本帖最後由 lsc0019 於 2009-11-4 23:14 編輯
作者：Yael Waknine
出處：WebMD醫學新聞
October 16, 2009 — 美國食品藥物管理局（FDA）已經核准二價（基因重組）人類乳突病毒（HPV）疫苗（Cervarix，格蘭素史克藥廠）用於預防年齡介於10至25歲HPV第16、18型病毒造成的子宮頸癌與癌前病變。
北美藥廠、格蘭素史克藥廠總裁Deirdre Connelly在公司的一篇新聞稿中表示，接種疫苗，例如Cervarix，配合每年就診與進行Pap檢驗，將可以協助保護女性免於罹患子宮頸癌；子宮頸癌是20至30歲女性癌症死亡第二常見原因。
在臨床研究中，疫苗在預防子宮頸癌前病變（子宮頸上皮癌分級≧2以上病灶以及原發性上皮惡性腫瘤）與HPV第16、18型病毒相關癌症上療效達93%，這些約佔了北美子宮頸癌病患的75%。
研究結果也顯示疫苗可以預防70%的癌前病灶，無論HPV亞型；進一步研究分析顯示，對抗因HPV第31型引起病灶的療效約89%，第31型為北美第三常見子宮頸癌病因。
建議疫苗接種療程為0.5 ml肌肉注射一次，之後在1、6個月時再接種兩次。由於可能昏厥的風險，接種疫苗的病患在每次接種後都應該觀察15分鐘。
在這項研究中，病患報告發生率超過20%的不良事件，包括注射部位反應（疼痛、發紅與腫脹）、疲倦、頭痛、肌肉疼痛、腸胃道症狀與關節痛。
二價HPV疫苗過去於歐盟、澳洲、巴西、南韓、墨西哥與台灣核准使用。
四價HPV疫苗（Gardasil，默克藥廠）過去於2006年6月由FDA核准用於因HPV第6、11、16與18型引起的疾病。
FDA Approves Cervarix for Cervical Cancer Prevention
By Yael Waknine
Medscape Medical News
October 16, 2009 — The US Food and Drug Administration has approved a bivalent [recombinant] human papillomavirus (HPV) vaccine (Cervarix, GlaxoSmithKline) for the prevention of cervical cancer and precancers caused by HPV types 16 and 18 in women aged 10 through 25 years.
"Immunization with a vaccine such as Cervarix — along with annual doctor visits and Pap tests — will help protect women from cervical cancer, the second leading cause of cancer death in women in their twenties and thirties," said Deirdre Connelly, president, North American Pharmaceuticals, GlaxoSmithKline, in a company news release.
In clinical studies, the vaccine demonstrated a 93% efficacy rate for preventing cervical precancer (cervical epithelial neoplasia grade ? 2 lesions and adenocarcinoma in situ) and cancer associated with HPV types 16 and 18, which are responsible for approximately 75% of cervical cancers in North America.
Study results also showed that the vaccine prevented 70% of precancerous lesions, regardless of HPV type; further analysis revealed an approximately 89% efficacy rate against lesions caused by HPV type 31, the third most common cancer-causing type in North America.
The recommended vaccination regimen for the drug consists of a 0.5-mL dose administered intramuscularly at baseline, 1, and 6 months. Because of the risk for syncope, those receiving the vaccine should be observed for 15 minutes after each dose.
Adverse events most commonly reported in more than 20% of study patients included injection site reactions (pain, erythema, and swelling), fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.
The bivalent HPV vaccine previously was approved for use in the European Union, Australia, Brazil, South Korea, Mexico, and Taiwan.
A quadrivalent HPV vaccine (Gardasil, Merck & Company, Inc) previously was approved by the FDA in June 2006 for the prevention of disease caused by HPV types 6, 11, 16, and 18. |
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