Thermal ablation versus loop electrosurgical excision procedure and cold knife conization for cervical intraepithelial neoplasia: efficacy and HPV clearance in a 5-year cohort of Chinese women.

内容摘要

To evaluate the 5-year efficacy of thermal ablation (TA) for cervical intraepithelial neoplasia (CIN) and high-risk HPV (hrHPV) clearance in Chinese women. A total of 17,202 women aged 20-65 years were recruited to screening cohorts in 2017-2018 from 3 rural counties in Shanxi and Inner Mongolia and an urban area in Shenzhen with follow-up evaluations until 2022. The hrHPV-positive women with ablation-eligible lesions on colposcopy underwent biopsy and TA (n = 228) in one visit. A loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC) was recommended for ineligible women with high-grade CIN on histology (n = 106 and 41, respectively), while untreated hrHPV-positive women served as controls. Treated women had annual hrHPV testing and cytology. Untreated women had annual hrHPV testing. Positive cases were referred for colposcopy, with biopsy performed when indicated. Cure rates and hrHPV clearance rates were analyzed using Kaplan-Meier and competing risk models with sub-distribution hazard ratios (SHRs) assessing treatment effects. The 5-year cure rate for CIN1 regressing to normal was 79.0% after TA treatment and the 5-year cure rate for CIN2 regressing to CIN1/normal was 87.9%, comparable to LEEP (90.3%) and CKC (94.4%) for CIN2 (P = 0.54). The TA cure (66.0%) was significantly lower for CIN3 than LEEP and CKC (97.0% and 94.1%; P = 0.006). TA achieved 98.0% 5-year hrHPV clearance in CIN1/normal cases, which was higher than untreated women (87.7%; SHR = 0.81, 95% CI = 0.73-0.90), particularly for HPV16 (SHR = 0.67), HPV31 (SHR = 0.56), and HPV33 (SHR = 0.65). The 5-year hrHPV clearance after TA was comparable to LEEP and CKC for CIN2/3. TA provides durable efficacy for CIN1 and CIN2 and promotes hrHPV clearance, reducing progression risk. It could complement excisional treatments for CIN2 and enhance treatment accessibility in low-resource settings.