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134例接种甲型H1N1流感病毒裂解疫苗的不良反应监测分析 被引量:2

Adverse reaction of H1N1 influenza A vaccine
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摘要 目的监测接种甲型H1N1流感病毒裂解疫苗的不良反应。方法对134例首批接种甲型HINt流感病毒裂解疫苗者进行不良反应监测。结果28例接种者发生ADR,发生率为20.9%,共38例次,其中局部反应为7例次,全身反应为31例次。以1级反应为主,未发现其他异常反应、偶合反应和任何有临床意义的严重不良事件;不良反应主要发生于接种第1d(71.4%)或第2d(25.0oA);不良反应病程主要为1~2d,其中23倒不良反应者(82.1%)为自行缓解,5例(17.9%)曾使用药物治疗,所有不良反应发生者均治愈。结论接种甲型H1N1流感病毒裂解疫苗可能发生轻度的不良反应,一般很快自愈,该疫苗有较好的安全性。 Objective To summarize the adverse reaction of HIN1 influenza A vaccine. Methods Data of adverse reaction collected from 134 inoculated patients were analyzed. Results There were 28 cases ( 38 times) with adverse reaction, including local reaction ( 7 cases) and systemic reaction ( 31 eases). Most ADR course was in 1-2 day. In all ADR, there were 23 eases to self-healing and 5 eases treated with drugs. All ADR cases were cured. Conclusion The H1N1 Influenza A Vaccine could cause a few people with mild adverse reactions, and the symptoms were quickly self-healing.
出处 《西部医学》 2011年第1期154-155,共2页 Medical Journal of West China
关键词 甲型H1N1流感病毒裂解疫苗 不良反应 监测分析 H1N1 Influenza A Vaccine Adverse reaction Influenza vaccine Surveillance and Analysis
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  • 1Centers for Disease Control and Prevention(CDC). Swine influenza A/H1N1 infection in two children--Southern California, March-April 2009 [J]. MMWR Morb Mortal Wkly Rep, 2009 [J], 58 (15): 400-402.
  • 2中国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[Z].2005:10.
  • 3Deem MW, Pan K. The epitope regions of Hi-subtype influenza A, with application to vaccine efficacy[J]. Prot Eng, Des Sel, 2009, 22 (9) :543-546.
  • 4庄茂欣,潘红星,姚根红,陈维金,张雪梅,姜崴,李晓波,王轶文,蔡岩,赵晓青,胡月梅,刘文东,周余春,曹民权,崔颖杰,郭立君,朱凤才.国产甲型H1N1流感病毒裂解疫苗的安全性及免疫原性[J].中国生物制品学杂志,2010,23(1):67-70. 被引量:14

二级参考文献8

  • 1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.2005-10-14.
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  • 7European Committee for Medicinal Products for Human Use. Guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application (EMEACPMP / VEG / 4717 / 03). European Agency for the Evaluation of Medicinal Products for Human Use, 2008. http://www.emea.europa.eu / pdfs / human/vwp/471703en.
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