Abstract：
This study investigated the efficacy of the prophylactic human papillomavirus (HPV) vaccine, which was initiated between 2009 and 2013 in Japan. The study involved 1529 eligible women aged 16-39 years who visited 11 outpatient clinics in Japan for various reasons. These patients underwent HPV genotype analysis and a Pap test of cervical cell samples. A total of 299 women (19.6%) had received the prophylactic HPV vaccine (bivalent:quadrivalent vaccine ratio = 2:1). Of the 5062 participants in the Japanese Human Papillomavirus Disease Education and Research Survey (J-HERS 2011), which was conducted in the pre-vaccination era, 3236 eligible participants were included as controls. In this study (J-HERS 2021), the highest rate of HPV vaccination (53%) was observed in patients aged 22-27 years. Vaccinated individuals exhibited a 49% rate of protection against low-grade intraepithelial lesions (LSILs) and atypical squamous cells, not excluding high-grade squamous intraepithelial lesions (ASCH) or worse (LSIL/ASCH+), and a 100% rate of protection against high-grade squamous intraepithelial lesions (HSILs) or worse (HSIL+). Significant reductions in HPV16 (95%) and HPV18 (100%) infections were noted, but no differences were observed in HPV6 and HPV11 infections. The prevalences of HPV51 and HPV59 increased with vaccination, although these changes were not confirmed in the comparative study with J-HERS 2011. Comparing the prevaccination (J-HERS 2011) and postvaccination (J-HERS 2021) periods, 43%, 51%, 88%, and 62% reductions in HPV16, HPV18, HPV16/18, and HPV31/58 infection rates were observed, respectively. Similarly, 62% and 71% reductions in LSIL/ASCH+ and HSIL+ rates were noted, respectively. There were 88% and 87% reductions in LSIL/ASCH+ and HSIL+ rates in 16-21- and 28-33-year-old patients, respectively. Bivalent or quadrivalent vaccines provided 100% protection against high-grade squamous cell lesions (suggestive of CIN2 or CIN3) in young women aged <39 years at 9-12 years after initiation of Japan\'s first nationwide HPV vaccination program. Cross-protection against HPV31 and HPV58 is likely to occur, although some HPV-type replacements are inconsistent across vaccination regimens. This demonstrates the effectiveness of the HPV vaccine. However, continuous monitoring of cervical cancer and precancer is necessary in younger generations (born 1997-2007), who were rarely vaccinated due to the prolonged suspension of the vaccine recommendations in Japan.
摘要：
这项研究调查了预防性人乳头瘤病毒（HPV）疫苗的功效，该项目于2009年至2013年在日本启动。该研究涉及1529名年龄在16-39岁之间的合格女性，出于各种原因在日本访问了11家门诊诊所。这些患者接受了HPV基因型分析和宫颈细胞样品的巴氏试验。共有299名妇女(19.6%)接受了预防性HPV疫苗(二价:四价疫苗比率=2:1)。在日本人乳头瘤病毒疾病教育和研究调查（J-HERS2011）的5062名参与者中，这是在疫苗接种前的时代进行的，3236名符合条件的参与者作为对照。在这项研究中（J-HERS2021），在22~27岁的患者中,HPV疫苗接种率最高(53%).接种疫苗的个体对低度上皮内病变（LSILs）和非典型鳞状细胞的保护率为49％，不排除高级别鳞状上皮内病变（ASCH）或更严重的病变（LSIL/ASCH+），对高度鳞状上皮内病变（HSIL）或更严重的病变（HSIL）的保护率为100％。注意到HPV16（95％）和HPV18（100％）感染显着减少，但在HPV6和HPV11感染中没有观察到差异。HPV51和HPV59的患病率随着疫苗接种而增加，尽管在与J-HERS2011的对比研究中未证实这些变化.比较疫苗接种前(J-HERS2011)和疫苗接种后(J-HERS2021)时期，43%,51%,88%,HPV16、HPV18、HPV16/18和HPV31/58感染率下降62%，分别。同样，注意到LSIL/ASCH+和HSIL+率分别降低了62%和71%，分别。在16-21岁和28-33岁的患者中，LSIL/ASCH+和HSIL+的发生率分别降低了88%和87%，分别。二价或四价疫苗在日本首个全国性HPV疫苗接种计划启动后9-12岁时，年龄<39岁的年轻女性对高级别鳞状细胞病变（提示CIN2或CIN3）提供了100％的保护。可能会发生针对HPV31和HPV58的交叉保护，尽管一些HPV型替代方案在不同的疫苗接种方案中不一致.这证明了HPV疫苗的有效性。然而,在年轻一代（1997-2007年出生）中，持续监测宫颈癌和癌前病变是必要的，由于日本长期暂停疫苗推荐，他们很少接种疫苗。
