PDF(Pubmed)
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]。
