前列腺素E_1乳膏治疗女性性唤起障碍的多中心随机双盲对照研究

Multicenter randomized,double-blind,placebo-controlled trial of prostaglandin E_1 cream for female sexual arousal disorder

目的:目前用于治疗女性性唤起障碍(FSAD)的药物尚属空白。通过多中心、随机、双盲、剂量组平行对照研究,评估前列腺素E1乳膏治疗FSAD的临床有效性及安全性,并确定临床有效治疗剂量。方法:受试者随机分配到4组,分别给予3种不同剂量(500μg、700μg、900μg)的试验药物或安慰剂,于性活动前外涂在阴蒂及G点(阴道前壁5cm处)。比较治疗前后的性唤起满意率、女性性功能问卷(FSFI)评分、女性性窘迫等级(FSDS)评分及其性活动的总体情况(GAQ)有效性指标。试验期间记录不良事件及实验室指标评价药物的安全性。结果:共400例受试者入组,374例进入疗效分析人群,387例进入安全性分析人群。4组的人口学特征及基线结果差异无统计学意义,4组(次序为安慰剂组,低、中、高剂量组)受试者的性唤起满意率与基线(治疗前)相比,分别提高了22.63%、36.67%、34.01%、44.29%(P<0.05);安慰剂组与高剂量组相比差异有统计学意义(P<0.0167);FSFI评分在结束时比基线提高了14.68、20.71、21.69、22.89(P<0.05);FSDS评分在结束时比基线降低了17.60、20.27、21.98、25.97(P<0.05);GAQ改善情况4组间差异无统计学意义(P=0.054)。主要不良反应为局部刺激症状,未发现与药物有关的体格检查、血生化检查、心电图、宫颈细胞学检测(TCT)异常。结论:前列腺素E1乳膏治疗女性性唤起障碍有效,剂量为900μg作用最佳,无明显全身副作用,不良反应以局部刺激症状为主。

Objective：To investigate the efficacy and safety of alprostadil cream in management of female sexual arouse disorder （FSAD）,and its appropriate dose for clinical prescription. Methods： 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. Results： 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〈0.016 7）. 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）. Conclusion： 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.