摘要：
Objective To evaluate the safety of hepatitis B vaccine in Zhejiang Province from 2012 to 2016.Methods The data of adverse events following immunization (AEFI) for hepatitis B vaccine in Zhejiang Province during 2012 to 2016 were collected through the AEFI information system,and were analyzed by descriptive epidemiological methods.Results A total of 1 051 AEFI cases were reported in Zhejiang Province in 2012-2016,and the estimated incidence rate was 9.61 per 100 000 doses,which showed an increasing trend year by year (x2trend=432.45,P＜0.01).A total of 110 cases had rare vaccine reactions with the incidence rate of 1.01 per 100 000 doses.Twenty-five cases had severe AEFI with the incidence rate of 0.23 per 100 000 doses,and 19 cases were coincidental diseases among whom 10 cases died.In all AEFIs,male cases were more than female ones (1.23 ∶ 1),and most cases were under 1 year old (915 cases,87.06％).The cases were often reported from May to August (43.20％) and in Hangzhou(352 cases).Hepatitis B vaccine adverse reactions mainly happened after the third dose (671 cases,63.84％) or within 1 day (931 cases,88.58％) after vaccination.The main symptoms of common vaccine reactions were fever,local swelling and indurations.The main diagnoses of rare vaccine reactions were anaphylactic rashes (68 cases,0.62 per 100 000 doses) with good prognosis.Conclusions The hepatitis B vaccine in Zhejiang Province is safe.However,we should pay more attention to the incidence,diagnosis and treatment of coincidental death reaction,and improve AEFI surveillance of hepatitis B vaccine.%目的 评价浙江省2012-2016年乙型肝炎(乙肝)疫苗接种的安全性.方法 通过中国疑似预防接种异常反应(AEFI)信息管理系统,收集2012-2016年报告的乙肝疫苗接种后发生的AEFI个案,采用描述性流行病学方法进行评价分析.结果 浙江省2012-2016年累计报告乙肝疫苗接种后AEFI个案1 051例,报告发生率9.61/10万,并呈逐年上升趋势(x2趋势--432.45,P＜0.01).其中异常反应110例,报告发生率1.01/10万剂;严重AEFI共25例,报告发生率0.23/10万剂,其中19例为偶合症,死亡10例.男性多于女性(1.23∶1),以1岁内为主(915例,占87.06％),5-8月份占全年报告总数的43.20％,杭州市报告最多(352例),主要集中在第3剂次(671例,占63.84％).88.58％(931例)的AEFI发生在接种后1d内.临床损害以发热、红肿、硬结等一般反应较多,异常反应则以过敏性皮疹为主(68例,报告发生率0.62/10万剂),预后较好.结论 浙江省乙肝疫苗安全性良好,但应重视偶合死亡反应的发生、诊断及处置,并进一步加强监测.
