摘要
目的评价两种部位接种吸附无细胞百白破、灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗(简称五联疫苗)的安全性。方法上海市奉贤区各预防接种门诊采用逢单月经大腿前外侧肌接种,双月经上臂三角肌接种的原则,在受种者监护人知情同意下,收集2015年1月1日~2017年6月30日期间婴幼儿接种五联疫苗后的安全性相关资料,分析不同接种部位的不良反应发生情况。结果共收集调查接种五联疫苗婴幼儿2 928人,接种7 243剂次,累计发生不良反应1 186人次,不良反应发生率为16. 37%。大腿前外侧肌接种的不良反应发生率(10. 80%)明显低于上臂三角肌(23. 89%),且差异有统计学意义(P <0. 05),其中局部反应、全身反应的轻、中、重度症状发生率也均明显低于上臂三角肌(P <0. 05)。两种不同部位接种第1剂次疫苗后不良反应的发生率均明显高于其他剂次(P <0. 05)。结论两种不同部位接种五联疫苗引起不良反应的发生率较低,均具有良好的安全性,大腿前外侧肌接种相对更安全,是五联疫苗的首选接种部位。
Objective To analyze the safety of diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine containing a polyribosyl-ribitol-phosphate-tetanus toxoid conjugate (DTacP-IPV// PRP -T)injected in different sites.Methods With the informed consent and voluntary basis,infants in all communities in Fengxian District,Shanghai City who were vaccinated with DTacP-IPV//PRP -T in January,March,May,July, September and November were injected in anterolateral thigh muscle,while those vaccinated in February,April,June, August,October and December in upper arm deltoid,from January 1,2015to June 30,2017,of whom the data on safety were collected and analyzed for the incidence of adverse reactions.Results A total of 2928 infants were inoculated with 7243 doses of DTacP-IPV//PRP -T,in whom 1186 cases of adverse reactions appeared,indicating an incidence of 16.37%.The incidence rate of adverse reactions in infants injected in anterolateral thigh muscle was 10.80%,which was significantly lower than that in upper arm deltoid (23.89%)(P <0.05).The incidence rates of local as well as mild,moderate and severe systemic reactions were also significantly lower in the infants injected in antero- lateral thigh muscle than in those injected in upper arm deltoid (P <0.05).However,the incidence rates of adverse reactions after the first dose injected in two sites were significantly higher than those after the other doses (P <0.05).Conclusion Both the incidence rates of adverse after injection with DTacP-IPV//PRP -T in two sites were low, indicating high safety.However,the inoculation in thigh anterolateral muscle was safer,indicating the site was the first choice for inoculation with the vaccine.
作者
李瑞平
胡斌
高彩红
俞辉红
沈群英
曹美芳
吴芳
LI Rui-ping;HU Bin;GAO Cai-hong;YU Hui-hong;SHEN Qun-ying;CAO Mei-fang;WU Fang(Fengxian District Center for Disease Control and Prevention,Shanghai 201499,China)
出处
《中国生物制品学杂志》
CAS
CSCD
2018年第12期1352-1355,1359,共5页
Chinese Journal of Biologicals
基金
上海市奉贤区卫生科技发展基金项目(奉科20141336)
