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的meta分析

Immunogenicity and safety of the acellular pertussis, diphtheria, tetanus,inactivated poliomyelitis, Haemophilus influenza type b conjugate vaccine(DTaP- IPV/Hib combined vaccine): a meta- analysis

目的评价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)(DTaP-IPV/Hib)五联疫苗与吸附无细胞百白破联合(DTaP)疫苗、b型流感嗜血杆菌结合疫苗(Hib)疫苗、灭活脊髓灰质炎(IPV)疫苗的免疫原性和安全性。方法检索国内外发表的有关DTaP-IPV/Hib联合疫苗与DTaP、Hib、IPV疫苗的随机对照试验(RCTs)文献,采用meta分析方法,利用RevMan 5.0软件评价DTaP-IPV/Hib联合疫苗的安全性和免疫原性。结果最终纳入6篇英文RCTs。DTaP-IPV/Hib五联疫苗对百日咳类毒素(PT)产生较高的血清保护性抗体水平(RR=0.26,95%CI:0.14~0.48)。抗百日咳抗体WMD=21.11,95%CI:9.36~32.86,抗1型脊髓灰质炎抗体WMD=59.15,95%CI:2.81~115.48和抗3型脊髓灰质炎抗体WMD=169.82,95%CI:75.33~264.30的抗体滴度水平在DTaP-IPV/Hib联合疫苗中均高于单种疫苗。但是抗b型流感嗜血杆菌荚膜多糖抗体的水平WMD=-3.58,95%CI:-5.52^-1.64在DTaP-IPV/Hib五联疫苗较低。安全性分析结果显示:红肿(RR=0.82,95%CI:0.72~0.93)和触痛(RR=0.45,95%CI:0.30~0.65),在五联疫苗中发生率较低,但是肿胀发生率较高。结论DTaP-IPV/Hib五联疫苗在基础免疫中的免疫原性与安全性与对照疫苗具有可比性。

Objective To evaluate the effectiveness and safety of DTaP-IPV/Hib combined vaccine in comparison with commercially available DTaP （diphtheria, tetanus and pertussis）, Haemophilus influenzae type b （Hib）, tetanus conjugate and IPV monovalent vaccine. Methods Randomized controlled trials （RCTs） on DTaP-IPV/Hib were retrieved by searching international and national databases. The pooled mean difference and relative risk and 95% CI were assessed by meta analysis with RevMan 5.0 software. Results Totally 6 studies were included for the final analysis. The seroprotection/seroconversion level of the Anti-PT （RR=0.26, 95% CI：0.14, 0.48） in combination vaccine was higher. The antibody titer levels of Anti-PT （WMD= 21.11, 95% CI：9.36, 32.86）, Anti-polio typel （WMD=-59.15, 95%CI：2.81, 115.48）, Anti-polio type 3 （WMD=169.82, 95%CI：75.33, 264.30） were higher respectively. But the antibody titer level ofAnti-PRP （WMD=-3.58, 95% CI： -5.52, -1.64） in the combination vaccine group was lower. Redness （RR=0.82, 95%CI：0.72, 0.93） and Tenderness （RR=0.45, 95%CI：0.30, 0.65） were lower in the combination vaccine. Swelling （RR=2.03, 95%CI： 1.02, 4.01） was more common in the patients given the combination vaccine. Conclusions This study supports the conclusion that the DTaP-IPV/Hib combination vaccine is equivalent to the separate injections based on similar antibody responses to the vaccine antigens, effectiveness and safety after primary doses.