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首页> 外文期刊>The journal of sexual medicine >Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: a phase III clinical trial.
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Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: a phase III clinical trial.

机译：盐酸洛地那非对勃起功能障碍口服治疗的疗效和耐受性：III期临床试验。

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INTRODUCTION: This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil. AIM: Expanding information on LC efficacy and safety. MAIN OUTCOME MEASURES: International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs). METHODS: A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC. RESULTS: IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] +/- standard deviation [SD]): placebo = 13.9 +/- 5.2 and 14.8 +/- 7.8; LC 40 mg = 13.6 +/- 5.3 and 18.6 +/- 8.0; LC 80 mg = 13.4 +/- 4.9 and 20.6 +/- 7.7 (analysis of variance [ANOVA] P < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M +/- SD): placebo = 55.3 +/- 43.2% and 52.1 +/- 41.4%; LC 40 mg = 46.4 +/- 44.3% and 63.5 +/- 42.0%; LC 80 mg = 50.2 +/- 40.9% and 80.8 +/- 32.3% (ANOVA P < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 +/- 32.3% and 29.7 +/- 38.1%; LC 40 mg = 19.6 +/- 34.3% and 50.8 +/- 44.4%; LC 80 mg = 20.8 +/- 33.2% and 66.0 +/- 39.3% (ANOVA P < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness. CONCLUSIONS: LC showed a satisfactory efficacy-safety profile for oral therapy of ED.
机译：简介：这是一项关于洛丹那非碳酸酯（LC）的III期，前瞻性，随机，双盲，安慰剂对照临床试验，洛丹那非是在巴西开发的新型磷酸二酯酶5抑制剂。目的：扩大有关LC疗效和安全性的信息。主要观察指标：国际勃起功能指数（IIEF）勃起功能域，性遭遇特征（SEP）-2和SEP-3问题的阳性答案以及不良事件（AEs）的发生率。方法：将总共350名各个程度的勃起功能障碍（ED）的男性随机分为安慰剂，LC 40 mg或LC 80 mg，并随访4周。他们在不使用和使用LC的情况下，每次性交后均完成了IIEF并回答了SEP问题2和3。结果：不使用药物和使用药物的IIEF勃起功能域得分如下（平均值[M] +/-标准差[SD]）：安慰剂= 13.9 +/- 5.2和14.8 +/- 7.8; LC 40mg ＝ 13.6 +/- 5.3和18.6 +/- 8.0。 LC 80 mg = 13.4 +/- 4.9和20.6 +/- 7.7（方差分析[ANOVA] P <0.01）。在未使用药物和使用药物的情况下，对SEP-2的肯定回答如下（M +/- SD）：安慰剂= 55.3 +/- 43.2％和52.1 +/- 41.4％; LC 40 mg = 46.4 +/- 44.3％和63.5 +/- 42.0％; LC 80 mg = 50.2 +/- 40.9％和80.8 +/- 32.3％（ANOVA P <0.01）。 SEP-3的肯定答案如下：安慰剂= 20.2 +/- 32.3％和29.7 +/- 38.1％; LC 40 mg = 19.6 +/- 34.3％和50.8 +/- 44.4％; LC 80 mg = 20.8 +/- 33.2％和66.0 +/- 39.3％（ANOVA P <0.01）。患有至少一种AE的患者为安慰剂= 28.7％，LC 40 mg = 40.9％，LC 80 mg = 49.5％。 LC引起的AEs明显高于安慰剂，包括鼻炎，头痛，潮红，视力障碍和头晕。结论：LC对ED的口服治疗显示出令人满意的疗效-安全性。

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