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10年了!千呼万唤的宫颈癌疫苗终于要在国内上市了!

2016-03-10 KL MedSci原创

荆楚网消息:3月8日,在中国癌症基金会宫颈癌健康讲座活动中,华中科技大学同济医学院王增珍教授告诉笔者:“今年内,宫颈癌疫苗将在国内上市。想打疫苗,再也不用奔赴香港或国外了。” 宫颈癌——女性第二位高发肿瘤 据最新2015中国癌症统计报告显示,宫颈癌是除乳腺癌外,女性第二位高发肿瘤,妇科发病率最高的恶性肿瘤,且发病年龄逐渐年轻化。2015年国内宫颈癌新发病例估计9.89万,死亡人

3月8日,在中国癌症基金会宫颈癌健康讲座活动中,华中科技大学同济医学院王增珍教授告诉媒体:“今年内,宫颈癌疫苗将在国内上市。想打疫苗,再也不用奔赴香港或国外了。”

宫颈癌——女性第二位高发肿瘤

据最新2015中国癌症统计报告显示,在女性特有的肿瘤中,乳腺癌位居第一,宫颈癌第二,是最常见的妇科恶性肿瘤,且发病年龄日益年轻化。2015年国内宫颈癌新发病例估计9.89万例,死亡人数有3.05万例,城市高于农村,考虑到缺乏筛查和治疗的人群,实际发病人数应高于统计数据。

HPV疫苗——救命的疫苗

宫颈癌是全球最致命、同时也是最容易预防的女性癌症类型,人乳头瘤病毒(HPV)感染是罪魁祸首,导致了99%的宫颈癌病例。《柳叶刀•肿瘤学》一篇研究显示,正确接种HPV疫苗后,随机感染预防有效率为94%,持续性感染预防有效率为95%,在预防2级及2级以上宫颈上皮内瘤(CIN 2 +)的有效率为86%。

2015美国妇产科医师协会最新宫颈癌筛查指南出台,HPV检测开始成为宫颈癌筛查的主角,细胞学检测成为辅助筛查方法。最新指南的制定是基于2014年美国妇科肿瘤(SGO)和美国阴道镜及宫颈病理协会(ASCCP)联合专家会议,会议肯定了HPV检测更加灵敏,阴性结果更加安全。

作为世界上第一个肿瘤疫苗,全球上市时间已经整整10年了!10年!拯救了无数宫颈癌潜在患者,中国女性HPV16型和HPV18型的感染率为84.5%。理论上说,疫苗对中国女性将更加有效。

上市之路——困难重重

目前,全球有两大HPV疫苗生产商,葛兰素史克的2价疫苗卉妍康和默沙东的4价、9价疫苗佳达修。葛兰素史克在2008年还未获得FDA批准之时,就已开始在中国招募志愿者,为进入中国市场做准备。而默沙东则在2009年2月起,在浙江大学医学院附属妇产科医院等医院进行为期3年的HPV疫苗Ⅲ期临床试验。在经历层层审批,四个时期的临床试验,样本量、重度感染指标不够,延长试验等重重障碍后,今年有望在国内上市。

目前,HPV疫苗已经在超过160多个国家和地区上市,包括日本、我国香港等。我国已有3家企业正式申请了HPV疫苗临床试验。沃森生物、厦门万泰沧海生物技术有限公司、浙江普康生物技术股份有限公司、厦门万泰已于2015年完成III期临床试验。今年内进口疫苗售价约在2000元左右,国产疫苗价格尚不清楚。

如何接种HPV疫苗

HPV疫苗不仅适用于女性,也适用于男性。众所周知,HPV的主要传播途径是性传播,HPV感染可致男性阴茎癌。JAMA最新研究显示,男性患与人乳头瘤病毒(HPV)相关的口腔和喉部癌症的风险是女性的两倍(怎么得的,应该有画面感)。目前,该疫苗可用于宫颈癌、外阴癌、肛门癌及阴道癌等癌症的预防,也可用于预防肛门癌及生殖器疣等疾病。

美国FDA日前批准扩大新一代九价HPV疫苗(佳达修9)的接种范围,将该疫苗接种的男性年龄组从此前的9~15岁扩展为9~26岁年龄组,9~26岁男性和女性均是这种疫苗的适用人群范围。

目前国内推荐的接种年龄为女性9-45岁,最佳年龄为10—14岁。但由于年龄越大,接种HPV疫苗后抗体滴度浓度越低。与16-26岁的人群相比,9-15岁接种疫苗后,抗体滴度可达到前一人群的2倍。
 
HPV疫苗通常采用3针接种,全程6个月内完成可达较好的接种效果。接种后最长保护时间尚不清楚,但不推荐增加注射次数或剂量强化免疫反应。

禁忌症:接种疫苗前已确定妊娠的女性和对酵母过敏的人群不应接种疫苗。

健康的生活方式仍是关键

虽然HPV疫苗预防的有效性高达90%以上,但仍不能100%预防宫颈癌。健康的生活方式,尤其是性生活方式仍是预防宫颈癌的关键。健康生活,早发现,早诊断,早治疗是远离癌症唯一的可行之路。

2016年,全世界都在庆祝宫颈癌疫苗应用十周年取得巨大疾病预防成就之时,如果HPV疫苗能在中国普及,那将是国民一大幸事!

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    2016-03-12 一闲
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    2016-03-11 柳青

    终于等到你了?

    0

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    2016-03-10 1dd82894m82(暂无匿称)

    终于!共党厉害啊!

    0

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    2016-03-10 jiangxianchen

    终于通过了

    0

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    2016-03-10 老刘2991

    好消息

    0

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    2016-03-10 dhzzm

    是否医疗体制有关系

    0

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