|
CERVARIX这种疫苗的靶向对象是HPV16及HPV18。据调查，在日本，大约每15个女性就有一人有感染HPV的可能，而且现在年青女性的患病率也在逐渐提高。在欧美地区开展的四年临床试验结果显示，该疫苗对宫颈癌有100%的预防效果。
Manufacturer:GlaxoSmithKline Pharmaceuticals
Pharmacological Class:Vaccine (HPV)
Active Ingredient(s):Bivalent human papillomavirus (HPV) vaccine types 16 and 18 vaccine; recombinant; aluminum adsorbed; suspension for IM injection; preservative-free.
Indication(s):In females 10–25 years old, to prevent cervical cancer, cervical intraepithelial neoplasia (CIN) grade 1, grade 2 or worse and adenocarcinoma in situ, (AIS), caused by HPV types 16 and 18.
Pharmacology:Cervarix is a non-infectiousvaccinethatcontainsrecombinant L1 protein, the major antigenic protein of the capsid (virus), of oncogenic HPV types 16 and 18.
Clinical Trials:Two trials were conducted to assess the efficacy of Cervarix in preventing CIN2/3 or AIS in 19,778 females 15–25 years of age.
The first study enrolled subjects who were negative for oncogenic HPV DNA (including types 16 and 18 and 12 other types) in cervical samples, seronegative for HPV-16 and HPV-18, and had normal cytology. A follow-up study for Study 1 was begun to assess the vaccine's long-term efficacy, safety, and immunogenicity. In both this study and the extension (with up to 6.4 years follow-up [mean 5.9 years]), efficacy against CIN2/3 or AIS associated with HPV-16 or HPV-18 was 100%.
In Study 2, subjects were vaccinated with Cervarix regardless of their baseline HPV DNA status, serostatus, or cytology. Before vaccination, cervical samples were assessed for oncogenic HPV DNA and serostatus of HPV-16 and HPV-18 antibodies. Efficacy analyses included lesions arising among women regardless of baseline DNA status and serostatus. In this population (naive and non-naive women), Cervarix was effective in the prevention of precancerous lesions or AIS associated with HPV-16 or HPV-18. Among women who were HPV DNA positive regardless of serostatus at baseline, efficacy was not demonstrated against precancerous lesions or AIS associated with HPV-16 or HPV-18. In the population naive to oncogenic HPV, Cervarix reduced the overall incidence of CIN1/2/3 or AIS, CIN2/3 or AIS, and CIN3 or AIS regardless of the HPV DNA type in the lesion. In the naive and non-naive group, the vaccine was shown to be effective against CIN1/2/3 or AIS, CIN2/3 or AIS, and CIN3 or AIS in all women regardless of HPV DNA type in the lesion.
The efficacy of Cervarix in girls 10–14 yearsofageisinferredbasedonimmunogenicity data obtained from Studies 3 and 4. Study 3 compared the immunogenicity of Cervarix to Hepatitis A vaccine. All initially seronegative subjects given the 3-dose course of Cervarix for whom assay results were available converted toseropositive for HPV-16 and HPV-18. In Study 4, the immunogenicity of Cervarix in girls 10–14 years old was compared to that in females 15–25 years old. Measured 1 month after dose 3, the immune responses in the younger group were non-inferior to those of the older group.
Legal Classification:
Rx
Adults & Children:Give by IM inj in deltoid. Each dose is 0.5mL. <10 years: not recommended. Females 10–25 years: Give 1st dose at elected date, 2nd dose 1 month after 1st dose, 3rd dose 6 months after 1st dose.
Monitor 15 minutes post-dose.
Precaution(s):Not a substitute for routine cervical screening.
Immunosuppressed. Latex allergy (prefilled syringes). Pregnancy (Cat.B):
not recommended. Nursing mothers.
Interaction(s):Immunosuppressants: may get suboptimal response.
