MEDICINE OR SURGERY? (MS?)

描述：建议的研究是一项随机临床试验，比较 强化内科治疗与子宫切除术对患者功能和功能的影响 无异常子宫出血的绝经前妇女的幸福感 在最初的医疗管理三个月后做出充分反应。一个 第二个随机试验将比较宫颈上和全宫颈的效果 子宫切除术对腹部手术妇女功能和健康的影响 子宫切除术。生活质量、临床、性别方面的组间差异 功能，并将检查经济结果。 四个临床中心将招募和筛选约3000人 绝经前妇女，年龄超过30岁，有异常子宫出血，超过 为期两年。在这项研究中，异常出血的定义是 每月月经8天或贫血(红细胞压积32%) 有大量血液流动且无其他贫血原因的妇女。排除的标准 包括：妊娠、生殖道或乳腺恶性肿瘤，其他适应症 子宫切除或附件切除，口服黄体酮禁忌症 避孕药，或前列腺素抑制剂，无法遵守 药物方案或研究随访，GnRH激动剂治疗在6个月内 研究进入，子宫迅速增大(在6个月内翻一番)。 最初，为期三个月的传统孕激素疗法将是 管理。然后进行几个假设以得出样本量 在300名患者中，他们将随机接受任何一种药物治疗(口服 避孕药和前列腺素抑制剂)或子宫切除术(腹部 或阴道，根据妇科医生会诊的临床判断 和那个女人)。对于那些计划接受腹部手术的患者 子宫切除术，第二个水平的随机选择将发生 子宫次全切除术或全子宫切除术。将对患者进行两次跟踪 好几年了。

DESCRIPTION: The proposed study is a randomized clinical trial comparing the effects of enhanced medical therapy vs. hysterectomy on functioning and well-being in premenopausal women with abnormal uterine bleeding who do not respond adequately after three months of initial medical management. A second randomized trial will compare the effects of supracervical vs. total hysterectomy on function and well-being in women who undergo abdominal hysterectomy. Group differences in quality-of-life, clinical, sexual function, and economic outcomes will be examined. Four clinical centers will recruit and screen approximately 3000 premenopausal women, over age 30 with abnormal uterine bleeding, over a two-year period. For this study, abnormal bleeding is defined as more than eight days of menstrual flow per month or anemia (hematocrit <32 percent) in women with heavy flow and no other cause for anemia. Criteria for exclusion include: pregnancy, genital tract or breast malignancy, other indications for hysterectomy or adnexal removal, contraindications to progestins, oral contraceptive pills, or prostaglandin inhibitors, inability to comply with medical regimen or study follow-up, GnRH agonist therapy within 6 months of study entry, and rapid uterine enlargement (doubling over 6 months). Initially, three months of traditional progestin therapy will be administered. Several assumptions are then made to arrive at a sample size of 300 patients, who will be randomized to either medical therapy (oral contraceptive pills and prostaglandin inhibitors) or hysterectomy (abdominal or vaginal, based on clinical judgment of the gynecologist in consultation with the woman). For those patients scheduled to undergo abdominal hysterectomy, a second level of randomization will take place to have either a supracervical or a total hysterectomy. Patients will be followed for two years.