预防性HPV疫苗预防宫颈癌有效性和安全性Meta分析

被引：35

作者：

杨丽

王静

马彩玲

机构：

[1] 新疆医科大学第一附属医院妇科

来源：

中华肿瘤防治杂志 | 2015年 / 22卷 / 09期

关键词：

HPV疫苗; 宫颈癌; 随机对照试验; 系统评价; Meta分析;

D O I：

10.16073/j.cnki.cjcpt.2015.09.018

中图分类号：

R737.33 [子宫肿瘤];

学科分类号：

100214 ;

摘要：

目的系统评价预防性HPV疫苗预防宫颈癌的有效性与安全性。方法计算机全面检索Cochrane Library、PubMed、EMbase、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)以及万方数据库,并辅以手工检索,检索时间从建库至2014-08,查找关于预防性HPV疫苗预防宫颈癌的随机对照研究(randomized control trials,RCT)。由2名评价员按照纳入和排除标准独立进行文献筛选、资料提取和质量评价后,采用RevMan 5.2软件进行Meta分析。结果最终共纳入22篇RCT,包括14项原始研究,8项随访研究。Meta分析结果显示,与对照组相比,预防性HPV疫苗对HPV16和HPV18相关的宫颈上皮内瘤样变(cervical intraepithelial neoplasia,CIN)Ⅱ+感染的相对危险度(RR)及其95%可信区间(95%CI),在按照预案规定(PP)人群分析分别为0.03(0.01～0.07)和0.05(0.02～0.13),在意向性分析(ITT)人群分别为0.51(0.41～0.63)和0.15(0.10～0.22)。HPV疫苗对HPV16和HPV18相关的≥6个月持续性感染的RR及其95%CI,在PP人群分析分别为0.06(0.04～0.08)和0.19(0.12～0.32),在ITT人群分析分别为0.14(0.10～0.21)和0.07(0.02～0.26),HPV疫苗对CINⅠ+感染也有相似的有效性。同时,HPV疫苗对于高风险HPV所引起的CINⅡ+、HPV持续性感染和CINⅠ+也有交叉保护效果,其差异有统计学意义。预防性HPV疫苗的主要不良反应较轻微,严重不良反应和死亡率在疫苗组和对照组保持均衡。结论预防性HPV疫苗对预防宫颈癌前病变及HPV持续性感染显示了高效的保护效应和交叉保护效果,是安全有效的。然而现有报道尚不能提供预防宫颈癌的直接证据,有待开展更多高质量RCT并延长随访时间以进一步验证。

引用

页码：719 / 727

页数：9

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