七价肺炎球菌结合疫苗的安全性监测评价

Surveillance and Safety Evaluation of Pneumococcal 7-Valent Conjugate Vaccine

[目的]评价七价肺炎球菌结合疫苗的安全性。[方法]2010年10～11月对215名到济南市中心医院预防接种门诊接种七价肺炎球菌结合疫苗者,年龄为3个月至3岁的婴幼儿进行七价肺炎球菌结合疫苗(沛儿prevenar)接种后不良反应的临床观察,分别于接种疫苗后30min和12、24、48、72h观察不良反应,直至不良反应消失。[结果]共观察215名婴幼儿,19人(占8.84%)发生不良反应,共23例次,不良反应发生率为8.84%。3个月至1岁11个月组接种112人,发生不良反应的10人,不良反应发生率8.93%;2～3岁组接种103人,发生不良反应的9人,不良反应发生率为8.74%,二者差异无统计学意义(P>0.05)。局部反应为14例次,全身反应为9例次,均于对症治疗3日内缓解、消失。[结论]临床观察证明接种七价肺炎球菌结合疫苗有较好的安全性。

[Objective]To evaluate safety of pneumococcal 7-valent conjugate vaccine. [Methods]Clinical observation of adverse reaction was carried out for 215 children aged from 3 months to 3 years who were given pneumococcal 7-valent conjugate vaccine in immunization service department of the hospital from October to November 2010. The observation began 30 min,24 h,48 h and 72 h later after vaccination until adverse reaction disappeared. [Results]Of the 215 children,19 of them had adverse reactions, accounting for 8.84% （23 cases）. The adverse reaction rate was 8.84 %, of the 112 children aged from 3 months to 1 year and llmonths,10 of them had adverse reaction, accounting for 8.93%. Of the 103 children aged from 2 to 3 years old,9 of ichem had adverse reaction, accounting for 8.74% ,there was no difference （ P 〉0.05）. 14 of them had local reaction and 9 of them had systemic reaction, adverse reaction had improved and disappeared within 3 days after treatment. [Conclusion]Pneumococcal 7-Valent Conjugate vaccine is safe after clinical observation.