Dell'Atti L, Galosi A B, Ippolito C
Department of Urology, University Hospital "St. Anna", Ferrara, Italy.
Eur Rev Med Pharmacol Sci. 2017 Mar;21(5):1036-1040.
The use of topical local anesthetics in the form of creams, gel or spray is the oldest method of retarding ejaculation. However, several studies have suggested that phosphodiesterase type 5 inhibitors (5-PDEiS) show a potential therapeutic use in the treatment of premature ejaculation (PE). The aim of this study was to compare the efficacy and tolerability of tadalafil-only, tadalafil plus local anesthetic spray (lidocaine), and topical lidocaine spray-only before intercourse on the intravaginal ejaculatory latency time (IELT) of patients with lifelong PE.
The study included 78 men in stable heterosexual, monogamous relationships (of ≥3 months) who were diagnosed with lifelong PE. The patients were divided into three groups: G1: 25 patients who received lidocaine spray 10 g/100 ml at 5 min before intercourse; G2: 27 patients who received tadalafil 5 mg once daily; G3: 26 patients who treated with tadalafil once daily plus lidocaine spray before planned sexual activity. The treatments were continued for up to three months in all groups. Moreover, the quality of their sexual attempts was rated on a 5-point scale. Follow-up was made at 1-month and 3-month.
Not statistically significant differences emerged between the three groups at baseline. Mean ejaculatory latency time at the 3-month follow-up in G1, G2 and G3 was 3.7±1.3, 3.4±1.5, 5.6±1.7 (p<0.001). Mean satisfaction score was at the 3-month follow-up in G1: 2.8±1.4, in G2: 2.9±1.8, and G3: 3.7±1.5 (p<0.002). None of the patients withdrew from the study because of these adverse events.
This study demonstrates that tadalafil used daily has a role on treatment in lifelong PE. This action is valid when combined strategically to the synergistic action of lidocaine spray applied before intercourse increasing significantly the mean IELT.
使用乳膏、凝胶或喷雾形式的局部麻醉剂是延迟射精的最古老方法。然而，多项研究表明，5型磷酸二酯酶抑制剂（5-PDEiS）在早泄（PE）治疗中显示出潜在的治疗用途。本研究的目的是比较仅使用他达拉非、他达拉非加局部麻醉喷雾（利多卡因）以及仅在性交前使用局部利多卡因喷雾对终生早泄患者阴道内射精潜伏期（IELT）的疗效和耐受性。
该研究纳入了78名处于稳定异性恋、一夫一妻制关系（≥3个月）且被诊断为终生早泄的男性。患者被分为三组：G1组：25名患者在性交前5分钟接受10 g/100 ml的利多卡因喷雾；G2组：27名患者每天服用一次5 mg他达拉非；G3组：26名患者每天服用一次他达拉非并在计划的性活动前使用利多卡因喷雾。所有组的治疗持续长达三个月。此外，他们的性尝试质量按5分制评分。在1个月和3个月时进行随访。
三组在基线时未出现统计学上的显著差异。G1、G2和G3组在3个月随访时的平均射精潜伏期分别为3.7±1.3、3.4±1.5、5.6±1.7（p<0.001）。G1、G2和G3组在3个月随访时的平均满意度评分分别为2.8±1.4、2.9±1.8、3.7±1.5（p<0.002）。没有患者因这些不良事件退出研究。
本研究表明，每日使用他达拉非对终生早泄有治疗作用。当与性交前使用利多卡因喷雾的协同作用进行策略性联合时，这种作用有效，可显著增加平均IELT。
