Federal University of Juiz de Fora, Juiz de Fora, MG, 36036-110, Brazil.
Department of Surgery Medical School, Federal University of Juiz de Fora, Juiz de Fora, MG, 36036-110, Brazil.
BMC Res Notes. 2023 Mar 10;16(1):33. doi: 10.1186/s13104-023-06300-7.
The main objective of the study was to describe and compare the feasibility of using fractional CO laser to the usual treatment with Clobetasol. Randomized clinical trials brought together 20 women from a Brazilian university hospital, 9 of them were submitted to Clobetasol treatment and 11 to laser therapy. Sociodemographic data were obtained and quality of life parameters, vulvar anatomy, self-perception and histopathological analysis of vulvar biopsies were evaluated. Evaluations were made before the beginning of the treatment, during its implementation, right after its completion (3 months), and 12 months after. The SPSS 14.0 software was used, obtaining descriptive measurements. The level of significance adopted was 5%.
The clinical/anatomical characteristics of the vulva did not differ between the treatment groups, as much before as after its performance. There was no statistically significant difference between the treatments performed regarding the impact on the life quality of the patients. A higher satisfaction degree with the treatment was obtained with the patients in the Laser group in the third month of evaluation. Laser therapy also revealed higher occurrence of telangiectasia after treatment completion. Fractional CO2 laser has proven to be well accepted and is a promising therapeutic option. Registration number and name of trial registry The institutional review board status was approved by the Research Ethics Committee of HU/ UFJF under advisory number 2881073 and registered in the Brazilian Clinical Trials, with consent under registration RBR-4p9s5y. Access link: https://ensaiosclinicos.gov.br/rg/RBR-4p9s5y.
本研究的主要目的是描述和比较使用分数 CO2 激光与常规氯倍他索治疗的可行性。将来自巴西大学医院的 20 名女性纳入随机临床试验，其中 9 名接受氯倍他索治疗，11 名接受激光治疗。收集社会人口统计学数据，并评估生活质量参数、外阴解剖结构、自我感知和外阴活检的组织病理学分析。在治疗开始前、治疗过程中、治疗完成后 3 个月（即 12 个月）进行评估。使用 SPSS 14.0 软件进行描述性测量。采用 5%的显著性水平。
治疗组之间的外阴临床/解剖特征在治疗前后均无差异。两种治疗方法对患者生活质量的影响无统计学差异。在评估的第三个月，激光组的患者对治疗的满意度更高。治疗完成后，激光治疗组出现更多的毛细血管扩张。分数 CO2 激光已被证明是可以接受的，并且是一种有前途的治疗选择。注册号和试验登记处名称：该机构审查委员会的状态已获得 HU/UJF 的伦理委员会批准，编号为 2881073，并在巴西临床试验中注册，注册号为 RBR-4p9s5y。访问链接：https://ensaiosclinicos.gov.br/rg/RBR-4p9s5y。
