经皮用雌二醇凝胶预防绝经早期骨丢失用量的探索

探索经皮用雌激素凝胶对中国妇女预防绝经早期骨丢失的用量 ,进行 2年开放随机前瞻性研究。采用周期性联合应用雌孕激素 ,雌激素为经皮用雌二醇 (E2 )凝胶 ,孕激素为口服微粉化孕酮 (microprogesterone,MP)和醋甲羟孕酮 (MPA)。 60名妇女 ,身体健康 ,绝经 1～ 5年 ,随机进入 4组 :G1 :E2 1 .5 mg/ d+ MP1 0 0 mg/ d;G2 :E2 1 .5mg/ d+ MPA 2 mg/ d;G3 :E2 0 .75 mg/ d+ MP 1 0 0 mg/ d;G4:E2 0 .75 mg/ d+ MPA 2mg/ d。每日睡前应用 ,每月连用 2 5 d。用 SPA法测前臂骨密度 (CBMD) ;QCT法测腰椎松质骨骨密度 (TBMD) ;DEXA法测腰椎 (L 2 -4 )与髋部骨密度。分别在用药 0、 6、1 2、 1 8和 2 4个月时测量骨密度、骨代谢生化指标、评分绝经症状及骨质疏松症状及记录阴道出血。结果 :5 9名 (98% )完成 1年 ;5 6名 (93 % )完成 2年。用药 6个月时 4组症状平均缓解约 80 % ;2年时腰椎 TBMD平均升高 4.3 %～ 7.5 % ;L 2 -4升高 2 .7%～4.5 % ;股骨颈升高 2 .0 %～ 4.2 %。E2 1 .5 mg(G1 + G2 )与 E2 0 .75 mg(G3 + G4)比较 ,对骨密度的改善无显著性差异 (P=0 .0 7～ 0 .93 )。不规则阴道出血率 G2最高 (41 .3 % )、G3最低 (1 0 .2 % )。结论 :每日经皮用 0 .75 mg E2 凝胶可有效缓解绝经相关症状 ,预防绝经早期

Search for the optimal application of estrogel preventing bone lossin early post-menopausal women in China

Objective: To search for the optimal application of percutaneous estrogel preventing bone loss in early post menopausal women in China Methods: A 2 year open randomized clinical study was designed. Sixty healthy women (natural menopause for 1 to 5 years) were recruited and divided into four groups. The regimen as follows: G1 percutaneous estrogel (gel) containing 1.5 mg of 17 β estradiol (E 2)/d plus micronized progesterone (MP) 100 mg/d (E 2 1.5+MP); G2 gel 1.5 mg E 2/d plus medroxyprogesterone acetate (MPA) 2 mg/d (E 2 1.5+MPA);G3 gel 0.75 mg E 2/d plus MP 100 mg/d (E 2 0.75+MP);G4 gel 0.75 mg E 2/d plus MPA 2 mg/d (E 2 0 75+MPA)。All were given for 25 d/month. Bone mineral density (BMD)were measured at baseline,0,6,12,18, and 24 months respectively. Forearm, lumbar trabecular lumbar 2 4,and hip BMD were measured by single photon absorptiometry (SPA), quantitative computerized tomography (QCT)and dual energy X ray absorptionmetry (DEXA) respectively. Bone metabolic indices were also determined. Improvement of menopausal syndrome was analysed using Kuppermann score. The vaginal bleeding rate was also recorded. Results: Average BMD in all four groups increased. By the end of 24 month, the mean increases of BMD range from 4.3% to 7.5% in trabecular bone, 2.7% to 4.5% in the L2 4, 2 0% to 4.2% in the femoral neck. Comparing G1+G2 vs G3+G4, and G1+G3 vs G2+G4, no any significant difference was found in improvement of symptoms, bone markers and BMD ( P=0.07～0.93 )。The frequency of irregular bleeding in G3 was the lowest (10.2%) and the highest in G2(41.3%) Conclusions: We concluded that the gel containing 0.75 mg E 2 daily is effective to prevent the early postmenopausal bone loss and improve the menopausal symptoms as well. The vaginal bleeding rate was low when combined with 100 mg micronized progesterone daily.