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目的分析黑龙江省疑似预防接种异常反应(adverse events following immunization,AEFI)的发生特征,评价AEFI监测系统运转情况及国家免疫规划(national immunization program,NIP)疫苗的安全性。方法通过全国AEFI监测系统,收集黑龙江省截至2013年3月31日报告的2012年AEFI个案数据,采用描述性方法进行分析。结果全省2012年AEFI监测系统共收到4 077例个案,其中≤1岁占56.44%,男女之比为1.21∶1,全年在6-7月和10-11月报告个案相对较多。AEFI以NIP疫苗和第1剂接种为主;一般反应占97.30%,其中76.45%发生在接种后≤1d;异常反应占2.26%,以过敏性皮疹、荨麻疹和BCG淋巴结炎为主。估算全省NIP疫苗不良反应报告发生率为49.20/10万剂次。4 065例(99.71%)病例治愈或好转。全省132个县(区)均有AEFI数据报告,48h内报告率为100%,48h内调查率为100%。结论全省AEFI监测的敏感性仍需进一步提高。主动监测较被动监测敏感性更高。AEFI常发生在NIP疫苗、小年龄儿童、第一剂次和接种后2d内。NIP疫苗不良反应报告发生率不高于预期,疫苗安全性和各接种单位预防接种的服务质量良好。
Objective To analyze the occurrence characteristics of suspected AEFI in Heilongjiang Province and evaluate the operation of AEFI monitoring system and the safety of the national immunization program (NIP) vaccine. Methods Through the national AEFI monitoring system, the 2012 AEFI case data reported by Heilongjiang Province as of March 31, 2013 was collected and analyzed by descriptive method. Results A total of 4077 cases were reported in the AEFI monitoring system in 2012 in the province, of which ≤1 years old accounted for 56.44%, the ratio of male to female was 1.21:1. There were relatively more reported cases in June-July and October-November. AEFI was mainly inoculated with NIP vaccine and the first dose. The average reaction rate was 97.30%, of which 76.45% occurred after inoculation ≤1d. The abnormal reaction accounted for 2.26%. Allergic rash, urticaria and BCG lymphadenitis were the most common. Estimates of the province’s NIP vaccine adverse reaction rate was 49.20 / 100,000 doses. 4 065 cases (99.71%) were cured or improved. The province’s 132 counties (districts) have AEFI data reports, reporting rate was 100% within 48h, 48h survey rate was 100%. Conclusion The sensitivity of AEFI monitoring in the province still needs to be further improved. Active monitoring is more sensitive than passive monitoring. AEFI often occurs in the NIP vaccine, young children, the first dose and 2d after inoculation. The incidence of NIP vaccine adverse reactions was not higher than expected, and the vaccine safety and quality of vaccination services at all vaccination units were good.