摘要
目的分析含b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)成分类疫苗的预防接种不良反应特征。方法通过中国疑似预防接种异常反应信息管理系统收集2012～2016年上海市浦东新区报告的含Hib成分类疫苗预防接种不良事件(Adverse Events Following Immunization,AEFI)数据,通过上海市免疫规划信息系统收集接种数据,采用描述性流行病学方法进行统计分析。结果 2012～2016年共报告接种含Hib类成分疫苗AEFI 1 766例,报告发生率318. 78/10万剂,其中一般反应1 735例,报告发生率313. 36/10万剂,异常反应30例,报告发生率5. 42/10万剂,偶合症1例,报告发生率0. 18/10万剂。Hib、流脑HI、DTaP-Hib、DTaP-IPV-Hib疫苗不良反应报告发生率分别为160. 69/10万剂、203. 28/10万剂、358. 24/10万剂和590. 59/10万剂,差异有统计学意义(P <0. 001)。各疫苗基础免疫(前3剂次之和)共接种473 223剂次,不良反应报告发生率224. 84/10万剂,加强免疫共接种80 457剂次,不良反应报告发生率871. 27/10万剂,基础免疫与加强免疫之间不良反应报告率差异有统计学意义(P <0. 001);Hib、DTaP-Hib、DTaP-IPV-Hib疫苗在加强免疫中的不良反应报告发生率均高于基础免疫(P均<0. 001)。各疫苗在不同接种部位的不良反应报告率差异有统计学意义(P均<0. 001),其中Hib、流脑HI疫苗不良反应发生部位主要在上臂,不良反应报告率分别为118. 71/10万剂和203. 28/10万剂,DTaP-IPV-Hib疫苗不良反应发生部位主要在大腿,不良反应报告率545. 75/10万剂,DTaP-Hib疫苗不良反应发生部位主要在臀部,不良反应报告发生率259. 41/10万剂。各疫苗的不良反应发生时段主要集中在6～24和24～48 h,不良反应报告率255. 92/10万剂,不同时间间隔的不良反应报告发生率差异有统计学意义(P均<0. 001)。结论含Hib成分类疫苗不良反应报告发生率低,安全性较好,建议接种部位为上臂和大腿,同时应做好接种后1～2
Objective To analyze the characteristics of adverse events following immunization(AEFI)reaction of Haemophilus influenzae b(Hib)containing vaccines.Methods The data on AEFI of Hib containing vaccines reported in Pudong New District,Shanghai were collected through China AEFI Information Management System during 2012 ~2016,while that on vaccination through the Shanghai Immunization Program Information System,and subjected to statistical analysis by descriptive epidemiological methods.Results A total of 1 766 cases of AEFI of Hib were reported during 2012 ~2016,indicating an incidence rate of 318.78/100 000 doses,of which 1 735 cases were general reactions(98.24%),indicating an incidence rate of 313.36/100 000 doses,while 30 cases of abnormal reaction were reported,indicating an incidence rate of 5.42/100 000 doses.One case of coincidence was observed,indicating an incidence rate of 0.18/100 000 doses.The incidence rates of AEFI of Hib,epidemic encephalitis-HI,DTaP-Hib,DTaP-IPV-Hib were 160.69/100 000 doses,203.28/100 000 doses,358.24/100 000 doses and 590.59/100 000 doses respectively,which showed significant difference(P< 0.001).A total of 473 223 doses of various vaccines were inoculated for primary immunization(three doses),of which the incidence rate of AEFI was 224.84/100 000 doses.However,a total of 80 457 doses were inoculated for booster immunization,of which the incidence rate of AEFI was 871.27/100 000 doses,indicating a significant difference with that of primary immunization(P< 0.001).The incidence rates of AEFI of Hib,DTap-Hib and DTaP-IPV-Hib in booster immunization were significantly higher than those in primary immunization(each P< 0.001).The incidence rates of AEFI of various vaccines in various injection sites showed significant difference(each P< 0.001).The AEFI of Hib and epidemic encephalitis-HI mainly appeared in upper arm,with incidence rates of118.71/100 000 doses and 203.28/100 000 doses respectively.The AEFI of DTaP-IPV-Hib mainly appeared in thigh,with an incidence rate of 545.75/100 000
作者
杨来宝
周翠萍
肖绍坦
邓鹏飞
陈红英
费怡
YANG Lai-bao;ZHOU Cui-ping;XIAO Shao-tan;DENG Peng-fei;CHEN Hong-ying;FEI Yi(Pudong New A tea Center for Disease Control and Prevention,Shanghai 200136,China)
出处
《中国生物制品学杂志》
CAS
CSCD
2019年第1期57-61,65,共6页
Chinese Journal of Biologicals
