HORMONE REPLACEMENT AND RISK OF UTERINE FIBROID GROWTH

激素替代和子宫肌瘤生长的风险

• 批准号: 2889296
• 负责人: Kristen Hawthorne Kjerulff
• 金额: $ 57.53万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-04-07 至 2001-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2889296
• 关键词: African American; cancer risk; caucasian American; clinical research; clinical trials; estrogens; female; hormone therapy; human subject; human therapy evaluation; leiomyoma; longitudinal human study; neoplastic growth; postmenopause; progestins; quality of life; ultrasound; uterus neoplasms; women's health

DESCRIPTION: (Adapted from Applicant's Abstract). The disease of uterine fibroids is a common and significant public health problem, affecting women of all ages, racial backgrounds and socioeconomic levels. When women with fibroids reach the perimenopausal or postmenopausal periods, they face a troubling treatment dilemma. If they wish to preserve their uterus, they take an unknown risk of causing fibroid growth by taking HRT. On the other hand, the benefits of using HRT are substantial, particularly for women at risk for cardiovascular disease or osteoporosis. There are been little, if any, research done to examine the effect of HRT use on fibroid proliferation and growth among uterine fibroid patients. The proposed randomized, controlled, double-blinded clinical trial will investigate the extent to which a commonly prescribed low dose, continuous estrogen-progestin HRT regimen stimulates fibroid growth and proliferation among black and white postmenopausal fibroid patients. Ultrasound assessments will be conducted for 300 postmenopausal fibroid patients at baseline, 6, 12 and 24 months, which will allow an examination of the extent to which fibroid growth occurs, and if so, whether growth continues or plateaus. The extent to which this HRT regimen affects menopause-related symptoms, fibroid-related symptoms and quality of life will also be examined. A risk-benefit analysis will be conducted, taking into account both uterine and non-uterine risks and benefits, based on the results of this study and reviews of other studies. The results of this study will be of significant value to a growing body of fibroid patients reaching the menopause and to the clinicians who treat these patients.

描述：（改编自申请人摘要）。 子宫疾病 纤维瘤是一种常见的重大公共卫生问题，影响妇女 所有年龄、种族背景和社会经济水平的人。 当女性与 子宫肌瘤达到围绝经期或绝经后时期，他们面临着一个 令人困扰的治疗困境。 如果他们想保留子宫， 服用激素替代疗法会导致纤维瘤生长，这是一个未知的风险。 另 另一方面，使用HRT的好处是巨大的，特别是对女性来说， 心血管疾病或骨质疏松症的风险。 很少有，如果 任何，研究做检查的影响，HRT的使用对子宫肌瘤增殖 和子宫肌瘤患者的生长。 建议的随机， 对照、双盲临床试验将调查 其中一个常用的处方低剂量，连续雌激素-孕酮HRT 方案刺激纤维瘤生长和增殖之间的黑色和白色 绝经后纤维瘤患者。 将进行超声评估 在基线、6、12和24个月时， 这将允许检查纤维瘤生长的程度 发生，如果是，是否继续增长或高原。 在多大程度 这种HRT方案会影响更年期相关症状、纤维瘤相关症状 并会检查病人的病征及生活质素。 风险受益分析 将考虑子宫和非子宫风险 和好处，根据这项研究的结果和审查其他 问题研究 这项研究的结果将具有重要价值， 越来越多的子宫肌瘤患者达到更年期， 治疗这些患者的医生。