伐地那非对肾阳虚、肾阴虚及肝气郁结型勃起功能障碍的疗效分析

目的:观察伐地那非对肾阳虚、肾阴虚及肝气郁结型勃起功能障碍(ED)的临床疗效。方法:将124例ED患者按中医辨证分为肾阳虚型ED(44例)、肾阴虚型ED(41例)、肝气郁结型ED(39例),所有患者每天服用伐地那非5 mg,总疗程为8周。结果:伐地那非能显著提高各型ED患者的勃起功能问卷-5(IIEF-5)和勃起质量表(EQS)评分,且各组间比较差别有统计学意义(P<0.01);伐地那非显著提高肾阳虚和肾阴虚型ED患者性交成功百分率(P<0.01),肝气郁结型ED在治疗后性交成功百分率也有明显提高(P<0.05);伐地那非还能显著提高各型ED患者阴茎勃起硬度,3组治疗后总体有效率分别为81.82%、73.17%、43.59%。结论:伐地那非对肾阳虚和肾阴虚型ED患者疗效优于肝气郁结型ED患者。     

真空负压水动按摩联合低频电脉冲治疗早泄的对照研究

目的评价真空负压水动按摩联合低频电脉冲穴位刺激治疗早泄的临床疗效和安全性。方法 86例早泄患者随机分为两组,其中治疗组56例,采用真空负压水动按摩联合低频电脉冲穴位刺激治疗,每周3～5次,15次为一疗程。对照组30例,仅予心理治疗。观察两组治疗后射精潜伏期（IELT）以及勃起功能情况变化。结果治疗组早泄治愈21例,有效12例,有效率为76.8%;对照组有效9例,有效率为30%;治疗组疗效明显高于对照组（P〈0.05）。治疗组合并轻度勃起功能障碍（ED）者32例,治疗后勃起功能改善23例,有效率为71.88%;对照组合并轻度ED者18例,治疗后勃起功能改善5例,有效率为27.78%;治疗组疗效优于对照组（P〈0.05）。两组均无明显不良反应。结论真空负压水动按摩联合低频电脉冲穴位刺激治疗早泄有效、安全,同时适合于伴轻度ED的早泄患者。     

西地那非治疗合并勃起功能障碍的早泄病人的临床观察

目的 :评价枸橼酸西地那非对合并勃起功能障碍 (ED)的早泄病人的临床疗效和安全性。　方法 :45例诊断为合并ED早泄病人 ,以西地那非片可调整用药方案治疗 1～ 3个月。以阴道内射精潜伏期及配偶性交满意度来评价早泄治疗效果 ,并评估ED的总体疗效和治疗满意度 ,比较治疗前后的国际勃起功能指数评分 5 (IIEF 5 )。　结果 :早泄改善者共 2 7例 ,有效率为 6 0 %。勃起功能改善者共 40例 ,改善率为 88.88%。 2 7例早泄有效者均为 5 0mg西地那非改善了勃起功能的病人 ,且满意率为81.48%;18例早泄无效者中ED治疗满意率仅为 5 .5 6 %。在早泄有效者和无效者间比较其治疗前、后IIEF 5评分及增加值 ,差异均有显著性 (P <0 .0 0 1)。不良反应共 9例(2 0 %) ,均为轻度或中度 ,未经特殊处理即自行缓解。　结论 :对合并ED的早泄病人 ,枸橼酸西地那非片能安全有效地改善其勃起功能 ,如获得满意疗效多能使病人早泄得到改善。     

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。     

伐地那非治疗难治性勃起功能障碍的最新进展

5型磷酸二酯酶(phosphodiesterase 5,PDE5)在阴茎勃起功能中所起的作用越来越引起人们的关注。环磷酸鸟苷(cGMP)信号通路介导的一氧化氮平滑肌舒张效应是正常勃起功能的必要条件,这个信号通路的下调能引起勃起功能障碍(erectile dysfunction,ED)的许多病理状态,并导致一些慢性疾病的发生。本文回顾了伐地那非治疗ED患者的有效性和安全性。结果表明,伐地那非对于合并异常脂蛋白血症和高血压、糖尿病、抑郁症、前列腺切除术后、外伤性脊髓损伤、西地那非治疗无效、肾移植术后、慢性前列腺炎和早泄的ED患者安全有效,为这些难治性ED患者提供了一种合理的治疗选择。另外,伐地那非还能延长ED患者的勃起时间。     

