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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 investigate the deaths and public-related reactions suspected of hepatitis B vaccination from November to December 2013 and to analyze the causes of such diseases, risk prevention and vaccination risks related to scientific communication. Methods: Two groups of patients with medical background (35 in group A) and non-medical background group (32 in group B) were investigated to determine their correlation with the quality of hepatitis B vaccine. Collect various types of media published 11-12 months of infant vaccination and death time, the incident area, dosage, product origin and lot number, premature birth or cesarean section, gender and other information, parallel classification analysis. Results: 40% and 12.5% of the respondents in groups A and B considered that the incident had nothing to do with the quality of hepatitis B vaccine. If the quality of hepatitis B vaccine was defective, the two groups of respondents whose deaths occurred in the first or second dose respectively 54.3% and 65.6%, 5.7% and 6.3% respectively. The total number of infants who died during the 11th to 12th incidents was at least 21 cases, including 16 males (76.2%) and 5 females (23.8%). The three batches and two cases were not disclosed. 19 cases distributed in 19 areas, only 2 cases were vaccinated with the same lot number. 6 cases (28.6%) occurred in the first dose, 13 cases (61.9%) occurred in the second dose, 10 cases (47.6%) were combined with BCG, 10 cases (47.6%) were cesarean section or premature delivery Only 3 (14.3%) children were inoculated alone and were born. Conclusion: Hepatitis B vaccination is mostly found in combination with BCG vaccination and non-normal infant vaccination. Prompts should be studied as soon as possible to amend the hepatitis B vaccine and other instructions to reduce the incidence of abnormal response during vaccination. Scientific dissemination involving the risk of vaccination needs to be improved.