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人乳头瘤病毒疫苗的两剂接种方案:系统评价与荟萃分析

Two-dose schedules for human papillomavirus vaccine: Systematic review and meta-analysis.

作者信息

D'Addario Maddalena, Redmond Shelagh, Scott Pippa, Egli-Gany Dianne, Riveros-Balta A Ximena, Henao Restrepo Ana Maria, Low Nicola

机构信息

Institute of Social and Preventive Medicine (ISPM), University of Bern, Finkenhubelweg 11, 3012 Bern, Switzerland.

Institute of Social and Preventive Medicine (ISPM), University of Bern, Finkenhubelweg 11, 3012 Bern, Switzerland; Department of Pathology, University of Otago, 2 Riccarton Ave., Christchurch 8011, New Zealand.

出版信息

Vaccine. 2017 May 19;35(22):2892-2901. doi: 10.1016/j.vaccine.2017.03.096. Epub 2017 Apr 25.

DOI:10.1016/j.vaccine.2017.03.096
PMID:28455170
Abstract

Simpler schedules for human papillomavirus (HPV) vaccine delivery could improve vaccine coverage and the effectiveness of cervical cancer prevention. The objective of this study was to systematically review evidence about the effects of two-dose compared with three-dose schedules for human papillomavirus (HPV) vaccine and to describe the uptake of two-dose HPV vaccination schedules globally. We searched PubMed, the Cochrane Central Registry of Controlled Trials, trials registers, and manufacturers' databases from their earliest date to February 2016. We selected randomised controlled trials and controlled clinical trials that directly compared HPV vaccine schedules with two or three doses. We extracted data on immunological and clinical outcomes and used meta-analysis where appropriate. We also described the use of two-dose HPV vaccine schedules globally. We screened 1464 items and included seven eligible noninferiority trials in 11 countries. In randomised comparisons amongst adolescent girls (three trials), geometric mean concentrations (GMC) of antibodies against HPV16 and HPV18 were non-inferior or inconclusive, up to 24months after a two-dose compared with a three-dose schedule. One trial with a clinical outcome found no persistent HPV infections occurred after either two or three doses. In non-randomised comparisons, GMC were non-inferior or superior in adolescent girls receiving the two-dose schedule compared with women receiving the three-dose schedule for at least 21months after vaccination. By February 2017, 23 low and middle income and 25 high income countries had adopted a two-dose HPV vaccination schedule. A two-dose HPV vaccine schedule provides satisfactory immunological outcomes in adolescent girls, but uptake globally is limited, particularly in countries with the highest burden of cervical cancer.

摘要

更简化的人乳头瘤病毒(HPV)疫苗接种程序可能会提高疫苗接种覆盖率以及宫颈癌预防的有效性。本研究的目的是系统评价关于两剂次与三剂次人乳头瘤病毒(HPV)疫苗接种程序效果的证据,并描述全球两剂次HPV疫苗接种程序的采用情况。我们检索了PubMed、Cochrane对照试验中心注册库、试验注册库以及制造商数据库,检索时间从各数据库最早记录至2016年2月。我们选择了直接比较两剂次和三剂次HPV疫苗接种程序的随机对照试验和对照临床试验。我们提取了免疫和临床结局的数据,并在适当情况下进行荟萃分析。我们还描述了全球两剂次HPV疫苗接种程序的使用情况。我们筛选了1464篇文献,纳入了11个国家的7项符合条件的非劣效性试验。在青春期女孩中的随机比较(三项试验)中,与三剂次接种程序相比,两剂次接种程序后24个月内,针对HPV16和HPV18抗体的几何平均浓度(GMC)非劣效或结果不确定。一项有临床结局的试验发现,两剂次或三剂次接种后均未发生持续性HPV感染。在非随机比较中,与接受三剂次接种程序的女性相比,接受两剂次接种程序的青春期女孩在接种后至少21个月内GMC非劣效或更高。截至2017年2月,23个低收入和中等收入国家以及25个高收入国家已采用两剂次HPV疫苗接种程序。两剂次HPV疫苗接种程序在青春期女孩中可提供令人满意的免疫结局,但全球采用率有限,尤其是在宫颈癌负担最高的国家。

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