Low-dose mifepristone for uterine leiomyomata
Low-dose mifepristone for uterine leiomyomata
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DOI：
10.1016/s0029-7844(02)02511-5
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发表时间：
2003-02-01
影响因子：
7.2
通讯作者：
Guzick, DS
中科院分区：
文献类型：
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作者：
Eisinger, SH;Meldrum, S;Guzick, DS
目的：比较5和10毫克的米非司酮对子宫平滑肌瘤的大小和症状的影响，并测量副作用.METHODS：40绝经前妇女与大，症状性平滑肌瘤随机接受5或10毫克的米非司酮，每天6个月的开放标签研究。每两个月用超声测量子宫体积。血红蛋白水平，促卵泡激素，肝酶的血清浓度，子宫内膜样本，症状，月经出血也assessed.RESULTS：十九20名受试者服用5毫克，所有20名受试者服用10毫克完成所有6个月的研究。5 mg组平均子宫体积缩小48%（P <0.001），10 mg组缩小49%（P <0.001），无显著差异。两组中与平滑肌瘤相关的症状相对减少。两组患者的闭经发生率均为60-65%。贫血受试者的血红蛋白水平升高2.5 g/dL。在10 mg组中，潮热的发生率较基线显著增加，但在5 mg组中未增加。所有受试者中有28%发生单纯性子宫内膜增生，组间无差异。结论：米非司酮5 mg和10 mg治疗子宫肌瘤的疗效相当，症状改善，副作用少。小剂量米非司酮的长期安全性和有效性有待进一步研究。(C)2003年由美国妇产科医师学会。
OBJECTIVE: To compare the effect of 5 and 10 mg of mifepristone on uterine leiomyoma size and symptoms, and to measure side effects.METHODS: Forty premenopausal women with large, symptomatic leiomyomata were randomized to receive either 5 or 10 mg of mifepristone daily for 6 months in an open-label study. Uterine volume was measured at bimonthly intervals by sonography. Serum concentrations of hemoglobin levels, follicle-stimulating hormone, and liver enzymes were obtained, and endometrial samples, symptoms, and menstrual bleeding were also assessed.RESULTS: Nineteen of 20 subjects taking 5 mg and all 20 subjects taking 10 mg completed all 6 months of the study. Mean uterine volume shrank by 48% (P < .001) in the 5-mg group and 49% (P < .001) in the 10-mg group, a nonsignificant difference. Leiomyoma-related symptoms were comparably reduced in both groups. Amenorrhea occurred in 60-65% of both groups. Hemoglobin levels increased by 2.5 g/dL in anemic subjects. The incidence of hot flashes increased significantly over baseline in the 10-mg group but not in the 5-mg group. Simple endometrial hyperplasia occurred in 28% of all subjects, with no difference between groups. No atypical hyperplasia was noted.CONCLUSION: Mifepristone in doses of 5 mg or 10 mg results in comparable leiomyoma regression, improvement in symptoms, and few side effects. Further study is needed to assess the long-term safety and efficacy of low-dose mifepristone. (C) 2003 by The American College of Obstetricians and Gynecologists.