Lombardi Giuseppe, Macchiarella Angelo, Cecconi Filippo, Del Popolo Giulio
Careggi Hospital, University of Florence, Neurourology Department, Florence, Italy.
J Sex Med. 2009 Feb;6(2):535-43. doi: 10.1111/j.1743-6109.2008.01106.x. Epub 2008 Dec 2.
The efficacy of phosphodiesterase type 5 inhibitors for a broad spectrum of erectile dysfunction (ED) is largely reported in literature. Data are lacking concerning medium and long-term effects and safety of these treatments.
The aim of this study was to evaluate the efficacy and safety of medium and long-term use of tadalafil in subjects with ED because of spinal cord injury (SCI).
Phase 1: From March 2003 to March 2007, 103 SCI patients with ED, mean age 39 years, were given 10 mg of tadalafil after a 4-week treatment-free period. For patients with a score lower than 26 in the erectile domain of the International Index of Erectile Function (IIEF15) and with total unsuccessful sexual attempts of more than 25% according to the Sexual Encounter Profile questions 2 and 3 (SEP2-3), the dosage of tadalafil was increased to 20 mg. Phase 2: Only responding patients entered phase 2 where the subjects were evaluated in office visits every 6 months using the IIEF15 questionnaire and a diary reporting the day and time the drug was taken. All final visits were concluded by May 2008.
The improvement of ED was measured using the IIEF15 and the SEP2-3 questions.
Twenty-nine patients were excluded from phase 2: Twenty-seven did not respond to the drug and two left the study because of mild drawbacks. During the 6-month follow-up, nine left the study. Sixty-five individuals continued treatment with median follow-up of 33.6 months, 31 of whom took 10 mg and 34 who used 20 mg. Each group maintained up until the final visit a significant statistical improvement in erectile function, sexual satisfaction, overall satisfaction and percentages of "yes" responses to the SEP2-3 compared with baseline using the Wilcoxon test (P < 0.05).
Tadalafil represents an effective and safe long-term option for SCI patients with ED.
文献中大量报道了5型磷酸二酯酶抑制剂对广泛类型勃起功能障碍（ED）的疗效。关于这些治疗的中长期效果和安全性的数据尚缺。
本研究的目的是评估长期使用他达拉非对脊髓损伤（SCI）所致ED患者的疗效和安全性。
第一阶段：从2003年3月至2007年3月，103例平均年龄39岁的SCI所致ED患者，在经过4周无治疗期后给予10mg他达拉非。对于国际勃起功能指数（IIEF-15）勃起领域得分低于26分，且根据性接触概况问题2和3（SEP2-3）性尝试完全失败率超过25%的患者，将他达拉非剂量增至20mg。第二阶段：只有有反应的患者进入第二阶段，每6个月在门诊使用IIEF-15问卷进行评估，并通过日记记录服药日期和时间。所有最终访视于2008年5月结束。
使用IIEF-15和SEP2-3问题评估ED的改善情况。
29例患者被排除在第二阶段：27例对药物无反应，2例因轻微不良反应退出研究。在6个月随访期间，9例退出研究。65例患者继续治疗，中位随访时间为33.6个月，其中31例服用10mg，34例服用20mg。与基线相比，每组直至最终访视时在勃起功能、性满意度、总体满意度以及对SEP2-3的“是”反应百分比方面均保持显著统计学改善（Wilcoxon检验，P<0.05）。
他达拉非是SCI所致ED患者有效且安全的长期治疗选择。
