澳大利亚新南威尔士大学Jason A. Abbott团队比较了二氧化碳激光与假手术治疗对绝经后有阴道症状妇女症状严重程度的影响。2021年10月12日，《美国医学会杂志》发表了这一成果。

绝经后阴道症状很常见，且常常对妇女的生活质量有害。分段式二氧化碳阴道激光作为一种治疗手段应用越来越多，但其疗效尚未得到证实。

为了探讨分段式二氧化碳激光治疗绝经后阴道症状的疗效，研究组在澳大利亚悉尼的一家三级转诊医院进行了一项为期12个月的双盲、随机、假对照试验，2016年9月19日开始招募绝经后阴道症状严重，需要接受治疗的女性，最终随访日期为2020年6月30日。在232名参与者中，共有85人被随机分组。43名间隔4到8周采用分段式微消融二氧化碳激光系统进行三次治疗（激光组），42名接受假手术（假手术组）。

共同主要结局是在12个月时使用视觉模拟量表（VAS；0-100分；0表示无症状，100表示最严重症状）和外阴阴道症状问卷（VSQ；0-20；0表示无症状，20表示最严重症状）评估症状严重程度。最小临床重要差异定义为VAS和VSQ严重程度评分降低50%。5个预先指定的次要结局包括生活质量（0-100；得分越高，生活质量越好）、阴道健康指数得分（5-25；得分越高，健康状况越好）和阴道组织学（绝经前或绝经后状态）。

85名参与者的平均年龄为57岁，其中78名（91.7%）完成了12个月的随访。从基线检查到12个月，激光组和假手术组在症状严重程度变化方面没有显著差异，总体阴道症状的VAS评分分别降低17.2分和26.6分，最严重症状的VAS评分分别降低24.5分和20.4分，VSQ评分分别降低3.1分和1.6分。激光组和假手术组在平均生活质量评分和阴道健康指数评分以及组织学比较方面均没有显著差异。激光组发生16例不良事件，假手术组发生17例，包括阴道疼痛/不适、斑疹、分泌物和下尿路症状。两组均未报告严重不良事件。

研究结果表明，对于绝经后有阴道症状的妇女，使用二氧化碳激光治疗12个月后，与假手术治疗相比，并未显著改善阴道症状。

附：英文原文

Title: Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial

Author: Fiona G. Li, Sarah Maheux-Lacroix, Rebecca Deans, Erin Nesbitt-Hawes, Aaron Budden, Kimberly Nguyen, Claire Y. Lim, Sophia Song, Lalla McCormack, Stephen D. Lyons, Eva Segelov, Jason A. Abbott

Issue&Volume: 2021/10/12

Abstract:

Importance  Postmenopausal vaginal symptoms are common and frequently detrimental to a woman’s quality of life. Fractional carbon dioxide vaginal laser is increasingly offered as a treatment, but the efficacy remains unproven.

Objective  To determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause.

Design, Setting, and Participants  A double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized.

Interventions  Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group.

Main Outcomes and Measures  The co–primary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status).

Results  Of 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: –17.2 vs –26.6; difference, 9.4 [95% CI, –28.6 to 47.5]; VAS score for the most severe symptom: –24.5 vs –20.4; difference –4.1 [95% CI, –32.5 to 24.3]; VSQ score: –3.1 vs –1.6; difference, –1.5 [95% CI, –5.9 to 3.0]). There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8 [95% CI, –3.9 to 13.5]) and Vaginal Health Index Score (0.9 vs 1.3; difference, –0.4 [95% CI, –4.3 to 3.6]) or in histological comparisons between laser and sham treatment groups. There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group.

Conclusions and Relevance  Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months.

DOI: 10.1001/jama.2021.14892

Source: https://jamanetwork.com/journals/jama/article-abstract/2784960