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江苏省2007-2013年乙肝疫苗疑似预防接种异常反应监测分析 被引量:18

Analysis on surveillance of adverse events following immunization for Hepatitis B vaccine in Jiangsu,2007-2013
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摘要 目的了解江苏省乙型肝炎疫苗(HepB)疑似预防接种异常反应(AEFI)发生的流行病学特征,评价HepB预防接种的安全性和AEFI监测系统的运转情况。方法通过AEFI信息管理系统和江苏省免疫规划信息系统,收集江苏省2007-2013年报告的HepB接种数据和AEFI个案,采用描述流行病方法对相关指标进行分析。结果江苏省2007-2013年共报告HepB AEFI 3 576例,报告发生率164.09/100万剂;年龄分布以<1岁组为主,占80.96%;男女比为1.29∶1;主要报告月份为5-8月。一般反应报告发生率为144.68/100万剂,异常反应为17.39/100万剂,严重异常反应为0.60/100万剂。临床诊断以发热/红肿/硬结和过敏性皮疹为多见,发生率分别为137.85/100万剂、15.10/100万剂。结论 HepB具有较好的预防接种安全性,不良反应以发热/红肿/硬结和过敏性皮疹为主,严重异常反应发生率较低;江苏省AEFI监测系统运转正常,可为疫苗的安全性评价提供依据。 Objective To analyze the epidemiological features of adverse events following immunization (AEFI) of Hepatitis B vaccine (HepB) in Jiangsu Province and to evaluate the immunization safety of HepB and the running condition of AEFI Sur- veillance System. Methods The HepB AEFI data of Jiangsu Province from 2007 to 2013 were collected through the AEFI In formation System and descriptive epidemiology method was used. Results A total of 3 576 HepB AEFI cases were reported during the period,and the annual incidence was 164.09/106 in an average . People aged^l year old accounted for 80.960~, and the male to female ratio was 1.29 : 1. Most of AEFI were reported during May to August. In adverse reactions, the reporting rate of common adverse reaction was 144.68/106 , the reporting rate of rare adverse reaction and serious rare adverse reaction were 17.39/106 and 0. 60/106 respectively. The main clinical diagnosis in HepB adverse reactions were fever/redness and swelling/induration and anaphylactic rash,of which reporting rate were 137.85/106 and 15.10/106 respectively. Conclusion HepB has good effect on immunization safety. Fever/redness and swelling/induration and anaphylactie rash were the predominant diagnosis; following immunization and the incidence of serious rare adverse reaction is very low. The AEFI Information System runs well in Jiangsu Province and provides a scientific basis for vaccine safety.
出处 《江苏预防医学》 CAS 2014年第5期39-41,共3页 Jiangsu Journal of Preventive Medicine
关键词 乙肝疫苗 疑似预防接种异常反应 报告率 Hepatitis B vaceine adverse events following immunization reporting rate
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  • 1李克莉,张丽娜,叶家楷,吉赛赛,余文周,曹雷,曹玲生,尹遵栋.中国2017年疑似预防接种异常反应监测[J].中国疫苗和免疫,2020,0(1):9-18. 被引量:128
  • 2中华人民共和国卫生部.预防接种工作规范[M].2005.9.
  • 3国家食品药品监督管理局.预防用疫苗临床试验不良反应分级标准指导原则[s].2005.10.14.
  • 4Liang X,Bi S,Yang W,et al.Evaluation of the impact of hepatitis B vaccination among children born during 1992-2005in China[J].J Infect Dis,2009,200(1):39-47.
  • 5Division of microbiology and infections diseases(DMID)pediatric toxicity tables(November 2007,Draft)[S].http://www.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/Documents/dmidpedtox.pdf.
  • 6Martínez-Sernández V,Figueiras A.Central nervous system demyelinating diseases and recombinant hepatitis B vaccination:a critical systematic review of scientific production[J].J Neurol,2012,260(8):1951-1959.
  • 7Fabrizi F,Dixit V,Messa P,et al.Hepatitis B virus vaccine in chronic kidney disease:Improved immunogenicity by adjuvants?A meta-analysis of randomized trials[J].Vaccine,2012,30(13):2295-2300.
  • 8Hepatitis B vaccines[J].Wkly Epidemiol Rec,2009,84(40):405-419.
  • 9Zhou W, Pool V, Iskander JK, et al. Surveillance for safety after immunization : Vaccine Adverse Event Reporting System (VAERS) -United States, 1991-2001 [J]. Morbidity and mortality weekly report. Surveillance summaries (Washington, D.C.: 2002) , 2003, 52 (1): 1-24.
  • 10WHO Regional Office for the Western Pacific . Immunization safety surveillance guidelines for immunization programme managers on surveillance of adverse events following immunization (Second Edition)[M].Geneva: WHO, 2013.

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