Primary HPV testing with cytology versus cytology alone in cervical screening—A prospective randomized controlled trial with two rounds of screening in a Chinese population

摘要

We conducted a prospective randomized controlled trial with two screening rounds to evaluate the effectiveness of combining HPV testing with liquid-based cytology (LBC) as a co-test, compared to LBC only in cervical cancer screening of a Chinese population. First, 15,955 women aged 30-60 were randomized at a 1:1 ratio into an intervention group (Digene Hybrid Capture 2 HPV test with LBC) and a control group (LBC alone). Women in the intervention group would be referred for colposcopy and biopsy immediately if they were found to have high-risk HPV regardless of cytology results. The detection of cervical intraepithelial neoplasia grade 2 or above (CIN2+) lesions was significantly higher in the intervention group compared to the control (0.95 vs. 0.38, OR 2.50,95 Cl 1.65-3.88). At the subsequent round of screening approximately 36 months later, CIN2+ detection was significantly lower in the intervention group (0.08 vs. 0.35, OR 0.23,95 Cl 0.08-0.57). Over the two rounds of screening, the total detection of CIN2+ was higher in the intervention group (1.01 vs. 0.66, OR 1.53,95 Cl 1.09-2.19). There was a fourfold increase (10.6 vs. 2.4, p < 0.001) in the number of colposcopies performed in the intervention arm. Adding a high-risk HPV test to cytology for primary cervical screening led to earlier detection of clinically significant preinvasive lesions, resulting in a reduced detection of CIN2+ lesions in subsequent rounds and an increased rate of colposcopy.