Gräser T, Müller A, Mellinger U, Mück A O, Lippert T H, Oettel M
Department of Clinical Research, Jenapharm GmbH & Co. KG, Otto-Schott-Strasse 15, 07745, Jena, Germany.
Maturitas. 2000 Jun 30;35(3):253-61. doi: 10.1016/s0378-5122(00)00112-2.
To determine the progestational efficacy of continuous treatment with various doses of dienogest, combined with oestradiol valerate, on the basis of endometrial histology, effect on climacteric symptoms and bleeding profile in postmenopausal women.
Patients were randomised to one of five fixed-combination treatments, oestradiol valerate 2.0 mg plus dienogest 0.5, 1.0, 2.0, 3.0 or 4.0 mg. Efficacy was assessed by endometrial biopsy, menstrual charts and change in climacteric symptoms.
The endometrium was classified as atrophic in 20.0, 31.3, 25.0, 55.6 and 57.1% of patients in the 0.5, 1.0, 2.0, 3.0 and 4.0 mg dienogest groups, respectively. The frequency of uterine bleeding was dose-dependent. The most favourable bleeding profile was seen in the 3.0 mg dienogest group, whereas the lower doses of dienogest had advantages with respect to the efficacy of the combined preparation.
Dienogest 2.0 and 3.0 mg are the optimal doses for combination with 2.0 mg oestradiol valerate for continuous-combined hormone replacement therapy.
基于绝经后女性的子宫内膜组织学、对更年期症状的影响及出血情况，确定不同剂量地诺孕素与戊酸雌二醇持续联合治疗的孕激素效能。
患者被随机分配至五种固定复方治疗方案之一，即戊酸雌二醇2.0 mg加地诺孕素0.5、1.0、2.0、3.0或4.0 mg。通过子宫内膜活检、月经图表及更年期症状变化评估疗效。
地诺孕素0.5、1.0、2.0、3.0和4.0 mg组中，分别有20.0%、31.3%、25.0%、55.6%和57.1%的患者子宫内膜被分类为萎缩型。子宫出血频率呈剂量依赖性。地诺孕素3.0 mg组的出血情况最理想，而较低剂量的地诺孕素在复方制剂疗效方面具有优势。
地诺孕素2.0和3.0 mg是与2.0 mg戊酸雌二醇联合用于连续联合激素替代治疗的最佳剂量。
