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目的分析我国7个省(自治区、直辖市,下同)接种甲型H1N1流行性感冒(甲流)疫苗后,严重不良反应(Serious Adverse Reaction,SAR)的发生特征和危险性,评价疫苗的安全性。方法通过全国疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)信息管理系统,收集2009年9月21日～2010年3月1日,接种甲流疫苗后SAR个案信息,通过儿童预防接种信息管理系统,收集2009年9月21日～2010年3月1日接种个案信息,采用描述性方法对相关指标进行流行病学分析。结果 2009年9月21日～2010年3月1日,7个省共报告AEFI2372例,报告发生率12.65/10万。其中不良反应(一般反应和异常反应)1992例,发生率10.63/10万。不良反应中,SAR746例,报告发生率3.98/10万,其中高热(≥38.6℃)429例,报告发生率2.29/10万;严重局部反应(>5cm)16例,报告发生率0.09/10万;过敏反应292例,报告发生率1.56/10万;热性惊厥7例,报告发生率0.04/10万;臂丛神经炎2例,报告发生率0.01/10万。从年龄、性别、职业、地域、生产企业分布及聚集性反应分析,SAR总报告发生率女性高于男性,但其中高热和热性惊厥报告发生率男性高于女性。SAR报告发生率随年龄增长而下降。过敏性紫癜5～14岁报告发生率最高;热性惊厥发生在5～14岁;随着年龄增长高热构成比下降,过敏反应构成比增加。按职业分布,SAR报告发生率最高的为儿童,其次为医务人员和学生、教师,且医务人员SAR构成比以过敏反应居多。从地域分析,SAR报告发生率最高的为江苏,其余依次为北京、河北、上海、广西、甘肃、湖北。8个甲流疫苗生产企业(A、B、C、D、E、F、G、H)中,SAR报告发生率最高的为企业C,其次为企业E、A、G、D。将不同生产企业的SAR发生率按年龄组进行标化后显示,SAR发生危险性由高到低为:企业C>G>E>A>B>D>F。聚集性分析显示,企业C、E聚集性反应发生率较高。在过敏反应中,过敏性休克和喉头水肿发生时间间隔中位数分别为15min和30min。结论我国甲流疫苗上市后预防接种安全性好,AEFI、SAR报告发生率均较低。无证据表明接种甲流疫苗可能增加死亡或格林巴利综合征以及其他SAR发生的危险;我国甲流疫苗SAR报告发生率随着年龄增长呈下降趋势,女性高于男性,儿童、医务人员、学生报告发生率最高;生产企业E、C的甲流疫苗SAR发生率和聚集性反应均较高。
Objective To analyze the characteristics and risks of Serious Adverse Reaction (SAR) after vaccination against influenza A (H1N1) in seven provinces (autonomous regions, municipalities directly under the Central Government, the same below) and evaluate the safety of the vaccine . Methods AEFI information management system was used to collect information on SAR cases after vaccination with Influenza A vaccine from September 21, 2009 to March 1, 2010. Through the information management system of vaccination against childhood, System to collect the vaccination case information from September 21, 2009 to March 1, 2010, and use the descriptive method to conduct epidemiological analysis of related indicators. Results A total of 2372 AEFI cases were reported in 7 provinces from September 21, 2009 to March 1, 2010, with a reported incidence of 12.65 / 100000. One of the adverse reactions (general reaction and abnormal reaction) in 1992 cases, the incidence of 10.63 / 100,000. Among the adverse reactions, SAR746 cases reported a prevalence rate of 3.98 / lakh, of which 429 were high fever (≥38.6 ℃), with a reported incidence of 2.29 / lakh and 16 severe local reactions (> 5cm) with the reported rate of 0.09 / lakh ; 292 cases of allergic reaction, the report rate of 1.56 / 100000; febrile seizures in 7 cases, the report rate of 0.04 / 100000; brachial plexus in 2 cases, the report rate of 0.01 / 100000. According to the analysis of age, sex, occupation, region, manufacturer distribution and aggregate reaction, the total incidence of SAR was higher in women than in men, but the incidence of reports of fever and febrile seizures was higher in males than in females. The incidence of SAR reports declines with age. Henoch-Schonlein purpura 5 to 14 years old report the highest incidence; febrile seizures occurred in 5 to 14 years old; with age, the proportion of high-heat composition decreased, the proportion of allergic reactions increased. By occupation distribution, the highest incidence of SAR was reported for children, followed by medical staff and students and teachers, and the proportion of SARs among medical staff was mostly allergic. According to geographical analysis, the highest incidence of SAR was reported in Jiangsu, followed by Beijing, Hebei, Shanghai, Guangxi, Gansu and Hubei. Among the eight A-strain vaccine manufacturers (A, B, C, D, E, F, G, H), the highest incidence of SAR was enterprise C, followed by enterprises E, A, G, According to the age group, the SAR incidence rate of different manufacturing enterprises was normalized. The SAR risk from high to low was: enterprise C> G> E> A> B> D> F. Aggregation analysis shows that there is a high incidence of C and E aggregation in the enterprise. In the allergic reaction, the median time interval for anaphylactic shock and laryngeal edema was 15 min and 30 min, respectively. Conclusion The safety of vaccination of A H1N1 vaccine after listing in our country is good, and the incidence of AEFI and SAR report is low. There is no evidence that the vaccination with a H1N1 influenza vaccine may increase the risk of death or Guillain-Barre syndrome and other SARs. The incidence of SARS in China is declining with age, and women are higher than those of men, children, medical staff and students The highest incidence of the report; manufacturing enterprises E, C influenza A influenza vaccine incidence and aggregation reaction were high.