摘要
OBJECTIVE: To identify the optimal dosage of 17beta-estradiol gel + oral progestin for preventing bone loss in postmenopausal Chinese women. METHODS: A 3-year open label, randomized, prospective clinical trial was conducted. Sixty healthy women who had been postmenopausal for 1 to 5 years were recruited and divided into following 4 groups: group 1, percutaneous gel 17beta-estradiol (E(2)) 1.5 mg/d plus micronized progesterone (MP) 100 mg/d; group 2, percutaneous gel 17beta-estradiol (E(2)) 1.5 mg/d plus medroxyprogesterone acetate (MPA) 2 mg/d; group 3, percutaneous gel 17beta-estradiol (E(2)) 0.75 mg/d plus micronized progesterone (MP) 100 mg/d; and group 4, percutaneous gel 17beta-estradiol (E(2)) 0.75 mg/d plus medroxyprogesterone acetate (MPA) 2 mg/d. Estrogen and progestin were given continuously for 25 days per month. Bone mineral density (BMD) was measured using quantitative computed tomography (QCT) for trabecular bone of L2-5 and dual energy X-ray absorptiometry (DEXA) for L2-4 and hip 5 times during the trial at baseline and at the 6-, 12-, 18-, 24- and 36-month visits. RESULTS: Fifty-nine patients (98.3%, 59/60) stayed in the study for 1 year, 56 patients (93.3%, 56/60) for 2 years, and 51 (85%, 51/50) for 3 years. On average, menopausal symptoms were relieved by 80% after 6 months of treatment. By the 24th month, the mean increase in BMD ranged from 4.3% to 7.5% in trabecular bone; and by the 36th month, it ranged from 4.2% to 6.2% in L2-4 and 1.61% to 3.77% in the neck. There were significant difference after treatment (P 0.05) was found in improvement of symptoms, levels of bone markers or BMD. CONCLUSION: A daily dose of estradiol gel, either 0.75 mg or 1.5 mg, is effective in preventing early postmenopausal bone loss and relieving menopausal symptoms. After 3-year treatment, spinal BMD could increase steadily, so does hip BMD, especially in the first 2 years.
目的 探索经皮用雌激素凝胶在中国妇女中预防绝经早期骨丢失的用法。方法 周期性联合应用雌孕激素 ,雌激素为经皮雌二醇凝胶 ,孕激素为口服微粉化天然孕酮和醋甲羟孕酮。选取60例身体健康、绝经 1- 5年的妇女 ,根据雌激素剂量与 2种孕激素开放随机分为 4组。每日睡前服用 ,每月连用2 5d ,停药 5d。单光子吸收法 (SPA法 )测定前臂皮质骨骨密度 ;QCT法测定腰椎松质骨骨密度 ;双能X线吸收法(DEXA法 )测定腰椎与髋部骨密度。在用药 0、6、12、18、2 4与 36个月时分别测量密度、骨代谢生化指标及绝经症状评分。结果 5 9例 (98% )完成 1年随访 ;5 6例 (93% )完成 2年随访 ,5 1例 (85 % )完成 3年随访。用药 6个月时 4组症状缓解率为 80 % ;2年时腰椎松质骨BMD升高平均 4 3% - 7 5 % ;3年时腰L2 4 升高 4 2 - 6 2 % ;股骨颈升高1 6% - 3 8%。与用药前相比 ,差异有显著性 (P <0 .0 5 ) ;4组间比较 ,对骨密度的改善无显著性差异 (P >0 .0 5 )。阴道出血率 2和 4组较高 ,1和 3组较低。结论 经皮 17 β雌二醇凝胶 (0 75mg/d或 1 5mg/d)可有效缓解绝经相关症状 ,预防绝经早期骨丢失。雌孕激素补充治疗 3年 ,可连续增加腰椎骨密度 。
