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目的:分析全国(未包括香港、澳门特别行政区和台湾地区,下同)2010~2012年脑膜炎球菌疫苗(meningococcal vaccine,MenV)预防接种异常反应的发生特征,评价MenV上市后预防接种安全性。方法:通过全国疑似预防接种异常反应信息管理系统,收集截至2010~2012年接种MenV发生的不良反应个案数据,采用描述流行病学方法进行分析。结果:2010~2012年中国共报告MenV接种后发生预防接种不良反应27046例,其中异常反应1724例,占6.38%;一般反应25322例,占93.62%。根据2010~2012年中国免疫规划信息管理系统中接种监测数据估算,4种MenV疫苗的一般反应报告发生率在7.84~54.37/10万;异常反应报告发生率在0.62~1.93/10万。不良反应以首剂为主。常见的异常反应为过敏性皮疹、血管性水肿等过敏反应。结论:中国MenV上市后不良反应发生率均较低,在可接受的预期范围内。
OBJECTIVE: To analyze the incidence of vaccination abnormalities in meningococcal vaccine (MenV) across the country (excluding Hong Kong, Macao Special Administrative Region and Taiwan, the same below) from 2010 to 2012 and to evaluate the safety of MenV vaccination. Methods: Through the national information system of suspected anaphylaxis vaccination, the data of adverse reactions in MenV vaccinated as of 2010 ~ 2012 were collected and analyzed by descriptive epidemiological method. Results: From 2010 to 2012, 27046 cases of adverse effects of vaccination against MenV were reported in China. Among them, 1724 cases were abnormal reactions, accounting for 6.38%; 25322 cases were common reactions, accounting for 93.62%. According to the surveillance data of immunization program information management system in China from 2010 to 2012, the average incidence of four MenV vaccines was 7.84-54.37 / 100 000; the incidence of abnormal reaction was 0.62-1.93 / 100 000. Adverse reactions to the first dose based. Common abnormal reaction allergic rash, angioedema and other allergic reactions. Conclusions: The incidence of adverse reactions after MenV was listed in China was low, within acceptable range.