The Ohio State University Medical Center, Columbus, OH.
Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University College of Medicine, Columbus, OH.
Menopause. 2021 Feb 1;28(6):642-649. doi: 10.1097/GME.0000000000001738.
The objective of this pilot study was to evaluate the change in sexual function following treatment with fractional CO2 laser therapy in breast cancer (BC) survivors with genitourinary syndrome of menopause (GSM).
A single-arm feasibility study of BC survivors with symptoms of GSM, including dyspareunia and/or vaginal dryness, was conducted. Participants who received three treatments with fractional CO2 laser and 4-week follow-up were contacted for patient-reported outcomes and adverse events at 12 months. Sexual function was measured using the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale Revised (FSDS-R). Descriptive statistics were calculated for patient demographics and disease characteristics for the set of participants who agreed to long-term follow-up and those who were lost to follow-up. FSFI and FSDS-R scores were summarized at baseline, 4 weeks and 12 months, as well as the change from baseline, and were compared using a Wilcoxon signed rank test.
A total of 67 BC survivors enrolled, 59 completed treatments and 4-week follow-up; 39 participated in the 12 month follow-up. The overall FSFI score improved from baseline to 4-week follow-up (median Δ 8.8 [Q1, Q3] (QS) (2.2, 16.7)], P < 0.001). There were improvements at 4 weeks in all domains of the FSFI (P < 0.001 for each) including desire (median Δ 1.2; QS [0.6, 1.8]), arousal (median Δ 1.2; QS [0.3, 2.7]), lubrication (median Δ 1.8 (0, 3.3), orgasm (median Δ 1.2; QS [0, 3.6]), satisfaction (median Δ 1.6 (0.4, 3.2)), and pain (median Δ 1.6 (0, 3.6). The FSDS-R score also improved from baseline to 4-week follow-up (median Δ -10.0; QS [-16, -5] P < 0.001) indicating less sexually related distress. The scores of the FSFI and FSDS-R remained improved at 12 months and there were no serious adverse events reported.
In BC survivors with GSM, the total and individual domain scores of the FSFI and the FSDS-R improved after fractional CO2 laser therapy.
本初步研究旨在评估 CO2 点阵激光治疗乳腺癌（BC）幸存者伴绝经后生殖泌尿系统综合征（GSM）患者性功能变化。
对伴有性交困难和/或阴道干燥等 GSM 症状的 BC 幸存者进行单臂可行性研究。对接受 3 次 CO2 点阵激光治疗并在 4 周后进行随访的患者，在 12 个月时通过患者报告的结局和不良事件进行联系。使用女性性功能指数（FSFI）和女性性功能困扰量表修订版（FSDS-R）测量性功能。对同意长期随访的患者和失访患者的患者人口统计学和疾病特征进行描述性统计。总结基线、4 周和 12 个月的 FSFI 和 FSDS-R 评分，以及与基线相比的变化，并使用 Wilcoxon 符号秩检验进行比较。
共有 67 名 BC 幸存者入组，59 名完成治疗和 4 周随访，39 名参加了 12 个月随访。FSFI 总分从基线到 4 周随访时改善（中位数 Δ 8.8[Q1，Q3]（QS）（2.2，16.7]，P<0.001）。在 FSFI 的所有领域均在 4 周时改善（P<0.001），包括性欲（中位数 Δ 1.2；QS [0.6，1.8]）、唤醒（中位数 Δ 1.2；QS [0.3，2.7]）、润滑（中位数 Δ 1.8[0，3.3]）、性高潮（中位数 Δ 1.2；QS [0，3.6]）、满意度（中位数 Δ 1.6[0.4，3.2]）和疼痛（中位数 Δ 1.6[0，3.6]）。FSDS-R 评分也从基线到 4 周随访时改善（中位数 Δ-10.0；QS[-16，-5]，P<0.001），表明与性相关的痛苦减轻。FSFI 和 FSDS-R 的评分在 12 个月时仍然改善，并且没有严重的不良事件报告。
在伴 GSM 的 BC 幸存者中，CO2 点阵激光治疗后 FSFI 和 FSDS-R 的总分和各领域评分均得到改善。
