Giuliano François, Sanchez-Ramos Antonio, Löchner-Ernst Dieter, Del Popolo Giulio, Cruz Natalio, Leriche Albert, Lombardi Giuseppe, Reichert Susanne, Dahl Palle, Elion-Mboussa Albert, Casariego Joaquin
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 104 Boulevard Raymond Poincaré, 92380 Garches, France.
Arch Neurol. 2007 Nov;64(11):1584-92. doi: 10.1001/archneur.64.11.nct70001. Epub 2007 Sep 10.
To determine the efficacy and safety of tadalafil when taken on demand by men with erectile dysfunction (ED) secondary to traumatic spinal cord injury (SCI).
Multicenter, randomized, double-blind, placebo-controlled, flexible dose-titration, parallel-group study in clinical practices in Europe. Patients Enrolled patients had ED secondary to SCI (all spinal levels) and sustained 6 months or longer before visit 1.
After a 4-week run-in period, patients were randomly assigned to tadalafil, 10 mg, (n = 142) or placebo (n = 44) for a 12-week, on-demand treatment period with assessments at 4-week intervals. The dose of tadalafil was maintained or titrated (10 or 20 mg) at 4 and 8 weeks.
Efficacy was measured using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ). Treatment-emergent adverse events and vital signs were collected at each visit.
Mean age was 38 years. Mean baseline IIEF erectile function domain score was 13.4, and following 12 weeks of treatment, 22.6 for tadalafil and 13.6 for placebo (P < .001). After treatment, the tadalafil group compared with the placebo group was significantly greater (P < .001) in mean per-patient percentage of successful penetration attempts (SEP question 2; 75.4% vs 41.1%) and intercourse attempts (SEP question 3; 47.6% vs 16.8%); percentage of improved erections (GAQ question 1; 84.6% vs 19.5%); and ejaculatory frequency (IIEF question 9; P = .03). The 2 most common treatment-emergent adverse events in the tadalafil group compared with placebo were headache (8.5% vs 4.5%) and urinary tract infection (7.7% vs 6.8%).
Tadalafil (10 mg and 20 mg) improved erectile function and was well tolerated by men with ED secondary to traumatic SCI.
确定按需服用他达拉非对创伤性脊髓损伤（SCI）继发勃起功能障碍（ED）男性的疗效和安全性。
欧洲临床实践中的多中心、随机、双盲、安慰剂对照、灵活剂量滴定、平行组研究。入选患者为SCI继发ED（所有脊髓节段）且在第1次就诊前病程持续6个月或更长时间。
经过4周的导入期后，患者被随机分配至他达拉非10mg组（n = 142）或安慰剂组（n = 44），进行为期12周的按需治疗，每隔4周进行评估。他达拉非的剂量在第4周和第8周维持或滴定（10或20mg）。
使用国际勃起功能指数（IIEF）、性经历记录（SEP）和总体评估问题（GAQ）来衡量疗效。每次就诊时收集治疗中出现的不良事件和生命体征。
平均年龄为38岁。平均基线IIEF勃起功能领域评分为13.4，经过12周治疗后，他达拉非组为22.6，安慰剂组为13.6（P <.001）。治疗后，他达拉非组与安慰剂组相比，每位患者成功插入尝试的平均百分比（SEP问题2；75.4%对41.1%）和性交尝试（SEP问题3；47.6%对16.8%）、勃起改善百分比（GAQ问题1；84.6%对19.5%）以及射精频率（IIEF问题9；P = .03）均显著更高。与安慰剂组相比，他达拉非组2种最常见的治疗中出现的不良事件为头痛（8.5%对4.5%）和尿路感染（7.7%对6.8%）。
他达拉非（10mg和20mg）可改善勃起功能，且创伤性SCI继发ED的男性对其耐受性良好。
