经皮雌二醇凝胶和口服替勃龙对手术绝经后健康相关生活质量的影响。

Effects of transdermal estradiol gel and oral tibolone on health-related quality of life after surgical menopause.

机构信息

KPC Medical College and Hospital, Kolkata, India.

出版信息

Int J Gynaecol Obstet. 2010 Sep;110(3):213-6. doi: 10.1016/j.ijgo.2010.04.023. Epub 2010 Jun 8.

DOI:10.1016/j.ijgo.2010.04.023

PMID:20570264

Abstract

OBJECTIVE

To study the effects of 6 months of treatment with transdermal estradiol gel versus oral tibolone on health-related quality of life (HRQOL) after surgical menopause.

METHODS

In a randomized single-blind trial, Indian women received either oral tibolone tablets (2.5 mg) or transdermal estradiol gel (0.06%) daily. Each woman scored herself on the Menopause Rating Scale (MRS) II at the beginning of the study and after 6 months. Independent t tests were used to determine the significance of changes in HRQOL.

RESULTS

In total, 31 (81.6%) women who received estradiol gel and 38 (100.0%) women who received tibolone completed treatment. Intent-to-treat analysis showed that, after 6 months of treatment, the total MRS score was significantly reduced in the tibolone group compared with the transdermal estradiol gel group (-9.5+/-5.1 versus -4.9+/-5.7; 95% confidence interval, 2.0-7.0; P<0.01). Significant improvements were also noted in the tibolone group in terms of somatovegetative (P=0.04) and psychologic (P<0.01) domains.

CONCLUSION

Oral tibolone treatment was more effective than transdermal estradiol gel at improving HRQOL in Indian women with surgical menopause.

摘要

目的

研究 6 个月经皮雌二醇凝胶与口服替勃龙治疗对手术绝经后健康相关生活质量（HRQOL）的影响。

方法

在一项随机单盲试验中，印度女性每天接受口服替勃龙片（2.5 毫克）或经皮雌二醇凝胶（0.06%）治疗。每位女性在研究开始时和 6 个月后均使用绝经评定量表（MRS）Ⅱ对自己进行评分。采用独立 t 检验确定 HRQOL 变化的显著性。

结果

共有 31 名（81.6%）接受雌二醇凝胶治疗的女性和 38 名（100.0%）接受替勃龙治疗的女性完成了治疗。意向治疗分析显示，替勃龙组治疗 6 个月后，MRS 总分较经皮雌二醇凝胶组显著降低（-9.5±5.1 比-4.9±5.7；95%置信区间，2.0-7.0；P<0.01）。替勃龙组在躯体植物神经（P=0.04）和心理（P<0.01）方面也有显著改善。