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澳大利亚女性鼻内与经皮基质雌激素替代疗法对比

Intranasal versus transdermal matrix oestrogen replacement in Australasian women.

作者信息

Davis Susan R, Davison Sonia L, Wilson Samantha, Shepherd Jill, Lawton Beverley

机构信息

Department of Obstetrics and Gynaecology, The National Health and Medical Research Council Centre of Clinical Research Excellence for Study of Women's Health, Monash University, Clayton, Victoria, Australia.

出版信息

Maturitas. 2005 Jun 16;51(2):163-71. doi: 10.1016/j.maturitas.2004.07.008.

Abstract

OBJECTIVES

To compare the efficacy and patient acceptability of intranasal and transdermal 17beta-oestradiol delivery systems for postmenopausal symptoms in Australasian women.

METHODS

Symptomatic postmenopausal women were randomly assigned to treatment with either intranasal 17beta-oestradiol, 300 microg daily (n = 66) or transdermal matrix patch 17beta-oestradiol, 50 microg/day (n = 66) for 12 weeks, followed by a 4-week period with the alternate treatment. Efficacy was compared between groups using the modified Greene climacteric scale, the menopause quality of life (MENQOL) questionnaire and vasomotor symptoms at week 12. Patient acceptability was compared by a satisfaction questionnaire at week 16 and patient preference at week 16.

RESULTS

Intranasal and transdermal therapy produced significant reductions in both the Modified Greene and MENQOL scores, and in the occurrence of hot flushes and night sweats at week 12. The overall rate of reported vasomotor symptoms was lower on patients treated with the nasal spray. Both therapies were well tolerated with similar adverse event rates. Satisfaction and preference were similar for both modes of drug delivery.

CONCLUSIONS

Intranasal oestradiol therapy route has comparable efficacy and safety to that of transdermal oestradiol matrix patch therapy with no difference in patient preference or satisfaction.

摘要

目的

比较鼻内给药和经皮给药的17β-雌二醇递送系统对澳大利亚女性绝经后症状的疗效和患者可接受性。

方法

有症状的绝经后女性被随机分配接受每日300微克鼻内17β-雌二醇治疗(n = 66)或每日50微克经皮基质贴片17β-雌二醇治疗(n = 66),为期12周,随后为期4周的交替治疗。使用改良的格林更年期量表、更年期生活质量(MENQOL)问卷和第12周时的血管舒缩症状比较两组间的疗效。通过第16周时的满意度问卷和第16周时的患者偏好比较患者的可接受性。

结果

鼻内给药和经皮给药治疗在第12周时均使改良格林量表和MENQOL评分显著降低,潮热和盗汗的发生率也显著降低。接受鼻喷雾剂治疗的患者报告的血管舒缩症状总体发生率较低。两种疗法耐受性均良好,不良事件发生率相似。两种给药方式的满意度和偏好相似。

结论

鼻内雌二醇治疗途径与经皮雌二醇基质贴片治疗具有相当的疗效和安全性,患者偏好或满意度无差异。

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