Menopausal symptom experience before and after stopping estrogen therapy in the Women's Health Initiative randomized, placebo-controlled trial.

Menopausal symptom experience before and after stopping estrogen therapy in the Women's Health Initiative randomized, placebo-controlled trial.
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DOI:
10.1097/gme.0b013e3181d76953
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发表时间:
2010-09
期刊:
Menopause (New York, N.Y.)
影响因子:
--
通讯作者:
Stefanick M
Stefanick M
中科院分区:
其他
文献类型:
--
作者:
Brunner RL;Aragaki A;Barnabei V;Cochrane BB;Gass M;Hendrix S;Lane D;Ockene J;Woods NF;Yasmeen S;Stefanick M

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在试验前、一年后、试验结束时和停用雌激素或安慰剂后再次评估血管痉挛和其他绝经期症状。基线症状和年龄的作用进行了检查,是激素使用的频率和决定因素和症状管理策略后,停止共轭马雌激素或安慰剂。在40个临床中心,对10,739名绝经后妇女在随机分配使用结合马雌激素(CEE)或安慰剂前和一年后进行意向治疗分析,以及对继续服用分配的研究药物直至试验结束并在试验结束前不久完成症状调查的受试者(n=3496)进行的队列分析(从基线平均7.4 ± 1.1年)和停药后(试验结束后平均306 ± 55天)。广义线性回归模型血管痉挛症状,阴道干燥,乳房压痛,疼痛/僵硬和情绪波动,作为治疗分配和基线症状的函数,在停止研究药物之前和之后。大约三分之一的参与者在基线时报告了至少一种中度至重度症状。随着年龄的增长,报告的症状越来越少,除了关节疼痛/僵硬,这在年龄组之间是相似的。一年后,CEE减少了潮热、盗汗和阴道干燥,而乳房压痛增加。在试验结束时,CEE组的乳房压痛也显著更高。与未报告症状的女性相比,在基线时报告症状的女性明显更多,并且分配到CEE组(9.8%)的参与者明显多于安慰剂组(3.2%);然而,在基线时没有中度或重度症状的女性中,停止CEE后报告潮热的人数(7.2%)是安慰剂组(1.5%)的5倍以上。CEE显著减少了基线症状的女性的血管扩张症状和阴道干燥,但增加了乳房压痛。无论基线症状状态如何,停止CEE后出现症状的可能性均显著高于安慰剂。在开始CEE以缓解更年期症状之前,应考虑这些潜在影响。
To assess vasomotor and other menopausal symptoms before, one year later, again at trial closure and after stopping estrogens or placebo. The role of baseline symptoms and age was examined as was the frequency and determinants of hormone use and symptom management strategies after discontinuing conjugated equine estrogens or placebo. Intention-to-treat analyses of 10,739 postmenopausal women before and one year after randomization to conjugated equine estrogens (CEE) or placebo at 40 clinical centers, and a cohort analysis of participants (n=3496) who continued taking assigned study pills up to trial closure and completed symptom surveys shortly before (mean 7.4 + 1.1 years from baseline) and after stopping pills (mean 306 + 55 days after trial closure). Generalized linear regression modeled vasomotor symptoms, vaginal dryness, breast tenderness, pain/stiffness and mood swings, as a function of treatment assignment and baseline symptoms, before and after stopping study pills. Approximately one-third of participants reported at least one moderate-to-severe symptom at baseline. Fewer symptoms were reported with increasing age, except joint pain/stiffness, which was similar among age groups. At one year, hot flashes, night sweats and vaginal dryness were reduced by CEE, whereas, breast tenderness was increased. Breast tenderness was also significantly higher in the CEE group at trial closure. Post-stopping, vasomotor symptoms were reported by significantly more women who had reported symptoms at baseline, compared to those who had not, and by significantly more participants assigned to CEE (9.8%) versus placebo (3.2%); however, among women with no moderate or severe symptoms at baseline, over 5 times as many reported hot flashes after stopping CEE (7.2%) versus placebo (1.5%). CEE significantly reduced vasomotor symptoms and vaginal dryness in women with baseline symptoms, but increased breast tenderness. The likelihood of experiencing symptoms was significantly higher after stopping CEE than placebo regardless of baseline symptom status. These potential effects should be considered before initiating CEE to relieve menopausal symptoms.
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发表时间: 2006-07-01
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DOI: 10.1016/s1047-2797(03)00045-0
发表时间: 2003-10-01
影响因子: 5.6
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