乙型肝炎疫苗疑似预防接种异常反应的文献计量学分析

目的 分析乙肝疫苗疑似预防接种异常反应（Adverse Events Following Immunization，AEFI）发生情况及病例特征，了解乙肝疫苗的安全性。方法 运用文献计量学方法对1987 - 2017年中国知网、万方和维普数据库收录的乙肝疫苗AEFI的中文文献进行定量统计分析。结果 纳入文献457篇，其中，乙肝疫苗AEFI监测分析268篇，AEFI个案分析189篇， 224例。268篇文献中，HepB的AEFI报告发生率为0.20/10万剂～258.62/10万剂，AEFI发生率在＜10/10万剂的文献64.93%。224例AEFI病例，男女性别比为1.59∶1；≤1岁占53.57%，AEFI病例主要集中在第1、2剂次和≤1 d；18种异常反应占65.18%，排前三位的是过敏性休克、过敏性皮疹和过敏性紫癜；14种偶合症占28.13%，排前三位的是维生素K缺乏症、肺炎、婴儿猝死综合征。49例AEFI死亡病例，偶合症死因排前三位的分别是维生素K缺乏症、肺炎和婴儿猝死综合征，异常反应死因均为过敏性休克。结论 乙肝疫苗AEFI为极罕见事件。乙肝疫苗AEFI死亡以维生素K缺乏症、肺炎和婴儿猝死综合征等偶合症多见，过敏性休克是乙肝疫苗异常反应的主要死亡原因。

Bibliometric analysis of literature on the adverse events following immunization (AEFI) of hepatitis B vaccine

Objective To analyze the occurrence of adverse events following immunization(AEFI) of hepatitis B vaccine(HepB) and characteristics of AEFI cases, evaluate the safety of HepB. Methods The bibliometric method was used to quantitatively analyze the Chinese literature of HepB AEFI included in the China National Knowledge Infrastructure(CNKI), Wanfang Medical Network and VIP database. Results A total of 457 documents were identified,of which consisted of 268 on surveillance of AEFI and 189 on AEFI cases’ analysis(including 224 cases). The reported occurrence rate of HepB AEFI was from 0.20 to 258.62 per 100,000 doses in 268 papers, 64.93% papers of the AEFI occurrence rate were less than 10 per 100,000 doses. There were 224 HepB AEFI cases, the sex ratio was 1.59:1, 53.57% cases were children under 1 year old. AEFI were mainly occurred 1st dose and 2nd dose, within 1d after vaccination. The top three 18 abnormal response cases (65.18%)were anaphylactic shock, anaphylactic rash, henochsch nlein purpura and 14 coincidental events(28.13%) were vitamin K deficiency, pneumonia, sudden infant death syndrome.49 were deaths among 224 AEFI cases, of which, the top three dead cases of coincidental event were vitamin K deficiency, pneumonia and sudden infant death syndrome, all of abnormal response were anaphylactic shock. Conclusion AEFI of HepB was an extremely rare event. Most of AEFI death cases were coincidental event which mainly included vitamin K deficiency, pneumonia and sudden infant death syndrome. Anaphylactic shock was the main cause of death of abnormal response.