Abstract:
Abstract Objective: To investigate the significance of high-risk human papilloma virus ( HR-HPV ) DNA testing as a predictor of residual or recurrent cervical intraepithelial neoplasia ( CIN ) after cold-knife conization for high-grade CIN. Methods: HR-HPV testing, cytology, and colposcopy were conducted on 118 female patients at 3, 6, 12, 18, and 24 months after cold-knife conization. Pathology confirmed the existence of CIN as postoperative residuals or the recurrence of the disease. Results: The positive rate of postoperative histopathologic margin was 8.5% in these patients (10/118). The incidence of residual or recurrent disease was 15.3% ( 18/118 ) at 24 months after the treatment. The negative HR-HPV rate at 3 months after the surgery was lower than that at 6 months, with statistically significant differences between the two. However, no statistically significant differences were observed between the HR-HPV negative rate at the sixth month after surgery and 6 months later. Up to 28 cases at 6 months after the treatment ( 27.3% ) were HR-HPV-positive, and 18 of the 28 patients ( 64.3% ) were positive for CIN. CIN was not detected in the negative cases. At six months after surgery, the sensitivity and specificity of the HR-HPV diagnosis of the residuals of the lesion or the recurrent diseases were 100.0% and 90.0%, respectively. The positive and negative predictive values were 64.3% and 100.0%, respectively. The diagnosis accordance rate of the HR-HPV test and the thin-prep-liquid-based cytology test ( TCT ) were 91.5% and 81.4%, and their Youden's indices were 0.900 and 0.598, respectively. The HR-HPV test was superior to the TCT. In addition, the rate of residual or recurrence was significantly higher in patients with positive margins ( 40.0% ) than in those with negative margins ( 13.0% ). The differences were statistically significant between the two ( P = 0.045 ). The risk of residual or recurrent disease was 4.5 times higher in patients with positive margins than in those with negative margins OR = 4.476 ( 95% CI ) = 1.121-17.866 . Conclusion: HR-HPV testing at the sixth month after cold-knife conization is an early and sensitive indicator for monitoring postoperative residuals or relapse of the lesion. Close surveillance of HR-HPV-positive patients and conventional monitoring of HR-HPV negative patients will not increase the onset risk. Furthermore, the positive margin is an important dangerous factor for residual or recurrent disease.