Dong Binhua, Zou Huachun, Mao Xiaodan, Su Yingying, Gao Hangjing, Xie Fang, Lv Yuchun, Chen Yaojia, Kang Yafang, Xue Huifeng, Pan Diling, Sun Pengming
Laboratory of Gynecologic Oncology, Department of Gynecology, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, P.R. China.
School of Public Health (Shenzhen), Sun Yat-sen University, Shenzhen, P.R. China.
Ther Adv Med Oncol. 2021 Apr 28;13:17588359211010939. doi: 10.1177/17588359211010939. eCollection 2021.
China's Fujian Cervical Pilot Project (FCPP) transitioned cervical cancer screening from high-risk human papillomavirus (HR-HPV) nongenotyping to genotyping. We investigated the clinical impact of this introduction, comparing performance indicators between HR-HPV genotyping combined with cytology screening (HR-HPV genotyping period) and the previous HR-HPV nongenotyping combined with cytology screening (HR-HPV nongenotyping period).
A retrospective population-based cohort study was performed using data from the FCPP for China. We obtained data for the HR-HPV nongenotyping period from 1 January 2012 to 31 December 2013, and for the HR-HPV genotyping period from 1 January 2014 to 31 December 2016. Propensity score matching was used to match women from the two periods. Multivariable Cox regression was used to assess factors associated with cervical intraepithelial neoplasia of grade 2 or worse (CIN2+). The primary outcome was the incidence of CIN2+ in women aged ⩾25 years. Performance was assessed and included consistency, reach, effectiveness, adoption, implementation and cost.
Compared with HR-HPV nongenotyping period, in the HR-HPV genotyping period, more CIN2+ cases were identified at the initial screening (3.06% 2.32%; < 0.001); the rate of colposcopy referral was higher (10.87% 6.64%; < 0.001); and the hazard ratio of CIN2+ diagnosis was 1.64 (95% confidence interval, 1.43-1.88; < 0.001) after controlling for health insurance status and age. The total costs of the first round of screening (US$66,609 US$65,226; = 0.293) were similar during the two periods. Higher screening coverage (25.95% 25.19%; = 0.007), higher compliance with age recommendations (92.70% 91.69%; = 0.001), lower over-screening (4.92% 10.15%; < 0.001), and reduced unqualified samples (cytology: 1.48% 1.73%, = 0.099; HR-HPV: 0.57% 1.34%, < 0.001) were observed in the HR-HPV genotyping period.
Introduction of an HR-HPV genotyping assay in China could detect more CIN2+ lesions at earlier stages and improve programmatic indicators. Evidence suggests that the introduction of HR-HPV genotyping is likely to accelerate the elimination of cervical cancer in China.
中国福建宫颈癌试点项目（FCPP）将宫颈癌筛查从高危型人乳头瘤病毒（HR-HPV）非基因分型转变为基因分型。我们研究了这一转变的临床影响，比较了HR-HPV基因分型联合细胞学筛查（HR-HPV基因分型阶段）与之前的HR-HPV非基因分型联合细胞学筛查（HR-HPV非基因分型阶段）之间的性能指标。
利用中国FCPP的数据进行了一项基于人群的回顾性队列研究。我们获取了2012年1月1日至2013年12月31日HR-HPV非基因分型阶段的数据，以及2014年1月1日至2016年12月31日HR-HPV基因分型阶段的数据。采用倾向得分匹配法对两个阶段的女性进行匹配。多变量Cox回归用于评估与2级或更高级别宫颈上皮内瘤变（CIN2+）相关的因素。主要结局是年龄≥25岁女性中CIN2+的发病率。对性能进行了评估，包括一致性、覆盖范围、有效性、采用率、实施情况和成本。
与HR-HPV非基因分型阶段相比，在HR-HPV基因分型阶段，初次筛查时发现更多CIN2+病例（3.06%对2.32%；P<0.001）；阴道镜转诊率更高（10.87%对6.64%；P<0.001）；在控制了医疗保险状况和年龄后，CIN2+诊断的风险比为1.64（95%置信区间，1.43-1.88；P<0.001）。两个阶段第一轮筛查的总成本相似（66,609美元对65,226美元；P=0.293）。在HR-HPV基因分型阶段，筛查覆盖率更高（25.95%对25.19%；P=0.007），年龄建议依从性更高（92.70%对91.69%；P=0.001），过度筛查更低（4.92%对10.15%；P<0.001），不合格样本减少（细胞学检查：1.48%对1.73%，P=0.099；HR-HPV：0.57%对1.34%，P<0.001）。
在中国引入HR-HPV基因分型检测可在更早阶段检测到更多CIN2+病变，并改善项目指标。有证据表明，引入HR-HPV基因分型可能会加速中国宫颈癌的消除。
