摘要
目的比较国产与进口水痘疫苗在中国人群中的安全性和免疫效果，为探讨适用于中国人群的疫苗提供循证医学依据。方法以“水痘”（varicella or chickenpox）、“水痘减毒活疫苗”（varicella or chickenpex attenuated live vaccine）、“安全性”（safety）、“免疫效果”（immunogenicity）为关键词，检索1998--2013年公开发表的、符合入选标准的有关水痘疫苗的中英文研究文献，进行Meta分析。结果有12篇文献纳入研究，其中水痘减毒活疫苗（VarV）实验性研究9篇（随机对照试验4篇），病例对照研究3篇。国产与进口VarV局部不良反应RR合并=0．45，95％CI为0．28～0．70（P〈0．05）；全身不良反应RR合并=1．45，95％CI为0．58—3．65（P〉0．05）；抗体阳转率RR合并=1．00，95％CI为0．97—1．02（P〉0．05）；疫苗保护效果OR合并=1，03，95％CI为0．52—2．03（P〉0．05）。结论国产VarV在中国人群中的安全性和免疫效果良好，与进口VarV差异无统计学意义。
Objective To compare the safety and immunogenicity between indigenously produced and imported varicella attenuated live vaccine among Chinese population. Methods All the published studies from 1998 to 2013 on the comparison be- tween indigenously produced and imported Varicella attenuated live vaccine were screened and evaluated, and recta-analysis was performed on safety and immunogenicity using fixed model or random model according the heterogeneity of the studies. Results A total of 12 studies were included, 4 studies were experimental study （4 RCT ）, 3 case-control studies. To compare the indigenously produced and imported varicella attenuated live vaccine, the pooled RR of local reaction was 0.45, 95% CI （0. 28, 0.70 ） ; the pooled RR of systemic reaction was 1.45, 95% CI（0. 58, 3.65） ; the pooled RR of antibody positive rate was 1.00, 95% CI （0.97, 1.02 ） ; the RR of immunogenicity was 1.03, 95% CI（ 0. 52, 2.03 ）. Conclusion There is no statistical difference in safety and immunogenicity between indigenously produced and imported varicella attenuated live vaccine, and the indigenously pro- duced varicella attenuated live vaccine has good prevention immune effect.
出处
《中国学校卫生》
CAS
北大核心
2014年第2期237-239,242,共4页
Chinese Journal of School Health
关键词
水痘疫苗
免疫
META分析
Chickenpox vaccine
Immunity
Meta-analysis
