| 何文刚,赵骏,黄守杰,吴婷.重组人乳头瘤病毒疫苗临床评价研究进展[J].Chinese journal of Epidemiology,2016,37(6):904-908 |
| 重组人乳头瘤病毒疫苗临床评价研究进展 |
| Research progress regarding the clinical evaluation on recombinant human papillomavirus vaccines |
| Received:October 26, 2015 |
| DOI：10.3760/cma.j.issn.0254-6450.2016.06.033 |
| KeyWord: 人乳头瘤病毒 疫苗 临床试验 宫颈癌 |
| English Key Word: Human papillomavirus Vaccine Clinical trials Cervical cancer |
| FundProject:"重大新药创制"科技重大专项(2015ZX09101034);福建省科技创新平台建设计划项目(2014Y2004) |
| Author Name | Affiliation | E-mail | | He Wengang | The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xia Men 361102, China | | | Zhao Jun | The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xia Men 361102, China | | | Huang Shoujie | The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xia Men 361102, China | | | Wu Ting | The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xia Men 361102, China | wuting@xmu.edu.cn |
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| Abstract: |
| HPV感染除能引起尖锐湿疣等良性病变外,还能引起宫颈等生殖器部位恶性肿瘤。目前国外已有3个HPV疫苗上市。临床试验数据表明HPV疫苗对成年年轻女性均具较好的保护性,能预防90%~100%疫苗相关型别HPV感染所致疾病。年长女性接种该疫苗的有效性虽低于成年年轻女性,但仍可受益。在未成年女性中进行的桥接试验表明,9~14岁者接种2针次HPV疫苗的免疫应答非劣效于成年女性接种3针次该疫苗。HPV疫苗能减少高度宫颈上皮内瘤变(CIN2+)患者手术后复发,对非疫苗型别HPV感染也有一定交叉保护作用。HPV疫苗的安全性已被广泛认可,可在适龄女性人群中推广使用。 |
| English Abstract: |
| Human papillomavirus (HPV) is the main cause for cervical cancer, anogenital cancers and genital warts. Three HPV vaccines have been licensed abroad. Data from clinical trials showed high efficacy of the HPV vaccines in young women with 90%-100% vaccine-related HPV diseases prevented. Though efficacy of the vaccine appears lower in older women, this population can still benefit from vaccination. Immunobriging trials show that the two-dose schedule in 9-14 years old girls elicits non-inferior immune response than the three-dose one in young adults. In addition, HPV vaccines can reduce the recurrent rates in CIN2+ patients after therapeutic surgery and the vaccines have cross-protection aganist diseases caused by non-vaccine type HPV. Safety data on HPV vaccines are assuring. Thus HPV vaccine should be widely used in adolescent girls and women of appropriate age groups. |
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