多剂量伐地那非治疗男性勃起功能障碍的临床研究

目的评估不同剂量新型磷酸二酯酶5（PED5）抑制剂伐地那非治疗男性勃起功能障碍（ED）的有效性和安全性。方法采用随机、双盲、安慰剂平行对照、3个药物剂量（5、10和20mg）的方法，对88例ED患者进行为期12周的临床研究。结果伐地那非5mg、10mg和20mg组均能改善患者国际勃起功能指数（IIEF）中勃起功能部分的得分、患者日记中插入和保持勃起的成功率，改善程度优于安慰剂组。伐地那非20mg组对IIEF问卷中勃起功能部分得分的改善优于伐地那非5mg组。伐地那非组不良事件的发生率高于安慰剂组，但多为轻中度，且可自行缓解。结论伐地那非是治疗男性勃起功能障碍的安全、有效药物。     

口服伐地那非治疗勃起功能障碍疗效和安全性的临床研究

目的 :评价伐地那非对男性勃起功能障碍 (ED)患者的疗效和安全性。　方法 :应用随机、双盲、安慰剂平行对照、剂量固定 (5、1 0和 2 0mg)方法 ,对 88例ED患者进行 1 2周的临床研究。　结果 :5、1 0和 2 0mg伐地那非使ED患者达到和维持勃起的临床主要和次要指标均明显高于安慰剂 (P <0 .0 1 ) ;伐地那非各剂量组不良事件发生率高于安慰剂组 ,均为轻至中度 ,呈一过性。　结论 :伐地那非是治疗各种病因导致ED的安全、有效的药物。     

伐地那非在肾移植伴勃起功能障碍患者中应用的有效性和安全性研究

目的:评估伐地那非在肾移植后伴阴茎勃起功能障碍(ED)患者中应用的有效性和安全性。方法:选取39例血浆肌酐值<2mg/dl的肾移植伴有ED患者进行为期4周随机、双盲的伐地那非研究,实验组20例,安慰剂组19例。应用勃起功能国际指数(IIEF)进行伐地那非有效性的评估;应用血清肌酐值,肌酐清除率和血液中免疫抑制剂环孢素浓度监测值评估伐地那非的安全性。结果:应用伐地那非治疗的ED患者评分从12.6±3.4改善到26.5±2.8(P<0.01)。肾功能和环孢素浓度在伐地那非治疗前后没有改变。有4例伐地那非组患者观察到不良反应,2例出现头痛,1例出现心悸伴颜面潮红,还有1例出现消化不良。结论:本研究证实伐地那非对肾移植伴ED患者勃起功能改善有效而且安全。     

盐酸曲唑酮治疗勃起功能障碍的随机对照研究

目的　为了观察盐酸曲唑酮治疗阴茎勃起障碍的疗效和安全性。方法　入选 6 5例轻、中度阴茎勃起功能障碍 (ED)患者 ,随机分 2组 :盐酸曲唑酮组 5 0mg每日一次口服 ,逐日增加至 15 0mg后维持 ;对照组给安慰剂。治疗前与治疗后 4周 ,以勃起功能国际指标评分问卷 (IIEF 5 )得分之和作为判断标准。结果　显效 3例(10 % ) ,有效 9例 (30 % ) ,总有效率为 4 0 % ,无效 18例 (6 0例 ) ;对照组有效 6例 (16 .7% ) ,曲唑酮组治疗前后比较差异有显著性 (P <0 .0 5 )。副作用为头晕、嗜睡。结论　本研究初步证明曲唑酮治疗轻、中度勃起功能障碍有一定疗效     

小剂量伐地那非对阴茎手术后勃起功能恢复的研究

目的:探讨阴茎手术对勃起功能的影响并评估术后长期小剂量使用伐地那非对勃起功能的恢复作用。方法:选择阴茎手术患者共60例,随机分为两组:伐地那非治疗组和对照组,每组30例。治疗组术后5~7 d开始服用伐地那非10 mg,隔日1次,持续12周;对照组口服维生素E 100 mg,每日1次,持续12周。IIEF-5问卷评估术前和用药后3个月、6个月勃起功能改变。结果:治疗组术前IIEF-5评分为(14.21±3.62)分,术后3、6个月IIEF-5评分[(18.83±2.98)分,(20.13±2.98)分]较手术前提高,差异均有显著性(P均<0.05);而对照组患者术后3个月勃起功能下降,IIEF-5评分(13.38±2.82)分较术前(15.80±3.02)分降低,差异有显著性(P>0.05)。治疗组术后IIEF-5评分较对照组高(P<0.05)。结论:阴茎手术后小剂量长期服用伐地那非有助于恢复和保持阴茎的勃起功能。     

