国产轮状病毒疫苗接种效果评价的病例对照研究

The utility of Lanzhou lamb rotavirus vaccine among children under 5 in two vaccination sites of Shenzhen

目的 评价我国国产轮状病毒口服活疫苗上市后的接种效果.方法 对北京市2011年北京地区哨点医院从2011年1月1日到2011年12月31日的5岁以下腹泻患儿,轮状病毒ELISA检测阳性的患儿为本次研究的病例,轮状病毒阴性作为对照,通过回顾患儿的轮状病毒疫苗接种资料进行分析.结果 我国轮状病毒疫苗的接种效果（VE）两剂次及一剂次接种的VE分别为-59％ （95％ CI-260％,30％）及52％（95％ CI-354％,95％）,针对我国2011年的流行毒株G3P[8]型的VE为-29％（95％CI-479％,71％）.结论 本研究数据不支持我国国产轮状病毒疫苗LLR对于轮状病毒腹泻具有良好保护作用的结论,但基于本研究流行病学设计的不足,需要更严谨的设计与研究。

Objective To evaluate the vaccine effectiveness of Lanzhou lamb rotavirus vaccine in post-licensed period.Methods Patients from viral diarrhea surveillance network from Beijing during January to December 2011 who were detected to be rotavirus positive were the cases.Those who were detected to be rotavirus negative to be the controls.Each patient＇s rotavirus vaccination history was reviewed.A case-control study was conducted to evaluate the vaccine effectiveness of LLR.Results The case-control study to evaluate the vaccine effectiveness of LLR showed that VEs of 1 dose and 2 doses are -59% （95% CI-260%,30%）and 52% （95% CI-354%,95%）,respectively.The VE of the dominant rotavirus strain （G3P [8]） is-29% （95% CI-479%,71%）.Conclusion LLR has little impact in protecting children from rotavirus diarrhea according to our data.Based on the limitations of our study,futher studies need to be conducted.