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。     

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。     

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。     

他达拉非不同给药方案对初次性生活失败的男性勃起功能障碍患者疗效观察

目的:评估他达拉非3种不同给药方案对初次性生活失败的年轻男性勃起功能障碍(ED)患者疗效。方法:将夜间阴茎勃起硬度检查正常、心理治疗无效的初次性生活失败的年轻男性ED患者分为他达拉非每日小剂量口服组(每日夜间睡前1~2 h口服他达拉非5 mg)、按需治疗组(性生活前1~2 h口服他达拉非10~20 mg,根据勃起硬度调整剂量)、每日小剂量与按需治疗联合组(无性生活时每日夜间口服他达拉非5 mg,性生活当日于性生活前1~2 h一次性服用他达拉非10~20 mg、其剂量根据勃起硬度确定)共3组,分别给予相应治疗2~3个月。以国际勃起功能指数(IIEF)5个专项评分分别评估疗效。结果:3组IIEF勃起功能、性高潮、插入满意度、总体满意度专项评分较治疗前均显著提高(P均0.05或0.01);按需治疗较每日小剂量治疗显著提高勃起功能和性高潮专项评分(P0.05),但在性欲专项评分方面,其效果低于每日小剂量治疗;当给予联合治疗时,5个专项评分均得到了最佳改善(P均0.05)。结论:由于缺乏专业的性心理治疗机构和医生,单纯心理治疗对心理性ED患者疗效较差,以每日小剂量口服联合按需服用他达拉非可明显提高初次性生活失败的年轻男性ED患者疗效。     

伐地那非治疗勃起功能障碍的有效性和安全性

伐地那非是一种有效的、高选择性的口服磷酸二酯酶 (PDE5 )抑制剂。它对各种病因、各种程度、各年龄段的男性勃起功能障碍 (ED)患者均有良好疗效 ,可显著改善勃起功能。该药口服后最快 10min即可起效 ,长期使用仍能保持疗效 ,不良反应少 ,耐受性好。因此 ,伐地那非是治疗男性ED患者的有效、安全的药物。     

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。     

伐地那非治疗勃起功能障碍的有效性和安全性

伐地那非是一种有效的、高选择性的口服磷酸二酯酶(PDE5)抑制剂。它对各种病因、各种程度、各年龄段的男性勃起功能障碍(ED)患者均有良好疗效，可显著改善勃起功能。该药口服后最快10min即可起效，长期使用仍能保持疗效，不良反应少，耐受性好。因此，伐地那非是治疗男性ED患者的有效、安全的药物。     

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。     

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。     

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。     

Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double-blind, 12-week, flexible-dose, placebo-controlled erectile dysfunction clinical trial

OBJECTIVE: To evaluate the efficacy of vardenafil in patients previously unresponsive to sildenafil. PATIENTS AND METHODS: A multicentre, double-blind, 12-week, flexible-dose, placebo-controlled trial was conducted, involving 463 men aged > or = 18 years with moderate-to-severe erectile dysfunction (ED) and who were unresponsive to sildenafil (by history). After a 4-week treatment-free run-in, patients received placebo or vardenafil 10 mg with the option to maintain current dose or to titrate by one dose level (5, 10 or 20 mg) based on efficacy and tolerability at 4 and 8 weeks. Outcome measures were the erectile function (EF) domain score of the International Index of Erectile Function, two Sexual Encounter Profile diary questions (vaginal penetration and maintenance of erection until successful completion of intercourse), and the Global Assessment Question (GAQ). RESULTS: There was significantly better EF with vardenafil than with placebo throughout the study. The least-square mean EF domain scores increased from 9.3 at baseline to 17.6 at the 'last' observation carried forward (LOCF) analysis with vardenafil (P < 0.001). Overall least-square mean per-patient success rates more than doubled for penetration (30.3% to 62.3%) and quadrupled for successful intercourse (10.5% to 46.1%) with vardenafil. Improved erections (positive response to the GAQ) were reported by 61.8% of patients receiving vardenafil and 14.7% of those receiving placebo at LOCF (P < 0.001). Normal EF (domain score > or = 26) was achieved by 30% of patients receiving vardenafil and 6% receiving placebo at LOCF (P < 0.001). Adverse events were infrequent and representative of the phosphodiesterase-5 inhibitor profile. CONCLUSION: Vardenafil is an effective and generally safe treatment for ED, even in men unresponsive to sildenafil (by history).     

