制造商: 药理分类: 活性成分(补): 临床试验: 在研究二,受试者接种Cervarix的HPV DNA的基线状态,血清状态,或细胞学无关。疫苗接种前,颈椎标本被评定为致癌的HPV DNA与人乳头瘤病毒- 16血清状况和HPV - 18抗体。包括病变的疗效分析,无论是妇女所产生的DNA的基线状态和血清状况。在这个人口(天真和非幼稚的妇女),Cervarix是在癌前病变或与HPV - 16或HPV - 18相关的AIS的有效预防。在妇女被人乳头状瘤病毒DNA阳性谁,无论在基线血清状态,疗效没有表现出对癌前病变或与HPV - 16或HPV - 18相关的AIS的。在人口天真的致癌HPV的Cervarix减少了CIN1/2/3或AIS,为CIN2 / 3或AIS,和CIN3或AIS总发病率无论人乳头状瘤病毒DNA的损伤类型。在幼稚和非幼稚集团,该疫苗被证明是在无论HPV DNA的损伤类型的所有妇女免受CIN1/2/3或认可机构,为CIN2 / 3或AIS,和CIN3或AIS有效。 在女孩的Cervarix疗效10-14岁是从研究的基础上推断3日和4获得免疫原性的数据。研究3比较了Cervarix对甲型肝炎疫苗的免疫原性。所有受试者由于最初阴性检测结果为他们的Cervarix 3剂量当然是可以转换为HPV - 16和HPV - 18阳性。在研究4,Cervarix在10-14岁女孩的免疫原性进行了比较,女性15-25岁了。测量剂量3一个月后,在低年龄组的免疫反应是不逊于老组。 法律分类: 成人和儿童: 警告/注意事项: 互动(补): 不良反应(补): 如何提供: 最后更新: 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-infectious vaccine that contains recombinant 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 years of age is inferred based on immunogenicity 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 to seropositive 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. Warnings/Precautions: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 美国FDA核准Cervarix的用于子宫颈癌预防 美国食品药物管理局(FDA)的已经核准二价(基因重组)人类乳突病毒(HPV)的疫苗(Cervarix的,格兰素史克药厂)用于预防年龄介于10至25岁人乳头瘤病毒第16,18型病毒造成的子宫颈癌与癌前病变。 北美药厂,格兰素史克药厂总裁迪尔德丽康奈利在公司的一篇新闻稿中表示,接种疫苗,例如Cervarix的,配合每年就诊与进行子宫颈抹片检验,将可以协助保护女性免于罹患子宫颈癌;子宫颈癌是20至30岁女性癌症死亡第二常见原因。 在临床研究中,疫苗在预防子宫颈癌前病变(子宫颈上皮癌分级≧2以上病灶以及原发性上皮恶性肿瘤)与人乳头瘤病毒第16,18型病毒相关癌症上疗效达93%,这些约占了北美子宫颈癌病患的75%。 研究结果也显示疫苗可以预防70%的癌前病灶,无论人乳头瘤病毒亚型;进一步研究分析显示,对抗因人乳头瘤病毒第31型引起病灶的疗效约89%,第31型为北美第三常见子宫颈癌病因。 建议疫苗接种疗程为0.5毫升肌肉注射一次,之后在1,6个月时再接种两次。由于可能昏厥的风险,接种疫苗的病患在每次接种后都应该观察15分钟。 在这项研究中,病患报告发生率超过20%的不良事件,包括注射部位反应(疼痛,发红与肿胀),疲倦,头痛,肌肉疼痛,肠胃道症状与关节痛。 二价人乳头瘤病毒疫苗过去于欧盟,澳洲,巴西,南韩,墨西哥与台湾核准使用。 四价人乳头瘤病毒疫苗(Gardasil的默克药厂)过去于2006年6月由美国FDA核准用于因第6,11,16与人乳头瘤病毒18型引起的疾病。 卉妍康Cervarix疫苗—预防子宫颈癌新武器 卉妍康Cervarix疫苗被批准用于10岁至25岁之女性,以预防由HPV16/18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。 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。 1.哪些人不可以接种卉妍康Cervarix疫苗: 2.接种卉妍康Cervarix疫苗之前哪些事情医师必须知道? 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: 3.疫苗接种异常反应报告:有下列疫苗接种异常反应发生时,要向医生报告: 5.临床卫教建议内容 |
卉妍康(cervarix)宫颈癌疫苗简介:
制造商: 葛兰素史克制药
药理分类: 疫苗病毒(HPV)
活性成分(补): 二价人类乳头状瘤病毒(HPV)的疫苗16型和18疫苗;重组;铝吸附;暂停肌注;不含防腐剂。 指示(补): 在女性10-25岁,以预防子 ... 责任编辑:admin |
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