DeBusk Robert F, Pepine Carl J, Glasser Dale B, Shpilsky Arkady, DeRiesthal Herb, Sweeney Michael
Stanford Cardiac Rehabilitation Program, Stanford University School of Medicine, Palo Alto, California 94304, USA.
Am J Cardiol. 2004 Jan 15;93(2):147-53. doi: 10.1016/j.amjcard.2003.09.030.
This was a double-blind, placebo-controlled, flexible-dose study of the efficacy and safety of sildenafil in men with erectile dysfunction (ED) and clinically stable coronary artery disease (CAD). Patients were randomized to receive sildenafil or placebo for 12 weeks. Primary outcomes were questions 3 and 4 of the International Index of Erectile Function (IIEF). Secondary outcomes included the other IIEF questions and functional domains, the Life Satisfaction Checklist, the Erectile Dysfunction Inventory of Treatment Satisfaction, 2 global efficacy assessment questions, and intercourse success rate. By week 12, sildenafil-treated patients (n = 70) showed significant improvements on questions 3 and 4 compared with placebo-treated patients (n = 72; p <0.01). Larger percentages of sildenafil-treated patients reported improved erections (64%) and improved intercourse (65%) compared with placebo-treated patients (21% and 19%, respectively). Sildenafil-treated patients were highly satisfied with treatment and their sexual life compared with placebo-treated patients. Forty-seven percent of sildenafil- and 32% of placebo-treated patients experienced adverse events, including transient headache, hypertension, flushing, and dyspepsia. There were no serious drug-related cardiovascular effects. Thus, sildenafil is an effective and well-tolerated treatment for ED in men with CAD. Sildenafil was not associated with additional safety risks in this patient population.
这是一项双盲、安慰剂对照、灵活剂量的研究，旨在评估西地那非对患有勃起功能障碍（ED）且临床冠状动脉疾病（CAD）病情稳定的男性的疗效和安全性。患者被随机分配接受西地那非或安慰剂治疗12周。主要结局指标是国际勃起功能指数（IIEF）的问题3和问题4。次要结局指标包括IIEF的其他问题和功能领域、生活满意度清单、治疗满意度勃起功能障碍量表、2个总体疗效评估问题以及性交成功率。到第12周时，与接受安慰剂治疗的患者（n = 72；p <0.01）相比，接受西地那非治疗的患者（n = 70）在问题3和问题4上有显著改善。与接受安慰剂治疗的患者（分别为21%和19%）相比，接受西地那非治疗的患者中有更大比例报告勃起改善（64%）和性交改善（65%）。与接受安慰剂治疗的患者相比，接受西地那非治疗的患者对治疗及其性生活高度满意。47%接受西地那非治疗的患者和32%接受安慰剂治疗的患者经历了不良事件，包括短暂性头痛、高血压、面部潮红和消化不良。未出现严重的药物相关心血管效应。因此，西地那非是治疗患有CAD的男性ED的一种有效且耐受性良好的治疗方法。在该患者群体中，西地那非未带来额外的安全风险。
