HR-HPV对CIN冷刀锥切后的随访价值

High-risk Human Papilloma Virus Testing for Monitoring Patients with High-grade Cervical Intraepithelial Neoplasia after Cold-Knife Conization

目的:探讨HR-HPV监测CIN冷刀锥切后病变残余或复发的价值。方法:118例冷刀锥切后患者第3、6、12、18、24个月均检测HR-HPV和细胞学及阴道镜,病理证实存在CIN视为残留或复发。结果:术后病理切缘阳性10例(8.5%);术后24个月残留或复发18例(15.3%)。术后第6个月HR-HPV转阴率较术后第3个月升高,差异有统计学意义,较6个月后的转阴率无统计学意义。术后第6个月HR-HPV阳性者28例(23.7%),阳性者发病18例(64.3%),阴性患者无发病。术后第6个月HR-HP3V诊断病变残留或复发的敏感度和特异度分别为100.0%和90.0%,阳性预测价值和阴性预测价值分别为64.3%和100.0%。HR-HPV与TCT正确诊断率为91.5%和81.4%,Youden's指数为0.900和0.598,HR-HPV优于TCT。切缘阳性者残留或复发率(40.0%)较阴性患者(13.0%)高(P=0.045),切缘阳性者发病风险是阴性者4.5倍(95%CI=1.121～17.866)。结论:术后第6个月HR-HPV检测是监测冷刀锥切后病变残留或复发的早期敏感指标,阳性者密切监测,阴性者常规监测不增加发病风险。此外,切缘阳性是病变残留或复发的一个重要危险因素。

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 （ C1N ） 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. Pa- thology 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 C1N. 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.