Relationship between changes in vasomotor symptoms and changes in menopause-specific quality of life and sleep parameters
Relationship between changes in vasomotor symptoms and changes in menopause-specific quality of life and sleep parameters
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DOI：
10.1097/gme.0000000000000678
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发表时间：
2016-10-01
影响因子：
2.7
通讯作者：
Komm, Barry S.
中科院分区：
文献类型：
--
作者：
Pinkerton, JoAnn V.;Abraham, Lucy;Komm, Barry S.
目的：本研究的特点和量化的关系，绝经期的血管紧张症状（VMS）与绝经期特定的生活质量（MSQOL）和睡眠参数，以帮助预测治疗结果和通知治疗decision-making.Methods：数据来自一个12周的随机，双盲，安慰剂对照的3期试验，评估了两种剂量的结合雌激素/bazedoxifene对VMS的影响nonendocardectomized绝经后妇女（N=318，平均年龄=53.39）经历至少7中度至重度潮热（HF）每天或每周至少50。重复测量模型用于确定HF频率和严重程度与绝经期特异性生活质量问卷和医学结局研究睡眠量表结果之间的关系。敏感性分析进行检查VMS和outcomes.Results之间的线性关系的假设：HF的频率和严重程度与MSQOL和睡眠参数呈近似线性关系。敏感性分析支持线性假设。与减少5个HF和严重程度降低0.5分相关的最大变化发生在更年期特异性生活质量血管功能领域（HF数量为0.78，严重程度为0.98）和医学结局研究睡眠障碍（7.38和4.86）和睡眠充足性（-5.60和-4.66）领域和两个整体睡眠问题指数（SPI：5.17和3.63; SPII：5.82和3.83）。结论：HF的发生率和严重程度与MSQOL和睡眠参数近似呈线性关系，即HF的改善与MSQOL和睡眠的改善相关。这样的关系可以使临床医生能够预测从各种VMS治疗中预期的睡眠和MSQOL的变化。
Objective:This study characterizes and quantifies the relationship of vasomotor symptoms (VMS) of menopause with menopause-specific quality of life (MSQOL) and sleep parameters to help predict treatment outcomes and inform treatment decision-making.Methods:Data were derived from a 12-week randomized, double-blind, placebo-controlled phase 3 trial that evaluated effects of two doses of conjugated estrogens/bazedoxifene on VMS in nonhysterectomized postmenopausal women (N=318, mean age=53.39) experiencing at least seven moderate to severe hot flushes (HFs) per day or at least 50 per week. Repeated measures models were used to determine relationships between HF frequency and severity and outcomes on the Menopause-Specific Quality of Life questionnaire and the Medical Outcomes Study sleep scale. Sensitivity analyses were performed to check assumptions of linearity between VMS and outcomes.Results:Frequency and severity of HFs showed approximately linear relationships with MSQOL and sleep parameters. Sensitivity analyses supported assumptions of linearity. The largest changes associated with a reduction of five HFs and a 0.5-point decrease in severity occurred in the Menopause-Specific Quality of Life vasomotor functioning domain (0.78 for number of HFs and 0.98 for severity) and the Medical Outcomes Study sleep disturbance (7.38 and 4.86) and sleep adequacy (-5.60 and -4.66) domains and the two overall sleep problems indices (SPI: 5.17 and 3.63; SPII: 5.82 and 3.83).Conclusions:Frequency and severity of HFs have an approximately linear relationship with MSQOL and sleep parametersthat is, improvements in HFs are associated with improvements in MSQOL and sleep. Such relationships may enable clinicians to predict changes in sleep and MSQOL expected from various VMS treatments.