绝经后女性中，雷洛昔芬与安慰剂、周期性激素替代疗法及单纯雌激素相比，对子宫内膜的影响。

Endometrial response to raloxifene compared with placebo, cyclical hormone replacement therapy, and unopposed estrogen in postmenopausal women.

作者信息

Davies G C, Huster W J, Shen W, Mitlak B, Plouffe L, Shah A, Cohen F J

机构信息

Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.

出版信息

Menopause. 1999 Fall;6(3):188-95.

PMID:10486787

Abstract

OBJECTIVE

To determine the endometrial effects of raloxifene 60 mg/day in postmenopausal women as assessed by vaginal bleeding and endometrial thickness.

DESIGN

Data from 1157 postmenopausal women were analyzed from a database consisting of four independent, double-blind, randomized, placebo-controlled trials (range = 6-30 months duration), a 24-month open-label randomized, cyclical hormone replacement therapy (HRT)-controlled trial, and a 6-month double-blind, randomized, unopposed estrogen-controlled trial. Vaginal bleeding rate was derived from self-reported adverse events collected at least every 6 months. Endometrial thickness was measured by ultrasonography at regular intervals.

RESULTS

Raloxifene 60 mg/day was not significantly different from placebo with regard to the incidence of vaginal bleeding, the baseline-to-endpoint change in endometrial thickness, or the proportion of women experiencing an increase in endometrial thickness above baseline after either 12 or 24 months of therapy. Unexpected bleeding was reported significantly more frequently in the unopposed estrogen groups compared with the raloxifene group (raloxifene 60 mg/day, 0% versus estrogen, 50%; p = 0.002). A significantly greater baseline-to-endpoint increase in endometrial thickness was observed in both the HRT and estrogen groups compared with their respective raloxifene comparison group (raloxifene 60 mg/day, 0.01 +/- 2.0 mm versus HRT, 1.8 +/- 3.2; p < 0.001; raloxifene 60 mg/day, 1.1 +/- 1.7 mm versus estrogen, 7.8 +/- 3.8; p < 0.001). No cases of endometrial hyperplasia or cancer were diagnosed in the placebo or raloxifene 60 mg/day groups. Endometrial hyperplasia was diagnosed in one case in the HRT group and in two cases in the estrogen group.

CONCLUSION

Raloxifene 60 mg/day for up to 30 months is not associated with vaginal bleeding or increased endometrial thickness in postmenopausal women.

摘要

目的

通过阴道出血情况和子宫内膜厚度评估，确定每日60毫克雷洛昔芬对绝经后女性子宫内膜的影响。

设计

对1157名绝经后女性的数据进行分析，这些数据来自一个数据库，该数据库包含四项独立、双盲、随机、安慰剂对照试验（持续时间为6 - 30个月）、一项为期24个月的开放标签随机、周期性激素替代疗法（HRT）对照试验以及一项为期6个月的双盲、随机、无对抗雌激素对照试验。阴道出血率来自至少每6个月收集一次的自我报告不良事件。定期通过超声测量子宫内膜厚度。

结果

就阴道出血发生率、子宫内膜厚度从基线到终点的变化，或治疗12个月或24个月后子宫内膜厚度超过基线增加的女性比例而言，每日60毫克雷洛昔芬与安慰剂无显著差异。与雷洛昔芬组相比，无对抗雌激素组报告意外出血的频率显著更高（每日60毫克雷洛昔芬组为0%，雌激素组为50%；p = 0.002）。与各自的雷洛昔芬对照组相比，HRT组和雌激素组子宫内膜厚度从基线到终点的增加均显著更大（每日60毫克雷洛昔芬组为0.01±2.0毫米，HRT组为1.8±3.2毫米；p < 0.001；每日60毫克雷洛昔芬组为1.1±1.7毫米，雌激素组为7.8±3.8毫米；p < 0.001）。安慰剂组或每日60毫克雷洛昔芬组均未诊断出子宫内膜增生或癌症病例。HRT组有1例诊断为子宫内膜增生，雌激素组有2例。