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目的系统评价HPV四价疫苗在健康人群中应用的安全性和免疫原性。方法计算机检索Pub Med、EMbase、The Cochrane Library(2013年第9期)、Web of Science、CBM、CNKI和Wan Fang Data数据库,同时辅以手工检索及追溯纳入文献的参考文献,查找HPV四价疫苗安全性和免疫原性的相关随机对照试验(RCT),检索时限均为建库至2013年10月。由2位评价员按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用Rev Man 5.2软件进行Meta分析。结果最终纳入9篇文献,共8个RCT,合计39 688例患者。安全性指标的Meta分析结果显示:HPV疫苗组的注射不良反应发生率(肿胀和红斑)高于安慰剂组[RR=1.22,95%CI(1.13,1.32),P<0.000 01],但两组系统不良反应发生率[RR=1.03,95%CI(0.99,1.07),P=0.1]和严重不良反应发生率[RR=1.06,95%CI(0.75,1.50),P=0.74]无明显差异。免疫原性指标的Meta分析结果显示:HPV疫苗组各亚型(HPV6、HPV11、HPV16和HPV18)的血清抗体阳转率均高于安慰剂组,其差异均有统计学意义。结论与安慰剂组相比,HPV四价疫苗组具有较高的注射不良反应发生率和高度的免疫原性,可广泛应用于青少年预防人乳头瘤病毒感染的相关疾病。其注射不良反应中主要以局部功能障碍为主,耐受性较好,可安全使用。受纳入研究数量和质量限制,上述结论尚有赖于进一步开展更多大样本、多中心、高质量的RCT加以验证。
Objective To evaluate the safety and immunogenicity of HPV quadrivalent vaccine in healthy population. Methods The databases of Pub Med, EMbase, The Cochrane Library (No.9, 2013), Web of Science, CBM, CNKI and Wan Fang Data were retrieved by computer and supplemented by hand-searched and retrospectively incorporated literature references to find the HPV quadrivalent vaccine Safety and immunogenicity related randomized controlled trials (RCTs), the search time limit are from the database to October 2013. Two reviewers independently screened the literature for inclusion and exclusion, extracted data, and assessed the methodological quality of the included studies. Meta-analysis was performed using Rev Man 5.2 software. The results eventually included 9 articles, a total of 8 RCTs, a total of 39 688 patients. Meta-analysis of safety indicators showed that the incidence of adverse events (swelling and erythema) in the HPV vaccine group was higher than in the placebo group [RR = 1.22, 95% CI (1.13, 1.32), P <0.000 01] The incidence of adverse reactions in the group system [RR = 1.03,95% CI (0.99, 1.07), P = 0.1] and the incidence of serious adverse reactions [RR = 1.06,95% CI (0.75,1.50), P = 0.74] difference. The results of meta-analysis of immunogenicity indicators showed that the seroconversion rates of all the HPV subtypes (HPV6, HPV11, HPV16 and HPV18) in the HPV vaccine group were higher than those in the placebo group, and the differences were statistically significant. Conclusion Compared with the placebo group, the HPV quadrivalent vaccine group has a high incidence of adverse reactions and a high degree of immunogenicity and can be widely used in adolescent prevention of human papillomavirus-related diseases. The main adverse reactions in the injection of the main local dysfunction, tolerance is better, safe to use. Subject to the number of studies and quality constraints, the above conclusion relies on the further validation of larger, multicenter, high-quality RCTs.