Rao Xuan, Wang Yue-Han, Chen Rui-Zhe, Wu Qian-Qian, Zhang Xiao-Fei, Fu Yun-Feng, Wang Xin-Yu, Li Xiao
Department of Gynecologic Oncology, Women's Hospital, School of Medicine Zhejiang University, Hangzhou, China.
Zhejiang Provincial Key Laboratory of Precision Diagnosis and Therapy for Major Gynecological Diseases, Hangzhou, China.
Ann Med. 2025 Dec;57(1):2451183. doi: 10.1080/07853890.2025.2451183. Epub 2025 Jan 17.
We attempted to evaluate the immediate high-grade squamous intraepithelial lesion-cervical intraepithelial neoplasia grade 2/3 or worse (HSIL-CIN2+/3+, hereafter referred to as CIN2+/3+) risk of specific human papillomavirus (HPV) genotype and form the precise risk-based triage strategy for atypical squamous cells of undetermined significance (ASC-US) women.
The clinical data of ASC-US women who underwent HPV genotyping testing and colposcopy were retrospectively reviewed. The distribution and CIN2+/3+ risks of specific HPV genotype were assessed by three approaches. The risk-based triage strategy was further established, and its efficacy in detecting CIN2+/3+ was estimated.
Totally, 5553 ASC-US women including 3648 HPV-positive and 1905 HPV-negative were analysed. CIN2+/3+ were 662/319 cases, including 639/306 HPV-positive and 23/13 HPV-negative women. HPV16, HPV52, HPV58 and HPV18 were always among the top 5 ranking genotypes, no matter in HPV-positive women or in HPV-positive CIN2+/3+ cases. HPV16 and HPV33 carried the highest risk, while HPV73 and 26 carried the least risk for CIN2+/3+. Based on the immediate CIN2+/3+ risk of specific HPV genotype, 18 HPVs were divided into three risk-stratified groups. Only women infected with HPVs included in group A were necessary for immediate colposcopy. Compared with conventional strategy, this new risk-based strategy not only had higher specificity (CIN2+: = .00; CIN3+: = .01) and positive predictive value (CIN2+: = .00; CIN3+: = .03) for detecting CIN2+/3+, but also needed fewer colposcopies to identify each CIN2+/3+.
A new triage strategy for ASC-US women was successfully constructed based on CIN2+/3+ risks of 14 high-risk and 4 intermediate-risk HPVs, which could significantly reduce unnecessary colposcopies.
我们试图评估特定人乳头瘤病毒（HPV）基因型导致即刻高级别鳞状上皮内病变-宫颈上皮内瘤变2/3级或更严重病变（HSIL-CIN2+/3+，以下简称CIN2+/3+）的风险，并为意义不明确的非典型鳞状细胞（ASC-US）女性制定基于精确风险的分流策略。
回顾性分析接受HPV基因分型检测和阴道镜检查的ASC-US女性的临床资料。通过三种方法评估特定HPV基因型的分布及CIN2+/3+风险。进一步建立基于风险的分流策略，并评估其检测CIN2+/3+的效能。
共分析了5553例ASC-US女性，其中3648例HPV阳性，1905例HPV阴性。CIN2+/3+有662/319例，包括639/306例HPV阳性和23/13例HPV阴性女性。无论在HPV阳性女性还是HPV阳性CIN2+/3+病例中，HPV16、HPV52、HPV58和HPV18始终位列前5种基因型。HPV16和HPV33导致CIN2+/3+的风险最高，而HPV73和26导致CIN2+/3+的风险最低。基于特定HPV基因型的即刻CIN2+/3+风险，将18种HPV分为三个风险分层组。只有感染A组所含HPV的女性需要即刻进行阴道镜检查。与传统策略相比，这种新的基于风险的策略在检测CIN2+/3+方面不仅具有更高的特异性（CIN2+：=0.00；CIN3+：=0.01）和阳性预测值（CIN2+：=0.00；CIN3+：=0.03），而且识别每例CIN2+/3+所需的阴道镜检查次数更少。
基于14种高危型和4种中危型HPV的CIN2+/3+风险，成功构建了一种针对ASC-US女性的新分流策略，可显著减少不必要的阴道镜检查。
