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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年含麻疹成分疫苗(MeaslesContained Vaccine,MCV)强化免疫活动(Supplementary Immunization Activity,SIA)的疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)的发生特征,评价AEFI信息管理系统运转情况及MCVSIA的预防接种安全性。方法通过AEFI信息管理系统,收集全国截至2012年3月13日报告的2010年MCVSIA发生的AEFI个案数据,采用描述性方法进行流行病学分析。结果全国AEFI信息管理系统共收到2010年MCVSIA15330例AEFI个案,报告发生率为148.21/100万剂;其中男性165.02/100万剂,女性130.41/100万剂;主要发生在≤1岁儿童,报告发生率为473.78/100万剂。不良反应的报告发生率为139.74/100万剂,其中一般反应报告发生率为113.70/100万剂,预防接种异常反应报告发生率为26.05/100万剂。预防接种异常反应的主要临床损害为过敏反应(25.12/100万剂)和神经系统反应(0.90/100万剂)。不良反应主要集中在接种后≤1d。报告13例死亡病例,均为偶合症。仅1例预防接种异常反应留有轻微后遗症。结论 2010年MCVSIA中未发现疫苗存在安全性问题,不良反应以一过性一般反应为主,预防接种异常反应以过敏反应为主,严重预防接种异常反应的报告发生率在预期范围内。
Objective To analyze the suspected immunization abnormalities in 2010 with Measles Vaccinated Vaccine (MCV) Supplementary Immunization Activity (SIA) across the country (excluding Hong Kong, Macau Special Administrative Region and Taiwan) (Adverse Events Following Immunization, AEFI), evaluate the operation of AEFI information management system and the vaccination safety of MCVSIA. METHODS AEFI information management system was used to collect data on AEFI cases in 2010 in MCVSIA across the country as of March 13, 2012, and a descriptive method was used for epidemiological analysis. Results The national AEFI information management system received a total of 153 330 AEFI cases from MCVSIA in 2010, with a reported incidence of 148.21 / 1 million doses, including 165.02 / 1 million males and 130.41 / 100 million females for males, mainly occurring in children ≤ 1 year old. The report The incidence was 473.78 / 1 million doses. The incidence of adverse reactions was 139.74 / 1 million doses, of which 113.70 / 1 million were general reaction reports and 26.05 / 1 million were vaccination anomalous reports. The main clinical impairments in the abnormal response to vaccination were allergic reactions (25.12 / 1 million doses) and nervous system responses (0.90 / 1 million doses). Adverse reactions mainly concentrated after inoculation ≤ 1d. Thirteen deaths were reported, both of which were incidental. Only 1 case of vaccination abnormalities left with slight sequelae. Conclusions There was no safety problem in MCVSIA in 2010, the adverse reaction was mainly one-pass general reaction, the abnormal reaction of vaccination was mainly allergic reaction, and the incidence of severe vaccination abnormal reaction was within the expected range.