口服西地那非治疗勃起功能障碍。西地那非研究小组。

Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group.

作者信息

Goldstein I, Lue T F, Padma-Nathan H, Rosen R C, Steers W D, Wicker P A

机构信息

Department of Urology, Boston University Medical Center, MA 02118, USA.

出版信息

N Engl J Med. 1998 May 14;338(20):1397-404. doi: 10.1056/NEJM199805143382001.

DOI:10.1056/NEJM199805143382001

PMID:9580646

Abstract

BACKGROUND

Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] in the corpus cavernosum and therefore increases the penile response to sexual stimulation. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, and mixed causes.

METHODS

In a 24-week dose-response study, 532 men were treated with oral sildenafil (25, 50, or 100 mg) or placebo. In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this dose-escalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a patient log, and a global-efficacy question.

RESULTS

In the dose-response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001). For the men receiving 100 mg of sildenafil, the mean score for the question about achieving erections was 100 percent higher after treatment than at base line (4.0 vs. 2.0 of a possible score of 5). In the last four weeks of treatment in the dose-escalation study, 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil, as compared with 22 percent for those receiving placebo (P<0.001). The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo (P<0.001). Headache, flushing, and dyspepsia were the most common adverse effects in the dose-escalation study, occurring in 6 percent to 18 percent of the men. Ninety-two percent of the men completed the 32-week extension study.

CONCLUSIONS

Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction.

摘要

背景

西地那非是海绵体中一种有效的环磷酸鸟苷水解抑制剂，因此可增强阴茎对性刺激的反应。我们在两项先后进行的双盲研究中，对患有器质性、心理性及混合性病因勃起功能障碍的男性按需服用西地那非的疗效和安全性进行了评估。

方法

在一项为期24周的剂量反应研究中，532名男性接受口服西地那非（25毫克、50毫克或100毫克）或安慰剂治疗。在一项为期12周的灵活剂量递增研究中，329名不同的男性接受西地那非或安慰剂治疗，并根据疗效和耐受性将剂量递增至100毫克。在这项剂量递增研究之后，329名男性中的225名进入了一项为期32周的开放标签扩展研究。我们根据国际勃起功能指数、患者日志和总体疗效问题评估疗效。

结果

在剂量反应研究中，西地那非剂量增加与勃起功能改善相关（关于实现和维持勃起问题的得分增加，P值<0.001）。对于接受100毫克西地那非治疗的男性，治疗后关于实现勃起问题的平均得分比基线时高出100%（可能得分5分中，治疗后为4.0分，基线时为2.0分）。在剂量递增研究的最后四周，接受西地那非治疗的男性所有性交尝试中有69%成功，而接受安慰剂治疗的男性为22%（P<0.001）。接受西地那非治疗的男性每月成功尝试的平均次数为5.9次，接受安慰剂治疗的男性为1.5次（P<0.001）。头痛、面部潮红和消化不良是剂量递增研究中最常见的不良反应，发生率为6%至18%。92%的男性完成了为期32周的扩展研究。