肾综合征出血热双价疫苗免疫原性和安全性的循证研究

Evaluation on Immunogenicity and Safety of HFRS Bivalent Vaccine by Evidence-based Medicine

目的评价HFRS双价疫苗免疫原性和安全性。方法在《中文科技期刊数据库》、《中国期刊全文数据库》、《万方全文数据库》、《中国生物医学文献数据库》和《中国医院数字图书馆》、MEDLINE和ProQuest数据库中检索,将HFRS双价疫苗免疫原性和安全性研究纳入分析,由2名研究者共同提取和评估数据质量。对观察性研究进行系统综述,利用Review Manager 4.2进行Meta分析。结果共有23篇HFRS双价疫苗免疫原性文献和26篇安全性文献纳入分析。除1篇免疫原性文献为随机对照实验外,其余32篇文献均为类实验。HFRS双价疫苗基础免疫2针组(免疫程序为0、14 d)IgG抗体阳性率在免后1个月内为49.69%～100%,半年后波动在8.45%～52.63%,加强免疫后2周维持在83.02%～100%,加强免疫后0.5～2.5年降至20.60%～48.39%;基础免疫3针组(免疫程序为0、7、28 d)IgG抗体阳性率在免后1个月内为69.41%～100%,1年后为20.93%～37.34%,加强免疫后2周维持在88.37%～100%,加强免疫后0.5～1.5年降至76.47%～77.50%。Meta分析表明,在基础免疫后2周左右时,2针组IgG抗体阳性率低于3针组。16岁以下及60岁以上年龄组抗体阳转率与成人组差异无统计学意义。2针组和3针组局部、全身和异常副反应分别为1.07%～4.50%、0.95%～2.44%、0和0～3.33%、0～2.83%、0.06%～0.25%,16岁以下及60岁以上年龄组副反应与16～60岁人群差异无统计学意义。结论无论2针或3针组HFRS双价疫苗均具有很好的免疫原性和安全性,但在基础免疫后进行加强免疫非常有必要。HFRS双价疫苗在儿童和老人中具有较好的免疫原性和安全性。有必要开展疫苗长期免疫效果研究。

Objective To evaluate the immunogenicity and safety of HFRS bivalent vaccine.Methods The articles about the immunogenicity and safety of HFRS vaccine were searched in the CSJD,CJFD,CNKI,MEDLINE,ProQuest and then were brought into analysis.Two researchers extracted data and evaluated the quality of data together.A systematic review was made and Meta analysis was performed with Review Manager 4.2 software.Results Thirty-three articles,23 articles about immunogenicity and 26 about safety,were included in the analysis.Of the 23 articles about immunogenicity,only one was randomized controlled study,and 22 were quasi experiments.Twenty-six articles about safety were all quasi-experiments.After immunization with two doses of HFRS bivalent vaccine（basic immunization program for the 0,14 d）,the IgG antibody positive rate was 49.69%～100% within the first month,fluctuated between 8.45% and 52.63% half a year later,remained at 83.02%～100% in two weeks after booster immunization and decreased to 20.60%～48.39% between half a year and half past two years after booster immunization.After immunization with three doses of HFRS bivalent vaccine（basic immunization program for the 0,7,28d）,the IgG antibody positive rate was 69.41%～100% within the first month,decreased to 20.93%～37.34% one year later,remained at 88.37%～100% in two weeks after booster immunization and decreased to 76.47%～77.50% between half a year and half past one year after booster immunization.Meta analysis showed that the IgG antibody positive rate of the two-dose recipients（basic immunization program for 0,14 d） was lower than that of the three-dose recipients（basic immunization program for the 0,7,28 d） in about two weeks after basic immunization.The incidences of local reaction,general reaction and abnormal reaction in the two-dose recipients were 1.07%～4.50%,0.95%～2.44%,0 and those in the three-dose recipients were 0～3.33%,0～2.83%,0.06%～0.25% respectively.The antibody positive rates and the incidences of side effects in the age groups under 16 and over 60 years were not significantly different from those of the people aged 16～60 years.Conclusions Two-dose immunization program and three-dose immunization program both have good immunogenicity and safety,but booster immunization after basic immunization is necessary.HFRS bivalent vaccine has good immunogenicity and safety in both children and the elderly.It is necessary to carry out a long-term study on the immune effects of HFRS vaccine.