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2017—2018年上海市浦东新区肠道病毒71型灭活疫苗安全性监测分析 被引量:2

Analysis on surveillance of safety for inactivated enterovirus 71 vaccine in Pudong New Area of Shanghai from 2017-2018
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摘要 目的分析2017-2018年上海市浦东新区肠道病毒71型(EV71)灭活疫苗疑似预防接种异常反应(AEFI)的发生特征,评价EV71疫苗预防接种安全性。方法通过中国AEFI信息管理系统收集2017-2018年上海市浦东新区EV71疫苗AEFI个案数据进行分析。结果两类EV71疫苗一般反应和偶合症报告发生率差异均无统计学意义(均P>0.05)。两类EV71疫苗AEFI性别构成差异无统计学意义(χ^2=2.20,P>0.05)。EV71疫苗(vero细胞)AEFI年龄以1~2岁为主(50.00%),EV71疫苗(人二倍体细胞)以>2岁为主(占38.30%)。两类EV71疫苗接种后AEFI年龄分布差异有统计学意义(χ^2=7.20,P<0.05)。两类EV71疫苗AEFI第1剂次高于第2剂次,两类EV71疫苗不同剂次AEFI的构成比较,差异无统计学意义(χ^2=0.03,P>0.05)。接种两种EV71疫苗后的一般反应中发热、局部红肿和局部硬结症状分布差异无统计学意义(χ^2=1.67、0.01和0.40,均P>0.05),接种两种EV71疫苗后的其他症状分布差异无统计学意义(χ^2=0.85,P>0.05)。两类EV71疫苗AEFI报告主要为接种后2天以内,两种EV71疫苗AEFI的发生不同时间间隔分布差异无统计学意义(χ^2=0.41,P>0.05)。AEFI转归均为痊愈或好转。结论两类EV71疫苗均具有良好的安全性,建议加强接种第1剂及每剂次接种后1天内做好不良反应监测与处置。 Objective To analyze the characteristics of adverse events following immunization(AEFI)on inactivated enterovirus 71(EV71)vaccine in Pudong New Area of Shanghai from 2017-2018,and evaluate the immunization safety of EV71 vaccine.Methods The data on AEFI cases with EV71 vaccine in Pudong New Area of Shanghai from 2017-2018 were collected through the China AEFI information system and analyzed.Results There were no statistically significant differences in the incidence rates of general reactions and coupling disease between two types of EV71 vaccines(all P>0.05).There was no statistically significant difference in gender composition of AEFI cases between two types of EV71vaccines(χ^2=2.20,P>0.05).The AEFI cases with EV71 vaccine(vero cell)was mainly reported among children aged 1-2 years old(50.00%),while AEFI cases with EV71 vaccine(human diploid)was reported highly among children in>2 year-old age group.The difference in age distribution of AEFI cases were statistically significant between two types of EV71 vaccines(χ^2=7.20,P<0.05).In both EV71 vaccines,the incidence of AEFI at the first dose was higher than that at the second dose.The Comparison of disease distribution of AEFI at different dose was not statistically significant between two types of EV71vaccines(χ^2=0.03,P>0.05).There were no statistically significant differences in the symptom distribution of fever,local swelling and local induration between two types of EV71vaccines(χ^2=1.67,0.01,0.40,a ll P>0.05),and the difference in the distribution of other symptoms was not statistically significant between two types of EV71vaccines(χ^2=0.85,P>0.05).Most of AEFI cases appeared within two day after immunization in both EV71 vaccines.The difference in distribution of AEFI cases in different time interval after vaccination was not statistically significant(χ^2=0.41,P>0.05).All AEFI cases were recovered or improved.Conclusion Both EV71 vaccines show good safety.It recommended that monitoring and disposal of AEFI should be strengthened in the first dose and the first day after each dose vaccination.
作者 周翠萍 杨来宝 邓鹏飞 王卫平 杨天 费怡 ZHOU Cui-ping;YANG Lai-bao;DENG Peng-fei;WANG Wei-ping;YANG Tian;FEI Yi(Department of Immunology,Pudong New Area Center for Disease Control and Prevention,Shanghai,200136,China)
出处 《职业与健康》 CAS 2019年第24期3374-3377,3381,共5页 Occupation and Health
基金 国家科技重大专项(20182X10713-001-008)
关键词 肠道病毒71型灭活疫苗 疑似预防接种异常反应 安全性 Inactivated enterovirus 71 vaccine Adverse events following immunization Safety
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