李广;秦逸飞;黄莉声;王卉;刘国炳;

• 1:南方医科大学南方医院妇产科

摘要(Abstract)：

目的:评价九价HPV疫苗在健康人群中应用的安全性。方法:检索PubMed、Cochrane library、EMbase、Web of science、CBM、CNKI及WanFang Data数据库,按纳入和排除标准独立筛查文献,进行方法学质量评价和数据提取。采用RevMan 5.3软件进行数据分析。结果:最终纳入4篇文献,均为随机对照试验(RCT),共27965例患者。Meta分析结果显示,九价HPV疫苗的注射部位不良反应发生率(90.35%vs 84.63%,P<0.001)、全身不良反应发生率(28.94%vs 26.96%,P=0.006)均高于四价HPV疫苗组,九价疫苗的严重不良反应发生率低,但两组无明显差异。结论:与四价HPV疫苗相比,九价HPV疫苗的注射部位不良反应和全身不良反应发生率更高,多为轻度与中度,严重不良反应发生率低。整体来说,九价HPV疫苗耐受性较好,可安全使用。

关键词(KeyWords)： 九价HPV疫苗;四价HPV疫苗;安全性;Meta分析

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 李广;秦逸飞;黄莉声;王卉;刘国炳;

DOI: 10.13283/j.cnki.xdfckjz.2018.12.005

参考文献(References)：

• [1] Torre LA,Bray F,Siegel RL,et al. Global cancer statistics,2012[J].CA Cancer J Clin,2015,65(2):87-108
• [2]陈万青,郑荣寿,张思维,等.2013年中国恶性肿瘤发病和死亡分析[J].中国肿瘤,2017,26(1):1-7
• [3] Hoots BE,Palefsky JM,Pimenta JM,et al.Human papillomavirus type distribution in anal cancer and anal intraepithelial lesions[J]. Int J Cancer,2009,124(10):2375-2383
• [4] De Vuyst H,Clifford GM,Nascimento MC,et al. Prevalence and type distribution of human papillomavirus in carcinoma and intraepithelial neoplasia of the vulva,vagina and anus:a meta-analysis[J]. Int J Cancer,2009,124(7):1626-1636
• [5] FUTURE II Study Group.Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions[J].N Engl J Med,2007,356(19):1915-1927
• [6] Wheeler CMPS,Group VS.Efficacy,safety,and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years:7-year follow-up of the phase 3,double-blind,randomised controlled VIVIANE study[J]. Lancet Infect Dis,2016,16(10):1154-1168
• [7] Goncalves AK,Cobucci RN,Rodrigues HM,et al.Safety,tolerability and side effects of human papillomavirus vaccines:a systematic quantitative review[J]. Brazil J Infect Dis,2014,18(6):651-659
• [8] Joura EA,Giuliano AR,Iversen OE,et al.A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women[J].N Engl J Med,2015,372(8):711-723
• [9] Serrano B,Alemany L,Tous S,et al.Potential impact of a nine-valent vaccine in human papillomavirus related cervical disease[J].Infect Agent Cancer,2012,7(1):38
• [10] Joura EA,Ault KA,Bosch FX,et al. Attribution of 12high-risk human papillomavirus genotypes to infection and cervical disease[J]. Cancer Epidemiol Biomarkers Prev,2014,23(10):1997-2008
• [11]马丁,谢幸,李双,等.九价人乳头状瘤病毒(HPV)疫苗在中国有条件批准的诠释[N].中国医药报,2018-05-18
• [12] Van Damme P,Meijer CJLM,Kieninger D,et al.A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men[J].Vaccine,2016,34(35):4205-4212
• [13] Vesikari T,Brodszki N,van Damme P,et al.A Randomized,Double-Blind,Phase III Study of the Immunogenicity and Safety of a 9-Valent Human Papillomavirus L1Virus-Like Particle Vaccine(V503)Versus Gardasilcin9-15-Year-Old Girls[J]. Pediat Infect Dis J,2015,34(9):992-998
• [14] Moreira EJ,Block SL,Ferris D,et al.Safety profile of the9-Valent HPV vaccine:a combined analysis of 7 Phase III clinical trials[J].Pediat,2016,138(2):1-17
• [15] Vesikari T,Brodszki N,van Damme P,et al.A Randomized,Double-Blind,Phase III Study of the Immunogenicity and Safety of a 9-Valent Human Papillomavirus L1Virus-Like Particle Vaccine(V503)Versus Gardasil?in 9-15-Year-Old Girls[J].Pediat Infect Dis J,2015,34(9):992-998
• [16] Huh WK,Joura EA,Giuliano AR,et al.Final efficacy,immunogenicity,and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16-26 years:a randomised,double-blind trial[J]. Lancet,2017,390(10108):2143-2159
• [17] Yang DY,Bracken K.Update on the new 9-valent vaccine for human papillomavirus prevention[J]. Can Fam Physic,2016,62(5):399-402
• [18] Luxembourg A,Brown D,Bouchard C,et al. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle(VLP)vaccine[J]. Hum Vaccin Immunother,2015,11(6):1313-1322
• [19]赵文华.HPV疫苗预防宫颈癌及HPV相关感染的有效性与安全性[J].中国医药科学,2012,2(20):233-234
• [20] Castellsague X,Giuliano AR,Goldstone S,et al.Immunogenicity and safety of the 9-valent HPV vaccine in men[J].Vaccine,2015,33(48):6892-6901
• [21] Ruiz-Sternberg a M,Moreira ED,Restrepo JA,et al.Efficacy,immunogenicity,and safety of a 9-valent human papillomavirus vaccine in Latin American girls,boys,and young women[J].Papillomavirus Res,2018,5:63-74
• [22] Garland SM,Cheung T,McNeill S,et al.Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine[J].Vaccine,2015,33(48):6855-6864