酚妥拉明治疗勃起功能障碍安全性和有效性的多中心评价

目的 :评价甲磺酸酚妥拉明胶囊 (MP)治疗男性勃起功能障碍 (ED)的安全性和有效性。　方法 :采用随机、双盲、安慰剂对照多中心临床试验 ,入选 168例病人 ,分别服用试验药物MP和安慰剂 ,4 0mg/次。观察服药后国际勃起功能指数 (IIEF)得分变化及夜间记录表。　结果 :试验组IIEF观察表中Q3、Q4及Q3+Q4得分增加明显高于对照组 (P <0 .0 0 1) ,试验组治疗ED显效率 10 .12 %、有效率 67.4 2 % ,对照组显效率 0 ,有效率 14 .2 9% (P均 <0 .0 1) ;试验组不良反应率 4 .76% ,对照组为 1.19% (P >0 .0 5 ) ,不良反应均不需特殊处置。　结论 :MP治疗ED安全、有效。     

伐地那非治疗老年糖尿病性勃起功能障碍疗效分析

目的:观察伐地那非治疗老年糖尿病(DM)性勃起功能障碍(ED)患者的临床疗效和安全性。方法:选择男性科门诊100例老年ED患者,其中DMED40例,非DMED60例。2组均使用伐地那非,首次剂量20mg,以后维持剂量10mg,1次/周,连续8周。采用国际勃起功能问卷勃起功能评分(IIEF-5)和勃起质量量表问卷(EQS)对患者勃起功能状况进行评估。结果:治疗前后,DMED组患者IIEF-5和EQS评分值分别为(8.1±0.5)分,(18.9±0.2)分(P<0.01);(9.1±1.3)分,(25.1±1.4)分(P<0.01);非DMED组患者评分值分别为(10.1±0.3)分,(21.1±0.2)分(P<0.01),(10.1±1.7)分,(34.2±1.2)分(P<0.01),2组间统计学处理差异有显著性(P<0.05)。DMED组显效17例(42.5%),有效9例(22.5%),总有效率65%。非DMED组显效28例(46.7%),有效16例(26.7%),总有效率73.3%。DMED和非DMED2组间统计学处理差异有显著性(P<0.05)。结论:伐地那非治疗能显著改善老年DMED患者的勃起能力,提高生活质量。     

舍曲林和伐地那非治疗合并勃起功能障碍的早泄患者的临床观察

目的:评价舍曲林和伐地那非治疗合并勃起功能障碍(ED)的早泄患者的临床疗效和安全性。方法:60例诊断为合并ED的早泄患者随机分为舍曲林组和伐地那非组,每组30例。舍曲林组每天服用舍曲林50 mg,疗程2个月。伐地那非组每次性生活前服用伐地那非10~20 mg,疗程2个月。以治疗前后IIEF-5评分的改变来评价ED治疗效果,以治疗前后阴道内射精潜伏期(IELT)的变化来评价早泄治疗效果。结果:伐地那非组勃起功能改善24例,有效率为80%;而舍曲林组仅8例勃起功能改善,有效率为27%,两者差异有显著性(P<0.05)。伐地那非组早泄改善20例,有效率为67%;而舍曲林组早泄改善12例,有效率为40%,两者差异有显著性(P<0.05)。两组患者中,勃起功能改善者的早泄治疗的有效率均显著高于勃起功能无改善者。两组的不良反应均为轻度,无停药者。结论:对合并ED的早泄患者,改善患者的勃起功能是关键。     

