POSTMENOPAUSAL ESTROGEN-PROGESTIN INTERVENTION

与长期使用绝经后激素相关的风险 替代品是有争议的。一直没有足够的研究 对这些风险进行了可靠的估计。此外，中国经济的重大变化 替代疗法的制定，以及缺乏关于 什么构成了与风险增加相关的“长期”使用 面对这些不确定因素。在过去，人们的注意力集中在增加的 子宫内膜癌的风险与未使用雌激素有关 绝经后的女性。也有一些报道称，没有人反对 服用雌激素的人患乳房的风险略有增加，但持续增加 癌症。然而，最近关于乳腺癌风险增加的报道 与绝经后妇女使用孕激素有关 都强调了这样一个事实，即风险也可能来自这一来源。 绝经后雌激素/孕激素干预志愿者(PEPI) 试验服用活性/安慰剂雌激素和孕激素三年， 构成了这项临床试验的活跃阶段。考虑到这些问题 综上所述，对PEPI进行安全跟踪非常重要 一群人。与使用替代疗法有关的主要安全问题 被认为与对子宫和乳房的影响有关。 因此，为了确保不发生有害的变化，三年 将对Pepi队列进行以下安全跟踪 目标： 1.获取一段时间内PEPI参与者的年度子宫内膜活检 三年了。 2.从PEPI参与者那里获得为期三年的年度乳房X光检查 好几年了。 3.对安全性随访数据进行评价。

The risks associated with long-term use of postmenopausal hormone replacement agents are controversial. Insufficient research has been conducted to reliably estimate these risks. Further, major changes in the formulation of replacement therapies, as well as lack of clarity as to what constitutes "long-term" use associated with increased risk contribute to these uncertainties. In the past, attention focused on the increased risk of endometrial cancer associated with unopposed estrogen use in postmenopausal women. There have also been some reports that unopposed estrogen users have a slight, but consistent increased risk of breast cancer. However, recent reports of increased breast cancer risk associated with the use of progestational agents in postmenopausal women have underscored the fact that risks may also derive from this source. Volunteers for the Postmenopausal Estrogen/Progestin Interventions (PEPI) trial took active/placebo estrogen and progestin for the three years which constituted the active phase of this clinical trial. Given the issues summarized above, it is important to conduct a safety followup of the PEPI cohort. The primary safety issues related to use of replacement therapies are believed to be related to effects on the uterus and the breasts. Thus, to ensure that deleterious changes have not occurred, a three-year safety followup of the PEPI cohort will be conducted with the following objectives: 1. Obtain annual endometrial biopsies from PEPI participants for a period of three years. 2. Obtain annual mammograms from PEPI participants for a period of three years. 3. Evaluate the safety followup data.