Zhang Miao, Liao Qin-ping, Yao Chen, Geng Li, Wang Xiang-ping, Song Xue-hong, Zhao Jian, Lv Tao, Lv Ming-qi, Chen Lei, Yao Yan-jun, Xia Bei, Zhang Hai-zhen, Wang Qiu-xi, Lu Jun-li
Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China.
Beijing Da Xue Xue Bao Yi Xue Ban. 2010 Dec 18;42(6):727-33.
To investigate the efficacy and safety of alprostadil cream in management of female sexual arouse disorder (FSAD), and its appropriate dose for clinical prescription.
The volunteers were assigned randomly to four groups which received alprostadil cream in different dosage (500 μg, 700 μg and 900 μg) or placebo cream, respectively. The cream was applied to the clitoris and G-spot before coitus. The efficacy was assessed by comparing the satisfactory rate of sexual arousal, the score of female sexual function index (FSFI) and female sex disorder scale (FSDS) and the general appraised question (GAQ) before and after the treatment. The safety was evaluated by the adverse effects that appeared including symptoms, physical and biochemical examination.
Totally, 400 women enrolled in this study with 374 assigned to the group for efficacy evaluation and 387 cases to the group for safety analysis. No significant difference was found among the four groups in the demographic characters and sexual baseline. The increase of satisfactory percentage of sexual arousal in the four groups (placebo, 500 μg, 700 μg and 900 μg) was 22.63%, 36.67%, 34.01%, and 44.29%, respectively (P<0.05), and the increase was statistically higher in the 900 μg group than in the placebo group (P<0.0167). The elevated FSFI score above the baseline in the treatment groups (900 μg 22.89, 700 μg 21.69, and 500 μg 20.71) were higher than that in the placebo group (14.68, P<0.05), while the reduced FSDS score below the baseline (900 μg 25.97, 700 μg 21.98, and 500 μg 20.27) were higher than that of the placebo (17.60, P<0.05). No significant difference was found in the four groups in GAQ (P=0.054). The main common adverse effect was topical stimulation. No adverse effect was reported in physical and biochemical examination, electrocardiogram (ECG) or Thinprep cytologic test (TCT).
Alprostadil cream can treat female sexual arousal disorder effectively with the maximum effect at the dose of 900 μg and without significant adverse effect except for mild topical stimulation.
探讨前列地尔乳膏治疗女性性唤起障碍（FSAD）的有效性和安全性及其临床处方的适宜剂量。
将志愿者随机分为四组，分别接受不同剂量（500μg、700μg和900μg）的前列地尔乳膏或安慰剂乳膏。在性交前将乳膏涂抹于阴蒂和G点。通过比较治疗前后性唤起满意度、女性性功能指数（FSFI）评分、女性性障碍量表（FSDS）评分及总体评价问题（GAQ）来评估疗效。通过出现的不良反应（包括症状、体格检查和生化检查）来评估安全性。
本研究共纳入400名女性，其中374名进入疗效评估组，387例进入安全性分析组。四组在人口统计学特征和性基线方面无显著差异。四组（安慰剂组、500μg组、700μg组和900μg组）性唤起满意度的提高分别为22.63%、36.67%、34.01%和44.29%（P<0.05），900μg组的提高在统计学上高于安慰剂组（P<0.0167）。治疗组（900μg组为22.89、700μg组为21.69、500μg组为20.71）高于基线的FSFI评分高于安慰剂组（14.68，P<0.05），而低于基线的FSDS评分降低值（900μg组为25.97、700μg组为21.98、500μg组为20.27）高于安慰剂组（17.60，P<0.05）。四组在GAQ方面无显著差异（P=0.054）。主要的常见不良反应为局部刺激。在体格检查、生化检查、心电图（ECG）或薄层液基细胞学检测（TCT）中未报告不良反应。
前列地尔乳膏可有效治疗女性性唤起障碍，900μg剂量效果最佳，除轻度局部刺激外无显著不良反应。
