2015-2017年上海市含无细胞百日咳、白喉和破伤风成分联合疫苗预防接种安全性
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摘要
目的评价上海市含无细胞百日咳、白喉和破伤风(DTaP)成分联合疫苗预防接种的安全性。方法通过中国免疫规划信息管理系统收集2015-2017年上海市报告的DTaP、DTaP-b型流感嗜血杆菌联合疫苗(DTaP-Hib)和DTaP-灭活脊髓灰质炎-Hib联合疫苗(DTaP-IPV-Hib)的疑似预防接种异常反应(AEFI)监测数据,进行描述性流行病学分析。结果 2015-2017年共报告含DTaP成分疫苗AEFI 18 220例,报告发生率为628.28/10万剂。在所有AEFI中,一般反应17 940例(618.62/10万剂),其中DTaP、DTaP-Hib、DTaP-IPV-Hib分别为9 807例(486.93/10万剂)、2 538例(617.84/10万剂)、5 595例(1 117.47/10万剂);异常反应247例(8.52/10万剂),其中DTaP、DTaP-Hib、DTaP-IPV-Hib分别为157例(7.80/10万剂)、35例(8.52/10万剂)、55例(11.58/10万剂)。结论上海市3种含DTaP成分疫苗均具有良好的安全性,仍应加强其AEFI监测。
Objective To evaluate the safety of diphtheria, tetanus and acellular pertussis(DTaP) containing combination vaccines used in Shanghai. Methods We used the Chinese Adverse Event Following Immunization(AEFI)Information System to collect AEFI reports of DTaP vaccine, DTaP-Haemophilus influenza type b combined vaccine(DTaP-Hib), and DTaP-inactivated poliovirus-Hib combined vaccine(DTaP-IPV-Hib) during 2015-2017 for a descriptive analysis. Results A total of 18 220 AEFIs were reported during 2015-2017, for an incidence of 628.28 per 100 000 doses.Among all AEFI cases, 17 940(618.62 per 100 000) were common adverse reactions, with 9 807(486.93 per 100 000),2 538(617.84 per 100 000), and 5 595(1 117.47 per 100 000) for DTaP, DTaP-Hib, and DTaP-IPV-Hib, respectively; 247(8.52 per 100 000) were rare adverse reactions, with 157(7.80 per 100 000), 35(8.52 per 100 000), and 55(11.58 per100 000) reactions for DTaP, DTaP-Hib, and DTaP-IPV-Hib, respectively. Conclusions All DTaP containing combination vaccines had good safety profiles. We should continue monitoring AEFI for these vaccines.
Objective To evaluate the safety of diphtheria, tetanus and acellular pertussis(DTaP) containing combination vaccines used in Shanghai. Methods We used the Chinese Adverse Event Following Immunization(AEFI)Information System to collect AEFI reports of DTaP vaccine, DTaP-Haemophilus influenza type b combined vaccine(DTaP-Hib), and DTaP-inactivated poliovirus-Hib combined vaccine(DTaP-IPV-Hib) during 2015-2017 for a descriptive analysis. Results A total of 18 220 AEFIs were reported during 2015-2017, for an incidence of 628.28 per 100 000 doses.Among all AEFI cases, 17 940(618.62 per 100 000) were common adverse reactions, with 9 807(486.93 per 100 000),2 538(617.84 per 100 000), and 5 595(1 117.47 per 100 000) for DTaP, DTaP-Hib, and DTaP-IPV-Hib, respectively; 247(8.52 per 100 000) were rare adverse reactions, with 157(7.80 per 100 000), 35(8.52 per 100 000), and 55(11.58 per100 000) reactions for DTaP, DTaP-Hib, and DTaP-IPV-Hib, respectively. Conclusions All DTaP containing combination vaccines had good safety profiles. We should continue monitoring AEFI for these vaccines.
引文
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[12]刘大卫,郭飚,曹玲生,等.吸附无细胞和全细胞百白破联合疫苗上市后预防接种安全性的比较分析[J].中国疫苗和免疫,2008,14(2):97-102.LIU Dawe i,GUO Bi a o,CAO L i n gs h e n g,e t a l.Comparative study on post-marketing immunization safety ofabsorbed diphtheria,tetanus and acellular pertussis combined vaccine,and absorbed diphther ia,tetanus and whole-cell pertussis combined vaccine in China[J].Chinese Journal ofVaccines and Immunization,2008,14(2):97-102.
[13]戚小华,凌罗亚,陈恩富,等.吸附无细胞百日咳-白喉-破伤风联合疫苗的安全性及免疫原性研究[J].中国疫苗和免疫,2013,19(4):308-311.QI Xiaohua,LING Luoya,CHEN Enfu,et al.The safety and immunogenicity ofthe absorbed diphtheria,tetanus and acellular per tussis combined vaccine[J].Chinese Journal ofVaccines and Immunization.2013,19(4):308-311.
