Gordon Stephen, Walsh Brian W, Ciaccia Angelina V, Siddhanti Suresh, Rosen Amy S, Plouffe Leo
Women's Health and Internal Medicine, Comprehensive NeuroScience, Inc, 6065 Roswell, Suite 820, Atlanta, GA 30328, USA.
Obstet Gynecol. 2004 Feb;103(2):267-73. doi: 10.1097/01.AOG.0000110247.98588.ff.
To compare vasomotor symptoms after transition from estrogen-progestin therapy to raloxifene 60 mg/d with and without a placebo washout.
Postmenopausal women currently taking continuous combined estrogen-progestin therapy (conjugated equine estrogen, 0.625 mg/medroxyprogesterone acetate, 2.5 or 5 mg) daily for 5 or more months were enrolled. Women were randomized to 1 of 4 blinded regimens: 1) 12 weeks estrogen-progestin; 2) 12 weeks placebo; 3) 4 weeks placebo, then 8 weeks raloxifene; or 4) 12 weeks raloxifene. For the final 36 weeks, all subjects received raloxifene. Vasomotor symptoms were assessed by patient diaries.
A total of 266 women (mean age 57.5) were enrolled. Mean hot flush frequency at baseline was approximately 1 per week in the entire population, with 16% of women reporting hot flushes. Mean frequency and severity of hot flushes during the first 12 weeks of the study were statistically greater in the 3 groups transitioned off estrogen-progestin (range of hot flushes per week: 4 weeks, 11-12; 8 weeks, 18-24; 12 weeks, 13-16), as compared with those continuing estrogen-progestin, with no difference between these 3 groups (P> or =.1). Approximately 50-70% of these women reported hot flushes, generally rated as mild to moderate by participants, after estrogen-progestin discontinuation.
A large proportion of women discontinuing estrogen-progestin experience hot flushes. Raloxifene does not appear to increase the frequency or severity of vasomotor symptoms in women discontinuing estrogen-progestin more than that observed with placebo treatment after estrogen-progestin discontinuation. Transition from estrogen-progestin to raloxifene with no washout period therefore may be acceptable.
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比较在有或无安慰剂洗脱期的情况下，从雌激素 - 孕激素疗法过渡到每日服用60毫克雷洛昔芬后的血管舒缩症状。
纳入目前连续联合服用雌激素 - 孕激素疗法（结合马雌激素，0.625毫克/醋酸甲羟孕酮，2.5或5毫克）每日达5个月或更长时间的绝经后女性。女性被随机分为4种盲法治疗方案中的1种：1）12周雌激素 - 孕激素治疗；2）12周安慰剂治疗；3）4周安慰剂治疗，然后8周雷洛昔芬治疗；或4）12周雷洛昔芬治疗。在最后的36周，所有受试者均接受雷洛昔芬治疗。通过患者日记评估血管舒缩症状。
共纳入266名女性（平均年龄57.5岁）。在整个人群中，基线时潮热的平均频率约为每周1次，16%的女性报告有潮热。在研究的前12周，与继续接受雌激素 - 孕激素治疗的组相比，停用雌激素 - 孕激素的3组潮热的平均频率和严重程度在统计学上更高（每周潮热次数范围：4周组，11 - 12次；8周组，18 - 24次；12周组，13 - 16次），这3组之间无差异（P>或 = 0.1）。在停用雌激素 - 孕激素后，约50 - 70%的这些女性报告有潮热，参与者普遍将其评为轻度至中度。
很大一部分停用雌激素 - 孕激素的女性会经历潮热。与停用雌激素 - 孕激素后接受安慰剂治疗相比，雷洛昔芬似乎不会增加停用雌激素 - 孕激素女性的血管舒缩症状的频率或严重程度。因此，在没有洗脱期的情况下从雌激素 - 孕激素过渡到雷洛昔芬可能是可以接受的。
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