论文标题： Efficacy, effectiveness and safety of vaccination against human papillomavirus in males: a systematic review

期刊：BMC Medicine

作者：Thomas Harder et al

发表时间： 2018/7/18

数字识别码：10.1186/s12916-018-1098-3

原文链接：https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1098-3?utm_source=WeChat&utm_medium=Social_media_organic&utm_content=DaiDen-BMC-BMC_Medicine-Cancer_Research-China&utm_campaign=BMCF_USG_BSCN_DD_BM_ARTICLE

研究已证明在发生性生活前注射HPV疫苗对女性具有保护作用。但HPV疫苗对男性有效吗？BMC Medicine最近发表的一篇研究在进行了系统回顾后，就这个问题给出了答案。他们的研究结果在医学界引起了反响，欧洲一个主要国家已因此更新了HPV疫苗的接种建议。

德国现已建议所有9-14岁的男孩和女孩接种HPV疫苗。

图片来源：Africa Studio / stock.adobe.com

多年来，科学家们一直试图开发各类疫苗。他们的努力不仅是为了预防“经典”的可预防疾病，如麻疹或脊髓灰质炎，也是因为期待它们能够对抗恶性肿瘤等慢性疾病。

2006年，科学家们的努力获得了成功，他们所研发的抗击肿瘤疫苗获得了上市许可。人乳头瘤病毒（HPV）感染会导致宫颈癌发生，给全球女性带来了巨大的健康负担，而HPV疫苗则能够有效阻断这种病毒的传染。因此，世界卫生组织建议为所有女孩接种HPV疫苗，许多国家已将女性HPV疫苗接种纳入其国家免疫规划。

但接种HPV疫苗对男性是否有益呢？在男性中，HPV感染可引起肛门和阴茎的恶性肿瘤，且目前有依据怀疑HPV参与了多种头颈癌的发病。目前，市场上共两种疫苗被批准用于预防男性HPV相关肿瘤，批准时间分别为2009年和2016年。

虽然已有文献对女性接种HPV疫苗的有效性和安全性进行了系统评价，但目前尚无针对男性的同类文章发表。为此，我们在各主要数据库中系统搜索了迄今为止相关主题的所有研究。

我们最终纳入了7项研究（4项随机试验和3项非随机试验），共5294名受试者。研究结果表明，倘若不考虑研究参与者接种疫苗时是否已感染HPV，疫苗接种对预防持续HPV感染和肛门癌高级别癌前病变的效能仅为中等（分别为46.9％和61.9％）。但在接种时尚未感染HPV的参与者，疫苗的效能显著提高（预防感染的效能为96％，预防癌前病变的效能为76％）。

这些数据表明，在感染HPV之前（例如发生性生活前）接种HPV疫苗，疫苗具有较好的保护效果，这和之前针对女性的研究结果相似。

我们纳入的研究中有两项报告了接种后的严重不良事件。接种后不良事件的发生率非常低（<1％），且接种组和安慰剂组之间没有显著差异。研究中发生的接种后不良事件与疫苗本身无关。

总的来说，尽管相关研究数量，证据等级有限，但我们分析后认为，在开始性生活前前对男孩进行HPV疫苗接种是预防男性HPV感染及HPV相关癌前病变的有效安全的措施。

除了学术影响力，我们的研究还直接影响了德国的疫苗接种计划。德国疫苗接种常设委员会（STIKO）根据我们的研究结论，在2018年6月发布了男孩接种HPV疫苗的建议——德国现已建议所有9-14岁的男孩和女孩接种HPV疫苗。

摘要：

Background

Human papillomavirus (HPV) vaccination is safe and effective in preventing cervical cancer in females. As HPV infections can also induce cancers of the anus, penis and oral cavity, male vaccination is also advocated, but systematic reviews on efficacy and safety in males are lacking.

Methods

We performed a systematic review on the efficacy, effectiveness and safety of HPV vaccination in males of any age. MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov were searched from inception to April 2017.

Results

We identified 5196 articles and seven studies (four randomized controlled trials (RCTs), three non-randomized studies) were included, comprising a total of 5294 participants. Vaccine efficacy against at least 6-month persisting anogenital HPV 16 infections was 46.9% (95% confidence interval (CI) 28.6–60.8%), whereas efficacy against persisting oral infections was 88% (2–98%). A vaccine efficacy of 61.9% (21.4–82.8%) and 46.8% (− 20 to –77.9%) was observed against anal intraepithelial neoplasia grade 2 and grade 3 lesions, respectively. No meaningful estimates were available on vaccine efficacy or effectiveness against penile intraepithelial neoplasia grade 2 or 3, and no data were identified for anal, penile or head and neck squamous cell cancer. In participants who were HPV-seronegative and PCR-negative at enrolment, efficacy against all outcomes was higher as compared to seropositive and/or PCR-positive individuals. Risk of bias was low in three RCTs and high in one, while the three non-randomized studies were at serious to critical risk of bias. Grading of Recommendations Assessment, Development and Evaluation evidence quality was moderate to low for most outcomes.

Conclusions

HPV vaccination in males is moderately effective against persistent anogenital HPV infection and high-grade anal intraepithelial lesions in studies where the population consists mainly of HPV-infected males. Vaccine effectiveness was high in study groups comprising HPV-naïve males. This supports a recommendation for vaccination of boys before the onset of sexual activity with the goal of establishing optimal vaccine-induced protection. Mathematical modelling studies will still be needed to assess the effects of adding males to existing HPV vaccination programs in females.

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https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1123-6?utm_source=Other_website&utm_medium=Website_links&utm_content=DaiDen-BMC-BMC_Medicine-Public_Health-China&utm_campaign=BMCF_USG_BSCN_DD_BMCMedicine

（来源：科学网）