(转载)The Lancet Oncology:预防宫颈癌,打一针就行!

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2015-06-1322:10:05 评论 2,090 views
摘要

宫颈癌是全球最致命但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,其中2种基因型(HPV-16/18)占到了70%。接种疫苗是预防宫颈癌的一种有效手段。

宫颈癌

(原文转载自生物谷http://news.bioon.com/article/6670280.html;图片来源于新京报)

宫颈癌是全球最致命但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,其中2种基因型(HPV-16/18)占到了70%。接种疫苗是预防宫颈癌的一种有效手段,当前宫颈癌疫苗的免疫程序通常为2针(0,6个月)或者3针(0,1,6个月)。然而令人担忧的现实情况是,有相当多的年轻女性并没有按规定及时地完成2针或3针注注射。这是否会降低疫苗预防HPV感染的效果呢?近日,来自美国路易斯维尔大学(UL)的研究人员,对宫颈癌疫苗Cervarix(HPV16/18 AS04)2个大规模随机双盲III期研究(NCT00128661,NCT001226810)的数据进行了汇总分析,比较了注射1针、2针、3针疫苗预防HPV感染的有效性。结果发现,接种Cervarix预防主要基因型HPV毒株(HPV-16/18)感染时,接种1针与2针或3针的免疫保护率一样好(85.7% vs 76.0% vs 77.0%)。该项激动人心的研究结果已于近日发表于国际期刊《柳叶刀•肿瘤学》(The Lancet Oncology)(IF=24.752)。

研究的共同作者、路易斯威尔大学医学院Diane Harper博士表示,这些激动人心的发现,有望解决宫颈癌疫苗接种方面存在的严重现实问题,即:有多达三分之二的年轻女性没有及时地完成免疫程序所要求的全部2针或3针接种。而对于卫生当局,这一发现则意味着,尽管大多数女性并没有完成接种程序,但也没有浪费钱。

该研究的数据具有重大的现实意义,相对于目前的2针(0,6个月)和3针(0,1,6个月)免疫程序,1针免疫程序不仅能够提高接种的完成率,还能够降低疫苗接种成本,这将促使更多的发展中国家将HPV疫苗纳入常规的疫苗接种。

人乳头瘤病毒(HPV)是引发宫颈癌的罪魁祸首,导致了99%的宫颈癌病例,其中2种基因型(HPV-16/18)占到了70%。这2种基因型HPV与其他基因型HPV导致了一种名为宫颈重度上皮内瘤样病变(CIN3)的宫颈癌癌前病变。Cervarix(HPV16/18AS04)是英国制药巨头葛兰素史克(GSK)研发的一款宫颈癌疫苗,其2针(0,6)和3针(0,1,6)免疫程序已获全球多个国家批准,并广泛用于年轻女性群体的免疫接种。尽管Cervarix只靶向HPV-16/18毒株,但根据已完成的全部临床数据,Cervarix预防全部基因型HPV毒株所致CIN3的有效率高达93%,与默沙东另一款HPV疫苗Gardasil(4价疫苗)不相上下,后者靶向4种基因型HPV毒株(HPV-6/11/16/18)。2014年12月,FDA批准了Gardasil(9价疫苗),这是Gardasil(4价疫苗)的升级版,涵盖9种基因型HPV毒株(HPV-6/11/16/18/31/33/45/52/58),具有预防大约90%子宫颈、外阴、阴道和肛门癌症的潜力。当然,这取决于疫苗接种率的提高。然而Gardasil 9在提高疫苗接种方面也面临着一些制约因素,包括男性儿童中疫苗接种报销政策的缺乏以及该疫苗的3针(0,1,6)免疫程序。

研究的完整数据:

为了评估疫苗接种少于3针时的有效性,研究人员将NCT00128661(CVT)研究和NCT001226810(PATRICIA)研究进行了汇总分析,这是调查Cervarix在年轻女性群体中预防HPV感染有效性的唯一2个大规模、随机、双盲III期研究。汇总后的结果,有22327人接种3针,1185人接种2针,543例接种1针)。针对HPV-16/18感染的保护率分别为:3针为77.0%(95% CI:74.7–79.1),2针为76.0%(95% CI:62.0–85.3),1针为85.7%(95% CI:70.7–93.7);针对HPV-31/33/45感染的保护率分别为:3针为59.7%(95% CI:56.0–63.0),2针为37.7%(95% CI:12.4–55.9),1针为36.6%(95% CI:-5.4–62.2)。

