论文部分内容阅读
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 To analyze the incidence of suspected AEFI in 2010 in the whole country (excluding Hong Kong, Macao Special Administrative Region and Taiwan, the same below), evaluate the operation of AEFI information management system and vaccination safety. Methods The 2010 AEFI case data reported as of March 13, 2012 were collected through a national AEFI information management system using a descriptive approach to epidemiological analysis. Results A total of 56001 cases were received in the AEFI information management system in 2010, with 1368 cases of AEFI and 54633 cases of non-severe AEFI. In addition to the Tibet Autonomous Region nationwide, all provinces (autonomous regions and municipalities directly under the Central Government, the same below) have AEFI data reports, a total of 2561 counties have data reports, reporting 82.88% of the county. The report rate was 95.35% in 48h and 98.72% in 48h. AEFI reported ≤1 years old accounted for 63.43%; male and female ratio was 1.41:1; concentrated in the third quarter. AEFI classification rate of 99.72%. The incidence of severe AEFI estimates for major vaccines ranged from 0.54 / 1 million doses to 31.08 / 1 million doses; non-severe AEFIs reported rates of 11.45 / 1 million doses to 1,494.38 / 1 million doses. The general reaction to fever, redness, induration mainly allergic reaction vaccination allergic rash, aseptic abscess, BCG lymphadenitis, allergic purpura and angioedema based. Adverse reactions mainly concentrated after inoculation ≤ 1d. Vaccination with different vaccines Abnormal response Estimated incidence of reports: systemic disseminated BCG infection 0.24 / 1 million doses; Vaccine associated paralytic polio 0.21 / 1 million doses; pertussis - diphtheria - tetanus combined vaccine aseptic abscess 6.55 / 1 million doses; live attenuated measles vaccine allergic purpura 0.25 / 1 million doses of thrombocytopenic purpura 0.03 / 1 million doses; Measles - Mumps - Rubella combined attenuated live vaccine Allergenic Purpura 0.84 / 1 million Agent; Hepatitis B vaccine anaphylactic shock 0.07 / 1 million. In all AEFIs, 98.07% were cured and improved, and 129 died, of which 17 cases were vaccinated with abnormal response. Conclusion The sensitivity of AEFI monitoring in China has been greatly improved, but there is a big difference in all provinces. AEFI often occurs in children with a small age and in a day after inoculation ≤1d. The incidence of adverse drug reactions reported by the national immunization program is within expected range.