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。     

5型磷酸二酯酶抑制剂治疗辅助生殖技术中偶发ED

目的:探讨5型磷酸二酯酶抑制剂(PDE5i)对辅助生殖技术(ART)中偶发阴茎勃起功能障碍(ED)的治疗价值。方法:2008年3月至2012年6月行ART治疗的因偶发性ED而发生取精困难的患者75例,给予口服PDE5i(西地那非、他达拉非、伐地那非)的方法进行治疗,采用勃起硬度分级(EHS)法对患者的勃起程度进行评价,对患者获取精液的成功率进行分析。结果:75例患者中,有28例、25例和22例分别服用西地那非、他达拉非和伐地那非,61例(81.3%)服药后有效勃起,其中西地那非24例,他达拉非20例,伐地那非17例,有效率分别为85.7%、80.0%和77.3%,三者比较差异无统计学意义(P>0.05)。75例患者中有53例(70.7%)服药后有效勃起并成功获取精液,其中西地那非21例,他达拉非17例,伐地那非15例,成功率分别为75.0%、68.0%和68.2%,三者比较差异无统计学意义(P>0.05)。75例患者中有37例和38例分别服用PDE5i一般推荐剂量(半量)和最大推荐剂量(全量),分别有28例和25例获取精液成功,成功率分别为75.7%和65.8%,两者相比差异无统计学意义(P>0.05)。75例患者中有5例(6.7%)服药后出现轻度一过性的颜面潮红、头晕等药物不良反应。结论:3种PDE5i均能帮助偶发性ED患者有效勃起并成功获取精液,是治疗ART中突发性取精困难患者的一种安全有效的药物。     

伐地那非治疗糖尿病患者的勃起功能障碍

勃起功能障碍 (erectiledysfunction ,ED)在糖尿病患者中发生率要高于非糖尿病人群 ,而且更难治疗。伐地那非是一种高选择性的新型磷酸二酯酶 5抑制剂 ,是广泛ED人群的一线治疗药物。最近发表的大型临床试验表明 ,无论糖尿病合并ED的患者基线时的病情严重程度如何 ,也无论他们的血糖控制情况如何 ,伐地那非都能有效地改善其勃起功能 ,而且使用安全 ,耐受性良好     

伐地那非治疗高血压患者勃起功能障碍的有效性和安全性

勃起功能障碍(erectile dysfunction,ED)在高血压患者中的发病率明显高于非高血压人群,由于担心联合用药会出现严重不良反应,医生往往不愿为该类患者处方治疗ED的药物。伐地那非是一种新型高选择性磷酸二酯酶5型抑制剂,它对心血管系统的安全性已被多项临床试验所证实。最近进行的一项大型临床研究表明,对于同时服用多种降压药的高血压合并ED患者,伐地那非能够显著改善患者的勃起功能,并且使用安全,尤其对于血压或心率等项指标均未见临床意义的改变。     

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。     

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.     

Up-titration of vardenafil dose from 10 mg to 20 mg improved erectile function in men with spinal cord injury

