BMJ:放宽心!亚洲44万人数据:HPV疫苗安全性报告

2021-02-08 MedSci原创 MedSci原创

该研究进一步证实了HPV在亚洲人群的安全性。

宫颈癌是全球女性最常见的癌症之一。2012年,与人类乳头瘤病毒(HPV)相关的癌症新发病例为63万例,其中53万例(84%)确诊为宫颈癌。约26.6万名宫颈癌的妇女因癌症死亡,占全球妇女癌症相关死亡人数的8%。根据世界卫生组织国际癌症研究机构(IARC)最新数据,2020年,全球超过60万女性被新诊断为宫颈癌,超过34万女性被宫颈癌夺走生命。

目前世界卫生组织对HPV免疫接种的建议是优先接种9-14岁未发生性行为的女孩。为此,截止2019年,已有124个国家将HPV疫苗接种政策纳入国家免疫计划。自20166月起,韩国疾病预防控制局也推出了针对12-13岁青春期少女的二价或四价HPV疫苗的两剂计划。在该计划实施第一年,适龄女性第一剂HPV疫苗覆盖率为61.5%,而到2018年,该覆盖率已提高到87.2%。

尽管HPV疫苗在全球范围内被广泛使用,但人们对HPV疫苗接种安全性的担忧一直存在,而证实对疫苗相关严重不良事件的担忧削弱了公众对免疫接种的信心。为此,一项来自韩国的全国性队列研究,对44万亚洲青春期女孩中评估了HPV疫苗接种与不良事件的关联进行了评估,为HPV疫苗用于亚洲人群的安全性增添了重要证据。结果发表在最新的《英国医学杂志》(BMJ)上。

研究人员在2017年1月至2019年12月期间,通过韩国免疫登记信息系统和国家健康信息数据库搜集大型链接数据。研究涵盖了2017年接种过疫苗的441399名11-14岁女孩。其中,382020人接种过HPV疫苗,59379人未接种过HPV疫苗。

该研究的主要结局为33种严重不良事件,包括内分泌(如甲状腺异常、糖尿病等)、胃肠道(克罗恩病、溃疡性结肠炎、胰腺炎、消化性溃疡等)、血管(雷诺氏综合征、静脉血栓栓塞、血管炎、高血压等)、肌肉骨骼、血液病、皮肤病和神经系统疾病等。

结果显示,在随访期间,并未发现上述33个预先定义的HPV疫苗接种相关严重不良事件中。但与非接种组相比,HPV疫苗接种组偏头痛发生风险增加11%,(两组的发病率分别为1235.0例/10万人-年 vs 920.9例/10万人-年)。

进一步使用自控风险区间的二次分析证实,HPV疫苗接种与严重不良事件(包括偏头痛)之间没有直接关联(调整后HR=0.6795%置信区间0.580.78)。同时,不同随访时间(90天、180天和2年)与不同HPV疫苗亚型的结果都是一致稳定的。

为此,研究人员指出,激素变化和月经是偏头痛的常见危险因素,而考虑到HPV疫苗组(12.42岁)和其他疫苗组(11.84岁)的平均年龄差异,以及韩国女孩初潮平均年龄(12.7岁),接种HPV疫苗的女孩更可能发生月经相关的偏头痛。研究的敏感性分析也支持,随着时间的推移,年龄对偏头痛的影响增加。

综上,与先前的欧美相关研究结果一致,该研究进一步证实了HPV在亚洲人群的安全性。

 

参考文献:

Yoon D, et al. Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: nationwide cohort study. BMJ. 2021 Jan 29;372:m4931. doi: 10.1136/bmj.m4931.

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    2021-12-04 gaoxiaoe
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    2021-02-08 ms8000000903832600

    加强HPV疫苗接种 很重要

    0

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    2021-02-09 曹江波

    加强疫苗接种

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    2021-02-08 ms8000000903832600

    加强HPV疫苗接种

    0