Nijland E A, Weijmar Schultz W C M, Davis S R
Department of Obstetrics and Gynecology, Academisch Ziekenhuis Groningen, 9713 GZ Groningen, The Netherlands.
Maturitas. 2007 Oct 20;58(2):164-73. doi: 10.1016/j.maturitas.2007.07.005. Epub 2007 Sep 17.
Study to compare the effects of tibolone and raloxifene on health-related quality of life, sexuality and vaginal atrophy.
A double-blind, randomized study was conducted in 308 osteopenic, but otherwise healthy, postmenopausal women (mean age 66 years) who received tibolone 1.25mg/day or raloxifene 60 mg/day for 2 years. Health-related quality of life was assessed by the women's health questionnaire (WHQ), sexual function by the McCoy female sexuality questionnaire (MFSQ) and vaginal atrophy by assessing the karyopycnotic index (KI) and vaginal maturation (VM).
At week 104, the tibolone group showed a trend towards an improved health-related quality of life (HRQoL) mean score in eight out of nine WHQ domains. HRQoL scores approximated values for premenopausal women, being pre-defined as "clinically relevant". The raloxifene group showed a trend to a diminished HRQoL mean score from baseline to week 104. No difference could be assessed between the tibolone and raloxifene group in mean total score and separate domains' scores of the MFSQ, except for the vaginal lubrication domain (p=0.037). The increase in KI and VM was statistically significantly greater with tibolone than with raloxifene (for both KI and VM p<0.0001). Tibolone and raloxifene were equally well tolerated.
In older postmenopausal women, tibolone treatment showed a trend towards an improvement in quality of life and sexuality when compared to raloxifene.
比较替勃龙和雷洛昔芬对健康相关生活质量、性功能及阴道萎缩的影响。
对308名骨质减少但其他方面健康的绝经后女性（平均年龄66岁）进行了一项双盲随机研究，她们接受每日1.25mg替勃龙或每日60mg雷洛昔芬治疗2年。通过女性健康问卷（WHQ）评估健康相关生活质量，通过麦考伊女性性功能问卷（MFSQ）评估性功能，通过评估核固缩指数（KI）和阴道成熟度（VM）评估阴道萎缩情况。
在第104周时，替勃龙组在9个WHQ领域中的8个领域显示出健康相关生活质量（HRQoL）平均得分有改善趋势。HRQoL得分接近绝经前女性的值，被预先定义为“临床相关”。雷洛昔芬组从基线到第104周显示出HRQoL平均得分有下降趋势。替勃龙组和雷洛昔芬组在MFSQ的平均总分和各领域得分方面，除阴道润滑领域外（p = 0.037），无差异可评估。替勃龙组KI和VM的增加在统计学上显著大于雷洛昔芬组（KI和VM的p均<0.0001）。替勃龙和雷洛昔芬的耐受性相当。
在老年绝经后女性中，与雷洛昔芬相比，替勃龙治疗在生活质量和性功能方面显示出改善趋势。
