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达泊西汀/西地那非复方片剂治疗早泄伴勃起功能障碍男性的疗效与安全性——DAP-SPEED研究

Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction-DAP-SPEED Study.

作者信息

Tuken Murat, Culha Mehmet Gokhan, Serefoglu Ege Can

机构信息

University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training & Research Hospital, Department of Urology, Istanbul, Turkey.

University of Health Sciences, Okmeydani Training & Research Hospital, Department of Urology, Istanbul, Turkey.

出版信息

Int J Impot Res. 2019 Mar;31(2):92-96. doi: 10.1038/s41443-019-0122-2. Epub 2019 Jan 31.

Abstract

Premature ejaculation (PE) and erectile dysfunction (ED) are the most prevalent sexual disorders in men. ED is commonly reported among patients with PE. Although recent guidelines recommend to treat ED first in men with both PE and ED, this recommendation is not based on evidence and there are limited data about the efficacy and safety of dapoxetine/sildenafil combination therapy for these patients. The aim of this study is to evaluate the clinical efficacy and safety of the dapoxetine/sildenafil combination (Dapoxil 30/50 mg film-coated tablet) in the treatment of patients with PE and concomitant ED. In a single-center, single-arm, open-label clinical study conducted between October 2016 and September 2017, 74 patients with lifelong or acquired PE and ED were included. All patients were instructed to record their intravaginal ejaculatory latency time (IELT) with a stopwatch for 4 weeks. After the screening, they were requested to complete Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP), and International Index of Erectile Function-Erectile Function (IIEF-EF) questionnaires before the treatment. The patients received on demand Dapoxil 1-3 h before sexual intercourse for the next 4 weeks (2 days a week and no more than once a day). The patients were also assessed with global impression of change (GIC) question for the treatment satisfaction and the side effects were recorded. The study was completed with 53 patients (53/74, 71.62%). Mean age of the patients was 45.32 ± 10.05 years. At the end of the 4-week treatment period, the geometric mean IELT of the patients significantly increased (from 22.72 ± 15.16 to 68.25 ± 82.33 s; p < 0.001). Similarly, significant improvements were observed in the mean PEP index score (0.86 ± 0.72 vs. 2.36 ± 1.13; p < 0.001) and mean IIEF-EF domain score (13.17 ± 3.33 vs. 24.60 ± 3.96; p < 0.001). According to the GIC results, 81.13% of the patients were satisfied with the treatment. Non-serious adverse events occurred in 10 patients (18.87%) and 4 (7.55%) of these patients dropped out of the treatment. The most common adverse events were headache, palpitation, and flushing. The dapoxetine/sildenafil combination therapy significantly improves the IELT values and patient reported outcome measures of PE patients who also suffer from ED. Although several side effects were reported, these were mild and transient.

摘要

早泄(PE)和勃起功能障碍(ED)是男性中最常见的性功能障碍。在早泄患者中,勃起功能障碍也很常见。尽管最近的指南建议对同时患有早泄和勃起功能障碍的男性先治疗勃起功能障碍,但这一建议并非基于证据,而且关于达泊西汀/西地那非联合治疗这些患者的疗效和安全性的数据有限。本研究的目的是评估达泊西汀/西地那非组合(30/50毫克薄膜包衣片)治疗早泄合并勃起功能障碍患者的临床疗效和安全性。在2016年10月至2017年9月进行的一项单中心、单臂、开放标签的临床研究中,纳入了74例患有终身性或获得性早泄和勃起功能障碍的患者。所有患者均被指示用秒表记录其阴道内射精潜伏期(IELT),为期4周。筛查后,要求他们在治疗前完成早泄诊断工具(PEDT)、早泄概况(PEP)和国际勃起功能指数-勃起功能(IIEF-EF)问卷。在接下来的4周内(每周2天,每天不超过一次),患者在性交前1-3小时按需服用达泊西汀。还通过总体变化印象(GIC)问题评估患者的治疗满意度,并记录副作用。该研究共有53例患者完成(53/74,71.62%)。患者的平均年龄为45.32±10.05岁。在4周治疗期结束时,患者的几何平均IELT显著增加(从22.72±15.16秒增加到68.25±82.33秒;p<0.001)。同样,平均PEP指数评分(0.86±0.72对2.36±1.13;p<*0.001)和平均IIEF-EF领域评分(13.17±3.33对24.60±3.96;p<0.001)也有显著改善。根据GIC结果,81.13%的患者对治疗满意。10例患者(18.87%)发生非严重不良事件,其中4例(7.55%)退出治疗。最常见的不良事件是头痛、心悸和脸红。达泊西汀/西地那非联合治疗显著提高了同时患有勃起功能障碍的早泄患者的IELT值和患者报告的结局指标。尽管报告了一些副作用,但这些副作用轻微且短暂。

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