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.     

伐地那非治疗ED的有效性及安全性研究

目的:探讨长期按需服用伐地那非治疗ED的有效性及安全性.方法:2007年3月至2010年1月,共筛选891例ED患者给予口服伐地那非20 mg,每3天1次,通过电话采用问卷调查的方式进行随访,了解ED患者一般资料,治疗的需求、态度、接受程度;服用药物后均要和伴侣性接触,治疗12周后对临床疗效、不良反应、患者以及伴侣满意...     

Endothelial rehabilitation: the impact of chronic PDE5 inhibitors on erectile function and protein alterations in cavernous tissue of diabetic rats

BACKGROUND: Diabetic men generally have reduced efficacy with PDE-5 inhibitors (PDE5i) for the treatment of erectile dysfunction (ED). OBJECTIVE: To determine whether chronic vardenafil exposure alters cavernous protein expression predicting improved erectile function in diabetes. DESIGN: Forty-two adult male Sprague Dawley rats with streptozotocin-induced (50mg/kg IP) diabetes for 4 wk, were exposed to either vehicle or vardenafil for 6 wk. Assessments compared the impact of vardenafil given at 1h and 20 h to erectile function and cellular alterations and downstream translation of cavernous protein profiles were aimed. INTERVENTION: Vehicle or vardenafil 0.5mg/kg/day by oral gavage for 6 wk. MEASUREMENTS: Erectile function, penile tissue morphology, protein expression and surface enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI) protein profiling were determined. RESULTS AND LIMITATIONS: A significant increase of intracavernous pressure was seen in both treatment arms compared to diabetic rats not receiving vardenafil. Immunohistochemical staining showed improved endothelial and smooth muscle cell staining with chronic vardenafil use. Western blot analysis demonstrated increased endothelial cell eNOS and smooth muscle alpha-actin protein content. SELDI protein profiling showed enhanced proteins expression at molecular weights of 14.7, 20, 41.9, 66.2, and 83.9 kDa in the chronically treated vardenafil group. CONCLUSIONS: Vardenafil was effective in treating diabetic-induced ED with the greatest effect achieved through chronic dosing, with no additive effect measured with the final acute dose. Changes noted in the histology and protein expression indicate that vardenafil may have a protective effect in this disease state. This finding may serve as a basis for further work evaluating the utility of chronic vardenafil dosing in diabetic men.     

Gene therapy and erectile dysfunction： the current status

Current available treatment options for erectile dysfunction （ED） are effective but not without failure and/or side effects. Although the development of phosphodiesterase type 5 （PDE5） inhibitors （i.e. sildenafil, tadalafil and vardenafil） has revolutionized the treatment of ED, these oral medications require on-demand access and are not as effective in treating ED related to diabetic, post-prostatectomy and severe veno-occlusive disease states. Improvement in the treatment of ED is dependent on understanding the regulation of human corporal smooth muscle tone and on the identification of relevant molecular targets. Future ED therapies might consider the application of molecular technologies such as gene therapy. As a potential therapeutic tool, gene therapy might provide an effective and specific means for altering intracavernous pressure ＂on demand＂ without affecting resting penile function. However, the safety of gene therapy remains a major hurdle to overcome before being accepted as a mainstream treatment for ED. Gene therapy aims to cure the underlying conditions in ED, including fibrosis. Furthermore, gene therapy might help prolong the efficacy of the PDE5 inhibitors by improving penile nitric oxide bioactivity. It is feasible to apply gene therapy to the penis because of its location and accessibility, low penile circulatory flow in the flaccid state and the presence of endothelial lined （lacunar） spaces. This review provides a brief insight of the current role of gene therapy in the management of ED.     

