首页 >>2013年10期
脊髓灰质炎灭活疫苗和减毒活疫苗不同序贯免疫程序基础免疫安全性观察
作者:张朱佳子 李娟 王海红 刘芳 宁召起 许颖 褚平 解艳涛 李晓梅 刘东磊 卢莉
全文:PDF()

摘要:

   目的评价脊髓灰质炎灭活疫苗(inactivated polio vaccine,IPV)和减毒活疫苗(oral polio vaccine,OPV)不同序贯免疫程序基础免疫的安全性。方法  2009至2011年在北京市选择2月龄(60~89 d)婴儿,分为1剂IPV和2剂OPV序贯(IOO)、2剂IPV和1剂OPV序贯(IIO)、IPV全程(III)、OPV全程(OOO)4个观察组,分别在2、3、4月龄时接种疫苗,收集每次接种后全身和局部不良反应发生情况,计算不良反应发生率。最终入组553名婴儿,中途退出89名,观察1492人次。结果  IOO组、IIO组、III组和OOO组总不良反应发生率分别为229%(94/410)、184%(60/327)、 220%(78/354)和177%(71/401),差异无统计学意义(χ2=484,P=0184)。第1剂不良反应发生率最高[227%(32/141)~353%(54/153)],第2、3剂依次降低。没有与接种疫苗有关的严重不良事件报告。IOO组、IIO组、III组和OOO组全身不良反应发生率分别为215%(88/410)、177%(58/327)、201%(71/354)和177%(71/401),差异无统计学意义(χ2=253,P=0472)。异常哭闹在各组中发生率最高[72%(29/401)~113%(37/327)],异常哭闹、嗜睡和易激惹观察到极少数重度不良反应,其他不良反应均为轻、中度反应。IOO组、IIO组和III组局部压痛、硬结和红肿发生率分别为22%(5/229)~56%(22/393)、0~09%(2/229)、0~10%(4/393),均以轻度为主[0~41%(5/121)]。结论  IPV全程及IPV/OPV序贯免疫程序与口服三剂OPV一样具有较好的安全性。

关键词:脊髓灰质炎;灭活疫苗;减毒活疫苗;安全性;序贯程序

Abstract:

   ObjectiveTo evaluate safety of different sequential immunization schedules of inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) primary vaccinationMethods  Infants of 2 months old (60-89 days) selected in Beijing,were assigned to four groups,1 dose IPV plus 2 doses OPV (IOO),2 doses IPV plus 1 dose OPV(IIO),3 doses IPV(III),and 3 doses OPV (OOO),and were vaccinated at the age of 2,3,4 months,from 2009 to 2011The frequencies of systemic as well as local injection site reactions after every dose were recorded and calculatedA total of 553 infants were enrolled in the study and 89 infants were quited,1492 doeses were observedResults The incidence of adverse events in IOO,IIO,III,OOO were 229%(94/410),184%(60/327),220%(78/354) and 177%(71/401) with no statistical differences (χ2=484,P=0184)Dose 1 (227%(32/141)-353%(54/153)) was more frequently than dose 2 and dose 3No serious adverse events (SAE) were reported during the studyThe incidence of systemic adverse reactions in IOO,IIO,III,OOO were 215%(88/410),177%(58/327),201%(71/354) and 177%(71/401) with no statistical differences (χ2=253,P=0472)Abnormal crying were the most frequence reactions (72%(29/401)-113%(37/327)) in 4 groupsRarely severe reactions were observed of abnormal crying,somnolence,irritability and mild or medium reactions occurred in other symptomsLocal adverse reactions such as injection site pain,scleroma and swelling were reported by 22%(5/229)-56%(22/393),0-09%(2/229) and 0-10%(4/393) in IOO,IIO and III,and most reactions were mildConclusion  Three IPV immunization and IPV/OPV sequential immunization as well as three OPV immunization demonstrated safe

Key words: Poliomyelitis;Inactivated vaccines;Attenuated live vaccines;Safety;Sequential immunization

发表日期:2013/10

引用本文:

图/表:

    暂无图表

参考文献:

