浙江省二价脊灰疫苗预防接种安全性监测分析

Adverse events following immunization of bivalent types 1 and 3 oral poliovirus attenuated live vaccines in Zhejiang province:analysis on surveillance data of 2016–2018

目的分析浙江省接种二价的Ⅰ型、Ⅲ型脊髓灰质炎减毒活疫苗(bOPV)报告疑似预防接种异常反应(AEFI)发生情况,评价bOPV预防接种的安全性。方法通过全国AEFI监测信息管理系统,收集2016年5月-2018年10月浙江省bOPV的AEFI监测数据进行描述性分析。结果浙江省2016年5月-2018年10月共报告bOPV引起的AEFI病例378例,报告发生率为7.96/10万剂,其中一般反应278例(73.54%)、报告发生率为5.86/10万剂,异常反应81例(21.43%)、报告发生率为1.71/10万剂,偶合症17例(4.50%)、待定2例(0.53%);1岁以内和4岁组分别报告260例(68.78%)和104例(27.51%),与接种程序相应年龄的接种剂次相关;接种1天及以内发生的AEFI占92.33%;报告严重异常反应血小板减少性紫癜2例、血管性水肿1例,偶合死亡2例(分别偶合窒息和急性肠坏死致中毒性休克)。结论提示浙江省bOPV预防接种安全性总体良好,但仍需关注罕见的严重异常反应病例的发生。

Objective To analyze the incidence of reported adverse events following immunization(AEFI)of bivalent type 1 and type 3 oral poliovirus attenuated live vaccine(bOPV)in Zhejiang province and to evaluate the safety of bOPV vaccination.Methods The AEFI surveillance data of bOPV in Zhejiang province from May 2016 to October 2018 were collected through the national AEFI surveillance information system for the descriptive analysis.Results From May 2016 to October 2018,totally 378 bOPV-related AEFI were reported in Zhejiang province and the reported incidence rate was 7.96/100000 doses.Of all the AEFI reported,278(73.54%)were common reactions,with a reported incidence rate of 5.86/100000 doses;81(21.43%)were abnormal reactions,with a reported incidence rate of 1.71/100000 doses;17(4.50%)were coincidental and 2(0.53%)were undetermined.For all the AEFI reported,260(68.78%)and 104(27.51%)occurred among the children aged less than one year and those aged 4 years,which were in accordance with the ages the vaccinees and vaccination doses required by immunization schedule.There were 92.33%of the reported AEFI occurred within one day after the inoculation.Two cases of severe abnormal thrombocytopenic purpura,one case of vascular edema and two cases of coincidental death(accidental asphyxia and toxic shock caused by acute intestinal necrosis,respectively)were reported.Conclusion The results indicated that the vaccination of bOPV is generally safe in Zhejiang province.However,attention should be paid to the occurrence of rare severe reactions of bOPV vaccination.