布雷美拉诺肽用于绝经前女性性功能障碍：一项随机、安慰剂对照的剂量探索试验。
Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.
作者信息
Clayton Anita H, Althof Stanley E, Kingsberg Sheryl, DeRogatis Leonard R, Kroll Robin, Goldstein Irwin, Kaminetsky Jed, Spana Carl, Lucas Johna, Jordan Robert, Portman David J
机构信息
University of Virginia, 2955 Ivy Road, Northridge Suite 210, Charlottesville, VA 22903, USA.
Case Western Reserve University School of Medicine, 11100 Euclid Avenue, Cleveland, OH 44106, USA.
出版信息
Womens Health (Lond). 2016 Jun;12(3):325-37. doi: 10.2217/whe-2016-0018. Epub 2016 May 16.
AIM
Evaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women.
METHODS
Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks. Primary end point was change in satisfying sexual events/month. Secondary end points included total score changes on female sexual function index and female sexual distress scale-desire/arousal/orgasm.
RESULTS
Efficacy data, n = 327. For 1.25/1.75-mg pooled versus placebo, mean changes from baseline to study end were +0.7 versus +0.2 satisfying sexual events/month (p = 0.0180), +3.6 versus +1.9 female sexual function index total score (p = 0.0017), -11.1 versus -6.8 female sexual distress scale-desire/arousal/orgasm total score (p = 0.0014). Adverse events: nausea, flushing, headache.
CONCLUSION
In premenopausal women with female sexual dysfunctions, self-administered, as desired, subcutaneous BMT was safe, effective, and well tolerated (NCT01382719).
目的
评估黑素皮质素受体-4激动剂布雷美拉诺肽（BMT）治疗绝经前女性性功能障碍的有效性/安全性。
方法
患者被随机分组，按需在12周内皮下自行注射安慰剂或0.75、1.25或1.75毫克的BMT。主要终点是每月满意性事件的变化。次要终点包括女性性功能指数和女性性困扰量表-性欲/性唤起/性高潮的总分变化。
结果
有效性数据，n = 327。1.25/1.75毫克合并组与安慰剂组相比，从基线到研究结束的平均变化为每月满意性事件+0.7比+0.2（p = 0.0180），女性性功能指数总分+3.6比+1.9（p = 0.0017），女性性困扰量表-性欲/性唤起/性高潮总分-11.1比-6.8（p = 0.0014）。不良事件：恶心、潮热、头痛。
结论
在患有性功能障碍的绝经前女性中，按需自行皮下注射BMT是安全、有效的，且耐受性良好（NCT01382719）。
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