摘要
目的评价国产与进口麻疹-腮腺炎-风疹三联疫苗（MMR）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—2014年Pub Med、BIOSIS Previews、CDSR、Cochrane Library、CBM、CNKI和VIP等数据库,纳入比较国产MMR与进口MMR免疫原性和安全性的随机对照试验（RCT）,对符合纳入标准的研究采用Rev Man 4.2.10进行Meta分析。结果共纳入4个RCTs,Meta分析结果显示,国产MMR组和进口MMR组免疫原性指标比较结果显示：⑴麻疹抗体阳转率差异有统计学意义[RR=1.06,95%CI（1.12-1.29）,P〈0.000 01],麻疹抗体几何平均滴度（GMT）差异有统计学意义[WMD=13.05,95%CI（5.11-20.99）,P=0.001],国产MMR接种后麻疹抗体阳转率和麻疹抗体GMT均高于进口MMR组;⑵腮腺炎抗体阳转率差异无统计学意义[RR=0.96,95%CI（0.92-1.01）,P=0.16];⑶风疹抗体GMT差异无统计学意义[WMD=-9.54,95%CI（-72.70-53.61）,P=0.77]。两组安全性指标比较：⑴接种后发热率差异有统计学意义[RR=2.29,95%CI（1.21-4.33）,P=0.01],接种后国产MMR组发热率显著高于进口MMR组;⑵接种对象全身皮疹率差异无统计学意义[RR=1.49,95%CI（0.53-4.19）,P=0.44]。结论与进口MMR相比,国产MMR表现出较好的免疫原性,虽接种后发热率高于进口组,但考虑到国产疫苗的成本较低,适于现阶段在我国推广。
OBJECTIVE To evaluate on immunogenicity and safety of domestic and imported Measles-Mumps-Rubella vaccine.METHODS The PubMed,BIOSIS Previews,CDSR,The Cochrane Library,CBM,CNKI and VIP were searched between Jan 1990 and Dec 2014.Studies were included in the review if they were randomized controlled trials（RCTs） about measles（M）-mumps（M）-rubella（R） vaccine.Trial screening,data exaction and quality assessment of included trials were conducted by method recommended by Cochrane Collaboration.Statistical analyses were conducted by using RevMan 4.2.10 Software.RESULTS 4 RCTs were involved.Meta analysis showed that to different inoculation methods（homegrown MMR group and imported MMR group）.The serum measles antibody positive rate was significantly different[RR=1.06,95%CI（1.12-1.29）,P〈0.000 01].The serum measles antibody GMT was significantly different[WMD=13.05,95%CI（5.11-20.99）,P=0.001].The positive rate and the GMT of measles antibody in the homegrown MMR group were higher than those in the imported MMR group.The serum mumps antibody positive rate was not significantly different[RR=0.96,95%CI（0.92-1.01）,P=0.16].The serum rubella antibody GMT was not significantly different[WMD=-9.54,95%CI（-72.70-53.61）,P=0.77].The rate of fever after inoculation was significantly different[RR=2.29,95%CI（1.21-4.33）,P=0.01].The rate of fever in the domestic MMR group were higher than that in the imported MMR group.The rate of skin rash after inoculation was not significantly different[RR=1A9,5%CI（0.53-4.19）,P=0.44].CONCLUSION Compared with the imported MMR,the domestic MMR was good in immunogenicity,although the incidence of fever was higher than that of the imported group,but the cost of domestic vaccine was low.The domestic MMR was suitable for child at the present stage in China.
出处
《中国初级卫生保健》
2015年第12期61-64,共4页
Chinese Primary Health Care
关键词
麻疹联合疫苗
免疫原性
安全性
国产
进口
measles combined vaccine
immunogenicity
safety
domestic
imported
