Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women
Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women
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DOI：
10.1016/j.fertnstert.2009.05.093
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发表时间：
2009-09-01
影响因子：
6.7
通讯作者：
Pickar, James H.
中科院分区：
文献类型：
--
作者：
Archer, David E.;Lewis, Vivian;Pickar, James H.
目的：评估巴多昔芬/结合雌激素 (BZA/CE)（一种组织选择性雌激素复合物）对绝经后妇女子宫出血的影响。设计：国际、多中心、随机、双盲、安慰剂和活性对照 III 期研究（选择性雌激素绝经和治疗反应 [SMART]-1）。地点：门诊临床。患者：健康、绝经后妇女 (N = 3,397)，年龄 40 至 75 岁，子宫完整。干预措施：每日口服 BZA 10、20 或 40 mg（每种含 CE 0.625 或 0.45 mg）、雷洛昔芬 60 mg 或安慰剂。主要结果指标：累积闭经情况以及 2 年内出血或点滴出血的发生率。 结果：BZA 20 或 40 mg 联合 CE 0.625 或 0.45 mg 治疗与累积闭经率（第 1-13 周期 > 83%，第 10-13 周期 > 93%）和出血或点滴出血发生率相关，与安慰剂相当。与接受安慰剂治疗的受试者相比，接受 BZA 10 mg/CE 0.625 mg 治疗的受试者在整个研究过程中累积闭经率略低。 结论：接受 BZA 20 或 40 mg 与 CE 0.625 或 0.45 mg 治疗的绝经后妇女的累积闭经率较高，与安慰剂治疗的情况相似。这种新的绝经疗法可能会提供良好的出血和耐受性。 （Fertil Sterit (R) 2009；92:1039-44。(C)2009，美国生殖医学会。）
Objective: To evaluate the effect of bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women.Design: International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause And Response to Therapy [SMART]-1).Setting: Outpatient clinical.Patient(s): Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus.Intervention(s): Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo.Main Outcome Measure(s): Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years.Result(s): Treatment with BZA 20 or 40 mg with CE 0.625 or 0.45 mg was associated with rates of cumulative amenorrhea (> 83% during cycles 1-13 and > 93% during cycles 10-13) and bleeding or spotting that were comparable to those with placebo. Subjects who received BZA 10 mg/CE 0.625 mg experienced slightly lower cumulative amenorrhea rates throughout the study compared with placebo-treated subjects.Conclusion(s): Postmenopausal women treated with BZA 20 or 40 mg with CE 0.625 or 0.45 mg had high rates of cumulative amenorrhea that were similar to those reported with placebo. This new menopausal therapy may offer a favorable bleeding and tolerability profile. (Fertil Sterit (R) 2009;92:1039-44. (C)2009 by American Society for Reproductive Medicine.)