Gil-Antuñano Santiago Palacios, Serrano Cogollor Luis, López Díaz Andrés C, González Rodríguez Silvia P, Dexeus Carter Damián, Centeno Mediavilla Cristina, Coronado Martín Pluvio, de la Fuente Valero Jesús, López Fernández José A, Vanrell Barbat Cristina, Cortés Bordoy Javier
Instituto Palacios, Salud y Medicina de la Mujer, C. Antonio Acuña, 9, 28009 Madrid, Spain.
Obstetrics and Gynaecology Unit, HM Gabinete Velázquez, C. de Jorge Juan, 19, 1°, 28001 Madrid, Spain.
J Pers Med. 2022 Sep 22;12(10):1559. doi: 10.3390/jpm12101559.
In the PALOMA trial, Papilocare demonstrated efficacy in repairing low-grade cervical lesions related to human papillomavirus (HPV). This sub-analysis aimed to evaluate its efficacy in repairing these cervical lesions and clearing HPV in women aged older than 40 years. This was a multicenter, randomized, open-label, parallel-group, controlled clinical trial. Patients with low-degree HPV-dependent cervical lesions receiving 6-month treatment with the vaginal gel were compared to those with a watchful waiting approach. Among the 41 women analyzed (aged 47.7 years), 31 presented high-risk (HR) oncogenic HPV subtypes, and 14 had 16-18-31 HPV genotypes. After 6 months, normalized cytology and concordant colposcopy were achieved by a greater percentage of treated women. The difference was significant in the total population (92.3% vs. 50.0%, = 0.007), and HR-HPV subpopulation (90.5% vs. 33.3%, = 0.003). In the HR HPVs-16-18-31 subpopulation, the values were 75.0% and 40.0% ( = 0.293). In the total population, 61.5% of treated patients obtained HPV clearance, compared to 50.0% in the control group. Regarding the HR-HPV subpopulation, these values were 66.7% and 44.4%, respectively. Papilocare demonstrated significant efficacy in repairing low-degree HPV-related cervical lesions and a positive trend to clear HPV in women older than 40 years old in comparison to the watchful waiting approach.
在PALOMA试验中，Papilocare在修复与人乳头瘤病毒（HPV）相关的低度宫颈病变方面显示出疗效。这项亚组分析旨在评估其在40岁以上女性中修复这些宫颈病变并清除HPV的疗效。这是一项多中心、随机、开放标签、平行组对照临床试验。将接受阴道凝胶6个月治疗的低度HPV相关性宫颈病变患者与采用观察等待方法的患者进行比较。在分析的41名女性（平均年龄47.7岁）中，31名呈现高危（HR）致癌HPV亚型，14名具有16-18-31型HPV基因型。6个月后，接受治疗的女性中有更高比例实现了细胞学正常化和阴道镜检查结果一致。在总人群中差异显著（92.3%对50.0%，P = 0.007），在HR-HPV亚组中差异也显著（90.5%对33.3%，P = 0.003）。在HR HPVs-16-18-31亚组中，相应数值分别为75.0%和40.0%（P = 0.293）。在总人群中，61.5%的治疗患者实现了HPV清除，而对照组为50.0%。对于HR-HPV亚组，这些数值分别为66.7%和44.4%。与观察等待方法相比，Papilocare在修复低度HPV相关宫颈病变方面显示出显著疗效，并且在40岁以上女性中清除HPV呈现出积极趋势。
