Iacono Fabrizio, Prezioso Domenico, Illiano Ester, Romeo Giuseppe, Ruffo Antonio, Amato Bruno
Department of Urology, University Federico II of Naples, Via S, Pansini 5, 80131 Naples, Italy.
BMC Surg. 2012;12 Suppl 1(Suppl 1):S23. doi: 10.1186/1471-2482-12-S1-S23. Epub 2012 Nov 15.
Reduced libido is widely considered the most prominent symptomatic reflection of low testosterone (T) levels in men. Testosterone deficiency (TD) afflicts approximately 30% of men aged 40-79 years. This study seeks to evaluate the effect of a new natural compound "tradamixina "in order to improve male sexual function in elderly men, particularly libido and possible erectile dysfunction, versus administration of tadalafil 5 mg daily.
Seventy patients (67.3 ± 3.7 years) with stable marital relations and affected by reduced libido, with or without erectile dysfunction were recruited. They were randomly separated in 2 groups A-B of 35. Group A was administered twice a day a new compound "Tradamixina" (150 mg of Alga Ecklonia Bicyclis, 396 mg of Tribulus Terrestris and 144 mg of D-Glucosamine and N-Acetyl-D-Glucosamine) for two months, while Group B was administered tadalafil 5 mg daily, for two months. At visit and after 60 days of treatment patients were evaluated by means of detailed medical and sexual history, clinical examination, laboratory investigations (Total and Free T), instrumental examination (NPTR- nocturnal penile tumescence and rigidity test- with Rigiscan). Patients completed a self-administered IIEF questionnaire (The international index of erectile function) and SQoLM questionnaire (Sexual quality of life Questionnarie-Male). The results pre and post treatment were compared by Student t test (p<0.005).
After 2 months of treatment in group A serum TT levels (230 ± 18 ng/dl vs 671 ± 14 ng/dl ) and FT levels(56 ± 2.4 pg/ml vs 120 ± 3.9 pg/ml) increased, while in group B serum TT levels (245 ± 12 ng/dl vs 247 ± 15 ng/dl ) and FT levels(53 ± 0.3 pg/ml vs 55 ± 0.5 pg/ml) increased not statistically significant. The patient's numbers with negative NPTR improved after treatment in group A and B (15 vs 18 and 13 vs 25 respectively). The IIEF total score in group A increased after treatment with tradamixina (15 ± 1.5 vs 29.77 ± 1.2); the IIEF total score in group B increased slightly (12 ± 1.3 vs 23.40 ± 1.2). The SQoLM total score improved in both groups (A:16 ± 2,3 vs 33 ± 4,1 and B: 16 ± 3,4 vs 31 ± 2,1).
The treatment twice a day with "Tradamixina" for 2 months improved libido in elderly men without side effects of Tadalafil.
性欲减退被广泛认为是男性睾酮(T)水平低下最突出的症状表现。睾酮缺乏(TD)困扰着约30%的40 - 79岁男性。本研究旨在评估一种新型天然化合物“tradamixina”改善老年男性性功能,尤其是性欲以及可能存在的勃起功能障碍的效果,并与每日服用5毫克他达拉非进行对比。
招募了70名婚姻关系稳定、受性欲减退影响(有或无勃起功能障碍)的患者(年龄67.3 ± 3.7岁)。他们被随机分为A - B两组,每组35人。A组每天服用两次新型化合物“Tradamixina”(150毫克海带双环藻、396毫克刺蒺藜和144毫克D - 葡萄糖胺及N - 乙酰 - D - 葡萄糖胺),持续两个月,而B组每天服用5毫克他达拉非,持续两个月。在就诊时以及治疗60天后,通过详细的病史和性史、临床检查、实验室检查(总睾酮和游离睾酮)、器械检查(NPTR - 夜间阴茎勃起硬度测试 - 使用Rigiscan)对患者进行评估。患者完成一份自我填写的IIEF问卷(国际勃起功能指数)和SQoLM问卷(男性性生活质量问卷)。治疗前后的结果通过学生t检验进行比较(p<0.005)。
治疗2个月后,A组血清总睾酮水平(230 ± 18纳克/分升 vs 671 ± 14纳克/分升)和游离睾酮水平(56 ± 2.4皮克/毫升 vs 120 ± 3.9皮克/毫升)升高,而B组血清总睾酮水平(245 ± 12纳克/分升 vs 247 ± 15纳克/分升)和游离睾酮水平(53 ± 0.3皮克/毫升 vs 55 ± 0.5皮克/毫升)升高但无统计学意义。治疗后A组和B组NPTR为阴性的患者数量有所改善(分别为15例 vs 18例和13例 vs 25例)。A组用tradamixina治疗后IIEF总分升高(15 ± 1.5 vs 29.77 ± 1.2);B组IIEF总分略有升高(12 ± 1.3 vs 23.40 ± 1.2)。两组的SQoLM总分均有所改善(A组:16 ± 2.3 vs 33 ± 4.1;B组:16 ± 3.4 vs 31 ± 2.1)。
每天服用两次“Tradamixina”进行2个月的治疗可改善老年男性的性欲,且无他达拉非的副作用。