HPV 疫苗显示持续有效


  August 6, 2007 (西雅图) — 美国食品药物管理局(FDA)在2006年6月核准的四价人类乳突病毒疫苗(Gardasil/Silgard, Merck & Co, Inc) 在预防生殖器疣方面,于接种后3年持续显示有大于99%的效果,因此可以潜在预防包括子宫颈癌、阴道癌、外阴癌、肛门癌四种癌症,这些癌症都是主要或单独由HPV所导致的;以上讯息来自一项合并3个四价HPV 疫苗 ( 6、11、16、18型)随机控制试验、共18,150位妇女的3年追踪效果数据,发表于国际性病研讨会第17届年会中。
  
  主要作者、格鲁吉亚州亚特兰大Emory大学妇产科副教授Kevin Ault医师表示,7,899位预防效果(PP)疫苗效果试验的参与者中—接受完整3剂的妇女确认血清HPV 6、11、16、18型阴性者达到100%;Ault医师认为前几个月发表的研究指出此疫苗对许多疾病有效,可以大大减少HPV相关的发病率;Ault医师参与这三个试验中的其中两个;他补充道,对于临床医师,我认为这些研究发现支持疾病管制局(CDC)公告的26岁以上妇女之预防疫苗建议;试验的参与者的年纪从16到26 岁,来自欧洲、美国和亚洲。
  
  Ault医师表示,疫苗的持续效果是受欢迎的好消息,有90%的生殖器疣是因为HPV 6和11型造成,30%病灶复发,在美国,每天约有10位妇女因为子宫颈癌死亡。
  
  整体观之,PP有2位接种疫苗的病患发生外阴湿疣 (vulvar condyloma),接受安慰剂的7,900位妇女有155人发生;安慰剂组有15例阴道湿疣,接种疫苗者则无;接种疫苗者有单一案例发生鳞状细胞子宫颈癌(squamous cell cervical cancer);值得注意的是,安慰剂组中发生湿疣的81%与 HPV 6或者11型有关;此疫苗迄今没有相关的严重不良反应。
  
  根据未参与此研究的华盛顿大学过敏与感染症副教授Jeanne Marrazzo医师表示,对于仍在观望哪里些病患该接受疫苗,或病患何时该接受疫苗的医师来说,这些有关疫苗效果的新数据提供一个不错的基础,鼓励年轻病患接受疫苗。
  
  Marrazzo医师表示,真正要表述的是,基于这些新的核准后最新数据且研究参与者的持续率相当高,预防HPV是实际的,应提高对此疫苗以及此疫苗预防疣相关疾病的信心;Marrazzo医师也是CDC赞助之西雅图性病–HIV预防中心的医疗主任。
  
  Marrazzo医师表示,当然,抗体反应的耐久性和持续性将是下一个重大议题,但是根据此一研究,很难质疑此疫苗的效果。
  
  Ault 医师和Marrazzo医师的报告没有相关财金关系。
  
  国际性病研讨会第17届年会:摘要131。发表于2007年8月1日。

HPV Vaccine Demonstrates Susta

By Bonnie Darves
Medscape Medical News

August 6, 2007 (Seattle) — The quadrivalent human papillomavirus (HPV) vaccine (Gardasil/Silgard, Merck & Co, Inc) approved by the US Food and Drug Administration in June 2006 continues to demonstrate greater than 99% effectiveness in preventing genital warts (condyloma acuminata) 3 years after immunization, thereby potentially preventing the 4 types of cancer — cervical, vaginal, vulvar, and anal — that are either solely or primarily caused by HPV. Combined 3-year follow-up efficacy data from 3 randomized controlled trials of the quadrivalent HPV vaccine (types 6, 11, 16, and 18), in 18,150 women, were presented here at the 17th Meeting of the International Society for Sexually Transmitted Diseases Research.

Vaccine effectiveness in the 7899 per protocol (PP) participants — women who took all 3 doses and who were confirmed seronegative for HPV types 6, 11, 16, and 18 — reached 100%, according to the study's chief author Kevin Ault, MD, associate professor of obstetrics and gynecology at Emory University in Atlanta, Georgia. "I think the published studies of the last few months indicate that the vaccine is clearly effective against many diseases, which could greatly reduce the morbidity associated with HPV," said Dr. Ault, who was an investigator in 2 of the 3 trials. "For the treating clinician, I think these findings support the [Center for Disease Control and Prevention's] CDC's broad recommendation for prophylactic vaccination" of women from adolescence through age 26 years, he added. The trials' participants ranged from age 16 to 26 years and included women from Europe, the Americas, and Asia.

The vaccine's sustained effectiveness is especially welcome news, Dr. Ault said, considering that 90% of anogenital warts are attributed to HPV types 6 and 11 and that 30% of lesions recur. About 10 women die daily of cervical cancer in the United States alone, Dr. Ault noted.

In all, 2 vaccinated patients in the PP group developed vulvar condyloma compared with 155 of the 7900 women who received placebo; 15 cases of vaginal condyloma occurred in the placebo group, yet none were found in vaccinated women. A single case of squamous cell cervical cancer occurred in a PP patient who received vaccine. Notably, 81% of the condyloma found in the placebo group was associated with HPV type 6 or type 11. The vaccine has not been associated with any severe adverse effects to date.

For physicians who have remained on the fence about which patients to vaccinate and when, these new data on the vaccine's overwhelming effectiveness should provide a sound basis for urging young patients to receive the vaccine, according to Jeanne Marrazzo, MD, MPH, associate professor in the Division of Allergy and Infectious Disease at the University of Washington in Seattle, who was not involved in the study.

"Prevention for HPV is really what this is all about, and this new data, because it's updated, postlicensure data and [the participant] adherence rate for this study was very high, should give providers increased confidence that the vaccine will at least prevent wart-related outcomes," said Dr. Marrazzo, who also is medical director of the CDC-funded sexually transmitted disease–HIV prevention center in Seattle.

"The durability and duration of the antibody response will be the next huge question, of course," Dr. Marrazzo said, "but it's hard to argue with the [vaccine] efficacy now, based on this study."

Dr. Ault and Dr. Marrazzo report no relevant financial relationships.

17th Meeting of the International Society for Sexually Transmitted Diseases Research: Abstract 131. Presented August 1, 2007.

    
相关报导
使用快速筛检问卷确认有遗传性癌症风险的妇女
2016/5/13 上午 09:15:29
Pap vs HPV检查:有做检查都比没做好
2014/6/26 上午 10:02:11
年轻时的性生活与停经时的HPV侦测高峰有关
2012/12/20 下午 05:26:06

上一页
   1   2   3   4   5   6   7   8   9   10  




回上一页