美蓝染色法提高静脉性勃起功能障碍手术疗效观察

目的 :探讨美蓝染色法提高静脉性勃起功能障碍 (ED)手术疗效。　方法 :78例静脉性ED在美蓝染色标识下切除和结扎回漏静脉 ,采用国际勃起功能指数 5 (IIEF 5 )得分对手术效果进行评估。　结果 :阴茎背深静脉切除 +属支结扎 2 6例 ,有效 2 0例 ( 76.9% ) ;背深静脉切除 +阴茎脚静脉结扎 3 2例 ,有效 2 5例 ( 78.1% ) ;背深静脉切除 +尿道海绵体分离和阴茎头静脉结扎 13例 ,有效 5例 ( 3 8.5 % ) ;单纯脚静脉结扎 7例 ,有效 3例 ( 4 2 9% )。术后随访 1～ 12个月、13～ 2 4个月和 2 5～ 3 6个月的总有效率分别为 67 9%、4 1.0 %和 3 3 .3 %。IIEF 5得分从术前的 ( 4 .8± 0 .5 )分分别提高到 ( 19.5± 0 .5 )分、( 18.6± 0 .5 )分和 ( 18.6± 0 .6)分 ,P值均 <0 .0 0 1。　结论 :阴茎海绵体注射美蓝染色可以提高静脉性ED的手术疗效。     

万艾可治疗勃起功能障碍的疗效和安全性

目的 :评估万艾可 (Viagra○R)治疗男性勃起功能障碍 (ED)的有效性和安全性。　方法 :本试验为双盲、随机(安慰剂 :西地那非 ,1:3)、安慰剂对照、剂量可调整 (2 5、5 0和 10 0mg)、持续 12周的临床研究。共有 84名受试者参与本研究。　结果 :对主要疗效指标 (IIEF问题 3、4)的分析结果显示 ,万艾可对ED病人达到和维持勃起能力的改善作用显著优于安慰剂 (P <0 .0 0 0 1) ,万艾可的临床总有效率为 86 % ,显著高于安慰剂 (37% ) ;对心理性、器质性和混合性ED的有效率分别为 83%、79%和 81% (安慰剂组分别为 5 0 %、33%和 30 % )。同时 ,对次要疗效指标评估 (IIEF其余 13个问题、记事表和总评题 )亦显示 ,万艾可改善性生活的作用明显优于安慰剂 ;万艾可组性交成功率平均为71.8% ,显著高于安慰剂组 (17.0 % ) ;有 87.3%的万艾可组受试者认为研究药物改善了其勃起功能 ,显著高于安慰剂组 (36 .8% )。无 1名受试者因不良事件而中断研究 ,万艾可组的不良事件发生率 (33.3% )较安慰剂组高(19.0 % ) ,但绝大多数为轻度、一过性的。　结论 :口服万艾可是一种可治疗各种病因导致的勃起功能障碍安全有效的药物 ,按需服用时能很好耐受。     

Safety and efficacy of vardenafil in patients with erectile dysfunction: Result of a bridging study in Japan

AIM: Vardenafil is a selective and highly potent phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED. The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED. METHODS: This was a prospective, double blind, randomized clinical trial designed to evaluate the efficacy and safety of vardenafil. Following a 4-week treatment-free observation period, 283 eligible patients were randomized to 12 weeks treatment with vardenafil 5 mg, 10 mg, 20 mg, or placebo. Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function (IIEF). RESULTS: All three vardenafil doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF questionnaire, either at 12 weeks or at the 'last observation carried forward' (LOCF, P < 0.0001). Q3 scores were improved to 4.06 with vardenafil 5 mg, 4.53 with vardenafil 10 mg, and 4.64 with vardenafil 20 mg, versus 3.17 with placebo. Comparable scores for Q4 were 3.47, 4.15 and 4.31 versus 2.31 for placebo. Up to 86% of patients achieved improved erections as assessed by the global assessment question (GAQ). Reported adverse event rates were 35.3%, 45.3% and 54.5% with vardenafil 5 mg, 10 mg and 20 mg, respectively, versus 21.1% in the placebo group. No serious adverse drug reactions were reported. The most common treatment-emergent adverse events were transient headache, flushing and rhinitis, which were mostly mild. CONCLUSION: Vardenafil is an effective and well-tolerated treatment for ED and provides improvement in key indices of erectile function among Japanese men with ED. The results of our trial show that up to nearly 90% of patients achieve improved erections with the administration of vardenafil.     

