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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
作者:周海 王锦瑜 谈晔 吕海英 王曼 蔡乾春 张瀚中
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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(χ2=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(χ2=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(χ2=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(χ2=1622,P<001)。结论   A、C群脑膜炎球菌多糖结合疫苗在5~24月龄儿童中使用具有良好的安全性。

关键词:脑膜炎,脑膜炎球菌性;疫苗,联合;安全

Abstract:

   ObjectiveTo evaluate the safety of meningococcal group AC bivalent polysaccharide 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 (χ2=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 (χ2=810,P<001)The incidence rate of local adverse effects in children vaccinated the first dose was 172% (536/31 129),which was higher than that in children vaccinated the second or third dose (055%,18/3282),the difference showed statistical significance (χ2=2581,P<001)The incidence rate of systemic adverse effects in children vaccinated the first dose was 173% (539/31 129),which was higher than that in children vaccinated the second or third dose (079%,26/5282),whose difference also showed statistical significance (χ2=1622,P<001).Conclusion  The safety of meningococcal group AC bivalent polysaccharide conjugate vaccine among children aged 5-24 months old is relative good

Key words: Meningitis,meningococcal;Vaccines,combined;Safety

发表日期:2013/10

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