Objective: To explore the effect of low-dose or standard-dose conjugated equine estrogen (CEE) combined with natural progesterone or dydrogesterone on bone density in menopause syndrome women. Methods: Totally 123 patients with menopause syndrome were recruited and randomly assigned to 3 treatment groups: group A (low-dose CEE+progesterone) , group B (standard-dose CEE+progesterone) , group C (standard-dose CEE+dydrogesterone) . Using continuous sequential regimen, the duration of intervention was 12 cycles. The bone mineral density of lumbar 2-4 and neck of femur, the bone metabolic markers, the level of FSH and estradiol were examined just before the drug administration and 12 months after the beginning of experiment. Results: There were 107 cases completed the one year trial. (1) Bone density: after 12 cycles of treatment, there was no significant change in bone density in group A (P>0.05) ; lumbar vertebrae of group B and C increased significantly, at 3.0% and 2.1%respectively (all P<0.05) . The bone density of left femoral neck of group C significantly increased by 2.9% (P=0.029) . There was no significant difference among the treatment groups at the beginning of experiment (P>0.05) . (2) Bone metabolic markers: after 12 cycles of treatment, the levels of calcium, phosphorus, alkaline phosphatase, Ca/Cr decreased significantly, the difference were statistically significant (all P<0.05) . There was no significant difference among the treatment groups at the beginning of experiment (P>0.05) . (3) Levels of FSH and estradiol: after 12 cycles of treatment, the levels of FSH in three groups were decreased significantly (all P<0.01) . The levels of estradiol in three groups were increased significantly (all P<0.01) . There was no significant difference among the treatment groups at the beginning of experiment (P>0.05) . Conclusions: Both low-dose and standard-dose menopause hormone therapy (MHT) could elevate the level of estradiol, reduce bone turnover, prevent bone loss of postmenopausal women effectively. The standard dose of MHT could also increase the density of vertebrae and femoral neck, and generate more clinical benefits.
目的： 观察低剂量结合雌激素（CEE）与标准剂量CEE联合天然黄体酮或地屈孕酮对围绝经期综合征患者骨密度的影响。 方法： 选取2014年2月至2015年12月就诊于北京协和医院的123例围绝经期综合征患者并以随机数字表法随机分为3组，最终共有107例完成试验，其中A组（予低剂量CEE+天然黄体酮）35例、B组（予标准剂量CEE+天然黄体酮）37例、C组（予标准剂量CEE+地屈孕酮）35例，以28 d为1个用药周期，共用药12个周期，用药方案均为连续序贯。于治疗前、治疗后测定腰椎2~4及股骨颈的骨密度、骨代谢指标、血清FSH及雌二醇水平。 结果： 治疗前3组患者间各部位的骨密度、骨代谢指标及FSH、雌二醇水平均无差异（P均>0.05）。治疗后与治疗前比较：（1）A组患者各部位的骨密度均无明显变化（P均>0.05）；B组、C组患者腰椎2~4的骨密度均显著增加，B组治疗前、后分别为（1.14±0.15）、（1.18±0.14）g/cm(2)，C组治疗前、后分别为（1.17±0.16）、（1.19±0.15）g/cm(2)，分别增加3.0%、2.1%（P均<0.05），C组左侧股骨颈的骨密度显著增加2.9%[治疗前、后分别为（0.91±0.15）、（0.94±0.16）g/cm(2)，P=0.029]；（2）3组患者的钙、磷、碱性磷酸酶、钙/肌酐比均显著下降（P均<0.05）；（3）3组患者的FSH水平均显著降低，雌二醇水平均显著升高（P均<0.01）。 结论： 低剂量与标准剂量的绝经激素治疗（MHT）均可升高雌二醇水平，有效预防绝经后的骨丢失，且标准剂量MHT在此基础上还可增加椎骨及股骨颈的骨密度，临床获益更多。.
Keywords: Bone density; Dose-respone relationship, drug; Estrogen replacement therapy; Hormone replacement therapy; Osteoporosis, postmenopausal; Perimenopause.