Abstract
纪文艳,卢莉,吕敏,苗良,高婷,黄若刚,索罗丹,刘东磊,马蕊,虞睿,张朱佳子,刘维祥,曾阳,李晓梅,吴疆.中国首批次甲型H1N1流感疫苗上市后安全性与保护效果的研究[J].Chinese journal of Epidemiology,2010,31(5):481-484
中国首批次甲型H1N1流感疫苗上市后安全性与保护效果的研究
Safety and epidemiological of the first China-made mass A (H1N1) influenza vaccination
Received:December 29, 2009  
DOI:10.3760/cma.j.issn.0254-6450.2010.05.001
KeyWord: 甲型H1N1流感疫苗  安全性  保护效果
English Key Word: A (H1N1) influenza vaccine  Safety  Epidemiological effect
FundProject:“十一五”国家科技支撑计划(2009BAl80801)
Author NameAffiliationE-mail
JI Wen-yan Beijing Center for Disease Control and Pievention, Beijing 100013, China  
LU Li Beijing Center for Disease Control and Pievention, Beijing 100013, China  
LV Min Beijing Center for Disease Control and Pievention, Beijing 100013, China  
MIA0 Liang Beijing Center for Disease Control and Pievention, Beijing 100013, China  
GAO Ting Beijing Center for Disease Control and Pievention, Beijing 100013, China  
HUANG Ruo-gang Beijing Center for Disease Control and Pievention, Beijing 100013, China  
SUO Luo-dan Beijing Center for Disease Control and Pievention, Beijing 100013, China  
LIU Dong-lei Beijing Center for Disease Control and Pievention, Beijing 100013, China  
MA Rui Beijing Center for Disease Control and Pievention, Beijing 100013, China  
YU Rui Beijing Center for Disease Control and Pievention, Beijing 100013, China  
ZHANGZHU Jia-zi Beijing Center for Disease Control and Pievention, Beijing 100013, China  
LIU Wei-xiang Beijing Center for Disease Control and Pievention, Beijing 100013, China  
ZENG Yang Beijing Center for Disease Control and Pievention, Beijing 100013, China  
LI Xiao-mei Beijing Center for Disease Control and Pievention, Beijing 100013, China  
WU Jiang Beijing Center for Disease Control and Pievention, Beijing 100013, China wj81732@yahoo.com.cn 
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Abstract:
      目的 了解和掌握由中国自行研制的甲型HINl流感疫苗的安全性与保护效果。方法 采用描述流行病学、队列研究方法,对95244名首批次接种甲型H1NI流感疫苗的受种者,开展安全性与流行病学保护效果评价。结果 95244名首批次接种甲型HINl流感疫苗人员中,累计报告不良反应人数为193例,报告率为2.03‰;其中71.0%(137/193)的病例发生在接种后24h内。有8l例不良反应确认与接种疫苗有关,其中78例(96.3%)属轻微反应。所有接种对象在接种后12周内未报告吉兰一巴雷综合征。甲型H1NI流感疫苗在不考虑接种率的情况下保护率可达到80.9%。结论 甲型H1N1流感疫苗具有良好的安全性和流行病学保护效果。
English Abstract:
      Objective To evaluate the safety and epidemiological effects on the fast mass vaccination program,using the China-made A (H1N1) influenza vaccine.Methods Descriptive epidemiology and cohort study design were used to assess the influenza A H1N1 vaccine on its safety and epidemiological effects.Results 95 244 subjects were immunized with A (H1N1) influenza vaccine.193 adverse events were reported through AEFI Management System,with the Reported rates of AEFI as 2.03‰.Most of the adverse events (137/193,71.0%) happened during the first 24 hours after immmni}ation was carried out.Of 81 adverse reactions confirmed to be related to invnunization,with 78 (96.3%)showed mild reactions.No Guillain-Barre Syndrome related to vaccination was reported through the AEFI Management System.The epidemiological protection rate of A (H1N1) vaccine could reach 80.9% when the coverage was not considered.Conclusion The A (H1N1) influenza vaccine showed a similar safety profile to seasonal flu vaccine.The vaccine demonstrates a good epidemiological effects against A (H1N1) influenza virus infection.
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