Wu Qiongyan, Zhao Xiumin, Fu Yunfeng, Wang Xinyu, Zhang Xiaofei, Tian Xun, Cheng Bei, Lu Bingjian, Yu Xiao, Lan Suqiu, Lu Weiguo, Ma Ding, Cheng Xiaodong, Xie Xing
Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Key Laboratory of Women's Reproductive Health of Zhejiang Province, Hangzhou, China.
Cancer Med. 2017 May;6(5):1091-1101. doi: 10.1002/cam4.1060. Epub 2017 Apr 4.
Cytology-based cervical cancer screening is restricted because of a lack of cytologists. Thus, HPV-based instead of cytology-based screening may be a more suitable strategy in China. Here, we assessed the effectiveness of HPV testing (Cobas 4800 Test, Roche) and HPV-based programs to detect high-grade cervical intraepithelial neoplasia (CIN) or cancer compared with cytology (Thinprep, Hologic) and cytology-based programs through a cross-sectional study in 11,064 Chinese women aged 21-65 years who were enrolled from Longyou County in Zhejiang Province, China. The rates of HPV positivity and cytology abnormality were 9.8% and 6.1%, respectively. The HPV positivity rate had two age peaks, 21-24 (15.4%) and 60-65 (14.4%) years. According to adjusted data, HPV testing demonstrated significantly higher sensitivity and negative predictive value (NPV) than cytology for detecting CIN2 or worse (90.0% vs. 66.7%, 99.9% vs. 99.5%), and there was an acceptable specificity (91.3%) and positive predictive value (PPV, 12.5%). Furthermore, primary HPV testing with type 16/18 genotyping showed the highest sensitivity (78.6%) and NPV (99.7%) among four screening strategies, and there was similar specificity (96.8%) and PPV (23.9%) compared with co-testing screening to detect CIN2+, while there were fewer colposcopies (4.2) and tests (106.3) performed than with co-testing and primary cytology screening to detect a case of high-grade CIN. The differences in effectiveness were approximately similar when CIN3+ was the identifying target. Our findings suggest that primary HPV testing with type 16/18 genotyping has a higher sensitivity and NPV, possesses optimal cost/effectiveness in the first round of screening and is a feasible strategy of cervical cancer screening for Chinese women.
由于缺乏细胞病理学家，基于细胞学的宫颈癌筛查受到限制。因此，在中国，基于人乳头瘤病毒（HPV）而非细胞学的筛查可能是一种更合适的策略。在此，我们通过一项横断面研究，对11064名年龄在21至65岁之间、来自中国浙江省龙游县的女性进行了评估，比较了HPV检测（Cobas 4800检测，罗氏公司）及基于HPV的筛查方案与细胞学检查（Thinprep，豪洛捷公司）及基于细胞学的筛查方案在检测高级别宫颈上皮内瘤变（CIN）或癌症方面的有效性。HPV阳性率和细胞学异常率分别为9.8%和6.1%。HPV阳性率有两个年龄高峰，分别为21至24岁（15.4%）和60至65岁（14.4%）。根据校正后的数据，在检测CIN2及以上病变时，HPV检测显示出比细胞学检查显著更高的灵敏度和阴性预测值（NPV）（90.0%对66.7%，99.9%对99.5%），且具有可接受的特异性（91.3%）和阳性预测值（PPV，12.5%）。此外，在四种筛查策略中，16/18型基因分型的HPV初筛显示出最高的灵敏度（78.6%）和NPV（99.7%），在检测CIN2+方面，与联合检测筛查相比，具有相似的特异性（96.8%）和PPV（23.9%），同时与联合检测及细胞学初筛相比，检测一例高级别CIN时所需的阴道镜检查次数（4.2次）和检测次数（106.3次）更少。当以CIN3+为识别目标时，有效性差异大致相似。我们的研究结果表明，16/18型基因分型的HPV初筛具有更高的灵敏度和NPV，在首轮筛查中具有最佳的成本效益，是中国女性宫颈癌筛查的一种可行策略。