[14]王伟.189例接种无细胞百白破疫苗发生疑似预防接种异常反应病例流行病学分析[J].中国医学创新,2013,10(36):80-82.WANG Wei.Study on the epidemiological characteristics of189 DTaP vaccine AEFI cases[J].Medical Innovation ofChina,2013,10(36):80-82.
[2]STANLEY A,WALTER A,PAUL AO.Vaccines[M].6th edition.New York:Elsevier/Saunder,2012:981-1007.
[3]卫生部办公厅,国家食品药品监督管理办公室.全国疑似预防接种异常反应监测方案[S].2010-06-03.General Office ofMinist ry ofHealth,General Office ofSta t e Food and Dr ug Adminis t r a t ion.Na t ional guideline for surveillance ofadverse events following immunization[S].2010-06-03.
[4]郑惠文,孙明波,杨净思.以吸附无细胞百日咳-白喉-破伤风疫苗为基础的联合疫苗的研究进展[J].中国疫苗和免疫,2014,20(1):67-72.ZHENG Huiwen,SUN Mingbo,YANG Jingsi.The research progress on combined vaccine ofabsorbed diphtheriatetanus and acellular pertussis vaccine[J].Chinese Journal ofVaccines and Immunization,2014,20(1):67-72.
[5]任军,李建民,陈薇.联合疫苗应用现状及评价[J].中国生物工程杂志,2009,29(11):89-93.REN Jun,LI Jianmin,CHEN Wei.Application status and evaluat ion ofcombinat ion vaccines[J].China Biotechnology,2009,29(11):89-93.
[6]叶家楷,李克莉,许涤沙,等.中国2014年疑似预防接种异常反应信息管理系统数据分析[J].中国疫苗和免疫,2016,22(2):125-137.YE Jiakai,WU Wendi,XU Disha,et al.Analysis ofsurveillance for adverse events following immunization in China,2014[J].Chinese Journal ofVaccines and Immunization,2016,22(2):125-137.
[7]叶家楷,李克莉,许涤沙,等.中国2015年疑似预防接种异常反应监测分析[J].中国疫苗和免疫,2017,23(5):481-492+511.YE Jiakai,WU Wendi,XU Disha,et al.Surveillance ofadverse events following immunization in China,2015[J].Chinese Journal ofVaccines and Immunization.2017,23(5):481-492+511.
[8]Wor ld Heal th Organization Regional Office for the Western Pacific.Immunizat ion safe ty survei l lance:guidelines for immunization programme managers on surveillance ofadverse events following immunization(second edition)[S].2013.
[9]DEY A,WANG H,QUINN H,et al.Surveillance ofadverse events following immunisation in Australia annual report,2015[J].Annual Report,2017,41(3):264-278.
[10]刘捷宸,邵慧勇,任佳,等.上海市2011~2015年含无细胞百日咳、白喉和破伤风成分联合疫苗预防接种安全性评价[J].中国疫苗和免疫,2016,22(2):197-201.LIU Jiechen,SHAO Huiyong,REN Jia,et al.Evaluation ofthe safety ofdiphtheria,tetanus and acellular pertussis containing combination vaccines in Shanghai,2011-2015[J].Chinese Journal ofVaccines and Immunization.2016,22(2):197-201.
[11]冯艳萍,赵蕊,郑晓红,等.吸附无细胞百白破与吸附百白破疫苗接种反应观察[J].实用预防医学,2009,16(6):1814-1815.FENG Yanping,ZHAO Rui,ZHENG Xiaohong,et al.Observation the reaction ofabsorbed diphtheria,tetanus and acellular pertussis combined vaccine,and absorbed diphtheria,tetanus and whole-cell per tussis combined vaccine[J].Practical Preventive Medicine,2009,16(6):1814-1815.
[12]刘大卫,郭飚,曹玲生,等.吸附无细胞和全细胞百白破联合疫苗上市后预防接种安全性的比较分析[J].中国疫苗和免疫,2008,14(2):97-102.LIU Dawe i,GUO Bi a o,CAO L i n gs h e n g,e t a l.Comparative study on post-marketing immunization safety ofabsorbed diphtheria,tetanus and acellular pertussis combined vaccine,and absorbed diphther ia,tetanus and whole-cell pertussis combined vaccine in China[J].Chinese Journal ofVaccines and Immunization,2008,14(2):97-102.
[13]戚小华,凌罗亚,陈恩富,等.吸附无细胞百日咳-白喉-破伤风联合疫苗的安全性及免疫原性研究[J].中国疫苗和免疫,2013,19(4):308-311.QI Xiaohua,LING Luoya,CHEN Enfu,et al.The safety and immunogenicity ofthe absorbed diphtheria,tetanus and acellular per tussis combined vaccine[J].Chinese Journal ofVaccines and Immunization.2013,19(4):308-311.
[14]王伟.189例接种无细胞百白破疫苗发生疑似预防接种异常反应病例流行病学分析[J].中国医学创新,2013,10(36):80-82.WANG Wei.Study on the epidemiological characteristics of189 DTaP vaccine AEFI cases[J].Medical Innovation ofChina,2013,10(36):80-82.