甲型H_1N_1流行性感冒疫苗安全性监测初步分析评价

Analysis on Safety of the Influenza A H_1N_1 Vaccine

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 occurrence feature of the influenza A H1N1 vaccine and to evaluate the immunization safety related to the vaccine in 7 provinces of china.Methods Through National Adverse Events Following Immunization（AEFI） Surveillance System,AEFI cases vaccinated were collected during September 21,2009 to March 1,2010.Vaccination cases vaccinated during the same period were collected by＂ Children vaccination information management system＂.The information were analyzed using descriptive methodology.Results 2372 AEFI cases were reported between September 21,2009 and March 1,2010 in 7 provinces,with an overall reporting rate of 126.5 per million dose administered.Of the reported cases,1992 were verified as adverse events（reporting rate：106.3 per million）.746 were verified as Serious Adverse Reaction（SAR,reported rate：39.8 per million）.SAR includes：Fever（≥38.6℃）（429cases,22.9 per million）,Local Reaction（5.0cm）（16 cases,0.9 per million）,Allergic reactions（292 cases,15.6 per million）,Febrile convulsion（7 cases,0.4 per million）,Brachial neuritis（2 cases,0.1 per million）.Analysis on the SAR with age,sex,occupation,provinces,manufacturer and cluster shows that the total reporting rate of SAR is higher in famale,but rate of fever（≥38.6℃） and febrile convulsion is lower.The reporting rate of SAR decreases with age.Reporting rate of Hench-schonlein purpura at the age of 5～14 is the highest;febrile convulsion happened at the age of 5～14,the proportion of Fever（≥ 38.6℃） decreases with age,while allergic reactions increase with age.According to the Occupation analysis,children＇s SAR reporting rate is the highest,followed by Medical staff,Student and Teacher.Most reactions in medical staff are allergic reactions.According to the provinces analysis,serious reaction reporting rate in Jiangsu is the highest,followed by Beijing,Hebei,Shanghai,Guangxi,Gansu and Hubei.According to the analysis of manufacturer,SAR reporting rate of C is the highest,followed by E,A,G and D.through standardized the reporting rate of SAR by group of age,the results shows that the reported rate of SAR from high to low is：CGEABDF.Cluster analysis shows that C and E＇s Cluster reporting rate is higher than the other manufacturers.Of the allergic reaction,the median interval of Anaphylactic shock is 15 minutes（range：2～30） after vaccination,and 30 minutes（range：5～645） for anaphylactic laryngeal edema.Conclusion The Influenza A H1N1 vaccine has good immunization safety.The reporting rate of AEFI and SAR are low.There is no evidence showing abnormally high rate of GBS or any other SAR in the vaccinated population.The reported rate of SAR decreases with age,but higher in female and in children,medical staff and students.The reporting rate of SAR and cluster rate are both higher in E and C.