Kalder M, Kyvernitakis I, Hars O, Kauka A, Hadji P
a Department of Obstetrics and Gynecology , Philipps University of Marburg , Germany ;
b Statistical Institute , Berlin , Germany ;
Climacteric. 2016 Oct;19(5):471-7. doi: 10.1080/13697137.2016.1198313. Epub 2016 Jun 27.
To compare the effects on bone mineral density (BMD) measured by dual-energy X-ray absorptiometry at the lumbar spine, the femoral neck and the total hip following 2 years of treatment with a low-dose combined hormone therapy (HT) comprised of 1 mg estradiol and 0.5 mg norethisterone acetate (E2/NETA) versus 2.5 mg tibolone in postmenopausal women. Additionally, quantitative ultrasonometry (QUS) of the os calcaneus and of the phalanges was performed.
Changes in BMD, QUS and side-effects were assessed at baseline, 6, 12 and 24 months in 50 postmenopausal women who received either E2/NETA (n = 26) or tibolone (n = 24) for 2 years.
Compared to women on tibolone, women receiving E2/NETA showed a significant increase in BMD from baseline to 12 and 24 months at the lumbar spine (3.07%, 3.86%; p < 0.01 vs. 1.13%, 2.23%; p < 0.05), and at the total hip (1.33%, 1.69%; p < 0.01 vs. 0.76%, 0.70%) and at the femoral neck from baseline to 24 months (1.10%; p < 0.05). QUS indices only showed a significant change with the ultrasound bone profile index with E2/NETA at 6 months (-2.32%; p < 0.001).
Low-dose E2/NETA showed a significantly higher increase in BMD compared to tibolone. QUS measurement was not considered to comprise beneficial effects in monitoring drug-induced bone changes.
比较在绝经后女性中,接受为期2年的由1毫克雌二醇和0.5毫克醋酸炔诺酮组成的低剂量联合激素疗法(HT)与2.5毫克替勃龙治疗后,通过双能X线吸收法测量的腰椎、股骨颈和全髋部骨密度(BMD)的变化。此外,还对跟骨和指骨进行了定量超声检查(QUS)。
对50名接受E2/NETA(n = 26)或替勃龙(n = 24)治疗2年的绝经后女性,在基线、6个月、12个月和24个月时评估BMD、QUS的变化以及副作用。
与接受替勃龙治疗的女性相比,接受E2/NETA治疗的女性在腰椎从基线到12个月和24个月时BMD显著增加(分别为3.07%,3.86%;与1.13%,2.23%相比,p < 0.01;p < 0.05),在全髋部从基线到24个月时BMD显著增加(分别为1.33%,1.69%;与0.76%,0.70%相比,p < 0.01),在股骨颈从基线到24个月时BMD显著增加(1.10%;p < 0.05)。QUS指标仅在6个月时使用E2/NETA治疗时,超声骨轮廓指数有显著变化(-2.32%;p < 0.001)。
与替勃龙相比,低剂量E2/NETA显示出BMD显著更高的增加。QUS测量在监测药物引起的骨变化方面未被认为具有有益作用。