美国默克制药公司出品的宫颈癌疫苗近日又有新适应症获准，即用于预防由人乳头瘤病毒（HPV）引起的癌症以及预防1、2、三级肛门上皮内瘤变（AIN）。
至此，Gardasil可用于预防由HPV16、18引起的肛门癌以及预防由HPV 6、11、16和18引起的AIN，9-26岁的男性及女性人群均适用。
之前，Gardasil已在美国获准的适应症如下：用于9-26岁的女性群体预防由HPV 16、18引起的宫颈癌、外阴癌和阴道癌；用于9-26岁女性群体预防由HPV 6、11、16、18引起的生殖器疣；以及用于9-26岁男性群体预防由HPV 6、11引起的生殖器疣。
默克相关负责人理查德•霍普特表示，Gardasil最新适应症的获准令人振奋，这个扩大适应症获准之后，不同性别的适用人群都可以利用这种疫苗预防癌症，这样效果会更好。

Advisory Committee on Immunization Practices has voted against Gardasil as a routine immunization for boys and men, although it has been proven to protect against two strains of the human papillomavirus (HPV) that cause cervical cancer, as well as two additional strains that cause genital warts.

The committee did vote, however, almost unanimously, to allow doctors to recommend the vaccine be administered to males to reduce their chances of acquiring genital warts. HPV is a sexually transmitted pathogen that is thought to cause approximately 70 percent of all cervical cancers. In addition, HPV has been connected with more rare forms of cancer of the throat, genitals and anus, as well as genital warts.

Findings have shown that Gardasil is far more effective in females when administered before they become sexually active. Gardasil is not only found to be safe, but also to be nearly 100 percent effective in preventing pre-cancerous cervical lesions from the four HPV strains that it targets. Gardasil for males has been strongly debated since it was first being approved by the U.S. Food and Drug Administration (FDA) in 2006 for use in females.

Advocates for use of Gardasil as a regular immunization among males believe that widespread use of the vaccine may lower cervical cancer rates, since males commonly transmit HPV to females. Although in early October the FDA approved the Gardasil vaccine for use among males aged 9 through 26, results of a study taking place in the same month showed that immunization among males was not cost effective, as costs would outweigh the health benefit of the vaccine.

The results of the final vote by the Advisory Committee on Immunization Practices reported to the U.S. Centers for Disease Control and Prevention (CDC) has apparently put this issue to rest. The vaccine is not approved for boys as part of the routine childhood immunization schedule. The crucial findings of the study published in the British Medical Journal made a comparison between a female-only vaccination program and a co-ed vaccination program.

The analysis was performed by researchers from the Harvard School of Public Health. Jane Kim, lead researcher, an assistant professor of health decision science, said “This study found that while vaccine coverage and capability are high in girls, also boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money.”

The cost of the vaccine versus the number of added years someone would gain by trying the vaccine on the basis of a good value was deemed as having cost-effectiveness ratios ranging from $50,000 to $100,000 per quality-adjusted life year. By assuming lifelong protection among 75 percent coverage, the regular vaccination of girls who were 12 years of age was found to be a fairly good value at less than $50,000 per quality adjusted life year. However, by adding boys of the same age, the cost-effectiveness percentage was increased to over $100,000 per quality adjusted life year.

Today, the CDC recommends Gardasil for girls ages 11 and 12, and for women ages 13 to 26 who have not been vaccinated for the prevention cervical cancer. In the United State alone, this disease claims 4,000 female lives annually. HPV-associated oral carsinoma occurs to a higher degree in men and does so at a younger age and at a more advanced stage than non-HPV-associated oral carcinoma.  If females and males are immunized, one would expect a reciprocal benefit to the population at large. All in all, the development of an FDA-approved vaccine against HPV is a major milestone for public health.

[-产地国家-] 美国
[-所属类别-] 抗癌药物->治疗宫颈癌药物
[-处方药-] 处方药
[-包装规格-] 1支x0.5毫升瓶/盒 10支装 6支装
[-计价单位-] 盒
[-生产厂家中文参考译名-] 默克
[-生产厂家英文名-] Merck & Co., Inc., West Point, PA, USA
[-原产地址英文商品名-] GARDASIL-10x0.5mLVial
[-原产地址英文药品名-] Quadrivalent Human Papillomavirus
(Types 6, 11, 16, 18)
Recombinant Vaccine
[-中文参考商品译名-] 加德西-10x0.5毫升瓶/盒
[-原产地址国家批准上市年份-] 2006/06/08
[-临床试验期-]
[-中文适应病症参考翻译1-] 宫颈癌
[-中文适应病症参考翻译2-] 生殖器疣(尖锐湿疣)
[-中文适应病症参考翻译3-] 癌前或癌前病变
[-中文适应病症参考翻译4-] 癌症