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首页> 外文期刊>The journal of sexual medicine >Efficacy of flibanserin in women with hypoactive sexual desire disorder: Results from the BEGONIA trial
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Efficacy of flibanserin in women with hypoactive sexual desire disorder: Results from the BEGONIA trial

机译：氟班色林在性欲减退妇女中的疗效：BEGONIA试验结果

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Introduction: Hypoactive Sexual Desire Disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty. Aim: The aim of this study was to assess the efficacy and safety of the 5-HT1A agonist/5-HT2A antagonist flibanserin in premenopausal women with HSDD. Methods: This was a randomized, placebo-controlled trial in which premenopausal women with HSDD (mean age: 36.6 years) were treated with flibanserin 100mg once daily at bedtime (qhs) (n=542) or placebo (n=545) for 24 weeks. Main Outcome Measures: Coprimary end points were the change from baseline to study end in Female Sexual Function Index (FSFI) desire domain score and in number of satisfying sexual events (SSE) over 28 days. Secondary end points included the change from baseline in FSFI total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, and FSDS-R Item 13 score. Results: Compared with placebo, flibanserin led to increases in mean (standard deviation) SSE of 2.5 (4.6) vs. 1.5 (4.5), mean (standard error [SE]) FSFI desire domain score of 1.0 (0.1) vs. 0.7 (0.1), and mean (SE) FSFI total score of 5.3 (0.3) vs. 3.5 (0.3); and decreases in mean (SE) FSDS-R Item 13 score of -1.0 (0.1) vs. -0.7 (0.1) and mean (SE) FSDS-R total score of -9.4 (0.6) vs. -6.1 (0.6); all P≤0.0001. The most frequently reported adverse events in the flibanserin group were somnolence, dizziness, and nausea, with adverse events leading to discontinuation in 9.6% of women receiving flibanserin vs. 3.7% on placebo. Conclusion: In premenopausal women with HSDD, flibanserin 100mg qhs resulted in significant improvements in the number of SSE and sexual desire (FSFI desire domain score) vs. placebo. Flibanserin was associated with significant reductions in distress associated with sexual dysfunction (FSDS-R total score) and distress associated with low sexual desire (FSDS-R Item 13) vs. placebo. There were no significant safety concerns associated with the use of flibanserin for 24 weeks.
机译：简介：性欲低下症（HSDD）的特征是性欲低下，导致明显的困扰或人际交往困难。目的：本研究旨在评估5-HT1A激动剂/ 5-HT2A拮抗剂氟班色林对绝经前HSDD妇女的疗效和安全性。方法：这是一项随机，安慰剂对照试验，其中绝经前女性HSDD（平均年龄：36.6岁）在睡前（qhs）（n = 542）或安慰剂（n = 545）每天一次接受氟班色林100mg治疗24周。主要结局指标：共同主要终点是从基线到研究终点的女性性功能指数（FSFI）欲望域得分和令人满意的性事件数（SSE）在28天内的变化。次要终点包括FSFI总分，女性性窘迫量表修订（FSDS-R）总分和FSDS-R第13项得分相对于基线的变化。结果：与安慰剂相比，氟班色林导致SFI平均值（标准差）分别为2.5（4.6）和1.5（4.5），平均值（标准误[SE]）FSFI期望域评分为1.0（0.1）和0.7（ 0.1），平均（SE）FSFI总分分别为5.3（0.3）和3.5（0.3）; FSDS-R第13项平均（SE）得分为-1.0（0.1）与-0.7（0.1）和-SE（FS）平均总得分分别为-9.4（0.6）和-6.1（0.6）;所有P≤0.0001。在氟班色林组中最常报告的不良事件是嗜睡，头晕和恶心，不良事件导致接受氟班色林治疗的女性中有9.6％停用，而在安慰剂中为3.7％。结论：与安慰剂相比，在绝经前患有HSDD的女性中，氟班色林100mg qhs导致SSE数量和性欲（FSFI欲望域评分）显着提高。与安慰剂相比，氟班色林与性功能障碍（FSDS-R总得分）和性欲低下（FSDS-R第13项）导致的困扰显着减少有关。服用氟班色林24周无明显安全隐患。

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