Maytom M C, Derry F A, Dinsmore W W, Glass C A, Smith M D, Orr M, Osterloh I H
Pfizer Central Research, Sandwich, UK.
Spinal Cord. 1999 Feb;37(2):110-6. doi: 10.1038/sj.sc.3100803.
This was a two-part pilot study in men with erectile dysfunction (ED) due to spinal cord injury (SCI: cord level range T6-L5). Part I was a randomised, double-blind, two-way cross-over study comparing a single dose of sildenafil 50 mg or placebo. Part II was a randomised, double-blind, parallel-group evaluation of sildenafil 50 mg or placebo, taken as required (not more than once daily) approximately 1 h prior to sexual activity, over a period of 28 days.
To assay the efficacy and safety of sildenafil 50 mg and placebo.
Clinic- and home-based assessments in the United Kingdom.
A total of 27 subjects who were able to achieve at least a grade 2 erection (hard, but not hard enough for penetration) in response to penile vibratory stimulation (PVS) were recruited. In Part I, the reflexogenic response of the penis to PVS was evaluated in the clinic while in Part II, the response to treatment was assessed in the home (global efficacy. questionniare, diary).
In Part I, 17/26 (65%) subjects had erections of >60% rigidity at the penile base (median duration 3.5 min) after sildenafil compared with 2/26 (8%) (median duration 0 min) alter placebo (P=0.0003). In Part II, 9/12 (75%) subjects on sildenafil and 1/14 (7%) subjects on placebo reported that the treatment had improved their erections (P<0.005), and 8/12 (67%) and 2/13 (15%) men, respectively, indicated that they wished to continue treatment (P<0.02). An analysis of diary data showed no difference between the groups with respect to the mean number of erections hard enough for penetration (P = 0.08). The mean proportion of attempts at sexual intercourse that were successful was 30 and 15%, respectively (P=0.21). Similarly, responses to the end-of-treatment questionnaire indicated that there were no significant differences between the groups with respect to the frequency of erections hard enough for sexual intercourse (P=0.47) or that lasted as long as the subject would have liked (P=0.11). No subject discontinued sildenafil due to adverse events.
Sildenafil is an effective, well-tolerated oral treatment for ED in SCI subjects.
这是一项针对因脊髓损伤（SCI：损伤节段范围为T6 - L5）导致勃起功能障碍（ED）男性的两部分试点研究。第一部分是一项随机、双盲、双向交叉研究，比较单剂量50毫克西地那非与安慰剂。第二部分是一项随机、双盲、平行组评估，在28天的时间里，于性活动前约1小时按需服用（每日不超过一次）50毫克西地那非或安慰剂。
测定50毫克西地那非和安慰剂的疗效与安全性。
英国基于诊所和家庭的评估。
共招募了27名在阴茎振动刺激（PVS）下能够至少达到2级勃起（坚硬，但硬度不足以插入）的受试者。在第一部分中，在诊所评估阴茎对PVS的反射性反应，而在第二部分中，在家庭中评估对治疗的反应（总体疗效问卷、日记）。
在第一部分中，服用西地那非后，26名受试者中有17名（65%）阴茎根部勃起硬度>60%（中位持续时间3.5分钟），而服用安慰剂后为2名（8%）（中位持续时间0分钟）（P = 0.0003）。在第二部分中，服用西地那非组的12名受试者中有9名（75%），服用安慰剂组的14名受试者中有1名（7%）报告治疗改善了他们的勃起（P<0.005），并且分别有12名中的8名（67%）和13名中的2名（15%）男性表示希望继续治疗（P<0.02）。对日记数据的分析显示，两组在硬度足以插入的勃起平均次数方面无差异（P = 0.08）。性交尝试成功的平均比例分别为30%和15%（P = 0.21）。同样地，治疗结束时问卷的回复表明，两组在硬度足以进行性交的勃起频率方面（P = 0.47）或勃起持续时间达到受试者期望的频率方面（P = 0.11）均无显著差异。没有受试者因不良事件而停用西地那非。
西地那非是治疗脊髓损伤患者勃起功能障碍的一种有效且耐受性良好的口服药物。
