甲磺酸酚妥拉明片治疗男性勃起功能障碍Ⅱ期临床报告

Evalution of efficacy and safety of oral Phentolamine Mesylate Capsules therapy for men with erectile dysfunction

目的评价甲磺酸酚妥拉明片治疗男性勃起功能障碍的有效性及安全性和耐受性。方法220例受试者(试验组112例、对照组108例),采用多中心、随机双盲、安慰剂平行对照、剂量视情增减的设计方案,在2周筛选期后进入4周的治疗期,在筛选期及研究结束时填写国际勃起功能问卷(IIEF)。研究者根据受试者记事表、IIEF和总评题对受试者进行疗效评价。结果主要疗效指标临床总有效率甲磺酸酚妥拉明组(A组)50．94%,安慰剂组(B组)16．82%：总评题：A组有57．55%的受试者认为研究药物改善了其勃起功能,B组22．43%。受试者记事表显示：A组受试者的性生活成功率为49．46%,B组17．88%。,不良反应发生率A组26．17%,B组7．62%,表现为轻度和短暂的鼻塞、面部潮红、心率快、口干、胸闷、胃不适、瘙痒、头痛、头晕、低血压。仅3名受试者因不良事件而终止研究。结论甲磺酸酚妥明片为一种安全、有效的治疗ED的药物。

Objective To evaluate the efficacy and safety of Phentolamine Mesylate Capsules therapy for men with erectile dysfunction （ED）. Methods The multi-center, randomized double-blind, placebo-controlled studies were used to assess the efficacy and safety of Phentolamine Mesylate Capsules in patients with ED. After 2 weeks screening therapy, 220 volunteers randomized to received Phentolamine Mesylate Capsules （group A） or placebo （group B） in 4 weeks studies. Efficacy was assessed using end-of-treatment response to the International Index of Erectile Function （I1EF）. Results At the end of treatment, main efficacy marker （clinical effectiveness） demonstrated significant increases in group A（50.94%）compared with group B （16.82%）. Mean end-of-treatment scores for improved erections of IIEF were reported by 57.55%of group A patients and 22.43%of group B. The volunteers＇ record suggested that the efficacy of sexual intercourse in group A was 49.46%and in group B was 17.88%. For the group A, the incidences of the most common adverse events （mild and transitory flushing, dizziness, headache, nasal of obstruction, dry mouth and dyspepsia） were 26.17% compared with group B 7.62%. Moreover, only three volunteer was out of investigation for severe adverse events. Conclusion The Phentolamine Mesylate Capsules had been demonstrated excellent efficacy and safety profile in men with ED of various etiolologies.