Predictors of hot flushes in postmenopausal women who receive raloxifene therapy
Predictors of hot flushes in postmenopausal women who receive raloxifene therapy
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DOI：
10.1016/j.ajog.2004.04.042
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发表时间：
2004-12-01
影响因子：
9.8
通讯作者：
Nickelsen, T
中科院分区：
文献类型：
--
作者：
Aldrighi, JM;Quail, DC;Nickelsen, T
目的：在以前的报告中，我们描述了一个随机的结果。对照试验，评价雷洛昔芬诱发或加重潮热的潜力。在这里，我们提供了额外的分析，进行了确定潜在的预测潮热和评估的临床实用性的各种治疗策略，减少潮热的绝经后妇女接受雷洛昔芬therapy.Study设计：在这个随机，双盲，安慰剂对照研究，487例绝经后妇女被随机分配到接受雷洛昔芬治疗8个月。其以60 mg/d的剂量每隔一天给药2个月，随后为60 mg/d（缓慢剂量递增）或60 mg/d（雷洛昔芬），或安慰剂。数据油的数量，持续时间。收集由于盗汗引起的潮热和觉醒的强度和严重程度。Logistic回归模型被用来检查预测，各种人口统计学和绝经因素油的发展或恶化的潮热。结果：在基线，40.4%的所有随机分配的患者有潮热。潮热的平均次数（每周3-5次）较低。绝经后更短的时间。手术绝经和既往雌激素或雌激素/孕激素治疗是基线潮热的重要预测因素，但不能预测雷洛昔芬治疗期间发生的潮热。在接受雷洛昔芬治疗的女性中，在基线时已有潮热，36%的女性在终点时没有潮热。绝经后早期和手术绝经是潮热生物学相关性增加（大于或等于14次潮热/周）的显著预测因素。绝经后早期，既往接受过雌激素/孕酮治疗。高体重指数基线时潮热持续时间较长是需要对症治疗的重要预测因素。治疗2个月后。在绝经后早期的妇女中，雷洛昔芬治疗组的潮热明显多于缓慢剂量递增组（P = 0.042），而在绝经后晚期的妇女中，雷洛昔芬治疗组和缓慢剂量递增组之间没有显著差异。在研究期间要求对症治疗的50名患者中，植物激素或维拉必利并未显着减少潮热的次数。结论：绝经后时间较短和手术绝经是雷洛昔芬治疗前和治疗期间潮热的重要预测因素。既往雌激素/孕激素治疗也会增加基线潮热的风险。对于绝经早期的女性，缓慢剂量递增的雷洛昔芬治疗可能是降低潮热风险的合适治疗策略。(C)2004年爱思唯尔公司All rights reserved.
Objective: In a previous report, we described the results of a randomized. controlled trial that evaluated the potential of raloxifene to induce or exacerbate hot flushes. Here, we provide additional analyses that were undertaken to identify potential predictors of hot flushes and to assess the clinical usefulness of various therapeutic strategies for the reduction of hot flushes in postmenopausal women who receive raloxifene therapy.Study design: In this randomized, double-blind, placebo-controlled study, 487 unselected postmenopausal women were assigned randomly to receive treatment for 8 months with raloxifene. which was administered either at a dose of 60 mg/d every other day for 2 months followed by 60 mg/d (slow-dose escalation) or 60 mg/d throughout (raloxifene), or placebo. Data oil the number, duration. intensity, and severity of hot flushes and awakenings because of night sweats were collected. Logistic regression models were used to examine the predictive, value of various demographic and menopausal factors oil the development or worsening of hot flushes.Results: At baseline, 40.4% of all randomly assigned patients had hot flushes. The mean number of hot flushes (3-5 per week) was low. Fewer years postmenopause. surgical menopause. and previous estrogen or estrogen/progestin therapy were significant Predictors of hot flushes at baseline but were not predictive of incident hot flushes during treatment with raloxifene. Of the women who received raloxifene therapy who had pre-existing hot flushes at baseline, 36% women had none at the end point. Early postmenopause and Surgical menopause were significant predictors of a biologically relevant increase in hot flushes ( greater than or equal to 14 flushes/week). Early post menopause, previous estrogen/progestin therapy. high body mass index. and greater duration of hot flushes at baseline were significant predictors of the need for symptomatic treatment. After 2 months of treatment. women in early post menopause had significantly more hot flushes with raloxifene therapy than with slow-dose escalation (P = .042), whereas there was no significant difference between raloxifene therapy and slow-dose escalation among women in later postmenopause . In the 50 patients who requested symptomatic treatment during the study, phytohormones or veralipride did not reduce the number of hot flushes markedly.Conclusion: A shorter time since menopause and surgical menopause are important predictors of hot flushes both before and during treatment with raloxifene. Previous estrogen/progestin therapy also increases the risk of hot flushes at baseline. For women in early postmenopause, slow-dose escalation of raloxifene therapy may be a suitable therapeutic strategy for the reduction of the risk of hot flushes. (C) 2004 Elsevier Inc. All rights reserved.