肠道病毒A71型灭活疫苗(人二倍体细胞)上市后安全性观察  

Post-marketing observation on safety of inactivated enterovirus A71 vaccine (human diploid cell)

作　　者：沈灵智[1] 符剑[1] 潘雪娇[1] 梁辉[1] 谢淑云[1] 陈直平[1] Shen Lingzhi;Fu Jian;Pan Xuejiao;Liang Hui;Xie Shuyun;Chen Zhiping(Department of Immunization Program, Zhejiang Provincal Center for Disease Control and Prevention, Hangzhou 310051, China)

机构地区：[1]浙江省疾病预防控制中心免疫规划所,杭州310051

出　　处：《中华预防医学杂志》2019年第3期258-261,共4页Chinese Journal of Preventive Medicine

摘　　要：目的评价肠道病毒A71型(EV-A71)灭活疫苗(EV-A71疫苗)(人二倍体细胞)上市后接种的安全性。方法以2016年9月至2017年12月在浙江省预防接种门诊接种EV-A71疫苗的6~59月龄健康儿童作为研究对象,共20191名。在每剂EV-A71疫苗接种后第4或5天对儿童监护人进行电话随访,记录儿童接种后3d内局部、全身和其他不良反应发生情况,描述不同特征儿童不良反应发生情况。结果共接种疫苗32230剂次,第1和2剂分别为20191和12039剂次,3d内不良反应发生率分别为2.045%(413剂次)和1.611%(194剂次)。第1和2剂全身不良反应剂次均较多,分别为371和175剂次,发生率分别为1.837%和1.454%;局部不良反应剂次均较低,分别为14和2剂次,发生率分别为0.069%和0.017%。接种后发生的局部不良反应一般症状轻微,出现3级不良反应病例仅2例;全身不良反应中,3级及以上发热病例为39例,占总发热例数的8.2%。局部不良反应中,仅有3例接种部位皮疹和2例瘙痒病例需自购药或门诊治疗,其余无需治疗;全身不良反应中,除5例发热病例外,其余症状均未住院治疗。结论儿童接种EV-A71疫苗后3d内不良反应发生率较低,主要为全身不良反应,且预后良好。Objective To evaluate the post-marketing safety of inactivated Enterovirus type 71 (EV-A71) vaccine (human diploid cell).Methods A total of 20 191 healthy children aged 6 to 59 months were invited to receive 2 doses of EV-A71 vaccine in Zhejiang Province from September 2016 to December 2017. Child caregivers were followed up on the 4th or 5th day after each EV-A71 vaccination, and the incidence of local, systemic, and other adverse events within 3 days after vaccination was recorded to assess vaccine safety. Describe the differences in adverse events among children with different characteristics.Results A total of 32 230 doses were observed in this study, of which 20 191 and 12 039 were vaccinated for the first and the second dose, respectively;and the incidence of adverse events within 3 days was 2.045%(413 doses) and 1.611%(194 doses), respectively. After the first and the second dose, the number of systemic adverse events was the highest, 371 and 175 cases, respectively, with an incidence of 1.837% and 1.454%, respectively;the number of local adverse events was the lowest, 14 and 2 doses, respectively, with an incidence of 0.069% and 0.017%. Local adverse events occurred after vaccination were generally mild, and only 2 patients had level of 3;among the systemic adverse events, 39 patients had a fever level of 3 or higher, accounting for 8.2% of the total fever. Most of the symptoms in the local adverse events did not require treatment, only 3 cases of vaccination site rash and 2 cases of pruritus were self-purchased drugs or outpatient treatment;except for 5 cases of fever, the other symptoms were not hospitalized in the case of systemic adverse events.Conclusion The incidence of adverse events within 3 days after vaccination with EV-A71 vaccine was low in children, mainly systemic adverse events, and the prognosis was good.

关 键 词：手足口病 肠道病毒属 疫苗 肠道病毒71型 安全性 

分 类 号：R186[医药卫生—流行病学]