Kaplan S A, Reis R B, Kohn I J, Ikeguchi E F, Laor E, Te A E, Martins A C
Department of Urology, Columbia University, New York, New York 10032, USA.
Urology. 1999 Mar;53(3):481-6. doi: 10.1016/s0090-4295(98)00633-5.
Sildenafil has been demonstrated to be safe and effective in the treatment of men with erectile dysfunction. The role of sildenafil in treating women with sexual dysfunction has heretofore not been reported. The purpose of this preliminary study was to ascertain the response of postmenopausal women with self-described sexual dysfunction treated with sildenafil for 3 months.
Thirty-three consecutive postmenopausal women with sexual dysfunction based on history were entered in this open-label, nonrandomized study. All patients received 50 mg of sildenafil. Efficacy was assessed at weeks 4, 8, and 12 using a newly developed 9-item, self-administered Index of Female Sexual Function (IFSF) and a global efficacy question ([GEQ] Did treatment improve your sexual function?). The IFSF quantifies the domains of desire, quality of sexual intercourse, overall satisfaction with sexual function, orgasm, lubrication, and clitoral sensation.
Of the group, 30 women (91 %) completed the study and were available for follow-up at 3 months. Mean baseline IFSF score before therapy was 24.8+/-9.8. Mean usage of sildenafil was 3.1+/-1.4 times per week for the duration of the study. The IFSF score improved to 29.5+/-7.6, 30.3+/-8.5, and 31.4+/-10.4 at 4, 8, and 12 weeks, respectively (P = 0.25). Mean scores for questions 2 (lubrication), 8 (orgasm), and 9 (clitoral sensation) improved by 23.2%, 7.4%, and 31.3%, respectively, at 12 weeks. Seven women (21%) noted improvement on the GEQ. Overall, only 6 (18.1%) of 33 patients had a significant (more than 60% improvement in IFSF score) therapeutic response. Clitoral discomfort and "hypersensitivity" occurred in 7 women (21%), 3 of whom withdrew from the study. Other side effects, which did not result in withdrawal from the study, included headache (n = 5), dizziness (n = 4) and dyspepsia (n = 3).
The data suggest that sildenafil is well tolerated in postmenopausal women with sexual dysfunction. Overall sexual function did not improve significantly, although there were changes in vaginal lubrication and clitoral sensitivity. The role of sildenafil in treating sexual dysfunction in various cohorts of women remains to be determined.
已证实西地那非治疗男性勃起功能障碍安全有效。此前尚无西地那非治疗女性性功能障碍作用的报道。这项初步研究的目的是确定用西地那非治疗3个月的自述性功能障碍绝经后女性的反应。
33例基于病史的连续性绝经后性功能障碍女性进入这项开放标签、非随机研究。所有患者均接受50毫克西地那非治疗。在第4、8和12周使用新开发的9项女性性功能指数（IFSF）自评量表和一个总体疗效问题（“治疗是否改善了您的性功能？”）评估疗效。IFSF对性欲、性交质量、性功能总体满意度、性高潮、润滑和阴蒂感觉等领域进行量化。
该组中，30名女性（91%）完成了研究并可在3个月时接受随访。治疗前IFSF平均基线评分为24.8±9.8。在研究期间，西地那非的平均使用频率为每周3.1±1.4次。IFSF评分在第4、8和12周分别提高到29.5±7.6、30.3±8.5和31.4±10.4（P=0.25）。在第12周时，问题2（润滑）、8（性高潮）和9（阴蒂感觉）的平均评分分别提高了23.2%、7.4%和31.3%。7名女性（21%）表示总体疗效问题有所改善。总体而言，33例患者中只有6例（18.1%）有显著（IFSF评分提高超过60%）的治疗反应。7名女性（21%）出现阴蒂不适和“过敏”，其中3人退出研究。未导致退出研究的其他副作用包括头痛（5例）、头晕（4例）和消化不良（3例）。
数据表明，西地那非在有性功能障碍的绝经后女性中耐受性良好。尽管阴道润滑和阴蒂敏感性有变化，但总体性功能未显著改善。西地那非在不同女性群体中治疗性功能障碍的作用仍有待确定。
