POSTMENOPAUSAL ESTROGEN/PROGESTIN INTERVENTIONS

在AS中，PEPI试验是建立 明确一种可能的方式，代谢和临床影响 绝经后妇女的雌激素/孕激素组合。 这项前瞻性随机临床试验将是其最大规模的临床试验 当结果最终出来的时候，我会很高兴。它可能会形成 未来的框架，甚至更大的研究，关于 雌激素/孕激素对疾病结局的影响，例如， 心血管疾病。从这个观点来看，Pepi试验假设 非常重要。 我们设计了一项临床试验，比较了两种形式的 雌激素制剂：结合马雌激素(CEE)和 透皮雌二醇(TDE)；并比较了两种形式的 孕激素：醋酸甲羟孕酮(MPA)和微粉化 孕酮(P)。第一，绝经后女性完好无损 子宫随机分为6组：CEE+MPA组、CEE+P组、CEE+P组、CEE+P组。 TDE+MPA；TDE+P；安慰剂贴片+安慰剂药丸；安慰剂药丸+ 安慰剂药片。然后我们可以比较不同的 服用相同雌激素的女性体内的孕激素，并比较 女性体内不同雌激素对同种孕激素的影响。我们 也可以将每一组与安慰剂组进行比较。第二, 无子宫的绝经后妇女将随机分为3人 组：CEE、TDE、安慰剂(1/2贴片)。从这个小组中我们可以 比较单独服用雌激素和添加雌激素的效果。 孕激素，如CEE+MPAvs VEE，等等，雌激素只对 安慰剂，以及不同雌激素制剂之间的关系。这 允许对代谢和临床结果进行多项比较 变量。 调查人员很兴奋，并致力于佩皮的审判 因为它对健康很重要。我们的经验相当丰富 在以下方面：(1)临床试验方案的制定， 征聘、维护和数据质量；(2)设立 骨密度测量的基于人群的标准数据； (3)提供功能齐全的血脂研究诊所护理 脂质实验室和首席研究员感兴趣的 血脂紊乱的管理；(4)心理研究。 和对疾病的性反应；以及(5)存在第一个- 对流行病学计划进行评级。

The PEPI Trial is an important method of establishing, in as unambiguous a manner possible, the metabolic and clinical effects of estrogen/progestin combinations in post-menopausal women. This prospective randomized clinical trial will be the largest of its kind when the results are finally available. It may form the framework for a future and even larger study, regarding the effects of estrogen/progestin on disease outcome e.g., cardiovascular. Taken with this view the PEPI Trial assumes great importance. We have designed a clinical trial that compares two forms of estrogen preparations: Conjugated equine estrogen (CEE) and transdermal estradiol (TDE); and compares two forms of progestins: Medroxyprogesterone acetate (MPA) and micronized progesterone (P). First, post-menopausal women with intact uterus will be randomized to 6 groups: CEE + MPA; CEE + P; TDE + MPA; TDE + P; placebo patch + placebo pill; placebo pill + placebo pill. We can then compare the effect of different progestins in women on the same estrogen, and compare the effect of different estrogens in women on the same progestin. We can also compare each group against the placebo group. Second, past-menopausal women without uterus will be randomized of 3 groups; CEE, TDE, placebo (1/2 patch). From this group we can compare the effects of estrogen only to those with added progestin e.g., CEE + MPA vs VEE, and etc., estrogen only against placebo, and between the different estrogen preparations. This allows multiple comparisons of metabolic and clinical outcome variables. The investigators are excited and committed to the PEPI Trial because of its health importance. Our experience is considerable in the following areas: (1) Clinical trial protocol development, recruitment, maintenance and data quality; (2) establishment of population based normative data for bone density measurements; (3) presence of a fully functioning Lipid Research Clinic Care Lipid Laboratory and principal investigator interested in management of lipid disorders; (4) research in the psychological and sexual responses to illnesses; and (5) the presence of a first- rate epidemiological program.