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基于预防接种信息管理系统的b型流感嗜血杆菌结合疫苗上市后安全性评价 被引量:1

Evaluation of safety of haemophilus influenza type b(Hib) conjugate vaccine in postmarketing based on the immunization information management system
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摘要 目的分析b型流感嗜血杆菌(Hib)结合疫苗接种后疑似预防接种异常反应(adverse event following immunization, AEFI)发生特征,评价Hib结合疫苗上市后安全性。方法Hib结合疫苗AEFl数据来源于全同AEFI信息管理系统,为2014年3月13日下载的2008--2013年接种Hib结合疫苗后江苏省报告发生的所有AEFI监测数据。Hib结合疫苗受种对象人口学信息和接种剂次数来源于江苏省预防接种信息管理系统。计算Hib结合疫苗接种后AEFI发生率、一般反应和异常反应发生率及其95%CI值,采用χ^2检验比较江苏省不同性别、月龄和剂次接种儿童一般反应和异常不良反应发生率的差异。结果2008-2013年江苏省接种Hib结合疫苗6159072剂,接种后报告AEFI4718例,发生率为76.60/10万剂(95%CI:74.42/10万剂~78.79/10万剂),其中一般反应发生率为71.10/10万剂(95%CI:68.99/10万剂~73.20110万剂),异常反应发生率为5.16/10万剂(95%CI:4.60/10万剂一5.73/10万剂);一般反应主要为发热(40.54/10万剂)、局部红肿(35.09/10万剂)、局部硬结(12.94/10万剂)和呕吐腹泻等胃肠反应(0.36/100万剂);异常反应主要为过敏性皮疹(4.77/10万剂)和血管性水肿(0.15/10万剂)。91.39%(4002/4379)的一般反应和88.36%(281/318)的异常反应在接种后≤1d内发生,过敏性休克(3例)和喉头水肿(1例)均在按种后〈1d内发生。一般反应发生率比较:男童(79.72/10万剂,2641/3313071)高于女童(61.07/10万剂,1738/2846001)(χ^2=74.92,P〈0.001);t〉12月龄儿童(86.82/10万剂,2200/2533949)高于2~11月龄儿童(60.11/10万剂,2179/3625123)(χ^2=149.79,P〈0.001);首剂接种Hib结合疫苗(78.93/10万剂,2666/3377614)高于第2、3或4剂接种者(61.59/10万剂,1713/2781458� Objective To analyze the occurrence feature of adverse events following immunization (AEFi)of Hib conjugate vaceine(HibCV) and to evaluate the safety of HibCV in postmarketing. Methods 2008-2013 HibCV AEFI data were collected through national AEFI information management system,which were downloaded in March 18,2014.The demographic information and inoculation quantity of HibCV were from Immunization information management system in Jiangsu province. The incidence rate and 95% CI value of AEFI, common vaccine reaction and rare vaccine reaction following immunization of HibCV were calculated. The differences in the incidence rate of common vaccine reaction and rare vaccine reaction among sex, months of age, and number of injections were compared by means of χ^2 tests.Results A total of 6.16 million doses of vaccine were administered in Jiangsu province during 2008-2013, and 4 718 vaceinees reported having adverse event, for a rate of 76.60/100 000(95% CI:74.42/100 000-78.79/100 000). The incidence rate of common vaccine reaction and rare vaccine reaction was 71.10/100 000(95%CI:68.99/100 000-73.20/100 000)and 5.16/100 000(95% CI:4.60/100 000-5.73/100 000), respectively. The main symptoms of common vaccine reactions were fever,swelling, indurations and gastrointestinal reactions. The incidence rates of them were 40.54/100 000,35.09/100 000,12.94/100 000 and 0.36/100 000 in turn. The main symptoms of rare vaccine reactions were anaphylactic rashes and angioedema, the incidence rates of which were 4.77/100 000 and 0.15/100 000 respectively. 91.39%(4 002/4 379) of common vaccine reactions and 88.36% (281/318) of rare vaccine reactions happened within 1 d after vaccination. Anaphylaetic shock (3 cases) and laryngeal edema (1 case) all happened within 1 d after vaccination.The incidence rate of common vaccine reactions among boys (79.72/100 000, 2 641/3 313 071) was higher than that of girls (61.07/100 000, 1 738/2 846 001)(χ^2=74.92,P〈0.001). The incidence rate of
作者 汪志国 马福宝 张晋琳 于静 康国栋 高君 Wang Zhiguo, Ma Fubao, Zhang Jinlin, Yu Jing, Kang Guodong, Gao Jun.(Institute of Immunization Program, Jiangsu Center for Disease Control and Prevention, Nanjing 210009, China)
出处 《中华预防医学杂志》 CAS CSCD 北大核心 2015年第6期475-480,共6页 Chinese Journal of Preventive Medicine
基金 艾滋病和病毒性肝炎等重大传染病防治重大专项(2012ZX10004-703)
关键词 嗜血菌 流感 疫苗 安全 疑似预防接种异常反应 预防接种信息管理系统 Haemophilus influenzae Vaccines Safety Adverse event following immunization Immunization information management system
作者简介 通信作者:汪志国,Email:njwang1718@163.com
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