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一项关于三种剂量经皮 17β-雌二醇预防绝经后骨质流失的临床试验:初步研究。

A clinical trial of 3 doses of transdermal 17beta-estradiol for preventing postmenopausal bone loss: a preliminary study.

作者信息

Yang Tzay-Shing, Chen Yi-Jen, Liang Wei-Hsing, Chang Cheng-Yen, Tai Ling-Chen, Chang Sheng-Pin, Ng Heung-Tat

机构信息

Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, and National Yang-Ming University School of Medicine, Taipei, Taiwan, ROC.

出版信息

J Chin Med Assoc. 2007 May;70(5):200-6. doi: 10.1016/S1726-4901(09)70358-2.

DOI:10.1016/S1726-4901(09)70358-2
PMID:17524997
Abstract

BACKGROUND

It is well documented that a daily oral dose of 0.625 mg of conjugated equine estrogen or 1-2 mg of 17beta-estradiol is needed to prevent postmenopausal bone loss. Recent studies have indicated that a lower dose of estrogen maybe as effective in maintaining bone mass. The purpose of this study was to evaluate the effects of 3 dosages of transdermally administered 17beta-estradiol gel in postmenopausal women stratified by oophorectomy and natural menopause.

METHODS

One hundred and twenty postmenopausal women were randomly selected to form 4 groups. Three groups of women were treated with a transdermal administration of estradiol gel at a daily dosage of 1.25, 2.5 and 5.0 g (containing 0.75, 1.5, and 3 mg of 17beta-estradiol/day), respectively. The 4th group of women, receiving estriol 2 mg/day p.o., was studied concurrently as a control. Bone mineral density was measured by quantitative computed tomography of the vertebrae from T12 to L3 at baseline, then at 6-month intervals for 1 year.

RESULTS

Women in all groups receiving 17beta-estradiol gel obtained a significant increase in bone mass, with the exception of the 1.25 g/day group, which showed a minimal increment at the 6-month period, compared with the control group. Comparisons of the increments in bone mass after estrogen therapy for both natural and surgical menopausal subjects found that there was a more prominent response in surgical menopausal women receiving a dosage of 2.5 g/day.

CONCLUSION

Estradiol gel at the dosage of 1.25 g/day, equivalent to 17beta-estradiol 0.75 mg/day, effectively prevented bone loss in postmenopausal women after a 12-month treatment period. The therapeutic effect of estradiol gel on bone mass was more prominent in the surgical menopausal groups at the dosage of 2.5 g/day. The atrophic ovaries may therefore play a crucial role in the subsequent decades of postmenopausal women.

摘要

背景

有充分文献记载,每日口服0.625毫克结合马雌激素或1 - 2毫克17β-雌二醇可预防绝经后骨质流失。近期研究表明,较低剂量的雌激素可能在维持骨量方面同样有效。本研究的目的是评估经皮给药的三种剂量17β-雌二醇凝胶对按卵巢切除术和自然绝经分层的绝经后妇女的影响。

方法

随机选取120名绝经后妇女,分为4组。三组妇女分别接受经皮给予雌二醇凝胶,每日剂量为1.25、2.5和5.0克(分别含0.75、1.5和3毫克17β-雌二醇/天)。第四组妇女口服每日2毫克的雌三醇作为对照同时进行研究。在基线时通过T12至L3椎体的定量计算机断层扫描测量骨密度,然后在1年的时间里每隔6个月测量一次。

结果

所有接受17β-雌二醇凝胶的组中,妇女的骨量均显著增加,但1.25克/天组除外,该组在6个月时与对照组相比仅显示出最小的增加。对自然绝经和手术绝经受试者雌激素治疗后骨量增加情况的比较发现,接受2.5克/天剂量的手术绝经妇女反应更为明显。

结论

每日剂量1.25克(相当于0.75毫克/天的17β-雌二醇)的雌二醇凝胶在12个月的治疗期后有效预防了绝经后妇女的骨质流失。每日剂量2.5克的雌二醇凝胶对手术绝经组骨量的治疗效果更为显著。因此,萎缩的卵巢可能在绝经后妇女随后的几十年中起关键作用。

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