The Women's Health Institute, Cleveland Clinic, Cleveland, OH.
Department of OBGYN, Stanford University School of Medicine, Palo Alto, CA.
Menopause. 2020 Jan;27(1):50-56. doi: 10.1097/GME.0000000000001416.
The aim of the study was to compare 6-month efficacy and safety for treatment of vaginal dryness/genitourinary syndrome of menopause in women undergoing fractionated CO2 vaginal laser therapy to women using estrogen vaginal cream.
This multicenter, randomized trial compared fractionated CO2 laser to estrogen cream at 6 institutions. We included menopausal women with significant vaginal atrophy symptoms and we excluded women with prolapse below stage 2, recent pelvic surgery, prior mesh surgery, active genital infection, history of estrogen sensitive malignancy, and other autoimmune conditions. The primary outcome was the visual analog scale vaginal dryness score. Secondary outcomes included evaluation of vaginal atrophy, quality of life symptoms, assessment of sexual function, and urinary symptoms. Adverse events (AEs) and patient global impression of improvement (PGI-I) and satisfaction were also assessed.
Sixty-nine women were enrolled in this trial before enrollment was closed due to the Federal Drug Administration requiring the sponsor to obtain and maintain an Investigational Device Exemption. Of the 69 participants enrolled, 62 completed the 6-month protocol; 30 women were randomized to the laser and 32 to estrogen cream from June 2016 to September 2017. Demographics did not differ between groups except the laser group was less parous (0 [range 0-4] vs 2 [0-6], P = 0.04). On patient global impression, 85.8% of laser participants rated their improvement as "better or much better" and 78.5% reported being either "satisfied or very satisfied" compared to 70% and 73.3% in the estrogen group; this was not statistically different between groups. On linear regression, mean difference in female sexual function index scores was no longer statistically significant; and, vaginal maturation index scores remained higher in the estrogen group (adj P value 0.02); although, baseline and 6-month follow-up vaginal maturation index data were only available for 34 participants (16 laser, 18 estrogen).
At 6 months, fractionated CO2 vaginal laser and vaginal estrogen treatment resulted in similar improvement in genitourinary syndrome of menopause symptoms as well as urinary and sexual function. Overall, 70% to 80% of participants were satisfied or very satisfied with either treatment and there were no serious adverse events. : Video Summary:http://links.lww.com/MENO/A470.
本研究旨在比较经阴道 CO2 激光分次治疗与雌激素阴道乳膏治疗阴道干燥/绝经后女性生殖泌尿系统综合征（GSM）的 6 个月疗效和安全性。
本多中心随机试验比较了 6 家机构的 CO2 激光分次治疗与雌激素乳膏治疗。我们纳入了有明显阴道萎缩症状的绝经后女性，并排除了脱垂程度低于 2 期、近期盆腔手术、既往网片手术、活动性生殖器感染、雌激素敏感恶性肿瘤病史和其他自身免疫性疾病的患者。主要结局为阴道干燥视觉模拟量表评分。次要结局包括阴道萎缩评估、生活质量症状、性功能评估和尿症状。还评估了不良事件（AE）和患者整体改善印象（PGI-I）和满意度。
在因联邦药物管理局要求赞助商获得和维持研究器械豁免而关闭入组之前，本试验共纳入 69 名患者。69 名入组患者中，62 名完成了 6 个月的方案；30 名患者随机分为激光组，32 名患者分为雌激素乳膏组，入组时间为 2016 年 6 月至 2017 年 9 月。除激光组的生育次数较少（0 [0-4] 与 2 [0-6]，P=0.04）外，两组的人口统计学特征无差异。在患者整体印象方面，85.8%的激光组参与者认为自己的改善“更好或好得多”，78.5%的人表示“满意或非常满意”，而雌激素组分别为 70%和 73.3%；两组间无统计学差异。线性回归分析显示，女性性功能指数评分的平均差值不再具有统计学意义；并且雌激素组的阴道成熟指数评分仍较高（调整 P 值 0.02）；尽管只有 34 名参与者（16 名激光组，18 名雌激素组）有基线和 6 个月随访时的阴道成熟指数数据。
在 6 个月时，CO2 阴道激光分次治疗和阴道雌激素治疗均可显著改善绝经后女性生殖泌尿系统综合征症状以及尿功能和性功能。总体而言，70%至 80%的参与者对两种治疗方法均满意或非常满意，且无严重不良事件。
