2013年底21例婴儿疑似乙肝疫苗接种死亡事件及接种风险的科学传播  

Twenty-one Infant Deaths after HBV Vaccination in China the End of 2013 and Science Communication for Vaccination Risk

作　　者：刘力 杨晓燕[2] 徐戎[2] 师少军[3] 曾繁典[2] 

机构地区：[1]不详 [2]华中科技大学同济医学院药理学系临床药理研究所 [3]华中科技大学同济医学院附属协和医院药剂科

出　　处：《药物流行病学杂志》2015年第11期686-694,共9页Chinese Journal of Pharmacoepidemiology

摘　　要：目的：系统研究2013年11-12月疑似乙肝疫苗接种死亡事件及民众相关反应,分析其起因、风险防范及疫苗接种风险的科学传播相关问题。方法：调研两组分别具有医学背景（A组35人）和非医学背景受访者（B组32人）,考察其对该事件与乙肝疫苗质量关联性的判断等。搜集各类媒体公开发布的11-12月婴儿接种与死亡时间、事发地区、剂次、产品产地和批号、早产或剖宫产、性别等信息,并行分类分析。结果：A、B两组中分别有40%和12.5%受访者认为事件与乙肝疫苗质量无关;认为若系乙肝疫苗质量缺陷,死亡发生在第一或第二剂的两组受访者分别为54.3%和65.6%,5.7%和6.3%。11-12月事件死婴总数至少为21例,其中男16例（76.2%）,女5例（23.8%）;3例的批号和2例的地区未见公开。19例分布于19个地区,仅2例接种同一批号。事件中6例（28.6%）发生在第1剂,13例（61.9%）于第2剂发生;10例（47.6%）曾联合接种卡介苗等,10例（47.6%）系剖宫产或早产儿,单独接种且顺产儿仅3例（14.3%）。结论：乙肝疫苗接种事件大多见于与卡介苗等联合接种及非正常生产婴儿接种。提示应尽快研究修订乙肝疫苗等的说明书,以降低接种中异常反应发生率。涉及疫苗接种风险的科学传播应待改进。Objective： To systematically study the infant deaths after receiving hepatitis B virus vaccine（ HBV）during Nov. to Dec. 2013 and the attitudes of common people,and to analyze the causes for these accidents and the risk prevention measures,as well as science communication for vaccination risk. Methods： We investigated two groups of respondents with medical background（ group A,35） and no medical background（ group B,32） to observe their views about the vaccine accidents and the relativity between the infant deaths and HBV quality. In addition,we collected and analyzed from all kinds of media about these accidents,such as the time of vaccination and death,accident region,production enterprises and batch number of vaccine,parturition,sex,etc. Results： We found that 40% of group A and 12. 5% of group B of the respondents believed these accidents were not relevant to the HBV quality. 54. 3% of group A and 65. 6% of group B thought the infants would die after their first vaccination,while 5. 7% and 6. 3% thought the infants would die after second vaccination. During November to December,at least 21 infants（ male 16,female 5） died after receiving HBV vaccine,and 19 babies died in 19 regions respectively. The batch numbers of 3 cases and regions of 2 cases were unknown.Only 2 infants received the same batch number of vaccine. 6 infants（ 28. 6%） died after their first vaccination,and 13 infants（ 61. 9%） died after second vaccination. 10 infants died after combined vaccination. Combined vaccination of different vaccines,premature or cesarean infants gave rise to 47. 6% of deaths in these accidents. Only 3 non-premature or noncesarean infants（ 14. 3%） died after non-combined vaccination. Conclusion： Most of deaths were contributed by combined vaccination of vaccination or cesarean or premature infants. The study suggested that the instructions of HBV should be revised as soon as possible to reduce the occurrence rate of paradoxical reaction. Science communication of vaccination risk should

关 键 词：乙肝疫苗 卡介苗 疫苗接种 异常反应 药物警戒 科学传播 风险管理 

分 类 号：R186[医药卫生—流行病学]