Abstract:
Objective: To analyze the course of p16/Ki-67-positive abnormal cytological cervical findings and high risk (hr)-HPV- and p16/Ki-67-clearances in women treated with a vaginal gel. Methods: 172 women with a histological diagnosis of CIN2 or p16-positive CIN1 lesions were selected based on a positive cytological p16/Ki-67 test. For 3 months, 75 patients in the active arm (AA) daily administered 5 ml of a vaginal gel. Ninety seven patients in the control arm (CA) underwent no treatment (\"watchful waiting\"). Endpoints were cytological evolution, p16/Ki-67- and hr-HPV-clearances. Results: At 3 months, cytological regression was observed in 76% (57/75) of patients in the AA compared with 25% (24/97) in the CA. Progression occurred in 5% (4/75) of the AA compared with 15% (15/97) of the CA. The p16/Ki-67 status change was statistically significantly (p < 0.001) in favor of the AA: 77% (58/75) became negative compared to 21% (20/97) in the CA. hr-HPV prevalence decreased significantly (p < 0.001) in the AA from 87 to 44%, while increasing in the CA from 78 to 84%. Cytological regression and p16/Ki-67 changes persisted in the AA at 6 months. Conclusions: The vaginal gel significantly cleared hr-HPV and p16/Ki-67 and was associated with improved cytological findings, thereby potentially offering an effective option against oncogenic risk. Clinical Trial Registration: Identifier: [ISRCTN11009040].
摘要:
目的:分析使用阴道凝胶治疗的妇女的p16/Ki-67阳性异常细胞学检查结果和高危(hr)-HPV和p16/Ki-67清除的过程。方法:根据细胞学p16/Ki-67阳性检测,选择172例组织学诊断为CIN2或p16阳性CIN1病变的女性。三个月,活动臂(AA)的75名患者每天服用5ml阴道凝胶。对照组(CA)的97名患者未接受治疗(“观察等待”)。终点是细胞学进化,p16/Ki-67-和hr-HPV-清除。结果:3个月时,在AA患者中观察到76%(57/75)的细胞学消退,而CA患者为25%(24/97).与CA的15%(15/97)相比,AA的5%(4/75)发生了进展。p16/Ki-67状态变化在统计学上显着(p<0.001)有利于AA:与CA中的21%(20/97)相比,77%(58/75)变为阴性。在AA中,hr-HPV患病率显着降低(p<0.001),从87%降至44%,而CA从78%增加到84%。细胞学消退和p16/Ki-67变化在6个月时在AA中持续存在。结论:阴道凝胶显着清除hr-HPV和p16/Ki-67,并与改善的细胞学结果相关,从而潜在地提供了一种有效的预防致癌风险的选择。临床试验注册:标识符:[ISRCTN11009040]。