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当前位置:药品说明书与价格首页 >> 抗肿瘤药 >> 新药动态 >> FDA批准默克生产Gardasil疫苗对男性生殖器疣有效

FDA批准默克生产Gardasil疫苗对男性生殖器疣有效

——加拿大批准默克公司宫颈癌疫苗Gardasil

2006-07-20 12:39:14  作者:新特药房  来源:中国医学论坛报  浏览次数:686  文字大小:【】【】【

美国食品和药物管理局(Food and Drug Administration, 简称FDA)周五表示,默克公司(Merck & Co. Inc., MRK, 又名:默沙东公司)生产的Gardasil疫苗能够有效预防男性生殖器疣。
另外,FDA表示,葛兰素史克(Glaxosmithkline)生产的Cervarix疫苗能够有效防止一种引发女性宫颈癌的癌症前期病变。Cervarix已获得美国以外近100个国家的上市批准。
上述两种疫苗将于下周三接受FDA外部医药专家委员会的审核。
 Cervical cancer screening, treatment & prevention
Pap smear

Cervical cancer screening involves routine Pap smears aimed at women with no symptoms. It is a simple painless test in which cells from the cervix and vagina are examined for any abnormalities that could lead to cancer. Fortunately, some early changes in the cervix can be seen long before cancer develops (pre-cancer stage). Once these changes are treated, cancer can be prevented. It is recommended that all women who have ever had sexual intercourse should have regular Pap smears so that problems can be detected early and thus treated before they become serious.

Colposcopy

  • Colposcopy is a way of looking at the cervix through a special magnifying device. This allows us to find problems that cannot be seen by the eye alone. It is a relatively painless procedure in which the cervix is examined under magnification after a mild vinegar-like solution (acetic acid) is applied to the cervix.

  • Biopsies of abnormal areas are taken for further evaluation and treatment can be performed based on these results.

  • The methods of treating pre-cancerous changes of the cervix include laser vaporization, LEEP and cone biopsy with laser, diathermy or knife.



  • LEEP (Loop Electrosurgical Excision Procedure) and Cone Biopsy

    LEEP or cone biopsy are minor surgical procedures that involve removal of a cylindrical or cone-shaped piece of cervix in which abnormal cells are located by using a heated electrical loop wire or with a laser, diathermy or knife respectively. For your comfort, a local anaesthetic is administered prior to the LEEP procedure which takes about 15 minutes. An anaesthetist will discuss the types of pain-relief available to you during your cone biopsy which lasts approximately 20 minutes.



    Cervarix® and Gardasil® Human Papilloma Virus (HPV) vaccination

  • Cervical cancer is the 2nd most common cancer worldwide in women over 15 years of age. Worldwide every 2 minutes a woman dies of cervical cancer. About 500,000 women globally are diagnosed with cervical cancer with an average of 270,000 deaths a year. Sexually active women may be at risk of being affected by cervical cancer or the early stages of the disease irrespective of age and lifestyle.

  • Cervical cancer is the 2nd most common female cancer in Asia and the 5th most common cause of cancer deaths among Singaporean women.

  • There are over 100 identified types of Human Papilloma Virus (HPV), most of which are harmless and asymptomatic. HPV is spread through sexual contact targeting the genitals.

  • There are 15 cancer-causing types which can lead to cervical cancer; HPV 16 and 18 together cause more than 70% of all cervical cancers in Asia Pacific and worldwide. Cancer-causing HPV types 16, 18, 45 and 31 together account for over 80% of cervical cancer cases in Asia Pacific.

    Cervarix®

  • Cervarix® cervical cancer vaccine provides 100% protection against HPV types 16 and 18 associated pre-cancerous lesions. Cervarix® uses the ASO4 adjuvant system technology which induces a stronger and more sustained immune response. Cervarix with AS04 provides cross protection against infection of HPV 45 & 31, which are the 3rd and 4th most common types found in cervical cancer globally.

  • Cervarix® vaccine is indicated in females aged 10 to 25 years for prevention of cervical cancer by protecting against incident and persistent infections as well as lesions caused by cancer-causing HPV types 16 and 18. The primary vaccination course consists of three doses, given at 0, 1 and 6 months. It is not a substitute for routine Pap smears for cervical cancer screening.




    Gardasil®

  • Gardasil® is a vaccine that helps protect against HPV types 6, 11, 16 and 18 which are associated with cervical cancer, precancerous changes of the cervix and vulva, and genital warts. It is estimated that in the absence of vaccination, the majority of sexually active people will be infected by HPV during their lifetime. Many people who have HPV may not show any signs or symptoms, hence they may transmit the virus unknowingly.

  • Children and adolescents aged 9 to 17 years and women aged 18 to 26 years can receive Gardasil®. The vaccine works best when given to persons with no prior HPV contact although possible benefits can be derived in persons who may have had previous HPV exposure. It is given as an injection and a complete course consists of 3 doses where the 2nd and 3rd doses are administered 2 months and 6 months after the 1st dose respectively.

  • This vaccine helps prevent but does not treat these diseases. However it is not a substitute for routine Pap smears for cervical cancer screening.


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