Wang H, Liu Y, Xu H F, Chen P P, Sun X Y, Li M J, Li P Y, Li K Y, Zheng L Y, Liu S Z, Sun X B, Qiao Y L, Zhang S K
Henan Office for Cancer Control and Research, Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital/Henan Engineering Research Center of Cancer Prevention and Control/Henan International Joint Laboratory of Cancer Prevention, Zhengzhou 450008, China.
Henan Office for Cancer Control and Research, Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital/Henan Engineering Research Center of Cancer Prevention and Control/Henan International Joint Laboratory of Cancer Prevention, Zhengzhou 450008, China Center for Global Health, School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
Zhonghua Zhong Liu Za Zhi. 2025 May 23;47(5):435-442. doi: 10.3760/cma.j.cn112152-20240219-00079.
To evaluate the clinical performance of high-risk human papillomavirus (HR-HPV) genotyping in cervical cancer screening. Between June and July 2017, a prospective cervical cancer screening cohort was established in Xiaye Town, Jiyuan City, Henan Province, China by recruiting 3 254 women aged 21 to 64 years. At baseline screening, cervical exfoliated cell specimens were collected for HR-HPV genotyping and liquid-based cytology testing. Follow-ups were conducted over a 3-year period, with cytology testing in the first and second years and both HR-HPV genotyping and cytology testing in the third year. Women meeting the referral criteria were referred for colposcopy, with cervical biopsy and histopathological diagnosis performed as necessary. The endpoint was defined as cervical intraepithelial neoplasia grade 2 (CIN2) or higher confirmed by histopathological diagnosis. The sensitivity and specificity for detecting CIN2 or higher lesions of HR-HPV genotyping were calculated, as well as the cumulative risk of developing CIN2 or higher lesions over the 4-year study period in women with different baseline HR-HPV genotyping results. A total of 2 741 women were included in the statistical analysis. Baseline HR-HPV genotyping detected 453 HR-HPV positive cases (16.53%), including 98 HPV 16/18 positive cases (3.58%) and 355 other HR-HPV positive cases (12.95%). During the 4-year period, 83 cases of CIN2 or higher were diagnosed. The sensitivity and specificity of baseline HR-HPV positivity for CIN2 or higher were 89.16% (95% : 80.66%-94.19%) and 85.74% (95% : 84.36%-87.02%), respectively. The corresponding rates for HPV 16/18 positivity were 43.37% (95% : 33.24%-54.09%) and 97.67% (95% : 97.02%-98.18%). The 4-year cumulative absolute risk of CIN2 or higher was highest in the HPV 16/18 positive group (36.73%, 95% : 27.85%-46.62%), followed by other HR-HPV positive groups (10.70%, 95% : 7.87%-14.38%), and the HR-HPV negative group was the lowest (0.39%, 95% : 0.19%-0.76%). HR-HPV genotyping testing exhibits high sensitivity and specificity for detecting CIN2 or higher lesions in cervical cancer screening. It also provides a scientific basis for stratifying the individual risk of developing CIN2 or higher lesions to guide subsequent management. Therefore, the HR-HPV genotyping testing can be considered as an effective method for cervical cancer screening.
评估高危型人乳头瘤病毒（HR-HPV）基因分型在宫颈癌筛查中的临床性能。2017年6月至7月，在中国河南省济源市下冶镇招募了3254名年龄在21至64岁之间的女性，建立了一个前瞻性宫颈癌筛查队列。在基线筛查时，收集宫颈脱落细胞标本进行HR-HPV基因分型和液基细胞学检测。随访为期3年，第一年和第二年进行细胞学检测，第三年同时进行HR-HPV基因分型和细胞学检测。符合转诊标准的女性被转诊进行阴道镜检查，必要时进行宫颈活检和组织病理学诊断。终点定义为经组织病理学诊断确诊的宫颈上皮内瘤变2级（CIN2）或更高级别。计算HR-HPV基因分型检测CIN2或更高级别病变的敏感性和特异性，以及不同基线HR-HPV基因分型结果的女性在4年研究期内发生CIN2或更高级别病变的累积风险。共有2741名女性纳入统计分析。基线HR-HPV基因分型检测到453例HR-HPV阳性病例（16.53%），其中98例HPV 16/18阳性病例（3.58%），355例其他HR-HPV阳性病例（12.95%）。在4年期间，诊断出83例CIN2或更高级别病例。基线HR-HPV阳性对CIN2或更高级别病变的敏感性和特异性分别为89.16%（95%：80.66%-94.19%）和85.74%（95%：84.36%-87.02%）。HPV 16/18阳性的相应比例分别为43.37%（95%：33.24%-54.09%）和97.67%（95%：97.02%-98.18%）。HPV 16/18阳性组CIN2或更高级别病变的4年累积绝对风险最高（36.73%，95%：27.85%-46.62%），其次是其他HR-HPV阳性组（10.70%，95%：7.87%-14.38%），HR-HPV阴性组最低（0.39%，95%：0.19%-0.76%）。HR-HPV基因分型检测在宫颈癌筛查中对检测CIN2或更高级别病变具有高敏感性和特异性。它还为分层个体发生CIN2或更高级别病变的风险提供了科学依据，以指导后续管理。因此，HR-HPV基因分型检测可被视为一种有效的宫颈癌筛查方法。
