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【文摘发布】三个随机临床试验合并分析： 4 合
DOI:10.1016/S0140-6736(07)60777-6
TITLE: Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials
AUTHOR: Elmar A Joura MD a, Prof Sepp Leodolter MD a, Prof Mauricio Hernandez-Avila MD b, Prof Cosette M Wheeler PhD c, Gonzalo Perez MD d, Prof Laura A Koutsky PhD e, Prof Suzanne M Garland MD f, Prof Diane M Harper MD g, Prof Grace WK Tang MD h, Prof Daron G Ferris MD i, Prof Marc Steben MD j, Ronald W Jones MD k, Janine Bryan PhD l, Frank J Taddeo PhD l, Oliver M Bautista PhD l, Mark T Esser PhD l, Heather L Sings PhD l, Micki Nelson BS l, John W Boslego MD l, Carlos Sattler MD l, Eliav Barr MD l and Prof Jorma Paavonen MD m
Summary
Background
Vulval and vaginal cancers among younger women are often related to infection with human papillomavirus (HPV). These cancers are preceded by high-grade vulval intraepithelial neoplasia (VIN2–3) and vaginal intraepithelial neoplasia (VaIN2–3). Our aim was to do a combined analysis of three randomised clinical trials to assess the effect of a prophylactic quadrivalent HPV vaccine on the incidence of these diseases.
Methods
18 174 women (16–26 years) were enrolled and randomised to receive either quadrivalent HPV6/11/16/18 L1 virus-like-particle vaccine or placebo at day 1, and months 2 and 6. Individuals underwent detailed anogenital examination at day 1, 1 month after dose three, and at 6–12-month intervals for up to 48 months. Suspect genital lesions were biopsied and read by a panel of pathologists and vaccine HPV type-specific DNA testing was done. The primary endpoint was the combined incidence of VIN2–3 or VaIN2–3 associated with HPV16 or HPV18. Primary efficacy analyses were done in a per-protocol population.
Findings
The mean follow-up time was 3 years. Among women naive to HPV16 or HPV18 through 1 month after dose three (per-protocol population; vaccine n=7811; placebo n=7785), the vaccine was 100% effective (95% CI 72–100) against VIN2–3 or VaIN2–3 associated with HPV16 or HPV18. In the intention-to-treat population (which included 18 174 women who, at day 1, could have been infected with HPV16 or HPV18), vaccine efficacy against VIN2–3 or VaIN2–3 associated with HPV16 or HPV18 was 71% (37–88). The vaccine was 49% (18–69) effective against all VIN2–3 or VaIN2–3, irrespective of whether or not HPV DNA was detected in the lesion. The most common treatment-related adverse event was injection-site pain.
Interpretation
Prophylactic administration of quadrivalent HPV vaccine was effective in preventing high-grade vulval and vaginal lesions associated with HPV16 or HPV18 infection in women who were naive to these types before vaccination. With time, such vaccination could result in reduced rates of HPV-related vulval and vaginal cancers. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领 RESOURCE: The Lancet, Current Issue, Volume 369, Number 9574, 19 May 2007 Contents in Full (The Lancet 2007; 369:1693-1702)
来源：柳叶刀，当前发行，第369卷，编号9574，2007年5月19日详细内容(The Lancet 2007; 369:1693-1702)
DOI:10.1016/S0140-6736(07)60777-6
TITLE: Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials
标题：四价体人类乳头瘤病毒(HPV; HPV-6、HPV-11、HPV-16 和HPV-18型)L1病毒样颗粒疫苗预防高分级外阴和阴道病变的功效：三组随机临床试验联合分析的结果
AUTHOR作者: Elmar A Joura MD a, Prof Sepp Leodolter MD a, Prof Mauricio Hernandez-Avila MD b, Prof Cosette M Wheeler PhD c, Gonzalo Perez MD d, Prof Laura A Koutsky PhD e, Prof Suzanne M Garland MD f, Prof Diane M Harper MD g, Prof Grace WK Tang MD h, Prof Daron G Ferris MD i, Prof Marc Steben MD j, Ronald W Jones MD k, Janine Bryan PhD l, Frank J Taddeo PhD l, Oliver M Bautista PhD l, Mark T Esser PhD l, Heather L Sings PhD l, Micki Nelson BS l, John W Boslego MD l, Carlos Sattler MD l, Eliav Barr MD l and Prof Jorma Paavonen MD m
Summary 摘要Background
Vulval and vaginal cancers among younger women are often related to infection with human papillomavirus (HPV). These cancers are preceded by high-grade vulval intraepithelial neoplasia (VIN2–3) and vaginal intraepithelial neoplasia (VaIN2–3). Our aim was to do a combined analysis of three randomised clinical trials to assess the effect of a prophylactic quadrivalent HPV vaccine on the incidence of these diseases.
背景：年轻女性发生外阴和阴道癌常常与人类乳头瘤病毒(HPV)感染有关。这些癌主要包括高分级的外阴上皮内瘤形成(VIN2–3)和阴道上皮内瘤形成(VaIN2–3)。我们的目标是通过三组随机临床试验的联合分析来评估预防性四价体HPV疫苗在这些疾病发病率中的作用。
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作者:admin@医学,生命科学 2010-09-23 05:11
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