Gallo Luigi, Pecoraro Stefano, Sarnacchiaro Pasquale, Silvani Mauro, Antonini Gabriele
Gallo Uro-Andrology Centre, Naples, Italy.
Division of Urology, Malzoni Clinic, Avellino, Italy.
Sex Med. 2020 Jun;8(2):178-185. doi: 10.1016/j.esxm.2020.02.003. Epub 2020 Mar 16.
A synergistic effect of the combination therapy tadalafil plus L-Arginine is conceivable in patients affected by erectile dysfunction (ED).
To evaluate the effectiveness and tolerability of tadalafil 5 mg and L-Arginine 2.5 grams in monotherapy and combination therapy.
Recruited patients completed the International Index of Erectile Function - Erectile Function domain (IIEF-EF) and Sexual Encounter Profile diaries completed at baseline and after treatment. The survey was randomized into 3 groups with an equal allocation ratio. Group A received daily L-Arginine 2,500 mg, group B received daily tadalafil 5 mg, and group C received both daily L-Arginine 2,500 mg plus daily tadalafil 5 mg. The duration of therapy in all 3 groups was 12 weeks. Safety was assessed by evaluating all reported treatment-emergent adverse events.
The main outcome measure was the change in IIEF-EF score and in per-patient percentage of "yes" responses to Sexual Encounter Profile Question 3 from baseline to after treatment.
300 eligible patients were enrolled, and 100 subjects for each group were allocated. Based on the IIEF-EF score, the participants were divided into 3 categories: severe, moderate, and mild ED. IIEF-EF score increased in group A from 15 ± 7 to 18.1 ± 9.2, in group B from 14.8 ± 6.9 to 20.8 ± 7.3, and in group C from 14.9 ± 7.1 to 22 ± 7.5. In mild ED group, the mean IIEF-EF score increased from 22.1 ± 2.2 to 27.5 ± 2.3 in group A; from 22.1 ± 2.2 to 27.8 ± 2 in group B, and from 22.2 ± 2.2 to 29.3 ± 0.9 in group C. We report a total of 11, 53, and 67 cases of adverse events in group A, B, and C respectively.
Combination therapy was superior to monotherapies. Gallo L, Pecoraro S, Sarnacchiaro P, et al. The Daily Therapy With L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study. Sex Med 2020;8:178-185.
对于勃起功能障碍（ED）患者，他达拉非联合L-精氨酸的联合治疗可能具有协同作用。
评估5毫克他达拉非和2.5克L-精氨酸单药治疗及联合治疗的有效性和耐受性。
招募的患者完成国际勃起功能指数-勃起功能领域（IIEF-EF）以及在基线和治疗后完成的性活动记录日记。该研究随机分为3组，分配比例相等。A组每日服用2500毫克L-精氨酸，B组每日服用5毫克他达拉非，C组每日服用2500毫克L-精氨酸加5毫克他达拉非。所有3组的治疗持续时间均为12周。通过评估所有报告的治疗中出现的不良事件来评估安全性。
主要观察指标是从基线到治疗后IIEF-EF评分的变化以及患者对性活动记录问题3回答“是”的百分比。
共招募了300名符合条件的患者，每组分配100名受试者。根据IIEF-EF评分，参与者分为3类：重度、中度和轻度ED。A组的IIEF-EF评分从15±7增加到18.1±9.2，B组从14.8±6.9增加到20.8±7.3，C组从14.9±7.1增加到22±7.5。在轻度ED组中，A组的平均IIEF-EF评分从22.1±2.2增加到27.5±2.3；B组从22.1±2.2增加到27.8±2，C组从22.2±2.2增加到29.3±0.9。我们分别报告A组、B组和C组的不良事件病例数为11、53和67例。
联合治疗优于单药治疗。加洛L、佩科拉罗S、萨尔纳基亚罗P等。每日服用2500毫克L-精氨酸和5毫克他达拉非联合及单药治疗勃起功能障碍：一项前瞻性、随机多中心研究。性医学2020；8：178 - 185。
