Sansalone Salvatore, Leonardi Rosario, Antonini Gabriele, Vitarelli Antonio, Vespasiani Giuseppe, Basic Dragoslav, Morgia Giuseppe, Cimino Sebastiano, Russo Giorgio Ivan
Department of Experimental Medicine and Surgery, Tor Vergata University of Rome, Rome, Italy.
Centro Uro Andrologico, Acireale, Italy.
Biomed Res Int. 2014;2014:121396. doi: 10.1155/2014/121396. Epub 2014 Jul 20.
We aimed to evaluate the efficacy of oral therapy with alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide (Tradamix TX1000) in patients with erectile dysfunction (ED) at 3 months of follow-up. From January 2013 to September 2013, 177 patients diagnosed with mild-moderate ED (IIEF-EF < 26) were enrolled in this multicenter, single-blinded, placebo-controlled study and randomized in Group A (Tradamix, n = 87) and Group B (placebo, n = 90). Penile color Doppler ultrasound measures, IIEF-15 questionnaire, male sexual health questionnaire-ejaculation disorder (MSHQ-EjD), and sexual quality of life (SQoL-M) were collected. We observed significant changes of the IIEF-15 in Group A (mean difference: 11.54; P < 0.05) at 3 months versus Group B (P < 0.05). PSV (P < 0.05), IIEF-intercourse satisfaction (P < 0.05), IIEF-orgasmic function (mean P < 0.05), IIEF-sexual desire (P < 0.05), IIEF-overall satisfaction (P < 0.05), MSHQ-EjD (mean difference: 1.21; P < 0.05), and SQoL-M (mean difference: 10.2; P < 0.05) were significantly changed in Group A versus baseline and Group B. Patients with moderate arterial dysfunction showed significant increase of PSV (P < 0.05), IIEF-EF (P < 0.05), MSHQ-EjD (P < 0.05), and SQoL-M (P < 0.05) in Group A. Therapy with Tradamix improves erectile and ejaculation function and sexual quality of life in patients with mild-moderate ED and in particular for those with moderate arterial dysfunction.
我们旨在评估在随访3个月时，口服昆布、刺蒺藜和氨基葡萄糖低聚糖（Tradamix TX1000）对勃起功能障碍（ED）患者的疗效。2013年1月至2013年9月，177例诊断为轻度至中度ED（国际勃起功能指数-勃起功能[IIEF-EF]<26）的患者被纳入这项多中心、单盲、安慰剂对照研究，并随机分为A组（Tradamix组，n = 87）和B组（安慰剂组，n = 90）。收集阴茎彩色多普勒超声测量结果、IIEF-15问卷、男性性健康问卷-射精障碍（MSHQ-EjD）和性生活质量（SQoL-M）。我们观察到，3个月时A组的IIEF-15与B组相比有显著变化（平均差异：11.54；P<0.05）（P<0.05）。与基线相比，A组的峰值收缩期血流速度（PSV）（P<0.05）、IIEF性交满意度（P<0.05）、IIEF性高潮功能（平均P<0.05）、IIEF性欲（P<0.05）、IIEF总体满意度（P<0.05）、MSHQ-EjD（平均差异：1.21；P<0.05）和SQoL-M（平均差异：10.2；P<0.05）均有显著变化，且与B组相比也有显著差异。中度动脉功能障碍患者在A组中PSV（P<0.05）、IIEF-EF（P<0.05）、MSHQ-EjD（P<0.05）和SQoL-M（P<0.05）显著增加。使用Tradamix治疗可改善轻度至中度ED患者的勃起和射精功能以及性生活质量，尤其是中度动脉功能障碍患者。
