Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas
Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas
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DOI：
10.1016/j.jmig.2005.01.022
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发表时间：
2005-05-01
影响因子：
4.1
通讯作者：
Guzick, DS
中科院分区：
文献类型：
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作者：
Eisinger, SH;Bonfiglio, T;Guzick, DS
研究目的：主要目的是评估小剂量米非司酮对肌瘤消退、症状和子宫内膜病理的长期影响。第二个目的是评估停用米非司酮后肌瘤的再生。设计：前瞻性、开放、随机、对照试验，在患有大型有症状的肌瘤的妇女中，每天5 mg和10 mg米非司酮，为期一年，并在一组受试者中进行不同的随访(加拿大工作组分类II-2)。设置：大学研究小组设在社区医院。患者：40名绝经前妇女，有症状的肌瘤。干预：口服米非司酮5或10 mg/d，为期一年。测量和主要结果：服用米非司酮6个月后，两组的平均子宫体积缩小48%，12个月后，两组的平均子宫体积缩小52%至53%。6个月闭经发生率为61%~65%，12个月闭经发生率为40%~70%。共进行了80例子宫内膜活检。6个月时36例中5例(13.9%)出现单纯性增生，12个月时21例中1例(4.8%)出现单纯增生。10 mg组全部出现增生。无子宫内膜标本显示细胞学异型性。9名女性在治疗后平均随访5.7个月。大多数受试者子宫体积增加，但仍比基线平均低42%。结论：长期服用小剂量米非司酮可导致肌瘤缩小和症状改善；轻度子宫内膜增生症的发生率也较低，但没有癌前病变的迹象。停药后再生缓慢。(C)2005年AAGL。版权所有。
STUDY OBJECTIVES: The primary aim was to assess long-term effects of low-dose mifepristone on myoma regression, symptoms, and endometrial pathology. The secondary aim was to assess regowth of myomas after cessation of mifepristone.DESIGN: Prospective, open-label, randomized, controlled trial of 5 mg versus 10 mg mifepristone daily for I year, in women with large, symptomatic myomas, with variable follow-up among a subset of subjects (Canadian Task Force classification II-2).SETTING: University research group set in a community hospital.PATIENTS: Forty premenopausal women with large, symptomatic myomas.INTERVENTION: Oral mifepristone 5 or 10 mg daily for I year.MEASUREMENTS AND MAIN RESULTS: Mean uterine Volumes decreased in both groups by 48% after 6 months of mifepristone and by 52% to 53% in both groups after 12 months. Amenorrhea Occurred in 61% to 65% at 6 months, and 40% to 70% tit 12 months. Eighty endometrial biopsies were performed. Simple hyperplasia was seen in 5(13.9%) of 36 Subjects at 6 months and 1 (4.8%) of 21 at 12 months. All cases of hyperplasia occurred in the 10 mg group. No endometrial sample showed cytologic atypia. Nine women were followed posttreatment for an average of 5.7 months. Uterine volumes increased among most of these subjects, although they remained on average 42% less than baseline.CONCLUSIONS: Long-term administration of low-dose mifepristone results in myoma shrinkage and amelioration of symptoms; modest rates of low-grade endometrial hyperplasia, but no evidence of premalignant potential, also occur. Regrowth occurs slowly following cessation of the drug. (c) 2005 AAGL. All rights reserved.