Berman J R, Berman L A, Lin H, Flaherty E, Lahey N, Goldstein I, Cantey-Kiser J
Department of Urology and Biostatistics, Boston Medical Center, Boston, Massachusetts, USA.
J Sex Marital Ther. 2001 Oct-Dec;27(5):411-20. doi: 10.1080/713846815.
Sexual dysfunction is a complaint of 30-50% of American women. Aside from hormone replacement therapy, there are no current FDA-approved medical treatments for female sexual complaints. The goal of this pilot study was to determine safety and efficacy of sildenafil for use in women with sexual arousal disorder (SAD). Evaluations were completed on 48 women with complaints of SAD. Physiologic measurements, including genital blood flow, vaginal lubrication, intravaginal pressure-volume changes, and genital sensation were recorded pre- and postsexual stimulation at baseline and following 100 mg sildenafil. Subjective sexual function was assessed using a validated sexual function inventory at baseline and following 6 weeks of home use of sildenafil. At termination of the study patients also completed an intervention efficacy index (FIEI). Following sildenafil, poststimulation physiologic measurements improved significantly compared to baseline. Baseline subjective sexual function complaints, including low arousal, low desire, low sexual satisfaction, difficulty achieving orgasm, decreased vaginal lubrication, and dyspareunia also improved significantly following 6 weeks home use of sildenafil. Sildenafil appears to significantly improve both subjective and physiologic parameters of the female sexual response. Double-blind, placebo-controlled studies are currently in progress to further determine efficacy of this medication for treatment of female sexual dysfunction complaints in different populations of women.
性功能障碍是30%至50%美国女性的一大困扰。除激素替代疗法外，目前美国食品药品监督管理局（FDA）尚未批准任何用于治疗女性性功能问题的药物。这项初步研究的目的是确定西地那非用于治疗女性性唤起障碍（SAD）的安全性和有效性。对48名主诉患有SAD的女性进行了评估。记录了她们在基线时以及服用100毫克西地那非后，性刺激前后的生理测量数据，包括生殖器血流量、阴道润滑、阴道内压力-容积变化和生殖器感觉。在基线时以及在家服用西地那非6周后，使用经过验证的性功能量表评估主观性功能。在研究结束时，患者还完成了干预效果指数（FIEI）。服用西地那非后，与基线相比，刺激后的生理测量数据有显著改善。在在家服用西地那非6周后，基线时的主观性功能问题，包括唤起不足、性欲低下、性满意度低、难以达到性高潮、阴道润滑减少和性交疼痛也有显著改善。西地那非似乎能显著改善女性性反应的主观和生理参数。目前正在进行双盲、安慰剂对照研究，以进一步确定这种药物对不同女性群体治疗女性性功能障碍问题的疗效。
