Safarinejad M R
Department of Urology, Military University of Medical Sciences, Tehran, Iran.
Urology. 2001 Jul;58(1):95-7. doi: 10.1016/s0090-4295(01)01084-6.
To determine the effectiveness and safety of high-dose isoxsuprine for the treatment of mixed-type erectile dysfunction.
Forty-four patients who had vasculogenic impotence diagnosed on the basis of their sexual history, physical examination, laboratory analysis, polysomnographic recording of nocturnal erections, and dynamic color Doppler sonography of the cavernosal arteries were entered into a randomized, double-blind, placebo-controlled, crossover comparison of a placebo with high-dose isoxsuprine hydrochloride (60 mg/day orally). The treatment consisted of two 30-day courses. After a 14-day washout period, the patients who initially received the placebo for 30 days switched to isoxsuprine hydrochloride for 30 days and vice versa. Erectile function, ejaculation, interest in sex, and physical examination findings were investigated before treatment and at the end of each drug period.
Thirty-six patients (82%) completed the entire treatment schedule. Positive clinical results (complete and partial responses) were obtained in 6 men (16.6%) at the end of the isoxsuprine phase and in 7 men (19.4%) after the placebo period. The statistical analysis disclosed no significant difference when isoxsuprine was compared with placebo (P >0.05). Significant drug-related adverse effects occurred in the isoxsuprine group and treatment was discontinued in 2 patients.
Isoxsuprine is no better than placebo as a first-line treatment for mixed-type erectile dysfunction.
确定大剂量异舒普林治疗混合型勃起功能障碍的有效性和安全性。
44例根据性病史、体格检查、实验室分析、夜间勃起的多导睡眠图记录以及海绵体动脉动态彩色多普勒超声诊断为血管性阳痿的患者，进入一项随机、双盲、安慰剂对照的交叉比较研究，比较安慰剂与大剂量盐酸异舒普林（60毫克/天口服）的疗效。治疗包括两个30天疗程。在14天的洗脱期后，最初接受30天安慰剂治疗的患者改用盐酸异舒普林治疗30天，反之亦然。在治疗前和每个药物疗程结束时，对勃起功能、射精、性兴趣和体格检查结果进行调查。
36例患者（82%）完成了整个治疗方案。在异舒普林治疗阶段结束时，6名男性（16.6%）获得了阳性临床结果（完全和部分反应），在安慰剂治疗期后，7名男性（19.4%）获得阳性临床结果。统计学分析显示，异舒普林与安慰剂相比无显著差异（P>0.05）。异舒普林组出现了显著的药物相关不良反应，2例患者停止治疗。
作为混合型勃起功能障碍的一线治疗药物，异舒普林并不比安慰剂更好。
