Luo Hongxue, Belinson Jerome L, Du Hui, Liu Zhihong, Zhang Lijie, Wang Chun, Qu Xinfeng, Pretorius Robert G, Wu Ruifang
1Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, PR China; 2Shenzhen Technical Research and Development Center on Gynecoligic Oncology, Shenzhen, PR China; 3Gynecologic Oncology Division, Women's Health Institute, Cleveland Clinic, Cleveland, OH; 4Preventive Oncology International, Cleveland Heights, OH; and 5Department of Obstetrics and Gynecology, Kaiser Permanente, Fontana, CA.
J Low Genit Tract Dis. 2017 Jan;21(1):12-16. doi: 10.1097/LGT.0000000000000277.
The aim of the study was to evaluate the human papillomavirus (HPV) viral load combined with cytology as a secondary screening strategy after primary HPV screening.
The data referring to direct Hybrid Capture 2 (HC2), cytology, and histology from Shenzhen Cervical Cancer Screening Trial II were re-analyzed to determine the correlation between viral load and cervical lesions. In addition, algorithms using different viral loads as cut points for immediate colposcopy plus cytology triage were compared with several recommended or controversial primary screening methods.
A total of 8,556 women with a mean age of 38.9 years were included in the analysis, of which 13.67% tested high-risk HPV positive with a prevalence of 2.72% for cervical intraepithelial neoplasia 2+ (CIN 2+) and 1.65% for CIN 3+. A significant correlation was observed between increasing relative light units/control (RLU/CO) values and worsening cervical lesions. The mean RLU/CO values for negative, CIN 1, CIN 2, CIN 3, and cancer were 6.86, 119.43, 410.90, 449.39, and 853.26, respectively. A larger proportion of HPV infections with relative high viral load (≥10 RLU/CO) were found in higher-grade lesions. The algorithm using 10 or greater RLU/CO as cut point for immediate colposcopy followed by triage cytology for the other positive (≥1 < 10 RLU/CO) had sensitivity of 93.13%/96.45% and specificity of 92.32%/91.44% for CIN 2+/3+, and the colposcopy referral rate was 10.00%.
Human papillomavirus viral load level is positively associated with cervical lesion grade. Ten relative light units/control or greater is a viable threshold for immediate colposcopy whereas 1 or greater or less than 10 RLU/CO is advised to reflex cytology for optimizing sensitivity and specificity, as well as referral rates.
本研究旨在评估人乳头瘤病毒（HPV）病毒载量联合细胞学检查作为初次HPV筛查后的二级筛查策略。
对深圳宫颈癌筛查试验II中直接杂交捕获2代（HC2）、细胞学及组织学数据进行重新分析，以确定病毒载量与宫颈病变之间的相关性。此外，将以不同病毒载量为切点进行直接阴道镜检查加细胞学分流的算法与几种推荐或有争议的初次筛查方法进行比较。
共有8556名平均年龄为38.9岁的女性纳入分析，其中13.67%高危HPV检测呈阳性，宫颈上皮内瘤变2级及以上（CIN 2+）患病率为2.72%，CIN 3+患病率为1.65%。相对光单位/对照（RLU/CO）值升高与宫颈病变加重之间存在显著相关性。阴性、CIN 1、CIN 2、CIN 3及癌症的平均RLU/CO值分别为6.86、119.43、410.90、449.39及853.26。在高级别病变中发现相对高病毒载量（≥10 RLU/CO）的HPV感染比例更高。以10或更高RLU/CO为切点进行直接阴道镜检查，然后对其他阳性（≥1且<10 RLU/CO）进行细胞学分流的算法，对CIN 2+/3+的敏感性为93.13%/96.45%，特异性为92.32%/91.44%，阴道镜转诊率为10.00%。
人乳头瘤病毒病毒载量水平与宫颈病变级别呈正相关。10个相对光单位/对照或更高是直接进行阴道镜检查的可行阈值，而建议以1或更高或低于10 RLU/CO进行细胞学检查，以优化敏感性、特异性及转诊率。
