Genistein aglycone: A new therapeutic approach to reduce endometrial hyperplasia

Genistein aglycone: A new therapeutic approach to reduce endometrial hyperplasia
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DOI:
10.1016/j.phymed.2010.03.024
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发表时间:
2010-09-01
期刊:
影响因子:
7.9
通讯作者:
Squadrito, Francesco
Squadrito, Francesco
中科院分区:
医学1区
文献类型:
--
作者:
Bitto, Alessandra;Granese, Roberta;Squadrito, Francesco

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目的:无细胞学异常的子宫内膜增生通常用孕激素治疗,但其他治疗方案可能具有等效的疗效和低副作用。设计:一项随机双盲,安慰剂和炔雌醇对照的临床试验,以评估染料木黄酮苷元在减少子宫内膜增生中的作用。患者:一组56名绝经前非典型子宫内膜增生的妇女被招募并接受:染料木黄酮苷元(n = 19; 54 mg/天);醋酸炔诺酮(n = 19; 10 mg/天,在月经周期的第16-25天)或安慰剂(n = 18)治疗6个月。3个月和6个月后评估子宫活检组织中雌激素(ER)和孕激素受体(PR)表达的影响。对于每种治疗,还评估了促卵泡激素(FSH)、促黄体生成激素(LH)、雌二醇(E2)、性激素结合球蛋白(SHBG)和孕酮(PG)水平。六个月后,42%服用染料木黄酮苷元的受试者症状有显著改善(在29%的受试者中组织学证实),而醋酸炔诺酮受试者中为47%(31%的患者经组织学证实),但安慰剂组只有12%,19%的患者表现出症状恶化和子宫内膜厚度增加。没有显着差异,注意到任何治疗的激素水平,但免疫组化分析显示显着减少染色ER-α和PR和增强ER-β 1染色在金雀异黄素管理的主题与一个完整的回归bleeding.Conclusions:这些结果表明,金雀异黄素苷元可能是有用的管理子宫内膜增生症,没有子宫内膜异位症的妇女,不能用resistin治疗。(C)2010年Elsevier GmbH。All rights reserved.
Objective: Endometrial hyperplasia without cytological atypia is commonly treated with progestins, but other treatment regimes may be available with equivalent efficacy and low side effects.Design: A randomized double-blind, placebo and progesterone-controlled clinical trial to evaluate the effects of genistein aglycone in reducing endometrial hyperplasia.Patients: A group of 56 premenopausal women with non-atypical endometrial hyperplasia were enrolled and received: genistein aglycone (n = 19; 54 mg/day); norethisterone acetate (n = 19; 10 mg/day on days 16-25 of the menstrual cycle) or placebo (n = 18) for 6 months.Measurements: Hysteroscopy was performed with biopsies and symptomology assessed at baseline, 3 and 6 months of administration. The effect on estrogen (ER) and progesterone receptors (PR) expression in uterine biopsies were assessed after 3 and 6 months. For each treatment follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), sex hormone-binding globulin (SHBG) and progesterone (PG) levels were also evaluated.Results: After 6 months, 42% of genistein aglycone-administered subjects had a significant improvement of symptoms (histologically confirmed in the 29%) compared to 47% of norethisterone acetate subjects (histologically confirmed in the 31%), but only 12% in the placebo group with 19% exhibiting worsening symptoms and increased endometrial thickness. No significant differences were noted for hormone levels for any treatment, but immunohistochemical analysis revealed significantly reduced staining for ER-a and PR and enhanced ER-beta 1 staining in genistein-administered subjects associated with a complete regression of bleeding.Conclusions: These results suggest that genistein aglycone might be useful for the management of endometrial hyperplasia without atypia in women that cannot be treated with progestin. (C) 2010 Elsevier GmbH. All rights reserved.