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

摘要

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 interna-tional 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 type1 (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 of Anti-PRP (WMD=-3.58, 95%CI:-5.52,-1.64) in the com-bination 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 combina-tion 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.%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。