国产成人流感裂解疫苗的安全性观察

Safety of domestic influenza split virion vaccine for adult use

目的观察国产成人流感裂解疫苗的安全性。方法对2013年四川省内3岁及3岁以上人群接种长春生物制品研究所有限责任公司(简称长春公司)生产的成人流感裂解疫苗以及其余所有厂家的流感裂解疫苗(对照流感疫苗)后报告的疑似预防接种异常反应(adverse events following immunization,AEFI)情况进行回顾性调查。结果2013年四川省接种长春公司流感裂解疫苗后共报告AEFI 36例,报告发生率为11.78/10万,其中一般反应发生率为8.5/10万,异常反应发生率为2.62/10万。与对照流感疫苗相比,长春公司流感疫苗的大年龄组别不良反应构成比较高。接种长春公司流感疫苗后,一般反应(发热、硬结、红肿)的发生率低于对照流感疫苗;除荨麻疹外,其余异常反应的报告发生率均低于对照流感疫苗;疫苗的异常反应无批号聚集性。结论长春公司生产的成人流感裂解疫苗安全性较好。

Objective To observe the safety of domestic influenza split virion vaccine for adult use. Methods The adverse events following immunization （AEFIs） in populations at ages of not less than 3 years in Siehuan Province in 2013 after inoculation with influenza split virion vaccine manufactured by Changchun Institute of Biological Products Co. , Ltd. （CIBP） and by other manufacturers as control were investigated retrospectively. Results Thirty-six cases of AEFIs were reported in Sichuan Province in 2013 after inoculation with the vaccine manufactured by CIBP, indicating an incidence of 11.78 / 10^5. The incidences of general and abnormal reactions were 8. 5 / 10^5 and 2. 62 / 10^5 respectively. However, the composition ratios of adverse reactions in elder age groups after inoculation with the vaccine manufactured by CIBP were higher than those with control vaccines. The incidences of general reactions including fever, duration and redness and swelling as well as abnormal reactions except urticaria after inoculation with vaccine manufactured by CIBP were lower than those with control vaccines. The abnormal reactions were not clustered in the subjects inoculated with vaccines of certain batches. Conclusion The influenza split virion vaccine for adult use manufactured by CIBP showed high safety.