[1] Bonnet MC,Dutta AWorld wide experience with inactivated poliovirus vaccineVaccine,2008,26(39):49784983
[2] 中国疾病预防控制中心脊髓灰质炎灭活疫苗使用指导意见中国疫苗和免疫,2009,15(6):541
[3] 卢莉,李晓梅,刘东磊,等脊髓灰质炎灭活疫苗和减毒活疫苗不同序贯免疫程序的基础免疫效果研究中华预防医学杂志,2012,46(6):510513
[4] 国家食品药品监督管理局预防用疫苗临床试验不良反应分级标准指导原则[EB/OL].[20051014]http://wwwsdagovcn/WSO1/CL0844/9350html
[5] 国家食品药品监督管理局药物临床试验质量管理规范[EB/OL][20030806]http://wwwsdagovcn/WSO1/CL0053/24473html
[6] Introduction of inactivated poliovirus vaccine into oral poliovirus vaccineusing countriesWkly Epidemiol Rec,2003,78(28): 241250
[7] Global Polio Eradication InitiativePolio Eradication and endgame strategic plan 20132018[EB/OL][20130329]http://wwwpolioeradicationorg/Resourcelibrary/Strategyandworkaspx
[8]Polio vaccines and polio immunization in the preeradication era: WHO position paperWkly Epidemiol Rec,2010,85(23): 213228
[9]熊小霞,吴水金关于脊髓灰质炎灭活疫苗的使用情况及存在的问题中国社区医师(医学专业),2012,14(27):316317
[10]Wattigney WA,Mootrey GT,Braun MM,et alSurveillance for poliovirus vaccine adverse events,1991 to 1998: impact of a sequential vaccination schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccinePediatrics,2001,107(5):E83
[11]刘美霞162例脊髓灰质炎灭活疫苗安全性调查中国现代医生,2011,(26):1516
[12]侯启明,田霖,周铁群,等吸附百日咳、白喉、破伤风、脊髓灰质炎四联疫苗的安全性和免疫原性研究中国计划免疫,2002,8(1):710
[13]Pietrzyk JJ,Wysocki J,Pejcz J,et alSafety and immunogenicity of a DTaPIPV(Vero) (serumfree) combination vaccine in comparison to DTaPIPV(Mkc) when administered simultaneously with Haemophilus influenzae type B conjugate vaccine (PRPT) in children at 2,35,5 and 16 months of ageVaccine,2008,26(41):52965303
[14]Macias M,Lanata CF,Zambrano B,et alSafety and immunogenicity of an investigational fully liquid hexavalent DTaPIPVHep BPRPT vaccine at two,four and six months of age compared with licensed vaccines in Latin AmericaPediatr Infect Dis J,2012,31(8):e126132
[15]李艳萍,李凤祥,侯启明,等中国婴幼儿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)联合疫苗的安全性和免疫原性研究中华流行病学杂志,2011,32(8):808815
[16]Thisyakorn U,Chotpitayasunondh T,Pancharoen C,et alEvaluation of an acellular pertussis,diphtheria,tetanus,inactivated poliovirus,Hibconjugate combined vaccine (Pentaxim) at 2,4,and 6 months of age plus hepatitis B vaccine at birth,2,and 6 months of age in infants in ThailandSoutheast Asian J Trop Med Public Health,2010,41(2):450462
[17]Pichichero ME,Bernstein H,Blatter MM,et alImmunogenicity and safety of a combination diphtheria,tetanus toxoid,acellular  pertussis,hepatitis B,and inactivated poliovirus vaccine coadministered with a  7valent pneumococcal conjugate vaccine and a Haemophilus influenzae type b conjugate vaccineJ Pediatr,2007,151(1): 4349
[18]Piirainen L,Stenvik M,Roivainen M,et alRandomised,controlled trial with the trypsinmodified inactivated poliovirus vaccine: assessment of intestinal immunity with live challenge virusVaccine,1999,17(9/10):10841090
[19]Plotkin SA,Orenstein WA,Offit PA,et alVaccines fifth editionPhiladelphia:Saunders Elsevier,2008:677678
[20]谢广中,刁连东,王树巧,等预防接种的反应和处理3版上海:上海科学技术出版社,2009:271382

用户评论 0条

用户名: 密码: 登陆 注册
 
  • 9
  • 3
  •  4 : 页次:0/0页 共0条记录 5条/每页
    关于我们 | 专家风采 | 会员注册 | 继续教育
    地 址:北京市西城区东河沿街69号正弘大厦511室 邮 编:100052
    电话:010-51322302
    版权所有 中华医学会及中华预防医学杂志编辑部
    京ICP备 07035254 号