Postmenopausal hormone therapy: new questions and the case for new clinical trials
Postmenopausal hormone therapy: new questions and the case for new clinical trials
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DOI：
10.1097/01.gme.0000177906.94515.ff
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发表时间：
2006-01-01
影响因子：
2.7
通讯作者：
Santoro, N
中科院分区：
文献类型：
--
作者：
Manson, JE;Bassuk, SS;Santoro, N
观察性研究表明，绝经后激素治疗（HT）可预防冠心病，而随机临床试验尚未证实其心脏保护作用。虽然观察性研究可能高估了绝经后使用激素对冠状动脉的益处，但对于先前的结果与临床试验（如大型妇女健康倡议）中不太有利的结果之间的明显差异，还有其他合理的解释。现在有大量的数据支持这样的假设，即年龄或绝经后的时间可能会重要地影响与激素治疗相关的获益-风险比，特别是心血管疾病的结果，外源性激素的给药方法、剂量和配方也可能相关。尽管证据表明老年妇女和有亚临床或显性冠心病的妇女不应服用激素治疗，但雌激素仍然是目前治疗血管舒缩症状最有效的方法，其对新绝经后妇女冠心病发展的影响尚不清楚。此外，激素对新近绝经妇女的生活质量和认知功能的影响值得进一步研究。这些尚未解决的临床问题为Kronos早期雌激素预防研究的设计提供了理论依据，这是一项为期5年的随机试验，将评估低剂量口服雌激素和经皮雌二醇在预防近期绝经后妇女动脉粥样硬化进展中的有效性。
Observational studies suggest that postmenopausal hormone therapy (HT) prevents coronary heart disease, whereas randomized clinical trials have not confirmed a cardioprotective effect. Although observational studies may have overestimated the coronary benefit conferred by postmenopausal hormone use, there are other plausible explanations for the apparent discrepancy between previous results and the less favorable findings from clinical trials such as the large Women's Health Initiative. There is now a critical mass of data to support the hypothesis that age or time since menopause may importantly influence the benefit-risk ratio associated with HT, especially with respect to cardiovascular outcomes, and that the method of administration, dose, and formulation of exogenous hormones may also be relevant. Although the weight of the evidence indicates that older women and those with subclinical or overt coronary heart disease should not take HT, estrogen remains the most effective treatment currently available for vasomotor symptoms, and its effects on the development of coronary disease in newly postmenopausal women remain unclear. Moreover, effects of HT on quality of life and cognitive function in recently postmenopausal women merit further study. These unresolved clinical issues provide the rationale for the design of the Kronos Early Estrogen Prevention Study, a 5-year randomized trial that will evaluate the effectiveness of low-dose oral estrogen and transdermal estradiol in preventing progression of atherosclerosis in recently postmenopausal women.