The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial

Vardenafil, a novel selective phosphodiesterase type 5 inhibitor, was evaluated in its first large-scale at-home trial. A total of 601 men with mild to severe erectile dysfunction (ED) were enrolled in this multi-centre, randomized, double-blind, placebo-controlled trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil. Primary endpoints were Q3 (vaginal penetration) and Q4 (maintenance of erection) of the International Index of Erectile Function (IIEF). In the intent-to-treat population (n=580), the changes from baseline for 5, 10 and 20 mg vardenafil (1.2, 1.3 and 1.5, respectively) were all improved (P<0.001) over placebo (0.2) for Q3 and were similarly improved for Q4 (1.4, 1.5 and 1.7) compared to placebo (0.5) (P<0.001). All vardenafil doses improved all IIEF domains compared to placebo (P<0.001). The percentage of successful intercourses was between 71 and 75% for the three vardenafil doses. For the 20 mg dose, 80% of the patients experienced improved erections (GAQ) compared to 30% for placebo. Most frequent treatment-emergent adverse events were headache (7-15%), flushing (10-11%) and up to 7% for dyspepsia or rhinitis. Vardenafil treatment resulted in a high efficacy and low adverse-event profile in a population with mixed ED etiologies.     

Efficacy and safety of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in Egypt and South Africa

The efficacy of sildenafil citrate (Viagra), an oral agent for the treatment of erectile dysfunction (ED), has been demonstrated in global studies. This 12-week randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study assessed the efficacy and safety of sildenafil to treat ED in men in Egypt and South Africa. Men with ED of varied etiology were randomized to receive sildenafil 50 mg (n=128) or placebo (n=126); doses could be adjusted to 100 or 25 mg. Questions from the International Index of Erectile Function (IIEF) assessing the ability to achieve (Q3) and maintain (Q4) erections demonstrated a significant improvement with sildenafil compared with placebo (P<0.0001). Improved erections were reported by 74% of patients receiving sildenafil and 27% of those receiving placebo (P<0.0001). Headache, dyspepsia, and flushing were the most common adverse events in sildenafil-treated patients. These results are consistent with clinical trials in other countries. We conclude that sildenafil is an efficacious and well-tolerated treatment for men with ED in Egypt and South Africa.     

Efficacy and safety of fixed-dose oral sildenafil in the treatment of erectile dysfunction of various etiologies

OBJECTIVES: To determine the efficacy and safety of fixed-dose oral sildenafil in patients with erectile dysfunction (ED) of various etiologies. METHODS: In a 12-week, double-blind, randomized, placebo-controlled, fixed-dose study, 514 men (mean age 56 years) with ED were randomized to receive 25, 50, or 100 mg of sildenafil or placebo. The primary etiology of ED was determined to be organic in 32% of men, psychogenic in 25%, or mixed in 43%. Sildenafil or placebo was taken in the home setting approximately 1 hour before sexual activity, not more than once daily. Efficacy was determined by responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) of the 15-item International Index of Erectile Function (IIEF). Other measures of efficacy included the five sexual function domains of the IIEF, a global efficacy question, event log data, and a partner questionnaire. RESULTS: Sildenafil significantly increased patients' ability to achieve and maintain erections (P <0.0001), with efficacy increasing with increasing dose. Significant improvements were also observed in the IIEF domains for erectile function, orgasmic function, intercourse satisfaction, and overall sexual satisfaction (P <0.0001). The proportion of subjects who felt that treatment with sildenafil improved their erections was significantly greater (67% to 86%) than that with placebo treatment (24%, P <0.0001). The proportion of successful attempts at sexual intercourse also increased significantly with sildenafil treatment (P <0.001). Partner responses corroborated patient reports. Sildenafil was well tolerated at the three doses studied. CONCLUSIONS: Oral sildenafil is an effective, well-tolerated treatment for ED of various etiologies.     

