Siseles N O, Halperin H, Benencia H J, Berg G, Pilnik S, Mesch V, Arrighi B, Wikinski R W
Climacteric Section, Hospital Italiano, Buenos Aires, Argentina.
Maturitas. 1995 Apr;21(3):201-10. doi: 10.1016/0378-5122(94)00889-f.
To assess the effect of tibolone on endometrial safety, plasma estradiol concentrations, lipid metabolism and climacteric symptoms in comparison to sequential conjugated equine estrogens and medroxyprogesterone acetate in postmenopausal women.
In a randomised, open-label, 6-cycle, group-comparative study, the effects on the aforementioned parameters were studied with tibolone 2.5 mg/day (N = 13) continuously, and with conjugated equine estrogens 0.625 mg/day continuously, combined with medroxyprogesterone acetate 5 mg/day (N = 11) (CEE/MPA) sequentially, during 12 days of each 28-day cycle. Within-group statistical analysis was performed with Student's t-test for paired samples, whereas between-group statistics were performed using the Student's t-test for independent groups.
Cytological evaluation revealed no endometrial stimulation in either group. In the tibolone group, there were no effects on estradiol levels, whereas in the CEE/MPA group, an increase in total and non-SHBG-bound estradiol plasma levels was reported. In the tibolone group, there were significant decreases in plasma total cholesterol, triglycerides, HDL-cholesterol and VLDL-cholesterol, whereas no significant changes in LDL-cholesterol and IDL-cholesterol were reported. In the CEE/MPA group there were significant decreases in plasma total cholesterol, HDL-cholesterol and LDL-cholesterol, whereas there were no significant changes in triglycerides, IDL-cholesterol and VLDL-cholesterol. Climacteric symptoms, particularly vasomotor episodes, decreased similarly in both groups.
Both tibolone and CEE/MPA were safe with respect to effects on the endometrium and both treatments induced changes in the plasma profiles of certain lipid and lipoprotein parameters. However, the overall clinical implications of these changes are unknown. Finally, both regimens were equally effective in the treatment of climacteric symptoms.
与序贯使用结合马雌激素和醋酸甲羟孕酮相比，评估替勃龙对绝经后女性子宫内膜安全性、血浆雌二醇浓度、脂质代谢及更年期症状的影响。
在一项随机、开放标签、6周期、组间比较研究中，分别连续给予2.5 mg/天替勃龙（N = 13）及连续给予0.625 mg/天结合马雌激素并在每28天周期的12天中序贯给予5 mg/天醋酸甲羟孕酮（N = 11）（CEE/MPA），研究对上述参数的影响。组内统计分析采用配对样本的Student t检验，组间统计分析采用独立组的Student t检验。
细胞学评估显示两组均无子宫内膜刺激。替勃龙组对雌二醇水平无影响，而CEE/MPA组报告血浆总雌二醇水平及非SHBG结合雌二醇水平升高。替勃龙组血浆总胆固醇、甘油三酯、高密度脂蛋白胆固醇和极低密度脂蛋白胆固醇显著降低，而低密度脂蛋白胆固醇和中间密度脂蛋白胆固醇无显著变化。CEE/MPA组血浆总胆固醇、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇显著降低，而甘油三酯、中间密度脂蛋白胆固醇和极低密度脂蛋白胆固醇无显著变化。两组更年期症状，尤其是血管舒缩症状，均有相似程度减轻。
替勃龙和CEE/MPA对子宫内膜的影响均安全，且两种治疗均引起某些脂质和脂蛋白参数血浆水平变化。然而，这些变化的总体临床意义尚不清楚。最后，两种治疗方案在治疗更年期症状方面同样有效。
