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一项关于替勃龙与经皮雌激素替代疗法对绝经后子宫肌瘤妇女影响的随机研究。

A randomized study of the effects of tibolone and transdermal estrogen replacement therapy in postmenopausal women with uterine myomas.

作者信息

Fedele L, Bianchi S, Raffaelli R, Zanconato G

机构信息

Department of Obstetrics and Gynaecology, University of Verona, Italy.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2000 Jan;88(1):91-4. doi: 10.1016/s0301-2115(99)00115-3.

DOI:10.1016/s0301-2115(99)00115-3
PMID:10659924
Abstract

OBJECTIVE

To evaluate the effects of two types of hormone replacement therapy, an estrogen-progestin combination and tibolone, on uterine myomas in menopausal women.

STUDY DESIGN

Thirty-eight menopausal women with one or more uterine myomas were randomized to treatment with a transdermal system continuously releasing estradiol 50 microg/day combined with oral medroxyprogesterone acetate (MPA) 10 mg/day for 12 days/month or tibolone tablets 2.5 mg/day. The scheduled duration of both treatments was 12 months. Physical examination and abdominal/transvaginal ultrasonography were performed before entering the study and at 3, 6 and 12 months of treatment. At each ultrasonography the overall uterine volume was determined as well as the size of each myoma and the endometrial thickness and characteristics.

RESULTS

No statistically significant difference was detected between the two groups at any time during treatment. However, within-group analysis showed a significant increase of uterine volume and of myoma number and size in the estrogen-progestin group, whereas no such increase occurred in the patients treated with tibolone. Also, the mean endometrium width increased significantly from baseline to the end of treatment in the estrogen-progestin group, but not in the tibolone group.

CONCLUSIONS

Tibolone seems a valid alternative in menopausal patients with uterine myomas as it provides adequate relief from menopausal symptoms and avoids volume increase of the uterus and myomas.

摘要

目的

评估两种激素替代疗法,即雌激素 - 孕激素联合疗法和替勃龙,对绝经后女性子宫肌瘤的影响。

研究设计

38名患有一个或多个子宫肌瘤的绝经后女性被随机分为两组,一组接受每日持续释放50微克雌二醇的经皮系统联合每日口服10毫克醋酸甲羟孕酮(MPA),每月治疗12天;另一组接受每日2.5毫克替勃龙片治疗。两种治疗的预定疗程均为12个月。在进入研究前以及治疗的第3、6和12个月进行体格检查和腹部/经阴道超声检查。每次超声检查时,测定子宫总体积、每个肌瘤的大小、子宫内膜厚度及特征。

结果

治疗期间两组在任何时间均未检测到统计学上的显著差异。然而,组内分析显示,雌激素 - 孕激素组子宫体积、肌瘤数量和大小显著增加,而接受替勃龙治疗的患者未出现此类增加。此外,雌激素 - 孕激素组从基线到治疗结束时平均子宫内膜宽度显著增加,而替勃龙组未增加。

结论

替勃龙似乎是患有子宫肌瘤的绝经后患者的有效替代疗法,因为它能充分缓解绝经症状,且避免子宫和肌瘤体积增大。

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