预防接种异常反应调查诊断个案及结论质量控制分析  

Analysis of investigation and diagnosis cases about abnormal reactions to vaccination and construction analysis for its conclusion quality control

作　　者：王如德[1] 高媛 WANG Rude;GAO Yuan(Linyi Center for Disease Control and Prevention,Linyi 276000,China)

机构地区：[1]临沂市疾病预防控制中心,山东临沂276000

出　　处：《山东第一医科大学（山东省医学科学院）学报》2022年第10期784-787,共4页Journal of Shandong First Medical University ＆ Shandong Academy of Medical Sciences

基　　金：临沂市科技发展计划(202120087)。

摘　　要：目的分析临沂市2020-2021年新冠病毒灭活疫苗接种属于和不排除预防接种异常反应调查诊断个案特征,构建预防接种调查诊断质量评估指引,探索质量控制对策。方法通过中国免疫规划信息系统收集临沂市2020年10月15日-2021年12月31日新冠病毒灭活疫苗疑似预防接种异常反应(adverse event following immunization,AEFI)个案数据,采用描述性和分析性流行病学方法进行分析。结果2020年10月15日-2021年12月31日临沂市新冠疫苗一般反应和异常反应报告发生率分别为0.8778/万、0.0165/万;异常反应发生率与既往年度常规免疫疫苗异常反应发生率相比,有统计学意义(χ^(2)=253.271,P<0.001)。3~17岁与18岁及以上人群第1针异常反应报告发生率(χ^(2)=0.260,P=0.610)、第2针报告发生率(χ^(2)=1.167,P=0.280)均无统计学意义,报告与首发症状时间差和报告与初次诊断时间差构成比无统计学意义(Fisher精确检验χ^(2)=6.721,P=0.150)。市县两级在作出属于和不排除异常反应结论上的差异无统计学意义(Fisher精确检验χ^(2)=6.721,P=0.150)。结论临沂市新冠疫苗异常反应报告发生率明显低于全国新冠疫苗异常反应报告发生率,市县两级调查诊断结论公正、无倾向性,但少数个案调查诊断依据不充分,需要加强培训,完善规范调查诊断指引。Objective:To analyze the characteristics of cases which belong to and without excluding abnormal vaccination reaction after the investigation and diagnosis about an inactivated SARS-CoV-2 vaccine inoculation in Linyi city during 2020-2021,to establish quality assessment guidelines for vaccination investigation and diagnosis,and to explore quality control measures.Methods:Adverse events following immunization(AEFI)data during 2020 to 2021 in Linyi city about inactivated SARS-CoV-2 vaccine were collected through the Chinese Immunization Planning Information System,and were analyzed by descriptive and analytical epidemiological methods.Results:The total reported incidence of AEFI about SARS-CoV-2 vaccine in Linyi city was 0.9956/10000 from October 15,2020 to December 31,2021 and the incidence of abnormal reactions was 0.0165/10000,which were statistically significant compared with the incidence of abnormal reactions about conventional immunization vaccine in previous years(χ^(2)=253.271,P<0.001).There was no statistical significance in the incidence of the first injection(χ^(2)=0.260,P=0.610)and the incidence of the second injection(χ^(2)=1.167,P=0.280)in 3-17 years old and 18 years old and above.There was no statistical significance on the time difference between reporting and first symptom and on the composition ratio between reporting and first diagnosis(Fisher’s exact testχ^(2)=6.721,P=0.150).There was no statistical significance about the conclusion of abnormal response on the city and county levels(Fisher’s exact testχ^(2)=6.721,P=0.150).Conclusions:The reported incidence of abnormal reactions to SARS-CoV-2 vaccine in Linyi City is significantly lower than that in the nationwide.The investigation and diagnosis conclusions at the city and county levels are fair and non-biased,but the basis of investigation and diagnosis in a few cases is not sufficient.So it is necessary to strengthen training and gradually improve the standardized investigation and diagnosis guidelines.

关 键 词：预防接种 异常反应 质量控制 

分 类 号：R186[医药卫生—流行病学]