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目的分析北京市顺义区疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)的发生特征,评价疫苗的安全性和预防接种服务质量。方法通过疑似预防接种异常反应信息管理系统,收集2008～2010年报告的个案数据,采用描述性方法对相关指标进行流行病学分析。结果北京市顺义区2008～2010年共报告AEFI337例,不良反应(一般反应和异常反应)占85.46%,偶合次之,心因反应最少,未出现接种差错和疫苗质量事故。总报告发生率为225/100万剂,一般反应和异常反应的报告发生率分别为162/100和30/100万剂。接种单位的报告覆盖率为96.15%,夏季(6～8月)的发生率较高,发生率为0.035%(χ2=42.66,P﹤0.01)。AEFI≤1岁的占1/2以上,发生的疫苗与剂次中接种百白破疫苗最多,占42.14%,接种第1剂发生最多,占53.71%,接种≤1d发生的占92.58%。临床诊断中以发热、红肿和硬结的一般反应,异常反应中以过敏性皮疹多见。AEFI报告的完整率、及时率均在95%以上。结论疫苗的安全性和预防接种服务质量良好,但尚需要进一步完善AEFI的监测方案和补偿办法,可以在加强AEFI被动监测的同时,在部分地区开展主动监测工作。
Objective To analyze the occurrence of suspected AVE in Shunyi District of Beijing and evaluate the safety of the vaccine and the quality of vaccination services. Methods Through the suspected vaccination anomaly information management system, we collected the case data reported from 2008 to 2010 and used descriptive method to carry out epidemiological analysis on related indicators. Results A total of 337 AEFI cases were reported in Shunyi District of Beijing from 2008 to 2010. The adverse reaction (general reaction and abnormal reaction) accounted for 85.46%. Coupling was the second, with the least cause of cardiac reaction. No vaccination errors and vaccine quality accidents occurred. The total reported incidence was 225/100 million doses and the reported rates of general and abnormal responses were 162/100 and 30/100 respectively. Inoculation units reported coverage of 96.15%, summer (June to August) a higher incidence, the incidence was 0.035% (χ2 = 42.66, P <0.01). AEFI ≤ 1 year old accounted for more than 1/2, the incidence of vaccine and dose vaccination Baipai the most, accounting for 42.14%, the first dose of inoculation occurred most, accounting for 53.71%, vaccination ≤ 1d accounted for 92.58%. Clinical diagnosis of fever, redness and induration of the general response to anaphylactic reactions in the more common allergic rash. AEFI report the complete rate, timely rate of more than 95%. Conclusions The safety and vaccination services of vaccines are good. However, the monitoring programs and compensation measures of AEFI are still needed to be improved. Active monitoring can be carried out in some areas while strengthening passive monitoring of AEFI.