Perez-Medina Tirso, Bajo-Arenas José, Haya Javier, Sanfrutos Luis, Iniesta Silvia, Bueno Beatriz, Castelo-Branco Camil
Santa Cristina University Hospital, Universidad Autónoma de Madrid, Madrid, Spain.
Menopause. 2003 Nov-Dec;10(6):534-7. doi: 10.1097/01.GME.0000064815.74043.32.
To assess the incidence of endometrial polyps during postmenopausal replacement therapy with tibolone, using an appropriate control group.
A total of 485 postmenopausal women were included in this open, prospective, comparative study for a duration of 36 months. Of this group, 249 women received 2.5 mg/day of tibolone and 244 women served as controls, receiving continuous-combined estrogen-progestogen therapy (HT). Transvaginal ultrasound, hysteroscopy, and directed biopsies were performed before treatment was initiated and at the end of the study.
Two hundred twenty-one of the women receiving tibolone and 203 receiving continuous-combined HT completed the study. Endometrial polyps were detected in 74 women (33.4%) from the tibolone group and in 22 women (10.8%) from the HT group (P < 0.01). The vaginal bleeding rate did not differ between the groups. The frequency of atrophic polyps was significantly higher in the tibolone group (P < 0.01). No difference was found in the size of the polyps.
Tibolone increases by threefold the risk for endometrial polyps.
通过设立合适的对照组，评估替勃龙在绝经后激素替代治疗期间子宫内膜息肉的发生率。
本开放性、前瞻性、对照研究共纳入485名绝经后女性，为期36个月。其中，249名女性接受每日2.5毫克替勃龙治疗，244名女性作为对照组，接受连续联合雌激素 - 孕激素治疗（激素替代疗法）。在治疗开始前和研究结束时进行经阴道超声、宫腔镜检查及定向活检。
接受替勃龙治疗的221名女性和接受连续联合激素替代疗法的203名女性完成了研究。替勃龙组74名女性（33.4%）和激素替代疗法组22名女性（10.8%）检测到子宫内膜息肉（P < 0.01）。两组间阴道出血率无差异。替勃龙组萎缩性息肉的发生率显著更高（P < 0.01）。息肉大小无差异。
替勃龙使子宫内膜息肉风险增加两倍。
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