国产水痘减毒活疫苗在中国人群中安全性和免疫原性的Meta分析

Meta analysis on the safety and immunogenicity of domestic varicella vaccine among Chinese population

摘要:

目的：评价国产水痘减毒活疫苗在中国人群中的安全性及免疫效果。方法：电子检索1996年1月至2010年6月公开发表的有关水痘减毒活疫苗安全性和免疫原性的研究文献，辅以手工检索以及利用搜索引擎在互联网上查询文献、追查纳入文献的参考文献的综合检索方式，纳入比较中国人群分别接种国产与进口、不同品牌国产水痘减毒活疫苗的随机对照试验。对符合纳入标准的研究采用RevMan 5.0统计分析软件进行Meta分析。结果：有7篇文献符合入选标准，其中涉及国产与进口水痘减毒活疫苗的随机对照试验5项、不同品牌国产水痘减毒活疫苗随机对照试验3项。Meta分析结果显示，安全性指标比较：国产水痘减毒活疫苗与进口水痘减毒活疫苗接种后局部不良反应发生率差异无统计学意义[OR=0.74，95%CI（0.37，1.49），Z=0.83，P=0.40]；全身发热反应发生率差异有统计学意义[OR=2.34，95%CI（1.5，3.64），Z=3.75，P=0.000 2]；全身其他不良反应发生率差异无统计学意义[OR=0.56，95%CI（0.18，1.70），Z=1.03，P=0.30]。不同品牌国产水痘减毒活疫苗接种后局部不良反应发生率差异无统计学意义[OR=0.91，95%CI（0.43，1.91），Z=0.26，P=0.80]；全身发热反应发生率差异无统计学意义[OR=0.80，95%CI（0.59，1.08），Z=1.44，P=0.15]；全身其他不良反应发生率差异无统计学意义[OR=0.89，95%CI（0.50，1.59），Z=0.40，P=0.69]。免疫原性指标比较：国产水痘减毒活疫苗与进口水痘减毒活疫苗接种后血清抗体阳转率差异无统计学意义[OR=1.41，95%CI（0.69，2.87），Z=0.94，P=0.35]；国产水痘减毒活疫苗接种后血清抗体阳转率差异无统计学意义[OR=3.41，95%CI（0.82，14.19），Z=1.68，P=0.09]。结论：与进口水痘减毒活疫苗相比，国产水痘减毒活疫苗具有同等的免疫效果，在安全性方面，除接种后发热率稍高外，其他局部和全身反应性良好。国产水痘减毒活疫苗之间安全性和免疫原性差异无统计学意义。鉴于接种国产水痘减毒活疫苗在安全性和免疫原性方面的良好表现以及价格上的优势，可作为儿童预防水痘经济、安全、有效的选择。

Abstract:

Objective：To evaluate on safety and immunogenicity of domestic varicella vaccine among Chinese population. Methods：The published studies related to safety and immunogenicity of varicella vaccine between January 1996 and June 2010 were searched，sup－plementing by handwork retrieval，search on the internet and references track. Studies were included in the review if they were ran－domized controlled trials（RCTs） between domestic and imported varicella vaccine or among different brands of domestic varicella vac－cines. Statistical analyses were conducted by using RevMan 5.0 software. Results：Seven RCTs were included，among which there are 5 Rcts between domestic and imported varicella vaccine and 3 Rcts among different brands of domestic varicella vaccines. Between domestic and imported vaccine，Meta analysis showed that there was no statistically significant difference in the local reaction inci－dences with OR being 0.74 and 95%CI ranging from 0.37 to 1.49（Z=0.83，P=0.40），there was no statistically significant difference in the systemic fever reaction incidence with OR being 2.34 and 95%CI ranging from 1.5 to 3.64（Z=3.75，P=0.000 2），there was no sta－tistically significant difference in the other systemic reaction incidences with OR being 0.56 and 95%CI ranging from 0.18 to 1.70（Z=1.03，P=0.30）. Among different brands of domestic vaccines，there was no statistically significant difference in the local reaction incidences with OR being 0.91 and 95%CI ranging from 0.43 to 1.91（Z=0.26，P=0.80），there was no statistically significant difference in the systemic fever reaction incidences with OR being 0.80 and 95%CI ranging from 0.59 to 1.08（Z=1.44，P=0.15），there was no sta－tistically significant difference in the other systemic reaction incidences with OR being 0.89 and 95%CI ranging from 0.50 to 1.59（Z=0.40，P=0.69）. Between domestic and imported vaccine，there was no statistically significant difference in the serum antibody se－roconversion incidences with OR being 1.41 and 95%CI rang－ing from 0.69 to 2.87（Z=0.94，P=0.35）. Among different brands of domestic vaccines，there was no statistically significant differ－ence in the serum antibody seroconversion incidenecs with OR being 3.41 and 95%CI ranging from 0.82 to 14.19（Z=1.68，P=0.09）. Conclusions：Domestic varicella vaccine has the same immune effect as imported varicella vaccine. In respect of immune safety，be－sides higher incidences of systemic fever reaction，other local or systemic reactions of domestic varicella vaccine are good. There is no statistical significance in safety and immunogenicity between domestic varicella vaccines. Domestic varicella vaccine can be regarded as the candidate vaccine for children in respect of its effectiveness，safety and cost-saving.