AIM: Vardenafil is a highly selective phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction (ED). Efficacy of vardenafil has been demonstrated in various ED populations, but that in Japanese patients with spinal cord injury (SCI) has not been assessed. METHODS: This was an open-label, multicenter, flexible dose, 12-week study in patients with ED due to SCI. Following a 4-week observation period, patients received vardenafil 10 mg for 4 weeks, and based on efficacy, tolerability and patient preference, doses for the remaining 8 weeks were decided by investigators. The primary efficacy parameter was erectile function domain score of the International Index of Erectile Function. RESULTS: Ten patients took 10 mg all through the study, while 22 patients took 20 mg after completing 4 weeks' treatment with 10 mg. The erectile function domain score increased from 12.2 at baseline to 25.0 at Last Observation Carried Forward (LOCF) in the former group and from 10.3 to 22.5 in the latter group, respectively. Importantly, there was a 5.0 point increase in erectile function domain score after up-titration in the latter group. Drug-related adverse events were observed in 22% of patients including hot flushes (9%) and headache (6%), but these were transient and mild in intensity. Serious adverse events and adverse events leading to discontinuation of the study drug were not reported. CONCLUSIONS: Vardenafil 10 and 20 mg was well tolerated and improved erectile function in patients with SCI. Of interest, erectile function was further improved by 20 mg in patients who were not sufficiently treated with 10 mg.     

Vardenafil 20-mg demonstrated superior efficacy to 10-mg in Japanese men with diabetes mellitus suffering from erectile dysfunction

AIM: Vardenafil is a highly selective and potent phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction (ED). The efficacy of vardenafil has been demonstrated in a broad range of ED populations, but has not yet been assessed in Japanese patients with diabetes mellitus (DM), although DM is frequently associated with difficult-to-treat ED. This is the first study to investigate whether high-dose vardenafil (20 mg) can demonstrate superior efficacy to the usual dose (10 mg) in this subpopulation in Japan. METHODS: The study was a randomized, placebo-controlled, double-blind, multi-centre, parallel group comparison 12-week study. Following 4 weeks observation period, 778 patients aged 26-64 years old with ED and DM (HbA1c >12% at screening was excluded) both of more than 3 years duration were randomly allocated to one of the three groups, vardenafil 10 mg, 20 mg, or placebo (randomization ratio 3:3:1). Erectile function (EF) domain score of the International Index of Erectile Function was estimated as the primary efficacy parameter. RESULTS: Vardenafil 10 and 20 mg both significantly improved the EF domain score from 13.6 and 13.9 at baseline to 21.8 and 22.9 at last observation carried forward (LOCF), respectively, compared to placebo (13.7 at baseline to 16.3 at LOCF; p<0.0001). In addition, vardenafil 20 mg demonstrated superior efficacy to 10 mg (p<0.05), and the difference was more evident in severe ED patients (baseline EF domain score <11). The safety profile was comparable between these two doses (drug-related adverse events: 6.6, 22.0 and 24.2% in placebo, vardenafil 10 mg, and 20 mg arms, respectively). The most common adverse events were hot flush, headache and nasal congestion, which were mild in intensity and transient, and are known to be common to PDE5 inhibitors. CONCLUSION: In Japanese men with DM and ED, vardenafil 10 mg and 20 mg were effective in improving erectile function with comparable safety profiles. Vardenafil 20 mg demonstrated superior efficacy compared with 10 mg, suggesting incremental clinical benefit in using the higher dose in this difficult-to-treat population.     

长期口服小剂量伐地那非治疗按需服药无效ED的疗效观察

目的:评估持续口服小剂量伐地那非治疗按需服药无效的勃起功能障碍(ED)患者的疗效及停药后效果维持状况.方法:将按需服药无效的39例ED患者改用长期口服小剂量伐地那非治疗3个月,在治疗前后及停药后3个月分别记录患者国际勃起功能指数-5(International index of erectile function-5,IIEF-5)评分及患者性生活日记中插入和保持勃起的成功率,并且记录治疗前后夫妻性满意度.结果:本组患者治疗后主要疗效指标均高于治疗前,且治疗前后指标差异有统计学意义(P<0.01);停药后3个月,主要指标仍高于基线水平,且差异有统计学意义(P<0.05).结论:每天口服小剂量伐地那非对约半数(48.6%)按需服药无效的ED患者,可改善勃起功能,且安全、有效.     

