北京市朝阳区12 241名婴幼儿三个部位接种无细胞百白破b型流感嗜血杆菌联合疫苗安全性分析  

Safety analysis of 12241 infants inoculated in three sites of diphtheria,tetanus,acellular pertussis and haemophilus influenzae type b combined vaccine in Chaoyang District of Beijing

作　　者：白云骅[1] 李淑萍[1] 丁舒 芦强[1] 杨立清[1] 张彦利[1] 张军楠[1] 李丽[1] 张政[1] Bai Yunhua;Li Shuping;Ding Shu;Lu Qiang;Yang Liqing;Zhang Yanli;Zhang Junnan;Li Li;Zhang Zheng(Department of Biological Products,Chaoyang District Center for Disease Control and Prevention,Beijing 100021,China;Baotou Medical College,Baotou 014040,China)

机构地区：[1]北京市朝阳区疾病预防控制中心生物制品科,100021 [2]内蒙古科技大学包头医学院,014040

出　　处：《中华预防医学杂志》2020年第9期953-957,共5页Chinese Journal of Preventive Medicine

摘　　要：目的分析三个部位接种无细胞百白破b型流感嗜血杆菌联合疫苗(DTaP‑Hib)不良反应发生情况。方法选取2015年5月至2019年4月北京市朝阳区所有接种门诊自愿接种DTaP‑Hib疫苗的婴幼儿为研究对象,共12241名。DTaP‑Hib疫苗推荐免疫接种程序为3、4、5月龄进行基础免疫,18~24月龄加强免疫。将研究对象按照接种部位分为3组,分别为股外侧肌组、上臂三角肌组和臀部肌肉组,收集研究对象每剂次疫苗接种后30 min、7 d内的不良反应情况,比较不同部位不良反应发生率。结果股外侧肌、上臂三角肌和臀部肌肉组分别为3461、2659和6121名;共接种35027剂次,股外侧肌、上臂三角肌和臀部肌肉组分别接种11129、7957和15941剂次;共观察到不良反应2489例次,总不良反应发生率为7.11%,其中上臂三角肌组总不良反应发生率为9.69%(771例次),高于臀部肌肉组(7.60%,1211例次)和股外侧肌组(4.56%,507例次)(P<0.001)。上臂三角肌组轻度、中度和严重的不良反应发生率均高于其他两组,发生率分别为4.85%(386例次)、3.77%(300例次)和1.07%(85例次),组间差异有统计学意义(P值均<0.001)。基础免疫3剂次和加强免疫第4剂次在不同部位的总不良反应趋势一致,发生率由高到低依次为上臂三角肌注射、臀部肌肉注射和股外侧肌注射,组间差异有统计学意义(P值均<0.001)。结论研究对象3个部位接种DTaP‑Hib不良反应发生率均较低,均具有较好的安全性,其中股外侧肌组不良反应发生率最低,建议推荐为DTaP‑Hib疫苗的优先接种部位。Objective To observe the adverse reactions of Diphtheria,Tetanus,Acellular Pertussis and Haemophilus Influenzae Type b Combined Vaccine conjugate vaccine at the anterolateral thigh muscle,upper arm deltoid muscle and upper gluteal region.Methods A total of 12241 infants who were voluntarily vaccinated DTaP‑Hib from April 2015 to April 2019 in Beijing were selected for the study.DTaP‑Hib vaccine is recommended for 3,4,5 months of age for basic immunization and 18 to 24 months of age to strengthen immunization.Subjects were divided into the groups of lateral thigh muscle,the upper arm deltoid and upper gluteal region according to the actual inoculation sites.Adverse reactions were collected within 30 minutes and 7 days after each does of vaccination at different sites and compared between three groups.The incidence of adverse reactions at the three different inoculation sites was compared by Chi‑square test.Results A total of 12241 infants and toddlers received combined DTaP‑Hib and 35027 doses of DTaP‑Hib were investigated.The number and of lateral thigh muscles,upper arm deltoids and gluteal muscles were 3461 infants and 11129 doses,2659 infants and 7957 doses,6121 infants and 15941 doses respectively.A total of 2489 adverse reactions occurred.The incidence of adverse reactions was 7.11%.The incidence of adverse reactions in deltoid muscle of upper arm was 9.69%(771 doses),which was higher than that in gluteal muscle(7.58%,1211 doses)and anterolateral muscle of thigh(4.56%,507 doses).The incidence of mild,moderate and severe adverse reactions in the upper arm deltoid group were higher than those in the other two groups.The incidence rates were 4.85%(386 doses),3.77%(300 doses)and 1.07%(85 doses)respectively.The differences between groups were statistically significant(P<0.001).The total adverse reactions of the three doses of basic immunization and the fourth dose of enhanced immunization had the same trend in different parts.The incidence of adverse reactions was in the order of the upper arm deltoid i

关 键 词：疫苗 联合 接种 安全性 评价研究 监测 

分 类 号：R186[医药卫生—流行病学]