Petre Izabella, Toader Daniela Oana, Petrita Ramona, Pinta Alexandru-Remus, Alexa Andreea-Anda, Bita Romina Georgiana
Discipline of Obstetrics and Gynecology XII, "Victor Babes" University of Medicine and Pharmacy, Timisoara, Romania.
Department of Obstetrics and Gynecology III, National Institute for Mother and Child Health, Clinic of Obstetrics and Gynecology "Polizu", Bucharest, Romania.
Curr Ther Res Clin Exp. 2024 Oct 9;101:100762. doi: 10.1016/j.curtheres.2024.100762. eCollection 2024.
Cervical ectropion is frequently associated with vaginal symptoms requiring therapeutic intervention. However, no scientific consensus has been reached regarding the use of local re-epithelialization therapy to prevent severe bleeding, wound inflammation, and infection of cervical lesions.
The aim of our study was to investigate the aspect of the cervix by colposcopy after a 3-month treatment with an intravaginal medical device in the context of postoperative care of the symptomatic ectropion. The study analyzed additional clinical parameters, such as the evolution of primary and secondary inflammation and the degree of cervical epithelialization as secondary objectives.
Our pilot study included 27 participants with symptomatic cervical ectopy, with or without an associated human papillomavirus infection. The treatment protocol consisted of the monthly delivery of the medical device intravaginally, during day 1 to day 15, with a total study duration of 3 months.
The medical device had a positive impact on cervical epithelialization, in terms of aspect of the cervix returning to normal for 100% of the participants. Between study visits, it was observed that primary inflammation was reduced by 85.19%, whereas vaginal ulceration, colpitis, and leukorrhea were improved by 70.37%, 81.48%, and by 66.67%, respectively.
The degree of cervical epithelialization reflects how well the cervix has healed after an injury or infection. The device showed clinical performance in complete re-epithelialization after surgical procedures. Moreover, our study findings suggest that supportive treatment with this intravaginal medical device can be recommended for cervical wound healing in patients with human papillomavirus infection. ClinicalTrials.gov identifier: NCT04735718.
宫颈外翻常伴有需要治疗干预的阴道症状。然而，关于使用局部再上皮化疗法预防宫颈病变严重出血、伤口炎症和感染，尚未达成科学共识。
我们研究的目的是在有症状的宫颈外翻术后护理中，使用阴道内医疗器械治疗3个月后，通过阴道镜检查观察宫颈情况。该研究分析了其他临床参数，如原发性和继发性炎症的演变以及宫颈上皮化程度作为次要目标。
我们的初步研究纳入了27例有症状的宫颈外翻患者，伴有或不伴有相关的人乳头瘤病毒感染。治疗方案包括在第1天至第15天每月经阴道放置该医疗器械，总研究持续时间为3个月。
该医疗器械对宫颈上皮化有积极影响，100%的参与者宫颈外观恢复正常。在研究访视期间，观察到原发性炎症减少了85.19%，而阴道溃疡、阴道炎和白带异常分别改善了70.37%、81.48%和66.67%。
宫颈上皮化程度反映了宫颈在受伤或感染后愈合的情况。该器械在手术后完全再上皮化方面显示出临床效果。此外，我们的研究结果表明，对于人乳头瘤病毒感染患者的宫颈伤口愈合，可推荐使用这种阴道内医疗器械进行支持性治疗。ClinicalTrials.gov标识符：NCT04735718。