Adverse Reaction(s):Injection site reactions, fatigue, headache, myalgia, GI upset, arthralgia, syncope (transient tonic-clonic movements, other seizure-like activity possible post-dose).
How Supplied:Single-dose vial—10
Prefilled syr—1, 5
Last Updated:1/7/2010
卉妍康 Cervarix HPV疫苗临床指引
卉妍康 Cervarix疫苗被核准用于10岁至25岁之女性，以预防由HPV 16/18型所引起的偶发性及持续性感染、与这两型病毒相关之子宫颈上皮内赘瘤及癌前病变，从而预防子宫颈癌。
1.适合接种卉妍康 Cervarix疫苗之对象：
各年龄层女性都有可能感染HPV，最理想的状况是能够在感染HPV前便接种HPV疫苗，可以更早达到最佳保护效果，积极防范子宫颈癌的发生。
10岁至25岁的女性，经家长或本人与医师讨论决定后，可以接种卉妍康 Cervarix疫苗。
2.哪些人不可以接种卉妍康 Cervarix疫苗：
(1)对本疫苗的任一成分过敏者。
(2)有急性严重发烧性疾病的患者应延后接种。但若只是出现像感冒这类的轻度感染，则非接种疫苗的禁忌症。
(3)孕妇不建议接种卉妍康 Cervarix疫苗。
3.卉妍康 Cervarix疫苗接种方式：
接种时间为第0、1及6个月，以肌肉注射的方式接种于上臂三角肌部位，共接种3剂。若无法如期接种，也应于一年内接种完毕。理想的接种时程如下：
(1)第一剂：经医师评估后确定接种日期。
(2)第二剂：在第一剂接种后的1个月时接种。
(3)第三剂：在第一剂接种后的6个月时接种。
如果发生疫苗漏打的情形，务必告知医师，医师会依照个人情形调整疫苗接种时程。
4.卉妍康 Cervarix疫苗预防接种期间之怀孕处置：
(1)接种第一剂之后才怀孕，后续剂量必须等产后再继续接种。
(2)接种卉妍康 Cervarix疫苗期间如有怀孕，不需终止怀孕。
5.临床卫教建议内容
(1)卉妍康 Cervarix疫苗乃用于预防而非治疗。
(2)卉妍康 Cervarix疫苗的预期效果：对未感染HPV 16/18型的女性，可预防由HPV16/18型所引起的子宫颈癌病变；可以降低60%~70%罹患子宫颈癌的风险。
(3)加强教育子宫颈抹片的重要性。接种疫苗后，有性行为的女性仍应定期接受子宫颈抹片检查。
(4)接种疫苗前，子宫颈HPV DNA筛检不是必备条件。
(5)接种卉妍康 Cervarix疫苗并不代表可以预防所有性病，所以应保持安全的性行为。
(6)接种卉妍康 Cervarix疫苗期间不要怀孕，所以应采取避孕措施。
6.接种卉妍康 Cervarix疫苗之前哪些事情医师必须知道？
(1)对卉妍康 Cervarix疫苗的任一成分过敏者。
(2)是否为血小板减少症或任何出血性疾病患者，因为这些患者在接受肌肉注射之后可能会发生出血的现象。
(3)孕妇或计画即将怀孕妇女。
(4)正在服用或即将服用的任何药物。
(5)正在罹患子宫颈癌或癌前期的女性，不建议接种卉妍康 Cervarix疫苗。
(6)无论子宫颈抹片检查是否有或曾经有过异常、HPV DNA测试结果是否为阳性，都可以接种卉妍康 Cervarix疫苗。
(7)是否发烧超过37.8℃
7.疫苗接种异常反应报告
有下列疫苗接种异常反应发生时，务必向学会与卫生署单位报告：
(1)于接种卉妍康 Cervarix疫苗期间怀孕。
(2)过敏反应。
(3)重大并发症。
(4)卉妍康 Cervarix疫苗接种后，检验出有HPV第16或18型的感染。 | 
