作者: Irwin Goldstein , Tom F. Lue , Harin Padma-Nathan , Raymond C. Rosen , William D. Steers
DOI: 10.1056/NEJM199805143382001
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摘要: BACKGROUND Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] in the corpus cavernosum and therefore increases penile response to sexual stimulation. We evaluated efficacy safety sildenafil, administered as needed two sequential double-blind studies men with erectile dysfunction organic, psychogenic, mixed causes. METHODS In 24-week dose-response study, 532 were treated oral sildenafil (25, 50, or 100 mg) placebo. 12-week, flexible dose-escalation 329 different placebo, dose escalation mg based on tolerance. After this 225 entered 32-week, open-label extension study. assessed according International Index Erectile Function, patient log, global-efficacy question. RESULTS increasing doses associated improved function (P values for scores questions about achieving maintaining erections <0.001). For receiving mean score question was percent higher after treatment than at base line (4.0 vs. 2.0 possible 5). last four weeks 69 all attempts intercourse successful compared 22 those placebo (P<0.001). The numbers per month 5.9 1.5 Headache, flushing, dyspepsia most common adverse effects occurring 6 18 men. Ninety-two completed 32-week CONCLUSIONS Oral an effective, well-tolerated dysfunction.