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。
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
出处
《中国新药杂志》
CAS
CSCD
北大核心
2012年第10期1186-1188,共3页
Chinese Journal of New Drugs
关键词
23价肺炎球菌多糖疫苗
不良反应
安全性
23-valent pneumococcal polysaccharide vaccine
adverse reaction
safety
