临床儿科杂志
臨床兒科雜誌
림상인과잡지
2014年
3期
271-277
,共7页
联合疫苗%免疫原性%安全性%基础免疫
聯閤疫苗%免疫原性%安全性%基礎免疫
연합역묘%면역원성%안전성%기출면역
combined vaccine%immunogenicity%safety%primary immunity
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。
目的:評價吸附無細胞百白破滅活脊髓灰質炎和b型流感嗜血桿菌(結閤()DTaP-IPV/Hib)五聯疫苗與吸附無細胞百白破聯閤(DTaP)疫苗、b型流感嗜血桿菌結閤疫苗(Hib)疫苗、滅活脊髓灰質炎(IPV)疫苗的免疫原性和安全性。方法檢索國內外髮錶的有關DTaP-IPV/Hib聯閤疫苗與DTaP、Hib、IPV疫苗的隨機對照試驗(RCTs)文獻,採用meta分析方法,利用RevMan 5.0軟件評價DTaP-IPV/Hib聯閤疫苗的安全性和免疫原性。結果最終納入6篇英文RCTs。DTaP-IPV/Hib五聯疫苗對百日咳類毒素(PT)產生較高的血清保護性抗體水平(RR=0.26,95%CI:0.14~0.48)。抗百日咳抗體WMD=21.11,95%CI:9.36~32.86,抗1型脊髓灰質炎抗體WMD=59.15,95%CI:2.81~115.48和抗3型脊髓灰質炎抗體WMD=169.82,95%CI:75.33~264.30的抗體滴度水平在DTaP-IPV/Hib聯閤疫苗中均高于單種疫苗。但是抗b型流感嗜血桿菌莢膜多糖抗體的水平WMD=-3.58,95%CI:-5.52~-1.64在DTaP-IPV/Hib五聯疫苗較低。安全性分析結果顯示:紅腫(RR=0.82,95%CI:0.72~0.93)和觸痛(RR=0.45,95%CI:0.30~0.65),在五聯疫苗中髮生率較低,但是腫脹髮生率較高。結論 DTaP-IPV/Hib五聯疫苗在基礎免疫中的免疫原性與安全性與對照疫苗具有可比性。
목적:평개흡부무세포백백파멸활척수회질염화b형류감기혈간균(결합()DTaP-IPV/Hib)오련역묘여흡부무세포백백파연합(DTaP)역묘、b형류감기혈간균결합역묘(Hib)역묘、멸활척수회질염(IPV)역묘적면역원성화안전성。방법검색국내외발표적유관DTaP-IPV/Hib연합역묘여DTaP、Hib、IPV역묘적수궤대조시험(RCTs)문헌,채용meta분석방법,이용RevMan 5.0연건평개DTaP-IPV/Hib연합역묘적안전성화면역원성。결과최종납입6편영문RCTs。DTaP-IPV/Hib오련역묘대백일해류독소(PT)산생교고적혈청보호성항체수평(RR=0.26,95%CI:0.14~0.48)。항백일해항체WMD=21.11,95%CI:9.36~32.86,항1형척수회질염항체WMD=59.15,95%CI:2.81~115.48화항3형척수회질염항체WMD=169.82,95%CI:75.33~264.30적항체적도수평재DTaP-IPV/Hib연합역묘중균고우단충역묘。단시항b형류감기혈간균협막다당항체적수평WMD=-3.58,95%CI:-5.52~-1.64재DTaP-IPV/Hib오련역묘교저。안전성분석결과현시:홍종(RR=0.82,95%CI:0.72~0.93)화촉통(RR=0.45,95%CI:0.30~0.65),재오련역묘중발생솔교저,단시종창발생솔교고。결론 DTaP-IPV/Hib오련역묘재기출면역중적면역원성여안전성여대조역묘구유가비성。
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.