The effect of simvastatin in penile erection: a randomized, double-blind, placebo-controlled clinical trial (Simvastatin treatment for erectile dysfunction-STED TRIAL)

The aim of the study is to evaluate the effect of simvastatin in erectile dysfunction (ED) secondary to endothelial dysfunction. This study is a double-blind, randomized, placebo-controlled, clinical trial in patients with ED and endothelial dysfunction. Patients were randomized to receive 20 mg simvastatin (n = 21) or placebo (n = 20) daily for 6 months and subsequently 10 mg of vardenafil on demand for 4 weeks. Serum cholesterol, hormone profile, ultrasensitive C-reactive protein, the International Index of Erectile Dysfunction (IIEF) and the ED Index of Treatment Satisfaction were evaluated. There was a significant reduction in serum cholesterol in the treatment group. The hormonal profile remained unaltered. There was no difference in the IIEF between the groups at follow-up, although, at the beginning, 26% of the patients of both groups presented with mild ED and 74% with moderate-to-severe ED; at the end of the 7th month, all patients from the simvastatin group progressed to mild ED, compared with only 83% in the placebo group. There was no statistically significant difference in penile erection after intake of simvastatin or placebo. This study does not support the use of simvastatin as erectogenic medication. Further studies are necessary to verify if simvastatin has any beneficial effect on ED.     

The efficacy and safety of flexible-dose vardenafil (levitra) in a broad population of European men

BACKGROUND: In fixed-dose studies, vardenafil 5, 10, and 20mg improves erectile function in men with erectile dysfunction (ED). Here, the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed. METHODS: In this multicenter trial, 323 patients randomly received vardenafil 10mg or placebo. After 4 weeks, patients could switch to 5 or 20mg (or corresponding placebo), or remain on 10mg for an additional 4 weeks; dose-switching was optional for the last 4 weeks. Efficacy variables included the IIEF-EF domain score, GAQ, and percentage of positive responses to SEP2/SEP3 questions. RESULTS: The IIEF-EF domain score significantly improved from a baseline of moderate ED (12.6-13.1) to mild ED in men on vardenafil (21.0-24.2) compared with placebo (13.7-15.6) at weeks 4, 8, 12, and last observation carried forward (LOCF) (p<0.005 vs. placebo). A significantly greater proportion of men receiving vardenafil at weeks 4, 8, 12, and LOCF reported improved erections (80-86% vs. 21-36% for placebo, p<0.005). Successful SEP2 rates increased after vardenafil, reaching 84% at weeks 8 and 12 vs. 49-53% receiving placebo (p<0.005 vs. placebo). Vardenafil improved successful SEP3 rates ranging from 58% to 74% compared to 22-34% for placebo. The most common adverse events, flushing and headache, were generally mild and transient. CONCLUSION: In this flexible dose study, vardenafil was well-tolerated, and produced clinically relevant improvements in erectile function in men with ED.     

Efficacy and safety of on-demand tadalafil for the treatment of erectile dysfunction in South-East Asian men

AIM: Tadalafil is an inhibitor of phosphodiesterase type 5 used for the treatment of erectile dysfunction (ED). The efficacy and safety of tadalafil have been evaluated extensively in Western populations. Our aim was to assess the efficacy and safety of on-demand tadalafil for the treatment of ED in South-East Asian men. METHODS: This was a randomized, double-blind, placebo-controlled study of men with mild to severe ED of various etiologies randomized to receive placebo (n = 122), tadalafil 10 mg (n = 120), or tadalafil 20 mg (n = 125), taken as needed (maximum once daily) for 12 weeks. Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). RESULTS: Men from China, Singapore, and the Philippines participated in this trial (n = 367). Compared with placebo, tadalafil significantly improved erectile dysfunction on all efficacy outcomes (P < 0.001). Patients receiving tadalafil 10 mg and 20 mg experienced a significant mean improvement of 8.1 and 8.7, respectively, in the IIEF Erectile Function (IIEF-EF) domain score from baseline (vs placebo 2.4, P < 0.001). In patients receiving tadalafil 10 mg and 20 mg, the mean per-patient success rate for intercourse attempts (SEP3) was 62% and 70%, respectively, compared with 32% for the placebo group (P < 0.001). Of patients who received tadalafil 10 mg and 20 mg, 81% and 86% reported improved erections at endpoint (GAQ) compared with 44% in the placebo group (P < 0.001). The most common adverse events reported by patients were headache, back pain, dyspepsia, and dizziness. CONCLUSIONS: Tadalafil was an effective and well-tolerated treatment for South-East Asian men with ED.