加衛苗
 | |
| 疫苗说明 | |
|---|---|
| 目標 | 人类乳突病毒（16、18、6、11型） |
| 种类 | 蛋白质亚基疫苗 |
| 臨床資料 | |
| 商品名 | Gardasil |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a607016 |
| 给药途径 | 肌肉注射 |
| ATC碼 | |
| 法律規範狀態 | |
| 法律規範 | |
| 识别信息 | |
| CAS号 | 910046-32-1  |
| ChemSpider |
|
加衛苗,（亦作Gardasil、Gardisil、Silgard、recombinant human papillomavirus vaccine [types 6, 11, 16, 18]），[1][2]是人類乳突病毒疫苗的一种，用于预防特定毒株的人类乳突病毒（HPV），[3]特别是6，11，16和18型。[4][5]约70%的子宫颈癌[6][7]，以及大多数的肛门癌[8]、外陰癌、阴道癌[9]和阴茎癌由16和18型HPV病毒感染造成。约90%的尖锐湿疣病例由6型和11型的HPV病毒感染引起。尽管加卫苗不能清除体内已经存在的病毒，仍然推荐HPV阳性患者接种，因为疫苗可以使患者免受其他种类毒株的感染。[10]加卫苗所预防的毒株都是通过性行为传播的。加卫苗在2006年6月8日由美国食药监局认可。至2008年，美国41个州也相继认可了该疫苗。[11]除美国外，还有120个国家认可加卫苗。[12]美国食药监局建议青春期前及无性行为经验的人群接种该疫苗。[4][13][14]
2014年12月，美国食药监局又认可了一支基于加卫苗开发的九价HPV疫苗，加卫-9[注 1]。这支疫苗新增了5种HPV毒株的表面蛋白[注 2][15]。
注解
[编辑]参考
[编辑]- ^ Silgard European Public Assessment Report. 歐洲藥品管理局. 2009-09-25 [2009-12-05]. （原始内容存档于2009-12-26）.
- ^ Waknine, Yael. International Approvals: Singulair and Gardasil/Silgard. Medscape Today. 2006-10-02 [2008-12-18]. （原始内容存档于2013-05-20）.
- ^ Richwine, Lisa. UPDATE 2-U.S. health officials back safety of Merck vaccine. Reuters. 2009-08-20 [2009-11-12]. （原始内容存档于2009-08-27）.
- ^ 4.0 4.1 Markowitz, L. E.; Dunne, E. F.; Saraiya, M.; Lawson, H. W.; Chesson, H.; Unger, E. R.; Centers for Disease Control Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP) (PDF). MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports / Centers for Disease Control. 2007, 56 (RR-2): 1–24 [2016-03-06]. PMID 17380109. （原始内容存档 (PDF)于2015-09-24）.
- ^ Centers for Disease Control and Prevention (CDC). FDA licensure of quadrivalent human papillomavirus vaccine (HPV4, Gardasil) for use in males and guidance from the Advisory Committee on Immunization Practices (ACIP) (PDF). MMWR. Morbidity and mortality weekly report. 2010, 59 (20): 630–632 [2016-03-06]. PMID 20508594. （原始内容存档 (PDF)于2015-09-24）.
- ^ Lowy DR, Schiller JT. Prophylactic human papillomavirus vaccines. J. Clin. Invest. May 2006, 116 (5): 1167–73 [2009-11-12]. PMC 1451224
. PMID 16670757. doi:10.1172/JCI28607. （原始内容存档于2008-12-29）. - ^ Muñoz N, Bosch FX, Castellsagué X. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int. J. Cancer. August 2004, 111 (2): 278–85. PMID 15197783. doi:10.1002/ijc.20244.
- ^ Cortez, Michelle Fay; Pettypiece, Shannon. Merck Cancer Shot Cuts Genital Warts, Lesions in Men (Update2). Bloomberg News. 2008-11-13 [2009-11-12].[永久失效連結]
- ^ FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers (新闻稿). 美國食品藥品監督管理局 (FDA). 2008-09-12 [2009-11-11]. （原始内容存档于2010-03-06）.
- ^ The Ethics of Vaccination. Springer Publishing Company. [2013-09-29].
- ^ The Ethics of vaccination. Springer Publishing Company. [2013-10-03].
- ^ Haupt, Richard; Sings, Heather. The efficacy and safety of the quadrivalent human papillomavirus 6/11/16/18 vaccine gardasil. Journal of Adolescent Health. November 2011, 49 (5): 467–475. PMID 22018560. doi:10.1016/jodohealth.2011.07.003.
- ^ Gardasil full prescribing information (PDF). Merck & Co. [2009-11-11]. （原始内容存档 (PDF)于2012-03-18）.
- ^ Gardasil Vaccine Safety. Vaccine Safety & Availability. 美國食品藥品監督管理局 (FDA). 2009-08-20 [2009-11-11]. （原始内容存档于2009-11-15）.
- ^ FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV (press release). 2014-12-10 [2015-02-28]. （原始内容存档于2015-01-10）.
外部链接
[编辑]- 官方网站
- Silgard EPAR summary for the public（页面存档备份，存于互联网档案馆）
- Shi, L; Sings, HL; Bryan, JT; Wang, B; Wang, Y; Mach, H; Kosinski, M; Washabaugh, MW; Sitrin, R; Barr, E. Gardasil: prophylactic human papillomavirus vaccine development – from bench top to bed-side. Clinical Pharmacology & Therapeutics. February 2007, 81 (2): 259–64. ISSN 0009-9236. doi:10.1038/sj.clpt.6100055.
- Ireland, Corydon. A Cancer Vaccine is Born. Rochester Review (University of Rochester). 2006, 68 (3) [2016-03-06]. （原始内容存档于2016-03-04）.
- Harris, Gardiner. Panel Unanimously Recommends Cervical Cancer Vaccine for Girls 11 and Up. The New York Times. 2006-06-30 [2016-03-06]. （原始内容存档于2017-03-11）.
- Product Approval Information（页面存档备份，存于互联网档案馆） 美國食品藥品監督管理局 (FDA)
- Hellerstein, Myra; Thieroff, Amanda. HPV and You: Girls learn about HPV from the commercials, not the classroom. The Indypendent. 2007-02-01 [2016-03-06]. （原始内容存档于2014-12-24）.
- McNeil, Donald G., Jr. How a Vaccine Search Ended in Triumph. The New York Times. 2006-08-29 [2016-03-06]. （原始内容存档于2016-04-15）.