中国2011～2013年灭活脊髓灰质炎病毒疫苗疑似预防接种异常反应监测分析

发布时间：2018-01-20 00:42

本文关键词： 灭活脊髓灰质炎病毒疫苗疑似预防接种异常反应监测　出处：《中国疫苗和免疫》2015年02期 　论文类型：期刊论文

【摘要】：目的分析中国(未包括香港、澳门特别行政区和台湾地区,下同)2011~2013年灭活脊髓灰质炎(脊灰)病毒疫苗(Inactivated Poliovirus Vaccine,IPV)疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)的发生特征,初步评价上市后IPV预防接种的安全性。方法通过中国食品药品检定研究院网站收集2011~2013年IPV批签发数据,通过中国AEFI信息管理系统收集2011~2013年接种IPV后AEFI个案数据,采用描述性方法对相关指标进行流行病学分析,计算构成比和AEFI估算报告发生率。结果中国2011~2013年共报告接种IPV(其中42.49%同时接种了其他疫苗)后AEFI 1923例,估算报告发生率为156.25/100万,其中不良反应1866例,估算报告发生率为151.62/100万。不良反应中,一般反应1642例,估算报告发生率为133.42/100万;异常反应224例,估算报告发生率为18.20/100万。报告最多的异常反应为过敏性皮疹,共191例,估算报告发生率为15.52/100万;其次为血小板减少性紫癜13例,估算报告发生率为1.06/100万;其他异常反应估算报告发生率均1/100万。结论IPV不良反应未出现明显的异常信号,严重异常反应无批号聚集性,预防接种安全性在可接受范围内。应加强培训和督导,提高AEFI监测敏感性,增强AEFI调查和因果关联评估能力,提高AEFI分类准确性。
[Abstract]:Objective to analyze the Chinese (not including Hongkong, the Macao Special Administrative Region and Taiwan region, the same below) 2011~2013 inactivated poliomyelitis (polio) virus vaccine (Inactivated Poliovirus, Vaccine, IPV) suspected abnormal reaction to vaccination (Adverse Events Following Immunization, AEFI) the occurrence characteristics, preliminary safety evaluation of IPV vaccination after the listing. Methods through the website Chinese Academy of food and drug test collection 2011~2013 IPV batch release data, through Chinese system AEFI management information collection of 2011~2013 data after inoculation of IPV AEFI case, using descriptive method to analyze the epidemiology related indicators, calculation of incidence ratio and AEFI estimation report. The results Chinese were reported during 2011~2013 were inoculated with IPV (including 42.49% at the same time with other vaccines) after AEFI in 1923 cases, the report estimated the incidence rate was 156.25/100 million, of which 1866 cases of adverse reactions. Is the report incidence rate was 151.62/100 million. The adverse reaction in 1642 cases, the general response estimates reported incidence rate of 133.42/100 million; 224 cases of abnormal reaction, estimate the report incidence rate was 18.20/100 million. Most of the reported abnormal reaction of allergic rash, a total of 191 cases, the report estimated the incidence rate was 15.52/100 million; thrombocytopenia purpura in 13 cases, the report estimated the incidence rate was 1.06/100 million; other estimates reported incidence of abnormal reaction of 1/100 million. Conclusion IPV adverse reactions did not appear obvious abnormal signal, serious abnormal reaction no batch aggregation, the safety of vaccination in the acceptable range. We should strengthen training and supervision, improve the sensitivity of AEFI surveillance. Enhanced AEFI investigation and causality assessment capabilities, improve the AEFI classification accuracy.

【作者单位】：中国疾病预防控制中心免疫规划中心;
【分类号】：R186
【正文快照】： 灭活脊髓灰质炎(脊灰)病毒疫苗(InactivatedPolioirus Vaccine,IPV)自1955年开始用于脊灰的预防,目前所有IPV的抗原性都显著高于20世纪50年代的产品[1]。按照世界卫生组织(World HealthOrganization,WHO)关于脊灰疫苗的立场文件[1],为最终消除疫苗相关麻痹型脊灰(Vaccine-asso

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