Kessel B, Nachtigall L, Plouffe L, Siddhanti S, Rosen A, Parsons A
Department of Obstetrics, Gynecology and Women's Health, University of Hawaii, Queen's Medical Center, Honolulu, Hawaii 96813, USA.
Climacteric. 2003 Sep;6(3):248-56.
To determine the effects of raloxifene on sexual function in postmenopausal women with pre-existing vaginal atrophy treated with vaginal estrogen cream.
A total of 187 naturally postmenopausal women, 42-80 years of age, with signs of genitourinary atrophy were enrolled in this 6-month, multicenter, parallel-group study. Subjects were randomized to oral raloxifene HCl 60 mg daily or matching placebo; the same subjects were also randomized to receive one application of either vaginal conjugated estrogen cream 0.5 g twice weekly for 6 months or non-hormonal vaginal moisturizer twice weekly for 3 months, followed by conjugated estrogen cream for 3 months. Both investigators and subjects were masked to the identity of the oral medication. The vaginal preparations were administered in an open-label fashion. The Sexual Activity Questionnaire (SAQ) was administered at baseline and at 3 and 6 months. Safety was assessed throughout the study.
A total of 102 women were sexually active at baseline and, of these, 82 were also sexually active at the 6-month end-point. At 6 months, raloxifene and placebo, in the presence of vaginal conjugated estrogen cream, were both associated with improvement from baseline in vaginal dryness and reduced discomfort during sexual activity. There were no significant differences between raloxifene and placebo groups in any SAQ item. Enjoyment of sexual activity significantly increased from baseline with raloxifene but not with placebo. No difference in adverse events was observed between groups.
Raloxifene had no negative effects on sexual function in postmenopausal women with vaginal atrophy who were treated concomitantly with vaginal estrogen cream.
确定雷洛昔芬对已使用阴道雌激素乳膏治疗的绝经后阴道萎缩女性性功能的影响。
本项为期6个月的多中心平行组研究纳入了187名42 - 80岁自然绝经且有泌尿生殖道萎缩体征的女性。受试者被随机分为每日口服60mg盐酸雷洛昔芬组或匹配的安慰剂组；同一受试者还被随机分为接受每周两次每次0.5g阴道结合雌激素乳膏共6个月，或每周两次非激素阴道保湿剂共3个月，随后3个月使用结合雌激素乳膏。研究者和受试者均对口服药物的身份不知情。阴道制剂采用开放标签方式给药。在基线、3个月和6个月时进行性活动问卷（SAQ）调查。在整个研究过程中评估安全性。
共有102名女性在基线时具有性活动能力，其中82名在6个月终点时仍具有性活动能力。在6个月时，在使用阴道结合雌激素乳膏的情况下，雷洛昔芬和安慰剂组均与基线相比阴道干燥情况改善以及性活动期间不适减轻相关。雷洛昔芬组和安慰剂组在任何SAQ项目上均无显著差异。使用雷洛昔芬后性活动的愉悦感较基线显著增加，而安慰剂组则未增加。两组间不良事件无差异。
对于同时接受阴道雌激素乳膏治疗的绝经后阴道萎缩女性，雷洛昔芬对其性功能无负面影响。
