MEDICINE OR SURGERY?(MS?)

描述：拟议的研究是一项随机临床试验， 增强药物治疗与子宫切除术对功能和 健康的绝经前妇女异常子宫出血谁不 在三个月的初步医疗管理后充分反应。 一 第二项随机试验将比较颈上与全颈的效果 子宫切除术对腹部手术妇女功能和健康影响 子宫切除术 生活质量、临床、性生活方面的组间差异 经济效益和经济效益将得到检验。 四个临床中心将招募和筛选约3000人 绝经前妇女，30岁以上，子宫异常出血， 两年期。 对于本研究，异常出血定义为超过 每月月经8天或贫血（红细胞压积<32%）， 没有其他原因导致贫血的女性。 排除标准 包括：妊娠、生殖道或乳腺恶性肿瘤、其他适应症 子宫切除术或附件切除术，孕激素禁忌症，口服 避孕药或前列腺素抑制剂，无法遵守 医疗方案或研究随访，6个月内接受GnRH激动剂治疗 进入研究，子宫迅速增大（6个月内加倍）。 最初，将进行三个月的传统抗肿瘤治疗， 管理。 几个假设，然后得出一个样本量 300例患者，随机接受药物治疗（口服 避孕药和前列腺素抑制剂）或子宫切除术（腹部 或阴道，基于妇科医生在咨询中的临床判断 的女人）。 对于计划接受腹部手术的患者， 子宫切除术后，将进行第二级随机化， 子宫切除或全子宫切除 患者将接受两次随访 年

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.