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国产23价肺炎球菌多糖疫苗上市后不良反应浅析

Analysis of adverse drug reactions for post-marketing domestic 23-valent pneumococcal polysaccharide vaccine

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【作者】 赵薇周本立张岷黄林孟丽

【Author】 ZHAO Wei,ZHOU Ben-li,ZHANG Min,HUANG Lin,MENG Li(Chengdu Institute of Biological Products Co.,Ltd.,Chengdu 610023,China)

【机构】 成都生物制品研究所有限责任公司

【摘要】 目的:评价国产23价肺炎球菌多糖疫苗上市后的安全性。方法:从日常收集、市场调查、文献资料3个方面收集23价肺炎球菌多糖疫苗上市后的不良反应,对其进行类型分析及不良反应发生率分析。结果:上市6年共销售1 074万人份国产23价肺炎球菌多糖疫苗,收集不良反应2 519例;不良反应以一般反应为主,局部反应和发热较多,严重不良反应数量极少。结论:国产23价肺炎球菌多糖疫苗上市后广泛使用是安全的。

【Abstract】 Objective: To evaluate the safety of post-marketing 23-valent pneumococcal polysaccharide vaccine.Methods: Information of adverse drug reactions was collected from daily report,market investigation and references.The adverse drug reactions were classified and the occurrence rate was analyzed.Results: In last 6 years,10.74 million doses of domestic 23-valent pneumococcal polysaccharide vaccine were sold and 2 519 cases of adverse drug reactions were reported and collected.Most of the cases were common vaccine reactions,including local reaction and fever.Serious adverse reaction was not common.Conclusion: The domestic 23-valent pneumococcal polysaccharide vaccine can be widely used and are safe in market.

  • 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2012年10期
  • 【分类号】R186
  • 【被引频次】7
  • 【下载频次】333
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