論文標題： Efficacy, effectiveness and safety of vaccination against human papillomavirus in males: a systematic review
期刊：BMC Medicine
作者：Thomas Harder et al
發表時間： 2018/7/18
數字識別碼：10.1186/s12916-018-1098-3
原文連結：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
研究已證明在發生性生活前注射HPV疫苗對女性具有保護作用。但HPV疫苗對男性有效嗎？BMC Medicine最近發表的一篇研究在進行了系統回顧後，就這個問題給出了答案。他們的研究結果在醫學界引起了反響，歐洲一個主要國家已因此更新了HPV疫苗的接種建議。
德國現已建議所有9-14歲的男孩和女孩接種HPV疫苗。
圖片來源：Africa Studio / stock.adobe.com
多年來，科學家們一直試圖開發各類疫苗。他們的努力不僅是為了預防「經典」的可預防疾病，如麻疹或脊髓灰質炎，也是因為期待它們能夠對抗惡性腫瘤等慢性疾病。
2006年，科學家們的努力獲得了成功，他們所研發的抗擊腫瘤疫苗獲得了上市許可。人乳頭瘤病毒（HPV）感染會導致宮頸癌發生，給全球女性帶來了巨大的健康負擔，而HPV疫苗則能夠有效阻斷這種病毒的傳染。因此，世界衛生組織建議為所有女孩接種HPV疫苗，許多國家已將女性HPV疫苗接種納入其國家免疫規劃。
但接種HPV疫苗對男性是否有益呢？在男性中，HPV感染可引起肛門和陰莖的惡性腫瘤，且目前有依據懷疑HPV參與了多種頭頸癌的發病。目前，市場上共兩種疫苗被批准用於預防男性HPV相關腫瘤，批准時間分別為2009年和2016年。
雖然已有文獻對女性接種HPV疫苗的有效性和安全性進行了系統評價，但目前尚無針對男性的同類文章發表。為此，我們在各主要資料庫中系統搜索了迄今為止相關主題的所有研究。
我們最終納入了7項研究（4項隨機試驗和3項非隨機試驗），共5294名受試者。研究結果表明，倘若不考慮研究參與者接種疫苗時是否已感染HPV，疫苗接種對預防持續HPV感染和肛門癌高級別癌前病變的效能僅為中等（分別為46.9％和61.9％）。但在接種時尚未感染HPV的參與者，疫苗的效能顯著提高（預防感染的效能為96％，預防癌前病變的效能為76％）。
這些數據表明，在感染HPV之前（例如發生性生活前）接種HPV疫苗，疫苗具有較好的保護效果，這和之前針對女性的研究結果相似。
我們納入的研究中有兩項報告了接種後的嚴重不良事件。接種後不良事件的發生率非常低（<1％），且接種組和安慰劑組之間沒有顯著差異。研究中發生的接種後不良事件與疫苗本身無關。
總的來說，儘管相關研究數量，證據等級有限，但我們分析後認為，在開始性生活前前對男孩進行HPV疫苗接種是預防男性HPV感染及HPV相關癌前病變的有效安全的措施。
除了學術影響力，我們的研究還直接影響了德國的疫苗接種計劃。德國疫苗接種常設委員會（STIKO）根據我們的研究結論，在2018年6月發布了男孩接種HPV疫苗的建議——德國現已建議所有9-14歲的男孩和女孩接種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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（來源：科學網）
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