Pines Amos
Department of Med T Ichilov Hospital, Tel Aviv.
Harefuah. 2003 Mar;142(3):163-5, 240.
The Women's Health Initiative (WHI) a double-blind, placebo-controlled trial studying the effects of continuous combined estrogen-progestin regimen (CEE 0.625 mg plus 2.5 mg MPA daily), was stopped prematurely on the basis of a slight increase in the risk of invasive breast cancer, myocardial infarction and stroke. The study was not planned to examine other important aspects of HRT treatment, such as menopausal symptoms and quality of life, since the CEE only arm of the study was not terminated, it is possible that the specific drug tested in the study had different effects on outcome than other preparations available in the market. One should remember that many previous observational studies actually demonstrated cardiovascular benefits in women using other types or regimens of hormones. There seems to be a consensus on the interpretation of the WHI trial: 1) hormones are the best treatment for symptomatic women since there are no real alternatives; 2) women who use HRT for more than 5 years should discuss the latest data with their physician, in order to consider their individual risk-benefit equation; 3) it is logical to prefer hormones, which are different from CEE plus MPA daily.
妇女健康倡议(WHI)是一项双盲、安慰剂对照试验,旨在研究连续联合雌激素 - 孕激素方案(每日0.625毫克结合雌激素加2.5毫克甲羟孕酮)的效果。该试验因浸润性乳腺癌、心肌梗死和中风风险略有增加而提前终止。该研究并未计划考察激素替代疗法(HRT)治疗的其他重要方面,如更年期症状和生活质量。由于该研究仅使用结合雌激素的部分未终止,所以有可能该研究中所测试的特定药物与市场上其他制剂相比,对结果有不同影响。应该记住,之前许多观察性研究实际上表明,使用其他类型或方案激素的女性具有心血管益处。对于WHI试验的解读似乎存在共识:1)由于没有真正的替代方法,激素是有症状女性的最佳治疗方法;2)使用HRT超过5年的女性应与医生讨论最新数据,以便考虑个人的风险 - 收益平衡;3)选择不同于每日结合雌激素加甲羟孕酮的激素是合理的。