中国疫苗和免疫

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预防接种安全性。方法通过全国AEFI信息管理系统,收集截至2012年3月13日报告的2010年AEFI个案数据,采用描述性方法进行流行病学分析。结果全国2010年AEFI信息管理系统共收到56001例个案,严重AEFI1368例,非严重AEFI54633例。全国除西藏自治区外,各省(自治区、直辖市,下同)均有AEFI数据报告,共2561个县有数据报告,报告县比例为82.88%。48h内报告率为95.35%,48h内调查率为98.72%。AEFI报告数≤1岁占63.43%;男、女性别比为1.41∶1;集中在第三季度。AEFI分类率为99.72%。主要疫苗的严重AEFI估算报告发生率在0.54/100万剂～31.08/100万剂;非严重AEFI报告发生率在11.45/100万剂～1494.38/100万剂。一般反应以发热、红肿、硬结为主,预防接种异常反应以过敏性皮疹、无菌性脓肿、卡介苗淋巴结炎、过敏性紫癜和血管性水肿为主。不良反应主要集中在接种后≤1d。不同疫苗的预防接种异常反应估算报告发生率为:全身播散性卡介苗感染0.24/100万剂;疫苗相关麻痹型脊髓灰质炎0.21/100万剂;百日咳-白喉-破伤风联合疫苗无菌性脓肿6.55/100万剂;麻疹减毒活疫苗过敏性紫癜0.25/100万剂,血小板减少性紫癜0.03/100万剂;麻疹-流行性腮腺炎-风疹联合减毒活疫苗过敏性紫癜0.84/100万剂;乙型肝炎疫苗过敏性休克0.07/100万。在所有AEFI中,治愈和好转占98.07%,死亡129例,其中预防接种异常反应17例。结论全国AEFI监测的敏感性有较大提高,但各省差异较大;AEFI常发生在小年龄儿童和接种后≤1d;国家免疫规划疫苗不良反应报告发生率均在预期发生范围内。

Objective This study is to analyze the occurrence features of adverse event following immunization (AEFI) in China, and to evaluate the implementation of AEFI surveillance system, and the immunization safety related to the national immunization program (NIP) vaccines. Methods 2010 AEFI data were collected through the national AEFI information system, which reported before March 13, 2012. The descriptive methodology was used in the study. Results 56 001 AEFI cases were reported, of which 1368 cases were serious AEFIs, 54 633 cases were non-serious AEFIs. 2561 counties (82.88%) in all provinces but Tibet autonomous region reported AEFI cases. The reported rate within 48h was 95.35%, and the investigated rate within 48h was 98.72%. Cases≤1 year old accounted for 63.43%, and the sex ratio (male to female) was 1.41:1. The cases often occurred in the third quarter of the year. The classification rate of AEFI was 99.72%. The different vaccines'estimated reported serious AEFI incidence rates were between 0.54 per million doses and 31.08 per million doses, and the estimated non-serious AEFI incidence rates were between 11.45 per million doses and 1494.38 per million doses. The common, minor vaccine reactions were mainly fever, local swelling and induration. The main diagnosis of rare, more serious vaccine reactions were anaphylactic rash, sterile abscess, lymphadenitis of Bacilli Calmette-Guerin vaccine(BCG), henoch-sch?nlein purpura and angioedema. The vaccine reactions often occurred in the vaccine day and 1d after. In all rare, more serious vaccine reactions, the estimated reported rates of main vaccines were as follows: 0.24 per million doses for disseminated BCG infection, 0.21 per million for vaccine-associated paralytic poliomyelitis, 6.55 per million doses for sterile abscess of diphtheria, tetanus pertussis combined vaccine, 0.25 per million doses for henoch-sch?nlein purpura of measles attenuated live vaccine, 0.03 per million doses for therombocytopenic purpura of measles attenuated live vaccine, 0.84 per million doses for henoch-sch?nlein purpura of measles, mumps and rubella combined attenuated live vaccine, and 0.07 per million doses for anaphylactic shock of hepatitis B vaccine. Of all AEFIs, 98.07% were cured or improved. In 129 death cases, 17 were rare, more serious vaccine reactions. Conclusions The sensitivity of national AEFI surveillance was increased greatly but still varied with provinces. AEFIs often occurred in young children, and within 1 day after vaccination. The estimated reporting rate of vaccine reactions of NIP vaccines were expected.