雌二醇皮贴与安宫黄体酮连续联合治疗改善绝经后症状及预防腰椎骨丢失的临床观察

Effects of continuous combined Dermstril and medroxyprogesterone acetate replacement therapy on climacteric symptoms and lumbar vertebral bone loss

目的 :比较两种剂量的雌激素贴剂 ( 2 5及 50μg/ 2 4h)对绝经后症状及腰椎骨密度 ( BMD)的影响。方法 :采用前瞻、随机的方法 ,对 40例绝经 1～ 4年的妇女随机接受得美素 2 5或得美素 50贴剂 ( 2贴 /周 ) ,同时每日口服安宫黄体酮 2 mg、元素钙 50 0mg,连续 1年。观察治疗期间症状的 Kuppermann评分、腰椎 BMD及子宫内膜的变化。结果 :治疗 1个月后 ,两组的 Kuppermann评分改善均 >60 % ,潮热消失率约 50 % ,两组间无显著差异 ;治疗 1年得美素 50组及 2 5组潮热消失率分别为 1 0 0 %及 79%。治疗 6个月后得美素 50组腰椎 BMD明显升高 ( +3 .53 % ) ,与得美素 2 5组 ( +0 .75% )比较有显著差异 ;治疗 1 2月个后 ,两组 BMD分别增加 4.1 6%和 1 .51 % ,两组有显著差异 ( P <0 .0 1 )。得美素 50组子宫内膜较治疗前明显增厚 ,1例内膜活检为单纯增生。在治疗最后 3个月 ,得美素 2 5组、50组阴道流血发生率分别为 1 6%、56% ,两组有显著差异 ( P<0 .0 5)。结论 :得美素 2 5及得美素 50均能有效地治疗绝经期症状并预防绝经后骨丢失 ,得美素 50较得美素 2 5对骨量的影响更迅速、更强 ,对内膜的影响更明显 ,阴道流血发生率高、时间长。

Objective: To compare the effects of estradiol patch (Dermestril) with doses of 50 μg/24 h or 25 μg/24 h combined with medroxyprogesterone acetate 2 mg/day on vasomotor symptoms and lumbar vertebral bone loss in postmenopausal women. Methods: This was an one year prospective randomized study.40 cases of postmenopausal women were divided into Dermestril 25 (which release 25 μg estradiol per 24 hours) or Dermestril 50 group (which release 50 μg estradiol per 24 hours)(2 patch/week). Women in either group were given 2 mg medroxyprogesterone acetate orally per day and calcium concurrently. Kuppermann score was recorded, lumbar vertebral bone mineral density(L2 4 BMD) was measured by DXA, and endometrium thickness was determined by transvaginal ultrasound Results: After 1 month of treatment, Kuppermann score decreased by 60% and hot flush completely disappear in 50% women in both groups; after 12 months of treatment, no woman suffered from hot flush in Dermestril 50 group, while 21% women still had hot flush in Dermestril 25 group. After 6 months of treatment, L2 4 BMD increased significantly only in Dermestril 50 group(+3.53%), no change was found in Dermestril 25 group, and difference between the two groups was significant. After 12 months treatment, L2 4 BMD of Dermestril 50 and Dermestril 25 group increased 4.16% and 1.51% respectively, showing statistical significance ( P<0.01 ). Simple hyperplasia was found in one patient with endometrium thickness >5 mm in Dermestril 50 group. During the last 3 months of treatment, vaginal bleeding rate was significantly lower in the Dermestril 25 group (16% vs 56%, P<0.05 ). Conclusions: Both Dermestril 25 and Dermestril 50 can effectively relieve climacteric symptoms and prevent bone loss in postmenopausal women. The effect of Dermestril 50 on bone metabolism was superior to Dermestril 25. However, the high dose of estradiol patch could result in more frequent and longer vaginal bleeding, and the combination of Dermestril 50 with medroxyprogesterone acetate 2 mg daily perhaps can not completely protect the endometrium from hyperplasia.