Pitfalls of the WHIs - Women's Health Initiative
Pitfalls of the WHIs - Women's Health Initiative
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DOI：
10.1196/annals.1365.030
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发表时间：
2006-01-01
期刊：
影响因子：
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通讯作者：
Creatsas, George
中科院分区：
文献类型：
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作者：
Mastorakos, George;Sakkas, Evangelos Gr.;Creatsas, George
最近，更年期激素替代疗法(HRT)的使用已经成为一个有争议的问题。在妇女健康倡议(WHI)研究结果公布后，其效用受到质疑。这项试验分为两组，第一组检查了HRT(持续雌激素加孕激素)的联合使用，第二组检查了更年期妇女单独使用雌激素。第一支手臂在5.2岁时被提前终止，因为如果考虑到名义可信区间(CI)，接受HRT的女性中冠心病(CHD)、中风、静脉血栓栓塞病和乳腺癌的病例数量比接受安慰剂的女性更多。然而，在同一项研究中，作者明确指出，应考虑调整后的身份证明，而不是名义身份证明。这两个人导致了审判的结束。此外，WHI因其关于心血管疾病的结论而受到批评，因为试验设计存在严重缺陷。如果将调整后的顺应性考虑在内，那么不良事件的增加只对深静脉血栓有显着影响。第二项研究表明，雌激素的使用与乳腺癌发病率和心血管疾病的增加无关。仔细观察WHI试验的结果发现，使用HRT 5年不应被认为对乳腺癌、心血管疾病、中风和肺血栓的出现有害。我们建议激素替代疗法应在绝经早期进行。治疗方案应针对每个患者进行个体化。对于有阳性乳腺癌家族史、诊断为冠心病的女性，以及易患深静脉血栓的女性，应给予更多的随访。
Recently, the use of hormone replacement therapy (HRT) at menopause has become a matter of debate. Its utility has been questioned after the publication of the results of the Women's Health Initiative (WHI) studies. This trial was divided in two arms of which the first examined the use of combined HRT (continuous estrogens plus progestins) and the second the use of estrogens alone in menopausal women. The first arm was terminated prematurely at 5.2 years because the number of cases of coronary heart disease (CHD), strokes, venous thromboembolic disease, and breast cancer were more in women receiving HRT than in women receiving placebo, if the nominal confidence intervals (CIs) were taken into account. However, in the same study the authors made clear that the adjusted CIs should be taken into account instead of the nominal ones. These latter ones caused the ending of the trial. Moreover, WHI was criticized for its conclusions as far as cardiovascular disease is concerned because of serious defects regarding design of the trial. If the adjusted CIs were taken into account then the increase in adverse events was significant only for deep vein thrombosis. The second arm demonstrated that the use of estrogens was not correlated to an increase of neither breast cancer incidence nor cardiovascular disease. A closer look at the results of the WHI trial reveals that the use of HRT for 5 years should not be considered deleterious for the appearance of breast cancer, cardiovascular diseases, strokes, and pulmonary embolisms. We suggest that HRT should be given early in menopause. The regimen should be individualized for each patient. More intense follow-up should be offered to women with a positive family history of breast cancer, diagnosed coronary disease, and to women with a predisposition to deep venous thrombosis.