Hudita D, Posea C, Ceausu I, Rusu M
Department of Obstetrics and Gynecology, Dr. I. Cantacuzino Clinical Hospital, Bucharest, Romania.
Eur Rev Med Pharmacol Sci. 2003 Sep-Oct;7(5):117-25.
tibolone at usual doses of 2.5 mg/day in postmenopausal women has been shown to improve climacteric complaints, without affecting endometrial thickness and lipid profile or blood glucose. However, the potentially similar efficacy, but better tolerability, of a low dose of this drug (1.25 mg) has never been established.
162 healthy, non-obese, post-menopausal women, aged 40-65 years, with an intact uterus were enrolled in a national, single centre, randomised, double blind, placebo controlled, parallel group trial. After 1 week of runin, patients were treated for 24 weeks with placebo, tibolone 1.25 mg or 2.5 mg/day. During the study laboratory tests, endometrial ultrasound scans and mammography were performed. Occurrence of menopausal signs and symptoms, including vaginal bleeding, and quality of sexual life were also checked.
in the 120 patients terminating the study without major protocol violations, climacteric symptoms were similarly improved by tibolone 1.25 and 2.5 mg (78% and 90% reduction at week 24 for hot flushes, 36% and 34% for sweating episodes and 44% and 51% for vaginal dryness), but not by placebo. Benefits occurred earlier in the group treated with tibolone 2.5 mg. Quality of sexual life was almost invariably improved by tibolone as compared to placebo, but improvement occurred earlier in the tibolone 1.25 mg group. Severity of vaginal bleeding was not different between placebo and active treatment groups, except at week 12 when was higher. At the end of treatment vaginal bleeding occurred in 15% of patients treated with placebo, 14% treated with tibolone 1.25 mg and 12% treated with tibolone 2.5 mg. Endometrial thickness and breast density were not changed by treatment, as well as FSH, 17-beta-estradiol, total cholesterol, HDL and LDL cholesterol, triglycerides and blood glucose. Adverse events were reported by 14.7%, 26.7% and 24.4% of patients treated with placebo, tibolone 1.25 mg and tibolone 2.5 mg/day, respectively.
tibolone at doses of 1.25 or 2.5 mg/day given for 24 weeks to postmenopausal women displayed similar efficacy and safety profiles, though were more effective than placebo. Tibolone 1.25 mg induced a more gradual relief from climacteric symptoms and a more prompt improvement of sexual function.
已证实，绝经后女性每日服用2.5毫克的替勃龙可改善更年期症状，且不影响子宫内膜厚度、血脂水平或血糖。然而，低剂量（1.25毫克）该药物是否具有类似疗效但耐受性更好，尚未得到证实。
162名年龄在40 - 65岁、子宫完好的健康非肥胖绝经后女性参加了一项全国性单中心随机双盲安慰剂对照平行组试验。经过1周的导入期后，患者接受为期24周的安慰剂、1.25毫克或2.5毫克/天替勃龙治疗。研究期间进行了实验室检查、子宫内膜超声扫描和乳房X光检查。还检查了更年期症状的出现情况，包括阴道出血，以及性生活质量。
在120名未违反主要研究方案而完成研究的患者中，1.25毫克和2.5毫克替勃龙对更年期症状的改善相似（第24周时潮热减少78%和90%，出汗发作减少36%和34%，阴道干燥减少44%和51%），而安慰剂组无改善。2.5毫克替勃龙治疗组的获益出现得更早。与安慰剂相比，替勃龙几乎总能改善性生活质量，但1.25毫克替勃龙组改善出现得更早。安慰剂组和活性治疗组之间阴道出血的严重程度无差异，仅在第12周时活性治疗组更高。治疗结束时，安慰剂组15%的患者出现阴道出血，1.25毫克替勃龙组为14%，2.5毫克替勃龙组为12%。治疗未改变子宫内膜厚度和乳房密度，以及促卵泡生成素、17-β-雌二醇、总胆固醇、高密度脂蛋白和低密度脂蛋白胆固醇、甘油三酯及血糖水平。安慰剂组、1.25毫克替勃龙组和2.5毫克/天替勃龙组分别有14.7%、26.7%和24.4%的患者报告了不良事件。
绝经后女性服用1.25毫克或2.5毫克/天的替勃龙24周，疗效和安全性相似，且比安慰剂更有效。1.25毫克替勃龙能更逐渐地缓解更年期症状，更快地改善性功能。
