摘要
目的评价麻疹-腮腺炎-风疹-水痘四联疫苗的免疫效果和安全性。方法采用Cochrane系统评价的方法,电子检索1990年到2010年4月期间PubMed、BIOSIS Previews、CDSR、Cochrane Library、CBM、CNKI、VIP等,辅以手工检索及追查已纳入文献的参考文献。纳入比较麻疹-腮腺炎-风疹-水痘四联疫苗(MMRV)与麻疹-腮腺炎-风疹三联疫苗和水痘疫苗(MMR+V)分别接种的随机对照试验(RCT)。由两名研究者独立筛选文献、评价质量、提取数据并交叉核对。对符合纳入标准的研究采用RevMan 4.2.10进行Meta分析。结果共纳入5个RCT,其中B级2个,C级3个。Meta分析结果显示,MMRV组和MMR+V组的安全性指标比较:①接种部位疼痛发生率差异无统计学意义[RR=0.94,95%CI(0.83,1.05),P=0.28];②接种部位红肿发生率差异无统计学意义[RR=1.08,95%CI(0.90,1.29),P=0.40];③接种部位硬结发生率差异无统计学意义[RR=1.16,95%CI(0.95,1.43),P=0.14];④接种后发热率差异有统计学意义[RR=1.20,95%CI(1.12,1.29),P<0.000 01];⑤接种后全身皮疹发生率差异无统计学意义[RR=1.18,95%CI(1.00,1.41),P=0.05];两组免疫原性指标比较:①接种后血清麻疹抗体阳转率差异无统计学意义[RR=1.00,95%CI(0.99,1.01),P=0.80];②血清腮腺炎抗体阳转率差异无统计学意义[RR=0.99,95%CI(0.50,1.01),P=0.11];③血清风疹抗体阳转率差异无统计学意义[RR=1.00,95%CI(0.99,1.01),P=0.68];④血清水痘抗体阳转率差异无统计学意义[RR=1.00,95%CI(0.99,1.01),P=0.58]。结论与MMR+V分开接种相比,MMRV四联疫苗具有同等的免疫效果,在免疫安全性方面,除接种后发热率稍高外,其他局部和全身反应性良好。鉴于MMRV四联疫苗在免疫效果和安全性方面的良好表现以及它在减少接种次数方面的作用,认为MMRV四联疫苗可以作为儿童预防接种的候选疫苗进行接种。后续工作中需加强对疫苗新组分引起发热机制的研究。鉴于纳入研究的整体质量不高且数
Objective To evaluate on immunogenicity and safety of measles-mumps-rubella-varicella vaccine. Methods The PubMed,BIOSIS Previews,CDSR,The Cochrane Library,CBM,CNKI and VIP were searched between Jan.1990 and April 2010.Studies were included in the review if they were randomized controlled trials（RCTs）about measles（M）–mumps（M）–rubella（R）and varicella（V）vaccine.Trial screening,data exaction and quality assessment of the included trials were conducted by the method recommended by Cochrane Collaboration.Statistical analyses were conducted by using RevMan 4.2.10 so ware.Results Five RCTs were included.Among those there were 2 trials of B degree and 3 trials of C degree.Meta-analyses showed that to different inoculation methods,（MMRV or MMR＋V）the rate of pain was not significantly different with RR 0.94 and 95%CI 0.83 to 1.05（P=0.28）.The rate of redness was not significantly different with RR 1.08 and 95%CI 0.90 to 1.29（P=0.40）.The rate of hardening was not significantly different with RR 1.16 and 95%CI 0.95 to 1.43（P=0.14）.The rate of fever was significantly different with RR 1.20 and 95%CI 1.12 to 1.29（P0.000 01）.The rate of skin rash was not signi cantly different with RR 1.18 and 95%CI 1.00 to 1.41（P=0.05）.The serum measles antibody positive rate was not significantly different with RR 1.00 and 95%CI 0.99 to 1.01（P=0.68）.The serum mumps antibody positive rate was not signi cantly different with RR 0.99 and 95%CI 0.50 to 1.01（P=0.11）.The serum rubella antibody positive rate was not significantly different with RR 1.00 and 95%CI 0.99 to 1.01（P=0.68）.The serum varicella antibody positive rate was not signi cantly different with RR 1.00 and 95%CI 0.99 to 1.01（P=0.58）.Conclusion Compared with MMR＋V vaccine,the MMRV vaccine has the same immune effect.In respect of immune safety,in addition to higher rate of fever a er vaccination,other local or systemic reaction is good.For the role of reducing vaccination times and good performance on immune effect and
出处
《中国循证医学杂志》
CSCD
2010年第7期862-868,共7页
Chinese Journal of Evidence-based Medicine
关键词
联合疫苗
免疫原性
免疫安全性
系统评价
Combined vaccine
Immunogencity
Immunization safety
System evaluation
