Faculty of Medicine - University of Barcelona, Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Department of Pathology, Biomedical Diagnostic Center, Hospital Clinic of Barcelona, Barcelona, Spain.
Climacteric. 2022 Oct;25(5):476-482. doi: 10.1080/13697137.2022.2050208. Epub 2022 Mar 28.
Due to safety concerns on estrogen-based treatments for genitourinary syndrome of menopause (GSM) in breast cancer survivors (BCS), new options are appearing, such as androgen-based treatments, which according to proprieties would not be transformed systemically to estrogens in patients receiving aromatase inhibitors (AIs).
The aim of this pilot study is to assess the security and efficacy of vaginal prasterone (dehydroepiandrostenedione [DHEA]) in BCS treated with AIs.
This open, prospective, pilot study included 10 BCS treated with AIs. All participants complained of severe GSM. DHEA was administrated as a vaginal ovule. Participants were instructed to use one ovule every night during the first month, and one ovule every two nights for the entire five remaining months. The patients were requested to attend seriated visits after the beginning of the prasterone treatment to evaluate symptoms, physical improvement and serum estradiol.
Mean serum estradiol remained low from 3.4 pg/ml to 4.3 pg/ml ( = 0.9136) after 6 months of follow-up. The visual analog scale of dyspareunia improved from 8.5 to mean values after treatment of 0.4 ( = 0.0178). The Vaginal Health Index (VHI) scale and Female Sexual Function Index improved from 9.75 to 15.8 ( = 0.0277) and from an initial score of 11.2 to 20.6 ( = 0.0277), respectively. Vaginal pH changed from basal 8.1 to final 6.5 ( = 0.0330).
Symptoms and physical examination regarding sexuality and vaginal health improved significantly, while serum estradiol remained at low levels. Prasterone seems a safe and effective option to treat GSM in BCS receiving AIs.
由于雌激素类药物治疗乳腺癌幸存者（BCS）泌尿生殖系统绝经综合征（GSM）的安全性问题，新的选择方案正在出现，例如雄激素类药物治疗，根据药物特性，在接受芳香化酶抑制剂（AIs）治疗的患者中，这些药物不会被系统转化为雌激素。
本研究旨在评估经 AIs 治疗的 BCS 患者阴道普拉睾酮（脱氢表雄酮 [DHEA]）的安全性和疗效。
这是一项开放、前瞻性的初步研究，纳入了 10 例接受 AIs 治疗的 BCS 患者。所有患者均抱怨有严重的 GSM。DHEA 作为阴道栓剂给药。要求患者在第一个月每晚使用一粒栓剂，在接下来的五个月中每两天使用一粒栓剂。患者在开始普拉睾酮治疗后定期就诊，以评估症状、身体改善情况和血清雌二醇水平。
经过 6 个月的随访，平均血清雌二醇水平从 3.4pg/ml 降至 4.3pg/ml（ = 0.9136）。治疗后，性交痛的视觉模拟评分从 8.5 分降至平均 0.4 分（ = 0.0178）。阴道健康指数（VHI）和女性性功能指数（FSFI）分别从 9.75 分提高到 15.8 分（ = 0.0277）和从初始评分 11.2 分提高到 20.6 分（ = 0.0277）。阴道 pH 值从基础值 8.1 变为最终值 6.5（ = 0.0330）。
性欲和阴道健康相关症状和体检均显著改善，而血清雌二醇水平仍保持在较低水平。普拉睾酮似乎是治疗接受 AIs 治疗的 BCS 患者 GSM 的一种安全有效的选择。
