【摘要】 目的 评价四价重组登革热减毒活疫苗（CYD-TDV）的免疫原性及安全性。方法 检索相关数据库，将已公开发表有关健康志愿者注射CYD-TDV的免疫原性和安全性的随机对照试验（RCT）纳人分析，将接种程序为0、6、12月这3个剂次的CYD-TDV（干预组）与安慰剂或任何其他疫苗（对照组）进行比较，以组间中和抗体几何平均滴度（GMT）的标准均数差（SMD）以及血清阳性率和不良反应发生的相对危险度（RR）作为研究效应值。以95%的可信区间（95%CI）作为估计值计算，P<0.05为差异统计学意义。结果 共纳入10篇文献进行Meta分析，包括35 362名随机接受CYD-TDV(23 677例)或安慰剂（11 685例）的志愿者。CYD-TDV的GMT合并的总效应值SMD为0.84(95%CI:0.68～0.99)。血清型特异性GMT的SMD分别为DENV1:0.51(95%CI:0.33～0.68),DENV2:0.75(95%CI:0.55～0.95),DENV3:0.89(95%CI:0.58～1.20),DENV4:1.21(95%CI:0.91～1.51)。组间登革热血清阳性率的总效应RR为1.46(95%CI:1.33～1.60)，血清型特异性血清阳性率RR值分别为：DENV1:1.44(95%CI:1.07～1.94),DENV2:1.43(95%CI:1.11～1.85),DENV3:1.47(95%CI:1.18～1.82),DENV4:1.77(95%CI:1.14～2.76)。最常见的不良反应是头痛和注射部位的疼痛，疼痛、红斑和肿胀发生率组间差异有统计学意义（P均<0.05）。结论 针对CYD-TDV的Meta分析结果可知其具有良好的免疫原性和安全性。更多还原

【Abstract】 Objective To evaluate the immunogenicity and safety of tetravalent recombinant dengue attenuated live vaccine(CYD-TDV).Methods After searching the relevant databases,the randomized controlled trials(RCT) in healthy volunteers published for evaluating immunogenicity or safety of CYD-TDV were included. The standard mean difference(SMD)of geometric mean titer(GMT)of the neutralizing antibody between groups and the relative risk(RR)of serum positive rate and adverse reaction were used as the effect values. All estimates were calculated as 95% confidence interval(95% CI),P<0.05 was considered statistically significant.Results A total of 10 articles were included in the Meta analysis,including 35 362 patients who received either CYD-TDV(23 677)or placebo(11 685)randomly. The total GMT(SMD)of the CYD-TDV was 0.84(95%CI:0.68-0.99). The serotype specific GMT were DENV1:0.51(95%CI:0.33-0.68),DENV2:0.75(95%CI:0.55-0.95),DENV3:0.89(95%CI:0.58-1.20),DENV4:1.21(95%CI:0.91-1.51). RR value of serum positive rate of dengue fever was 1.46(95%CI:1.33-1.60). The RR values of serotype specific serum positive rates were as follows:DENV1:1.44(95%CI:1.07-1.94),DENV2:1.43(95%CI:1.11-1.85),DENV3:1.47(95%CI:1.18-1.82),DENV4:1.77(95%CI:1.14-2.76). The most common adverse reactions were headache and pain at the injection site,with statistically significant differences in pain,erythema and swelling between groups(P all<0.05).Conclusion The results of CYD-TDV Meta-analysis show that CYD-TDV had good immunogenicity and safety.更多还原