Caan Bette, LaCroix Andrea Z, Joffe Hadine, Guthrie Katherine A, Larson Joseph C, Carpenter Janet S, Cohen Lee S, Freeman Ellen W, Manson JoAnn E, Newton Katherine, Reed Susan, Rexrode Kathy, Shifren Jan, Sternfeld Barbara, Ensrud Kris
From the 1Division of Research, Kaiser Permanente of Northern California, Oakland, CA; 2University of California, San Diego, CA; 3Brigham and Women's Hospital, Boston, MA; 4Dana Farber Cancer Institute, Boston, MA; 5MsFLASH Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA; 6School of Nursing, Indiana University, Indianapolis, IN; 7Massachusetts General Hospital, Boston, MA; 8Harvard Medical School, Boston, MA; 9Departments of Obstetrics/Gynecology and Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA; 10Group Health Research Institute, Seattle, WA; 11University of Washington School of Medicine, Seattle, WA; and 12VA Medical Center/University of Minnesota, Minneapolis, MN.
Menopause. 2015 Jun;22(6):607-15. doi: 10.1097/GME.0000000000000364.
This study aims to evaluate the effects of low-dose estradiol (E2) or venlafaxine on menopause-related quality of life and associated symptoms in healthy perimenopausal and postmenopausal women with hot flashes.
A double-blind, placebo-controlled, randomized trial of low-dose oral 17β-E2 0.5 mg/day and venlafaxine XR 75 mg/day, versus identical placebo, was conducted among 339 women (aged 40-62 y) experiencing two or more vasomotor symptoms (VMS) per day (mean [SD], 8.07 [5.29]) who were recruited at three clinical sites from November 2011 to October 2012. The primary trial outcome, as reported previously, was frequency of VMS at 8 weeks. Here, we report on secondary endpoints of total and domain scores from the Menopause-Specific Quality of Life Questionnaire (MENQOL) and from measures of pain (Pain, Enjoyment in life, and General activity scale), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder Questionnaire-7), and perceived stress (Perceived Stress Scale).
Treatment with both E2 and venlafaxine resulted in significantly greater improvement in quality of life, as measured by total MENQOL scores, compared with placebo (E2: mean difference at 8 wk, -0.4; 95% CI, -0.7 to -0.2; P < 0.001; venlafaxine: mean difference at 8 wk, -0.2; 95% CI, -0.5 to 0.0; P = 0.04). Quality-of-life domain analyses revealed that E2 had beneficial treatment effects on all domains of the MENQOL except for the psychosocial domain, whereas venlafaxine benefits were observed only in the psychosocial domain. Neither E2 nor venlafaxine improved pain, anxiety, or depressive symptoms, although baseline symptom levels were low. Modest benefits were observed for perceived stress with venlafaxine.
Both low-dose E2 and venlafaxine are effective pharmacologic agents for improving menopause-related quality of life in healthy women with VMS.
本研究旨在评估低剂量雌二醇（E2）或文拉法辛对有潮热症状的健康围绝经期和绝经后妇女绝经相关生活质量及相关症状的影响。
在2011年11月至2012年10月期间，于三个临床地点招募了339名年龄在40 - 62岁、每天经历两种或更多血管舒缩症状（VMS）（均值[标准差]，8.07 [5.29]）的女性，进行一项双盲、安慰剂对照、随机试验，比较每日口服低剂量17β - E2 0.5毫克和文拉法辛缓释片75毫克与相同安慰剂的效果。如先前报道，主要试验结局是8周时VMS的频率。在此，我们报告来自绝经特异性生活质量问卷（MENQOL）以及疼痛（疼痛、生活乐趣和一般活动量表）、抑郁（患者健康问卷 - 9）、焦虑（广泛性焦虑障碍问卷 - 7）和感知压力（感知压力量表）测量的总得分和领域得分等次要终点。
与安慰剂相比，用E2和文拉法辛治疗均使通过MENQOL总得分衡量的生活质量有显著更大改善（E2：8周时均值差异， - 0.4；95%置信区间， - 0.7至 - 0.2；P < 0.001；文拉法辛：8周时均值差异， - 0.2；95%置信区间， - 0.5至0.0；P = 0.04）。生活质量领域分析显示，E2对MENQOL除心理社会领域外的所有领域均有有益的治疗效果，而文拉法辛的益处仅在心理社会领域观察到。尽管基线症状水平较低，但E2和文拉法辛均未改善疼痛、焦虑或抑郁症状。文拉法辛对感知压力有适度益处。
低剂量E2和文拉法辛都是改善有VMS的健康女性绝经相关生活质量的有效药物。