伐地那非治疗勃起功能障碍的多中心、随机、双盲、对照研究

目的　观察伐地那非治疗勃起功能障碍的安全性和有效性。　方法　采用多中心、随机、双盲、安慰剂对照的方法 ,在国内 7家中心对 6 2 4例勃起功能障碍者口服伐地那非的勃起功能改善情况进行临床观察。患者随机按 1∶1∶1∶1进入安慰剂组及伐地那非 5、10、2 0mg组 ,每组各 15 6例 ,完成 4周洗脱期和 12周治疗期。患者按需在性交前 1h服用 1片研究药物。每日最多服用 1次研究药物。观察治疗 12周后国际勃起功能指数 (IIEF)问卷中有关勃起功能部分 (问题 1～ 5和 15 )的得分 ,患者日记中有关插入的成功率及成功保持勃起的成功率。　结果　共有 6 0 2例 (96 .5 % )进入安全性评估和意向性分析 ,各组分别为安慰剂组 14 8例 (94 .9% )、5mg组 15 1例 (96 .8% )、10mg组 15 0例 (96 .2 % )、2 0mg组 15 3例 (98.1% )。完全符合方案人群共 4 6 8例 (75 .0 % ) ,各组分别为 :安慰剂组 12 0例 (76 .9% )、5mg组 118例 (75 .6 % )、10mg组 10 6例 (6 8.0 % )、2 0mg组 12 4例 (79.5 % )。意向性分析人群的IIEF勃起功能部分 (问题 1～ 5 ,15 )得分的统计结果 ,用药 12周后 ,伐地那非 5mg组、10mg组和 2 0mg组的平均得分基线分别为 13.3分、14 .1分和 13.6分 ,分别增加到 2 2 .2分、2 2 .8分和 2 3.6分 ,与安慰剂组     

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。     

Comparable efficacy of once-daily versus on-demand vardenafil in men with mild-to-moderate erectile dysfunction: findings of the RESTORE study

BACKGROUND: Phosphodiesterase (type) 5 (PDE5) inhibitors are currently administered on demand for treatment of erectile dysfunction (ED). Once-daily dosing has been suggested to benefit patients. OBJECTIVE: To determine whether daily vardenafil use provides added clinical benefits to patients compared with on-demand dosing. DESIGN, SETTING, AND PARTICIPANTS: In this placebo-controlled, double-blind, multicentre parallel-group study, men with mild-to-moderate ED were randomised to 24 wk of treatment, followed by a 4-wk washout. INTERVENTION: Patients were randomised to receive once-daily vardenafil 10mg plus on-demand placebo for 12 or 24 wk, or once-daily placebo plus on-demand vardenafil 10mg for 24 wk. MEASUREMENTS: Primary efficacy variable was the between-group difference in change in International Index of Erectile Function-Erectile Function domain (IIEF-EF) score from baseline to end of washout. Secondary variables included change from baseline in proportion of positive respondents to Sexual Encounter Profile questions and in satisfaction with treatment as assessed with the Treatment Satisfaction Scale (TSS). RESULTS AND LIMITATIONS: LS mean changes from baseline in IIEF-EF scores were 2.02, 2.29, and 2.63 for vardenafil 12 wk once daily, 24 wk once daily, and 24 wk on demand, respectively. After washout, the trend was towards improved IIEF-EF scores in the on-demand group (20.58 [+/-0.96]) versus both once-daily groups (12 wk, 19.88 [+/-0.93]; 24 wk, 20.11 [+/-0.94]). Furthermore, there were no significant between-group differences in the percentage of patients with "normal" erectile function. TSS analyses demonstrated no significant differences between treatment groups. This study recruited patients with mild-to-moderate ED; therefore, the results may not be the same as in patients with severe ED. CONCLUSIONS: Once-daily vardenafil did not produce greater sustained effects on EF than on-demand vardenafil in men with mild-to-moderate ED, suggesting that daily dosing of PDE5 inhibitors does not produce sustained clinical benefits beyond cessation of treatment above those observed with on-demand administration.