Diterlizzi Alice, Tropea Anna, De Luca Eleonora, Guerriero Cristina, Merola Annamaria, Notaristefano Giovanna, Moricone Ambra, Policriti Martina, Ranalli Monia, Samasiuk Anastasyia, Ghi Tullio, Lanzone Antonio, Apa Rosanna
Department of Women's and Children's Health Sciences and Public Health, Fondazione Policlinico Universitario A. Gemelli, IRCCS, L.Go Agostino Gemelli, 8, 00168, Rome, Italy.
UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy.
Arch Gynecol Obstet. 2025 Sep 10. doi: 10.1007/s00404-025-08083-7.
Polycystic ovarian syndrome (PCOS) is a common endocrine-metabolic disorder affecting about 10% of reproductive-age women. Characterized by hyperandrogenism and ovulatory dysfunction, PCOS often involves metabolic features due to insulin resistance. Traditional treatment with combined oral contraceptive pills (COCP) effectively manages hyperandrogenism and menstrual irregularities. However, drospirenone-only pills (DRSP) may offer a viable alternative for patients who cannot take estrogen-based contraceptives due to cardiovascular risks or personal preference, owing to drospirenone's antiandrogenic properties and improved bleeding profile. This study aimed to evaluate the effects of DRSP-only pills on hyperandrogenism in PCOS patients. Secondary objectives included assessing changes in metabolic and hormonal features and bleeding profiles during therapy.
This monocentric observational retrospective study included 25 hyperandrogenic PCOS patients, aged 16 to 35, treated at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. Patients were prescribed DRSP-only therapy for 6 months. Clinical evaluations included ultrasonography, hormonal assays, and dermatological assessments using the Comprehensive Acne Severity Scale (CASS) and the modified Ferriman-Gallwey (mFG) score. Statistical analysis was performed using the two-tailed Wilcoxon test, with significance set at p < 0.05.
After 6 months of DRSP-only therapy, there was a significant reduction in CASS scores (2.4-1.8, p = 0.02) and mFG scores (12.31-6.31, p = 0.0053). In addition, significant reductions in 17-OH-progesterone (0.6-0.3 ng/ml, p = 0.03) and basal LH levels (5.8-3.55 UI/ml, p = 0.01) were observed. A trend toward a reduction in CRP levels (1.6-0.5 mg/l, p = 0.06) was noted. Any worsening in metabolic parameters was noted. Bleeding patterns were consistent with literature, with initial spotting decreasing over time.
This study showed that a 6-month drospirenone (DRSP)-only therapy significantly reduced hyperandrogenism symptoms, such as acne and hirsutism, in PCOS patients. It also lowered 17-OH-progesterone levels and showed a trend of reduced CRP values. Bleeding patterns were consistent with those in existing literature. We recommend DRSP-only therapy as a suitable option for PCOS patients with hyperandrogenism who cannot use combined oral contraceptives (COCs), as well as to minimize the metabolic risks of estrogen.
多囊卵巢综合征(PCOS)是一种常见的内分泌代谢紊乱疾病,影响约10%的育龄妇女。PCOS以高雄激素血症和排卵功能障碍为特征,常因胰岛素抵抗而伴有代谢特征。传统的复方口服避孕药(COCP)治疗可有效控制高雄激素血症和月经不规律。然而,由于屈螺酮具有抗雄激素特性且出血情况改善,对于因心血管风险或个人偏好而不能服用含雌激素避孕药的患者,仅含屈螺酮的避孕药(DRSP)可能是一种可行的选择。本研究旨在评估仅含DRSP的避孕药对PCOS患者高雄激素血症的影响。次要目标包括评估治疗期间代谢和激素特征以及出血情况的变化。
这项单中心观察性回顾性研究纳入了25例年龄在16至35岁之间、患有高雄激素血症的PCOS患者,这些患者在罗马的圣心天主教大学综合医院IRCCS接受治疗。患者接受了为期6个月的仅含DRSP的治疗。临床评估包括超声检查、激素测定,以及使用综合痤疮严重程度量表(CASS)和改良的费里曼 - 盖尔维(mFG)评分进行的皮肤病学评估。采用双侧Wilcoxon检验进行统计分析,显著性设定为p < 0.05。
经过6个月的仅含DRSP治疗后,CASS评分显著降低(从2.4降至1.8,p = 0.02),mFG评分也显著降低(从12.31降至6.31,p = 0.0053)。此外,观察到17 - 羟孕酮显著降低(从0.6降至0.3 ng/ml,p = 0.03),基础促黄体生成素(LH)水平也显著降低(从5.8降至3.55 UI/ml,p = 0.01)。注意到C反应蛋白(CRP)水平有降低趋势(从1.6降至0.5 mg/l,p = 0.06)。未观察到代谢参数有任何恶化情况。出血模式与文献一致,初始点滴出血随时间减少。
本研究表明,为期6个月的仅含屈螺酮(DRSP)治疗可显著降低PCOS患者的高雄激素血症症状,如痤疮和多毛症。它还降低了17 - 羟孕酮水平,并显示出CRP值降低的趋势。出血模式与现有文献一致。我们建议仅含DRSP的治疗作为不能使用复方口服避孕药(COC)的高雄激素血症PCOS患者的合适选择,同时可将雌激素的代谢风险降至最低。