四价HPV疫苗预防宫颈癌、HPV感染相关疾病Meta分析

Efficacy and Safety of Quadrivalent HPV Vaccine in Preventing Cervical Cancer and Infection and Diseases Associated With Vaccine-type HPV:a Meta-analysis

目的:评价四价人乳头瘤病毒(HPV)疫苗预防宫颈癌及HPV相关感染与疾病的有效性与安全性。方法:计算机检索Cochrane图书馆、MEDLINE,EMBASE,NGC和CBM,纳入所有关于四价HPV疫苗的随机对照试验(RCT),2名研究者独立提取数据并进行方法学质量评估。试验数据的统计分析采用Cochrane协作网提供的RevMan4.2软件。结果:共纳入5项RCT,包括23617例女性,Meta分析结果显示:与安慰剂相比,预防性四价疫苗明显降低与HPV6,11,16和18型相关的Ⅱ/Ⅲ级宫颈上皮内瘤样变、原位癌及Ⅱ/Ⅲ级外阴、阴道上皮内瘤样变和外生殖器疣的发病率。主要不良反应较轻微,严重不良反应在疫苗组和安慰剂组保持均衡。结论:四价HPV疫苗对预防相关类型HPV所致宫颈癌及外生殖器病变安全有效。

Objective： To assess the efficacy and safety of prophylactic quadrivalent human papillomavirus （HPV） vaccine in preventing cervical cancer and infection and diseases associated with vaccine-type HPV. Methods： The Coehrane library, MEDLINE, EMBASE, NGC, CBM were searched, the randomised controlled trials （RCTs） about the efficacy and safety of prophylactic quadrivalent HPV vaccine were included. Two reviewers independently abstracted the data and assessed the quality. The data were input and analyzed by RevMan 4.2 software. Results： Five RCTs involving 23, 617 women met the inclusion criteria, meta-analysis showed that prophylactic HPV vaccination was associated with a significant reduction in the frequency of grade2 or 3 cervical intraepithelial neoplasia, adenoearcinoma in situ, grade2 or 3 vulvar intraepithelial neoplasia or vaginal intraepithelial neoplasia and genital warts caused by vaccine-type HPV strains compared with those in the control groups. The major adverse events were minor. The incidence of serious adverse events was balanced between the vaccine and control groups. Conclusion： Prophylactic HPV vaccination was efficacious and safe in preventing cervical cancer and genital diseases associated with vaccine-type HPV.