另一方面,对于接种2针的女性群体,针对HPV-16/18感染,在第1个月接受第2针的保护率为75.3%(95% CI:54.2–87.5),在第6个月接受第2针的保护率为82.6%(95% CI:42.3–96.1,仅来自CVT研究数据)。针对HPV-31/33/45感染,在第1个月接受第2针的保护率为10.2%(95% CI:-42.0–43.3),在第6个月接受第2针的保护率为68.1%(95% CI:27.0–87.0,仅来自CVT研究数据),与接种3针的女性群体中的保护率相似。

数据解读:15-25岁女性群体,接种宫颈癌疫苗Cervarix(HPV16/18 AS04)4年后,针对HPV-16/18感染,接种1针和2针的保护率与接种3针的保护率相当。在6个月间隔接种2针(0,6),额外提供了针对HPV-31/33/45感染的横向保护。这些数据主张对HPV-16/18疫苗的一针有效性进行直接评估。(生物谷Bioon.com)

信源:One dose of GlaxoSmithKline's Cervarix may suffice

文献原文:Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials

DOI: http://dx.doi.org/10.1016/S1470-2045(15)00047-9

Background
There is some evidence to suggest that one or two doses of the HPV vaccine provides similar protection to the three-dose regimen. The main aim of the study was to ascertain HPV-16/18 vaccine efficacy in both full and naive cohorts and to explore protection conferred against non-vaccine HPV types, by number of doses received.

Methods
Summary data from the Costa Rica Vaccine Trial (CVT; NCT00128661) and ~the PATRICIA trial (NCT001226810), two phase 3, double-blind, randomised controlled clinical trials of the HPV-16/18 AS04-adjuvanted vaccine in young women, were combined in a post-hoc analysis (GlaxoSmithKline [GSK] e-track number 202142) to investigate the efficacy of fewer than three doses of the HPV-16/18 vaccine after 4 years of follow-up. Women were randomly assigned to receive three doses of the HPV-16/18 vaccine or to a control vaccine; yet, some received fewer doses. After exclusion of women with less than 12 months of follow-up or those who were HPV-16/18 DNA-positive at enrolment (for the HPV-16/18 endpoint), we calculated vaccine efficacy against one-time detection of incident HPV infections after three, two, and one dose(s). The primary study endpoint was one-time detection of first incident HPV-16/18 infections accumulated during the follow-up phase.

Findings
We assessed vaccine efficacy against incident HPV-16/18 infection in the modified total vaccinated cohort (22 327 received three doses, 1185 two doses, 543 one dose). Vaccine efficacy against incident HPV-16/18 infections for three doses was 77·0% (95% CI 74·7–79·1), two doses was 76·0% (62·0–85·3), and one dose was 85·7% (70·7–93·7). Vaccine efficacy against incident HPV-31/33/45 infections for three doses was 59·7% (56·0–63·0), two doses was 37·7% (12·4–55·9), and one dose was 36·6% (–5·4 to 62·2). Vaccine efficacy against incident HPV-16/18 infection for two-dose women who received their second dose at 1 month was 75·3% (54·2–87·5) and 82·6% (42·3–96·1) for those who received the second dose at 6 months (CVT data only). Vaccine efficacy against HPV-31/33/45 for two-dose women who received their second dose at 6 months (68·1%, 27·0–87·0; CVT data only), but not those receiving it at one month (10·1%, −42·0 to 43·3), was similar to the three-dose group.

Interpretation
4 years after vaccination of women aged 15–25 years, one and two doses of the HPV-16/18 vaccine seem to protect against cervical HPV-16/18 infections, similar to the protection provided by the three-dose schedule. Two doses separated by 6 months additionally provided some cross-protection. These data argue for a direct assessment of one-dose efficacy of the HPV-16/18 vaccine.

Funding
US National Cancer Institute, National Institutes of Health Office of Research on Women's Health, and Ministry of Health of Costa Rica (CVT); GlaxoSmithKline Biologicals SA (PATRICIA).

(原文转载自生物谷http://news.bioon.com/article/6670280.html;图片来源于新京报)

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