Department of Gynaecology and Obstetrics, Medical University of Vienna, Comprehensive Cancer Center, Währinger Gürtel 18-20, A-1090 Vienna, Austria.
BMJ. 2012 Mar 27;344:e1401. doi: 10.1136/bmj.e1401.
To determine the effect of human papillomavirus (HPV) quadrivalent vaccine on the risk of developing subsequent disease after an excisional procedure for cervical intraepithelial neoplasia or diagnosis of genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.
Retrospective analysis of data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)).
Primary care centres and university or hospital associated health centres in 24 countries and territories around the world.
Among 17,622 women aged 15-26 years who underwent 1:1 randomisation to vaccine or placebo, 2054 received cervical surgery or were diagnosed with genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.
Three doses of quadrivalent HPV vaccine or placebo at day 1, month 2, and month 6.
Incidence of HPV related disease from 60 days after treatment or diagnosis, expressed as the number of women with an end point per 100 person years at risk.
A total of 587 vaccine and 763 placebo recipients underwent cervical surgery. The incidence of any subsequent HPV related disease was 6.6 and 12.2 in vaccine and placebo recipients respectively (46.2% reduction (95% confidence interval 22.5% to 63.2%) with vaccination). Vaccination was associated with a significant reduction in risk of any subsequent high grade disease of the cervix by 64.9% (20.1% to 86.3%). A total of 229 vaccine recipients and 475 placebo recipients were diagnosed with genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia, and the incidence of any subsequent HPV related disease was 20.1 and 31.0 in vaccine and placebo recipients respectively (35.2% reduction (13.8% to 51.8%)).
Previous vaccination with quadrivalent HPV vaccine among women who had surgical treatment for HPV related disease significantly reduced the incidence of subsequent HPV related disease, including high grade disease.
NCT00092521 and NCT00092534.
确定人乳头瘤病毒（HPV）四价疫苗对宫颈上皮内瘤变切除术后或诊断为生殖器疣、外阴上皮内瘤变或阴道上皮内瘤变后发展为后续疾病的风险的影响。
对四价 HPV 疫苗两项国际、双盲、安慰剂对照、随机疗效试验（方案 013（FUTURE I）和方案 015（FUTURE II））的数据进行回顾性分析。
全球 24 个国家和地区的初级保健中心以及大学或医院附属保健中心。
在 17622 名年龄在 15-26 岁之间、1:1 随机接受疫苗或安慰剂治疗的女性中，2054 名女性接受了宫颈手术或诊断为生殖器疣、外阴上皮内瘤变或阴道上皮内瘤变。
在第 1 天、第 2 个月和第 6 个月给予三剂四价 HPV 疫苗或安慰剂。
从治疗或诊断后 60 天开始，HPV 相关疾病的发生率，以每 100 人年风险的女性终点人数表示。
共有 587 名疫苗组和 763 名安慰剂组接受了宫颈手术。疫苗组和安慰剂组随后 HPV 相关疾病的发生率分别为 6.6%和 12.2%（疫苗接种可降低 46.2%（22.5%至 63.2%））。接种疫苗与宫颈任何后续高级别疾病的风险显著降低 64.9%（20.1%至 86.3%）相关。共有 229 名疫苗组和 475 名安慰剂组女性被诊断为生殖器疣、外阴上皮内瘤变或阴道上皮内瘤变，疫苗组和安慰剂组随后 HPV 相关疾病的发生率分别为 20.1%和 31.0%（疫苗接种降低 35.2%（13.8%至 51.8%））。
在因 HPV 相关疾病接受手术治疗的女性中，先前接种四价 HPV 疫苗可显著降低随后 HPV 相关疾病的发生率，包括高级别疾病。
NCT00092521 和 NCT00092534。
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