人乳头瘤病毒疫苗预防宫颈癌及其相关感染有效性及安全性的Meta分析

被引：21

作者：

杨丽

何艳

马彩玲

机构：

[1] 新疆医科大学第一附属医院妇科

来源：

中国全科医学 | 2015年 / 18卷 / 12期

关键词：

乳头状瘤病毒疫苗; 宫颈肿瘤; 预防; 随机对照试验; Meta分析;

D O I：

暂无

中图分类号：

R737.33 [子宫肿瘤];

学科分类号：

100214 ;

摘要：

目的系统评价人乳头瘤病毒(HPV)疫苗预防宫颈癌及HPV相关感染的有效性与安全性。方法计算机检索Pub Med、EMBase、Cochrane Library、OVID、中国生物医学文献数据库(CBM)、中国知网、万方数据库,并辅以手工检索相关杂志和纳入研究的参考文献,查找关于HPV疫苗预防宫颈癌及HPV相关感染的随机对照研究(RCT),检索时限从建库至2014年7月。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Rev Man 5.2软件进行Meta分析。结果最终纳入23篇RCT。Meta分析结果显示,疫苗组宫颈上皮内瘤样病变(CIN)Ⅱ+发生率、6个月HPV持续性感染发生率、12个月HPV持续性感染发生率、阴道内皮瘤样变(VIN)Ⅱ+/外阴内皮瘤样变(Va IN)Ⅱ+发生率、外生殖器疣发生率、高危型HPV(HR-HPV)相关感染与疾病发生率均低于对照组(P<0.05)。按照预案规定(PP)人群及意向性分析(ITT)人群,疫苗组CINⅡ+发生率、6个月HPV持续性感染发生率、12个月HPV持续性感染发生率、VINⅡ+/Va INⅡ+发生率、外生殖器疣发生率、HR-HPV相关感染与疾病发生率均低于对照组(P<0.05)。疫苗组注射部位相关不良反应发生率高于对照组(P<0.05);疫苗组与对照组系统不良反应发生率、严重不良反应发生率、病死率比较,差异无统计学意义(P>0.05)。结论 HPV疫苗对预防宫颈癌前病变、HPV持续性感染、HPV相关外生殖器病变显示了高效的保护效应和交叉保护效果,因此是安全、有效的。然而现有报道尚未证明HPV疫苗预防宫颈癌的远期疗效,不能提供HPV疫苗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：1415 / 1424

页数：10

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