Ya-fei, WANG Yi-han, LI Jing, ZHANG Zhen-guo. Monitoring on safety of three types of poliomyelitis vaccines in Hebei province. , 2020, 27(11): 1299-1303.

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[1] World Health Organization. Polio eradication and endgame strategic plan, 2013-2018 [R]. Geneva: WHO, 2013:1-3.
[2] 国家卫生和计划生育委员会. 国家卫生计生委关于停用三价脊髓灰质炎减毒活疫苗的通知[EB/OL].(2016-04-29)[2019-12-16]. https://www.bbcyw.com/p-8481204.html.
[3] 中华人民共和国卫生部办公厅, 国家食品药品监督管理局办公室. 全国疑似预防接种异常反应监测方案[J]. 中国疫苗和免疫, 2011, 17(1):72-82.
[4] 熊玮仪, 董铎. 消灭脊灰后期的免疫策略及脊灰疫苗不同免疫程序的安全性比较[J]. 中国药物警戒, 2017, 14(2):90-94.
[5] 罗会明, 余文周, 温宁, 等. 中国脊髓灰质炎疫苗使用历史回顾及免疫策略调整建议[J]. 中国疫苗和免疫, 2014, 20(2):172-176.
[6] 孙丽, 丛艳丽, 王晶辉, 等. 二价脊灰疫苗疑似预防接种异常反应监测分析[J]. 中国公共卫生, 2018, 34(6):877-881.
[7] Nzolo D, Aloni MN, Ngamasata TM, et al. Adverse events following immunization with oral poliovirus in Kinshasa, Democratic Republic of Congo: preliminary results[J]. Pathog Glob Health, 2013, 107(7):381-384.
[8] Westphal DW, Williams SA, Leeb A, et al. Continuous active surveillance of adverse events following immunization using SMS technology[J]. Vaccine, 2016, 34(29):3350-3355.
[9] 付思美, 林琳, 曹凤瑞, 等. 吉林省4种脊髓灰质炎疫苗预防接种安全性比较分析[J]. 中国疫苗和免疫, 2017, 23(4):379-382.
[10] 王四全, 张迟, 王雷, 等. 2015—2017年湖北省脊髓灰质炎疫苗疑似预防接种异常反应监测分析[J]. 中国公共卫生, 2018, 34(5):736-740.
[11] 石晓娟, 周路平, 周莉薇, 等. 国产Sabin株脊髓灰质炎灭活疫苗接种后的安全性调查[J]. 中国疫苗和免疫, 2017, 23(4):383-386.
[12] 史鲁斌, 姬艳芳, 杨建辉, 等. 2011—2016年河南省无细胞百白破联合疫苗预防接种不良反应监测分析[J]. 实用预防医学, 2018, 25(2):180-184.
[13] 孙丽, 张富斌, 王丽娜, 等. 河北省脊髓灰质炎疫苗疑似预防接种异常反应监测分析[J]. 中国疫苗和免疫, 2017, 23(5):498-502.
[14] 孙丽, 丛艳丽, 张俊棉, 等. 河北省两种脊髓灰质炎减毒活疫苗异常反应安全性分析[J]. 医学动物防制, 2018, 34(2):103-107.
[15] 孙丽, 陈玫, 赵娜, 等. 河北省二价脊髓灰质炎减毒活疫苗预防接种安全性监测分析[J]. 中国疫苗和免疫, 2018, 24(4):475-478.
[16] 叶家楷, 李克莉, 许涤沙, 等. 中国2014年疑似预防接种异常反应信息管理系统监测数据分析[J]. 中国疫苗和免疫, 2016, 22(2):125-137.
[17] 李静, 丛艳丽, 张俊棉, 等. 河北省2011—2015年15岁以下儿童检出脊髓灰质炎病毒的麻痹型病例监测分析[J], 实用预防医学, 2017, 24(11):1371-1373.