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Understanding the effects of sildenafil treatment on erection maintenance and erection hardness.

机译:了解西地那非治疗对勃起维持和勃起硬度的影响。

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INTRODUCTION: Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance. Although intuitively related, the link between erection hardness and erection maintenance has not been formally established and quantified. AIM: To understand the components of erection maintenance through statistical modeling. METHODS: Data from a double-blind placebo-controlled trial of fixed-dose sildenafil (100 or 50 mg, 8 weeks) with open-label extension of flexible-dose sildenafil (100 and 50 mg, 4 weeks) were analyzed. Erection maintenance was assessed with item 4 (how often erection was maintained) or item 5 (difficulty in maintaining erection) of the International Index of Erectile Function (IIEF). Erection hardness was assessed with the Erection Hardness Score. MAIN OUTCOME MEASURES: Longitudinal modeling estimated mean treatment differences averaged over the double-blind phase for sildenafil 100 mg vs. placebo and 50 mg vs. placebo. Statistical mediation analysis was applied to partition the effect of sildenafil (pooled into one treatment group) on erection maintenance directly and indirectly through erection hardness. RESULTS: Longitudinal mean differences for sildenafil 100 and 50 mg vs. placebo were high (P < 0.0001 for each), with large standardized effect sizes (>0.8). Mediation modeling showed that sildenafil treatment affected maintenance directly as well as indirectly via erection hardness, when measured by IIEF item 4 (direct effect, 44.6%; indirect effect, 55.4%) or IIEF item 5 (direct effect, 56.9%; indirect effect, 43.1%). CONCLUSIONS: Sildenafil treatment significantly improved erection maintenance, a physiologic requirement for satisfactory sexual performance. According to our model, only approximately half of the effect of sildenafil on erection maintenance was estimated to be driven through direct effects. Rather, the effect of sildenafil on erection maintenance seems to be substantially driven by erection hardness. Therefore, achievement of optimal initial erection hardness appears to be an important treatment goal for enhancing erection maintenance and achieving successful ED treatment.
机译:简介:勃起功能障碍(ED)定义为无法获得和/或维持足以使性行为令人满意的阴茎勃起。尽管直觉上相关,但尚未正式建立和量化勃起硬度与勃起维护之间的联系。目的:通过统计建模了解勃起维护的组成部分。方法:分析了固定剂量西地那非(100或50 mg,8周)的开放标签扩展剂量的柔性剂量西地那非(100和50 mg,4周)的双盲安慰剂对照试验的数据。使用国际勃起功能指数(IIEF)的第4项(维持勃起的频率)或第5项(维持勃起的难度)评估勃起维持。用勃起硬度评分评估勃起硬度。主要观察指标:纵向模型估计的西地那非100 mg对安慰剂和50 mg对安慰剂在双盲阶段的平均治疗差异平均值。应用统计调解分析直接或间接通过勃起硬度分配西地那非(合并为一个治疗组)对勃起维持的作用。结果:西地那非100和50 mg与安慰剂的纵向平均差异较高(每种P均<0.0001),且标准化效应量较大(> 0.8)。调解模型显示,用IIEF第4项(直接作用,占44.6%;间接作用,占55.4%)或IIEF第5项(直接作用,占56.9%;间接影响,西地那非治疗直接或间接地影响勃起硬度)。 43.1%)。结论:西地那非治疗可显着改善勃起维持力,这是令人满意的性行为的生理要求。根据我们的模型,估计西地那非对勃起维持的作用仅约一半是由直接作用驱动的。相反,西地那非对勃起维持的作用似乎基本上是由勃起硬度驱动的。因此,达到最佳的初始勃起硬度似乎是增强勃起维持力和成功进行ED治疗的重要治疗目标。

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