Lippuner K, Haenggi W, Birkhaeuser M H, Casez J P, Jaeger P
Policlinic of Medicine, University Hospital of Berne, Switzerland.
J Bone Miner Res. 1997 May;12(5):806-12. doi: 10.1359/jbmr.1997.12.5.806.
Postmenopausal bone loss can be prevented by continuous or intermittent estradiol (E2) administration. Concomitant progestogen therapy is mandatory in nonhysterectomized women to curtail the risk of endometrial hyperplasia or cancer. However, the recurrence of vaginal bleeding induced by sequential progestogen therapy in addition to continuous estrogen administration is one of the reasons for noncompliance to hormone replacement therapy (HRT). Tibolone, a synthetic steroid with simultaneous weak estrogenic, androgenic, and progestational activity, which does not stimulate endometrial proliferation, has recently been proposed for the treatment of climacteric symptoms. To compare the efficacy of conventional oral and transdermal HRT with that of tibolone in the prevention of postmenopausal bone loss, 140 postmenopausal women (age, 52 +/- 0.6 years; median duration of menopause, 3 years) were enrolled in an open 2-year study. Volunteers had been offered a choice between HRT and no therapy (control group, CO). Patients selecting HRT were randomly allocated to one of the following three treatment groups: TIB, tibolone, 2.5 mg/day continuously, orally; PO, peroral E2, 2 mg/day continuously, plus sequential oral dydrogesterone (DYD), 10 mg/day, for 14 days of a 28-day cycle; TTS, transdermal E2 by patch releasing 50 microg/day, plus DYD as above. Bone densitometry of the lumbar spine, upper femur, and whole body was performed using dual-energy X-ray absorptiometry at baseline, and then 6, 12, 18, and 24 months after initiation of therapy. One hundred and fifteen women (82%) completed the 2 years of the study. The dropout rate was similar in each group. Over 2 years, bone preservation was observed in all three treatment groups as compared with controls, without significant differences among treatment regimens. In conclusion, tibolone can be regarded as an alternative to conventional HRT to prevent postmenopausal bone loss.
连续或间断给予雌二醇（E2）可预防绝经后骨质流失。对于未行子宫切除术的女性，必须同时进行孕激素治疗以降低子宫内膜增生或癌变的风险。然而，在持续给予雌激素的基础上，序贯孕激素治疗引起的阴道出血复发是导致不依从激素替代疗法（HRT）的原因之一。替勃龙是一种具有弱雌激素、雄激素和孕激素活性的合成类固醇，不会刺激子宫内膜增殖，最近被提议用于治疗更年期症状。为比较传统口服和经皮HRT与替勃龙在预防绝经后骨质流失方面的疗效，140名绝经后女性（年龄52±0.6岁；绝经中位时间3年）参加了一项为期2年的开放性研究。志愿者可在HRT和不治疗（对照组，CO）之间做出选择。选择HRT的患者被随机分配到以下三个治疗组之一：TIB组，替勃龙，每日口服2.5 mg；PO组，口服E2，每日持续2 mg，加序贯口服地屈孕酮（DYD），每日10 mg，在28天周期中的14天服用；TTS组，经皮E2贴片，每日释放50 μg，加上述DYD。在基线时，然后在治疗开始后的6、12、18和24个月，使用双能X线吸收法对腰椎、股骨上段和全身进行骨密度测量。115名女性（82%）完成了2年的研究。各组的退出率相似。在2年期间，与对照组相比，所有三个治疗组均观察到骨质得以保留，各治疗方案之间无显著差异。总之，替勃龙可被视为预防绝经后骨质流失的传统HRT的替代药物。
