国产与进口流行性腮腺炎联合疫苗(MMR)免疫原性与安全性系统评价

目的比较国产与进口含流行性腮腺炎成分的联合疫苗(MMR)接种后的抗体阳转率和副反应发生率,评价二者免疫学效果和安全性的差异,为应对流行性腮腺炎高发病率的情况,甄选安全性强、高效能和经济适用的流行性腮腺炎疫苗提供依据。方法全面收集国内外已发表的研究数据,对国产麻疹风疹腮腺炎联合疫苗(MMR)与进口联合疫苗(MMR)在免疫原性和安全性上进行系统差异性比较。结果经纳入和排除标准筛选,最终提取6篇关于含流行性腮腺炎疫苗成分的国产联合疫苗(MMR)与进口联合疫苗(MMR)免疫原性的文献资料,以接种后腮腺炎抗体阳性率为分析指标,结果显示:国产MMR接种组和进口MMR接种组的抗体阳性率差异无统计学意义RR=0.99,95%CI(0.96,1.03),P=0.671];入选的5篇文献报告了含腮腺炎疫苗成分的国产MMR组和进口MMR组接种后副反应发生率,研究发现:国产MMR接种组和进口MMR接种组在副反应发生率上差异无统计学意义RR=1.05,95%CI(0.87,1.27),P=0.620]。结论在选择联合疫苗预防腮腺炎疾病时,国产MMR和进口MMR具有相同的优势,国产MMR在免疫原性和免疫安全性方面和进口疫苗无明显差异。

Meta-analysis on the immunogenicity and safety of domestic and imported measles,mumps and rubella vaccines

Objective To compare the antibody positive conversion rate, the incidence of side effect and the differences of im- munogenicity and safety between domestic and imported measles, mumps and rubella （MMR） vaccines so as to provide a basis for coping with the status of high incidence of mumps and selecting the safe, high- quality, and affordable mumps vaccines. Methods We collected the data from the studies published in domestic and overseas journals, and then Meta - analysis was per- formed on the differences of immunogenicity and safety between domestic and imported MMR vaccines. Results According to the standards for selection and exclusion, 6 eligible studies regarding the immunogenicity of domestic and imported MMR vaccines were identified in this study. The positive rate of mumps antibody was considered as the analysis indicator, and the results showed that there was no statistically significant difference between the domestic MMR vaccine group and the imported MMR vaccine group （RR =0.99, 95%CI： 0.96, 95%（2/： 1.03, P=0.671）. Meanwhile, 5 of the 6 studies reported the incidence of side effect, and the results based on the 5 studies also showed that there was no statistically significant difference in the incidence of side effect between the domestic MMR vaccine group and the imported MMR vaccine group （RR = 1.05, 95 % CI：0.87, 9596 CI ： 1.27, P = 0. 620）. Conclusions The results suggest that the domestic and imported MMR vaccines show the similar ad- vantages in prevention of mumps; and hence, there is no significant difference in the immunogenicity and safety between the do- mestic and imported MMR vaccines.