POSTMENOPAUSAL ESTROGEN-PROGESTIN INTERVENTION

绝经后雌激素-孕激素干预

• 批准号: 2317972
• 负责人: CARL JOSEPH PAUERSTEIN
• 金额: $ 6.53万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-06-23 至 1997-12-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2317972
• 关键词: POSTMENOPAUSAL; ESTROGEN; PROGESTIN; INTERVENTION

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.

长期使用绝经后激素的风险 替代剂是有争议的。 研究不足， 以可靠地估计这些风险。 此外， 替代疗法的制定，以及缺乏明确性， 与风险增加相关的“长期”使用的构成因素 这些不确定性。 在过去，注意力集中在增加的 子宫内膜癌的风险与无对抗性雌激素的使用有关， 绝经后妇女。 也有一些报道称，没有遭到反对 雌激素使用者有轻微的，但一致的乳腺癌风险增加， 癌 然而，最近关于乳腺癌风险增加的报道 与绝经后妇女使用促孕药相关 这一事实也表明，风险也可能来自这一来源。 绝经后雌激素/孕激素干预（PEPI）的志愿者 一项为期三年的试验服用了活性/安慰剂雌激素和孕激素， 构成了本临床试验的活性阶段。 鉴于这些问题 如上所述，对PEPI进行安全性随访非常重要 队列。 与使用替代疗法相关的主要安全性问题 被认为与对子宫和乳房的影响有关。 因此，为了确保没有发生有害的变化， PEPI队列的安全性随访将采用以下方法进行 目的： 1. 在一段时间内每年从PEPI参与者中获取子宫内膜活检 三年了 2. 从PEPI参与者获得年度乳房X线照片，为期三年 年 3. 评估安全性随访数据。