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九价宫颈癌疫苗有条件批准上市

1日,记者从国家药品监督管理局获悉,为加快新药进口注册进程,满足公众用药需求,该局于4月28日有条件批准用于预防宫颈癌的九价人乳头状瘤病毒疫苗(以下简称HPV疫苗)上市。至此,全球已经上市使用的所有HPV疫苗品种在我国均有供应。

据介绍,HPV疫苗是全球首个把癌症作为适应症列入说明书的疫苗。我国批准的九价HPV疫苗由6型、11型、16型、18型、31型、33型、45型、52型、58型HPV的主要衣壳蛋白组成的病毒样颗粒经高度纯化、混合制成。

该疫苗适用于16到26岁的女性,用于预防HPV引起的宫颈癌、外阴癌、阴道癌、肛门癌、生殖器疣、持续感染、癌前病变或不典型病变。对此次批准上市产品或四价HPV疫苗的活性成分或任何辅料成分有超敏反应者禁用;注射此次批准上市产品或四价HPV疫苗后有超敏反应症状者,不应再次接种本品。

至于公众关心的疫苗价数越高是不是越好?北京协和医院妇产科主任医师谭先杰表示,目前全球上市的HPV疫苗有二价、四价、九价三种,“价”代表了疫苗可预防的病毒种类。

二价疫苗,可预防由HPV16和HPV18型病毒感染,适用于9至25岁的女性;四价疫苗可预防6、11、16、18型HPV感染,适用于20至45岁女性。尽管HPV6和HPV11不属于宫颈癌高危型HPV病毒,但它们可以引起外阴尖锐湿疣。

国内研究显示,超过84.5%的宫颈癌由HPV16和HPV18型病毒感染,目前国内上市的二价和四价疫苗,能够防控84.5%宫颈癌风险,而九价疫苗可预防92.1%的宫颈癌。公众可根据自身年龄和经济状况,选择接种不同价型的HPV疫苗。

随着HPV疫苗的走红,人们对宫颈癌似乎也陷入了另外一个误区,认为一旦感染上了HPV病毒,就会发展成癌。对此,北京大学第一医院妇产科宫颈诊疗中心负责人、副主任医师赵健解释,宫颈癌是长期持续感染HPV的结果,有性生活的妇女一生中感染HPV的可能性高达80%,只有极少数人会发展成癌。对大多数人而言,感染了HPV病毒,就像“宫颈得了一场感冒”,不用过于紧张。

 

来源:新华网

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