DTaP-IPV-Hib-HepB六联疫苗安全性及免疫原性的Meta分析  

Meta⁃analysis of safety and immunogenicity of DTaP⁃IPV⁃Hib⁃HepB hexavaccine

作　　者：刘静文 贾征[2] 罗兴献 傅书勇[1] 杨悦 邢花[1] LIU Jingwen;JIA Zheng;LUO Xingxian;FU Shuyong;YANG Yue;XING Hua(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,Liaoning Province,China;不详)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016 [2]唐山职业技术学院,河北唐山063000 [3]清华大学药学院药品监管科学研究院,北京100000

出　　处：《中国生物制品学杂志》2024年第2期195-201,共7页Chinese Journal of Biologicals

基　　金：2022年辽宁省科学事业公益研究基金(2022JH4/10100040)。

摘　　要：目的 比较接种无细胞百白破-灭活脊髓灰质炎-b型流感嗜血杆菌(结合)-重组乙型肝炎(DTaP-IPV-HibHepB)六联疫苗与DTaP-IPV-Hib五联疫苗加HepB单苗或DTaP-IPV-HepB五联疫苗加Hib单苗后的安全性和免疫原性差异,为六联疫苗在我国上市使用提供参考。方法 检索国内外发表的有关DTaP-IPV-Hib-HepB六联疫苗与无细胞百白破(DTaP)三联疫苗、Hib单苗、IPV单苗、HepB单苗的随机对照临床试验(randomized controlled trial,RCT),采用Meta分析方法,利用Revman 5.4.1软件评价六联疫苗的安全性及免疫原性。结果 共纳入7篇文献,共8个RCT,3429名受试者。安全性Meta分析显示,除接种部位硬结和哭闹外,接种六联疫苗与同时接种五联疫苗加单苗后的注射部位以及全身不良反应发生率差异均无统计学意义(P> 0.05);免疫原性Meta分析显示,接种六联疫苗的各项抗体指标与同时接种五联疫苗/单苗的差异无统计学意义(P> 0.05)。结论 DTaP-IPV-Hib-HepB六联疫苗在基础免疫中的安全性和免疫原性与对照疫苗相当,可应用于婴幼儿群体预防相关疾病。但受纳入研究数量和质量限制,尚有待进一步开展更大样本、多中心、高质量的RCT加以验证。Objective To compare the differences of safety and immunogenicity of DTaP-IPV-Hib-HepB hexavaccine,DTaPIPV-Hib pentavaccine plus HepB single vaccine or DTaP-IPV-HepB pentavaccine plus Hib single vaccine,so as to provide a reference for the marketing and use of hexavaccine in China.Methods Randomized controlled trials(RCTs)of DTaP-IPVHib-HepB hexavaccine,DTaP triple vaccine,Hib,IPV and HepB vaccines published at home and abroad were searched.The safety and immunogenicity of the hexavaccine were evaluated by Meta-analysis using Revman 5.4.1 software.Results A total of 7 articles,8 RCTs and 3429 subjects were included.Meta-analysis of safety showed that there was no significant difference in the incidence of injection site and systemic adverse reactions after vaccination with hexavaccine and pentavaccine plus single vaccine(P>0.05)except for induration at the inoculation site and crying.Meta-analysis of immunogenicity showed no significant difference in antibody indexes after vaccination with hexavaccine and pentavaccine plus single vaccine(P>0.05).Conclusion The safety and immunogenicity of DTaP-IPV-Hib-HepB hexavaccine in basic immunity was comparable to that of the control vaccine,and might be applied to infants and young children to prevent related diseases.However,due to the limitations of the quantity and quality of included studies,the above conclusions still depend on the further development of larger sample,multicenter and high-quality RCTs to verify.

关 键 词：DTaP-IPV-Hib-HepB 六联疫苗 安全性 免疫原性 血清保护性抗体水平 

分 类 号：R183[医药卫生—流行病学]