Mulhall John P, Levine Laurence A, Jünemann Klaus-Peter
Department of Urology, Weill Medical College of Cornell University, New York Presbyterian Hospital, New York, New York 10021, USA.
Urology. 2006 Sep;68(3 Suppl):17-25. doi: 10.1016/j.urology.2006.05.041.
The extensive sildenafil citrate erectile dysfunction (ED) database of double-blind, placebo-controlled clinical trials was examined to determine the relation between erection hardness graded on the Erectile Hardness Grading Scale (EHGS) and (1) erectile function (EF), as assessed by the EF domain of the International Index of Erectile Function (IIEF); (2) frequency of erections hard enough for penetration, as assessed by IIEF Q2; and (3) the percentage of successful sexual intercourse attempts according to patient event logs. Pooled data from 6549 men with ED provided strong proof and improved characterization of the response to sildenafil. Almost half of men with ED and a baseline IIEF EF domain score classified as "severe ED" (< or = 10) shifted to a score classified as "no ED" (> or = 26). Sildenafil recipients showed greater mean improvement from baseline to end point in IIEF Q2 scores versus placebo, regardless of baseline ED severity, and a higher mean percentage of successful sexual intercourse attempts occurred during the last 4 weeks of treatment versus placebo (5.4-fold vs 2.0-fold increase from baseline). At end point, 95% of men who scored "no ED" on the IIEF EF domain and 92% of men who reported "almost always/always" achieving an erection hard enough for penetration (IIEF Q2) had graded their erections hard (rigid) enough for penetration (grade 3) or completely hard and fully rigid (grade 4) during the last 4 weeks of treatment, suggesting that the IIEF EF domain and IIEF Q2 may be good surrogate end points for erection hardness. Furthermore, during the last 4 weeks of treatment, the percentage of grade 3 and/or 4 erections correlated positively with the percentage of successful sexual intercourse attempts. Hence, hard erections may be considered a unifying factor that defines response to ED treatment. Completely hard and fully rigid erections (grade 4) should be recognized as the optimal goal of an ED therapy. Evidence presented here demonstrates that sildenafil significantly improved EF as assessed by the IIEF EF domain and assessments of erection hardness in patients with ED; a dose-response relation was observed in the proportions of men with ED who graded their erections hard (rigid) enough for sexual penetration or completely hard and fully rigid.
对广泛的枸橼酸西地那非治疗勃起功能障碍（ED）的双盲、安慰剂对照临床试验数据库进行了研究，以确定根据勃起硬度分级量表（EHGS）分级的勃起硬度与以下各项之间的关系：（1）勃起功能（EF），通过国际勃起功能指数（IIEF）的EF领域进行评估；（2）硬度足以进行插入的勃起频率，通过IIEF Q2进行评估；以及（3）根据患者事件日志得出的成功性交尝试的百分比。来自6549名ED男性的汇总数据为西地那非的反应提供了有力证据并改善了其特征描述。几乎一半基线IIEF EF领域评分被归类为“重度ED”（≤10）的ED男性转变为被归类为“无ED”（≥26）的评分。无论基线ED严重程度如何，与安慰剂相比，西地那非接受者在IIEF Q2评分从基线到终点的平均改善更大，并且在治疗的最后4周期间，成功性交尝试的平均百分比高于安慰剂（与基线相比增加了5.4倍对2.0倍）。在终点时，95%在IIEF EF领域评分为“无ED”的男性以及92%报告“几乎总是/总是”实现硬度足以进行插入的勃起（IIEF Q2）的男性在治疗的最后4周期间将其勃起硬度评为足以进行插入（3级）或完全坚硬且完全勃起（4级），这表明IIEF EF领域和IIEF Q2可能是勃起硬度的良好替代终点。此外，在治疗的最后4周期间，3级和/或4级勃起的百分比与成功性交尝试的百分比呈正相关。因此，坚硬勃起可被视为定义ED治疗反应的统一因素。完全坚硬且完全勃起（4级）应被视为ED治疗的最佳目标。此处呈现的证据表明，西地那非显著改善了通过IIEF EF领域评估的EF以及ED患者的勃起硬度评估；在将勃起硬度评为足以进行性插入或完全坚硬且完全勃起的ED男性比例中观察到了剂量反应关系。
