摘要
目的分析浙江省金华市肠道病毒71型(EV71)灭活疫苗的预防接种安全性。方法 2016年9月至2018年7月,选择金华市6~47月龄儿童作为研究对象,采用主动监测方式进行面访和电话随访,并记录接种疫苗0~30 d的不良反应发生情况。结果研究纳入6 084名儿童,共主动监测疫苗9 090剂次,主动监测发现共有59名儿童发生不良反应,发生率为649.06/10万剂,96.61%发生于0~3 d。不良反应以发热(72.88%)、腹泻(27.12%)和恶心呕吐(10.17%)等全身反应为主,转归良好。≥3级反应15例,均在观察期内痊愈。不同性别、年龄、接种时间和接种剂次间的不良反应发生率差异无统计学意义(P>0.05),不同疫苗种类间的不良反应发生率差异有统计学意义(P<0.05),≥3级不良反应发生率差异无统计学意义(P>0.05)。Logistic回归模型分析结果显示,疫苗种类是不良反应发生的影响因素。结论 EV71灭活疫苗0~30 d内不良反应发生率较低,发生率与疫苗种类有关。
Objective To evaluate the safety of enterovirus 71 inactivated vaccine. Methods The children aged 6-47 months in Jinhua, Zhejiang province, were selected as the research subjects, active surveillance was conducted in forms of face to face interview and telephone interview, and the adverse reactions occurred during 0-30 days after vaccination were recorded. Results A total of 6 084 children were included in the study, and 9 090 vaccination doses were actively monitored,and 59 children were found to have adverse reactions, the incidence rate was 649.06 per 100 000 doses, and 96.61% of the adverse reactions occurred within 0-3 days after vaccination. The main adverse reactions were fever(72.88%), diarrhea(27.12%) and nausea and vomiting(10.17%), and the outcome was good. Fifteen cases with grade ≥3 reactions were cured in the observation period. There was no significant differences in gender, age, time and dose specific incidences of adverse reactions(P>0.05). There was significant difference in the incidence of adverse reactions among different vaccines(P<0.05),but no significant difference in the incidence of grade ≥3 adverse reactions(P>0.05). The results of logistic regression analysis showed that the type of vaccine was the influencing factor of adverse reaction. Conclusion The incidence of adverse reactions within 0-30 days after enterovirus 71 inactivated vaccine immunization was relatively low, which was related with the type of vaccine.
作者
章光明
吴晓虹
王凤英
Zhang Guangming;Wu Xiaohong;Wang Fengying(Jinhua Prefectural Center for Disease Control and Prevention,Jinhua 321002,Zhejiang,China)
出处
《疾病监测》
CAS
2020年第8期762-765,共4页
Disease Surveillance
基金
浙江省医药卫生科技计划(No.2019KY751)
金华市科学技术研究计划(No.2018–4–086,No.2019–4–083)。
