背景:女性癌症幸存者经常经历雌激素剥夺症状,这可能会导致性欲下降,外阴阴道健康(润滑,干燥度,不适),和性满足。需要采取干预措施来解决这些问题。
目的:此二级分析的目的是确定在女性性功能指数(FSFI)润滑和疼痛分量表上得分较高(更好)的女性在使用安非他酮与安慰剂治疗的基础上是否报告了更高的愿望得分。
方法:参与者是NRG肿瘤学的NRG-CC004(NCT03180294)的一部分,一项随机安慰剂对照临床试验,评估安非他酮(150vs300mg)改善乳腺癌或妇科癌症幸存者性欲的作用.所有来自FSFI润滑的基线数据的参与者,疼痛,并分析了具有5周和/或9周数据的愿望子量表。FSFI分量表得分使用Spearman相关系数进行关联。Logistic回归用于确定FSFI愿望和其他FSFI分量表之间的关联,同时考虑治疗组和其他协变量。
结果:NRG肿瘤学的NRG-CC004(NCT03180294)II期随机剂量发现试验的主要结果是在FSFI愿望量表评分上从基线变化到9周。类似于家长研究,这项辅助数据研究的主要结局是5周和9周时的FSFI欲望分量表评分.
结果:总体而言,230名参与者在基线时完成FSFI,189名参与者在9周时完成FSFI。基线时润滑和疼痛之间的相关性最强(所有参与者,rho=0.77;安非他酮臂,rho=0.82),第5周(所有参与者,rho=0.71;安非他酮臂,rho=0.68),第9周(所有参与者,rho=0.75;安非他酮臂,rho=0.78),最弱的相关性是欲望和痛苦之间。在治疗组的患者中,润滑或疼痛之间没有相互作用。在9周时,各种协变量对FSFI得分的影响表明,非白人种族的参与者(优势比[OR],0.42;95%CI,0.21-0.81;P=.010),具有高润滑分数(或,0.36;95%CI,0.21-0.61;P=.0002),疼痛评分高(疼痛较少)(或,0.50;95%CI,0.29-0.87;P=0.014),或先前的骨盆手术(或,0.38;95%CI,0.23-0.63;P=.0002)具有低欲望的几率较低。
结论:在进行性欲干预之前,应解决急性雌激素剥夺症状。
■此二次分析无法检查所有变量。
结论:润滑和疼痛是低欲望的预测因素。因此,外阴阴道萎缩和更年期相关的泌尿生殖系统症状,如阴道干燥和性交困难,应在干预性欲之前或同时解决。
Female cancer survivors often experience estrogen-deprivation symptoms, which may lead to decreases in sexual desire, vulvovaginal health (lubrication, dryness, discomfort), and sexual satisfaction. Interventions are needed to address these concerns.
The objective of this secondary analysis was to determine if women with higher (better) scores on the Female Sexual Function Index (FSFI) lubrication and pain subscales reported higher desire scores based on treatment with bupropion vs placebo.
Participants were part of NRG Oncology\'s NRG-CC004 (NCT03180294), a randomized placebo-controlled clinical
trial evaluating bupropion (150 vs 300 mg) to improve sexual desire in survivors of breast or gynecologic cancer. All participants with baseline data from the FSFI lubrication, pain, and desire subscales with 5- and/or 9-week data were analyzed. The FSFI subscale scores were correlated using Spearman correlation coefficients. Logistic regression was used to determine associations between FSFI desire and other FSFI subscales while accounting for treatment arm and other covariates.
The primary outcome of NRG Oncology\'s NRG-CC004 (NCT03180294) randomized phase II dose-finding
trial was change from baseline to 9 weeks on the FSFI desire subscale score. Similar to the parent
study, the primary outcome for this ancillary data
study was the FSFI desire subscale score at 5 and 9 weeks.
Overall, 230 participants completed the FSFI at baseline and 189 at 9 weeks. The strongest correlations were between lubrication and pain at baseline (all participants, rho = 0.77; bupropion arms, rho = 0.82), week 5 (all participants, rho = 0.71; bupropion arms, rho = 0.68), and week 9 (all participants, rho = 0.75; bupropion arms, rho = 0.78), and the weakest correlations were between desire and pain. In patients in the treatment arms there were no interactions between lubrication or pain.The impact of various covariates on the FSFI score for desire at 9 weeks demonstrated that participants of non-White race (odds ratio [OR], 0.42; 95% CI, 0.21-0.81; P = .010), with a high lubrication score (OR, 0.36; 95% CI, 0.21-0.61; P = .0002), with a high pain score (less pain) (OR, 0.50; 95% CI, 0.29-0.87; P = .014), or with prior pelvic surgery (OR, 0.38; 95% CI, 0.23-0.63; P = .0002) had lower odds of having low desire.
Acute estrogen-deprivation symptoms should be addressed prior to sexual desire intervention.
This secondary analysis was not powered to examine all variables.
Lubrication and pain were predictors of low desire. Therefore, vulvovaginal atrophy and associated genitourinary symptoms of menopause such as vaginal dryness and dyspareunia should be addressed prior to or in parallel with interventions for sexual desire.