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目的了解河南省水痘减毒活疫苗(varicella attenuated live vaccine,Var V)预防接种的不良反应发生状况,评价Var V预防接种的安全性。方法通过中国免疫规划信息管理系统收集2011—2016年河南省报告的Var V不良反应个案和Var V接种数据,采用描述性流行病学方法进行分析。结果 2011—2016年河南省共报告Var V不良反应686例,年均报告发病率为16.89/10万剂,不良反应报告发生率呈逐年升高趋势(P=0.017)。病例以1~<2岁为主,占80.61%,报告发生率为13.62/10万剂;4—6月份不良反应报告最多,占32.80%,报告发生率为5.54/10万剂;报告病例主要集中在郑州市、洛阳市、周口市和信阳市。不良反应发生时间主要在第1剂次接种后和接种后的1 d内,分别占全部发生数的94.90%和72.89%。Var V不良反应临床表现以发热、红肿、硬结和一过性过敏反应为主,过敏性休克报告发生率为0.37/10万剂,热性惊厥报告发生率为0.12/10万剂。结论河南省Var V不良反应报告发生率逐年升高,疫苗安全性总体良好,但需关注过敏性休克、热性惊厥等严重异常反应的发生。
Objective To investigate the incidence of adverse reactions of varicella attenuated live vaccine (Var V) vaccination in Henan Province and evaluate the safety of Var V vaccination. Methods Through the China immunization planning information management system, Var V adverse reactions reported in Henan province from 2011 to 2016 and Var V vaccination data were collected and analyzed by descriptive epidemiological method. Results A total of 686 cases of Var V adverse reactions were reported in Henan province from 2011 to 2016, with an average annual incidence of 16.89 / 100 000 doses. The incidence of adverse reactions was increasing year by year (P = 0.017). The cases were mostly 1 ~ <2 years old, accounting for 80.61%. The incidence of the report was 13.62 / 10 million doses. The most reported adverse reactions were in June-June, accounting for 32.80%, with a reported incidence of 5.54 / 10 million doses. The reported cases were mainly Concentrated in Zhengzhou City, Luoyang City, Zhoukou City and Xinyang City. Adverse events occurred mainly in the first dose after inoculation and 1 d after vaccination, accounting for 94.90% and 72.89% of the total number of occurrence. Var V adverse reactions Clinical manifestations of fever, redness, induration and transient allergic reactions, the incidence of anaphylactic shock was 0.37 / 10 million doses, the incidence of febrile seizures was 0.12 / 10 million doses. Conclusion The incidence of Var V adverse reactions in Henan Province is increasing year by year, and the overall safety of the vaccine is good. However, we should pay attention to the occurrence of serious abnormal reactions such as anaphylactic shock and febrile seizures.