A、C群脑膜炎球菌多糖结合疫苗在5～24月龄儿童中接种安全性评价  

Evaluation of safety of meningococcal group AC bivalent polysaccharide conjugate vaccine in children aged 5-24 months old

作　　者：周海[1] 王锦瑜[1] 谈晔[1] 吕海英[1] 王曼[1] 蔡乾春[1] 张瀚中[1] 

机构地区：[1]广东省中山市疾病预防控制中心,528400

出　　处：《中华预防医学杂志》2013年第10期920-923,共4页Chinese Journal of Preventive Medicine

基　　金：2011年度中山市科技局科技计划项目（医疗卫生）（20113A113）

摘　　要：目的 评价A、C群脑膜炎球菌多糖结合疫苗在5～24月龄儿童中使用的安全性.方法 于2011年7月至2012年6月,选取中山市辖区内自愿接种A、C群脑膜炎球菌多糖结合疫苗的5～24月龄儿童作为研究对象,共34 411名.记录并分析儿童接种后72 h内局部和全身不良反应发生情况.结果 34 411名研究对象包括男性18 708名（54.36％）,总体年龄为（11.4±3.9）月龄.72 h内局部不良反应发生率依次为：发红[0.76％（261/34 411）]、硬结[0.57％（197/34 411）]、肿胀[0.56％（191/34 411）]、疼痛[0.42％ （143/34 411）]、瘙痒[0.15％（53/34 411）]、注射部位皮疹[0.15％（50/34 411）],合计为1.61％（554/34 411；95％CI：1.48％～1.74％）；全身不良反应发生率依次为：发热[0.98％（312/34 411）]、厌食[0.48％（164/34 411）]、腹泻[0.31％ （108/34 411）]、乏力[0.29％（100/34 411）]、恶心呕吐[0.20％ （70/34 411）]和头疼[0.08％（26/34 411）],全身不良反应发生率合计为1.64％（565/34 411;95％CI：1.51％ ～ 1.78％）.25例（0.07％）出现高热（＞39℃）,持续时间均＜48 h.16例（0.05％）出现咳嗽、卡他感冒症状.无意外伤害事故和其他严重事件报告.男童全身不良反应发生率为1.79％（334/18 708）,高于女童的1.47％（231/15 703）,差异有统计学意义（Х^2=5.22,P＜0.05）.5～12月龄儿童全身不良反应发生率为1.78％ （411/23 113）,高于13～24月龄儿童的1.36％（154/11 298）,差异有统计学意义（Х^2 =8.10,P＜0.05）.首剂接种A、C群脑膜炎球菌多糖结合疫苗局部不良反应发生率为1.72％（536/31 129）,高于第2剂或第3剂接种者的0.55％（18/3282）,差异有统计学意义（Х^2=25.81,P＜0.01）；首剂全身不良反应发生率为1.73％（539/31 129）,高于第2剂或第3剂接种者的0.79％（26/3282）,差异有统计学意义（Х^2 =16.22,P＜0.01）.结论 A、C群脑膜炎球菌多糖结合疫苗在5～ 24月龄儿童�Objective To evaluate the safety of meningococcal group AC bivalent polysacchande conjugate vaccine among children aged 5-24 months old.Methods From July 2011 to June 2012,a total of 34 411 children aged 5-24 month-old who voluntarily vaccinated meningococcal group AC bivalent polysaccharide conjugate vaccine in Zhongshan city were included.The adverse effects within 72 hours were recorded and analyzed.Results 34 411 children were recruited,including 18 708 boys （54.36%）,whose mean age were （11.4 ± 3.9） months old.Within 72 hours,the incidence rates of local adverse effects were 0.76% （261/34 411） for erythema,0.57% （197/34 411） for sclerosis,0.56% （191/34 411） for swelling,0.42% （143/34 411） for pain,0.15% （53/34 411） for pruritus,and 0.15% （50/34 411） for rash on the injection site.The overall incidence rate of local adverse effects was 1.61% （554/34 411;95% CI：1.48%-1.74%）.The incidence rates of systemic adverse effects were 0.98% （312/34 411） for fever,0.48% （164/34 411） for anorexia,0.31% （108/34 411） for diarrhea,0.29% （100/34 411） for malaise,0.20% （70/34 411） for nausea and vomiting,and 0.08% （26/34 411） for headache.The overall incidence rate of systemic adverse effects was 1.64% （565/34 411; 95% CI：1.51%-1.78%）.25 children （0.07%） had hyperpyrexia （〉 39 ℃）,and the time of duration lasted less than 48 hours.16 children （0.05%） had symptoms of cold,such as cough and catarrh.No accident and other serious events were reported.The incidence rate of systemic adverse effects among boys was 1.79% （334/18 708）,which was higher than that of girls （1.47%,231/15 703）,the difference showed statistical significance （Х^2 =5.22,P 〈 0.01）.The incidence rate of systemic adverse effects among children aged 5-12 month-old was 1.78% （411/23 113）,which was higher than that among children aged 13-24 month-old （1.36%,154/11 298）,the difference showed statistical significance （Х^2 =8.10,P 〈 0.01）.The incidence rate

关 键 词：脑膜炎 脑膜炎球菌性 疫苗 联合 安全 

分 类 号：R186[医药卫生—流行病学]