Efficacy and safety of vardenafil in renal transplant recipients with erectile dysfunction

Erectile dysfunction (ED) profoundly affects the quality of life. The prevalence of ED in renal transplant recipients is reported by high as 50% to 60%. We evaluated the efficacy and safety of vardenafil in these patients with ED as well as its effects on graft function and on cylosporine or tacrolimus concentrations. Thirty-nine recipients with ED and serum creatinine values<2 mg/dL were treated with vardenafil. ED was assessed using the self-administered International Index of Erectile Function (IIEF). ED was diagnosed by using penile color-Doppler ultrasonography and intracavernosal injection. Vardenafil efficacy was assessed by readministering the IIEF questionnaire after 4 weeks of therapy. Serum creatinine levels, creatinine clearances, and cyclosporine/tacrolimus concentrations were measured before and after vardenafil therapy. Twenty-one recipients with ED served as placebo controls and 15 without ED as another control group. The IIEF scores improved from 12.80+/-3.5 to 26.46+/-2.4 in vardenafil-treated patients with ED (P<.001). Renal function and cyclosporine/tacrolimus concentrations did not change with vardenafil therapy. Side effects were observed in 7 (18%) patients: headache in three, palpitations in one, flushing in two, and dyspepsia in one. This study demonstrated that ED improved with vardenafil in renal transplant recipients with ED. For 4 weeks vardenafil therapy was free of side effects. Renal function tests did not change. Also, no dose change in immunosuppressive drugs was required during 4 weeks of verdanafil therapy.     

Vardenafil for the treatment of erectile dysfunction: a critical review of the literature based on personal clinical experience

OBJECTIVE: To critically review the literature on vardenafil in the treatment of erectile dysfunction while integrating the clinical findings with the personal experience of the authors. METHODS: Analysis of published full-length papers that were identified through Medline search from January 2000 through May 2004. Abstracts published in peer-reviewed journals from the same period were also considered. RESULTS: Efficacy, tolerability and safety, as reported in the peer-reviewed literature compares well with the authors' personal experience. Authors' personal observations include discussions on potency, selectivity, selection of initial dose, counselling for patients characteristically considered difficult-to-treat (diabetes, prostatectomy, depression), including the determination of the maximal efficacious dose and the possible role of daily dosing, optimisation of the use of vardenafil according to its pharmacokinetic and pharmacodynamic profiles (onset and reliability), and management of ED patients with or at risk for cardiovascular disease. CONCLUSIONS: Extensive experience with vardenafil as reported in peer reviewed literature confirms the important role of vardenafil in the management of patients with ED. The development of each physician's own experience with vardenafil is key to optimise overall satisfaction of this therapy by the patient and his partner.     

应用新的治疗满意度量表来评估ED患者及其性伴侣对伐地那非治疗的满意度

治疗满意度量表(TSS)是为评估男性勃起功能障碍(ED)患者及其性伴侣对ED治疗的满意度而制订的一个新量表。该自我报告式的调查问卷由四大部分组成:未治疗期的患者,治疗期的患者,未治疗期患者的性伴侣,以及治疗期患者的性伴侣。对以下6个方面进行评估:自信心、勃起的容易度、对勃起功能的满意度、性快感、对性高潮的满意度以及治疗满意度。TSS量表已经过多国有效性检验和心理学测验,被证明能可靠评价患者及其伴侣对ED治疗的满意度。在最近完成的一项双盲、多中心、平行组、灵活剂量的临床试验中,应用这个新的TSS量表比较了ED患者及其伴侣对伐地那非和安慰剂治疗的满意度。结果发现,伐地那非能显着改善勃起功能以及ED患者和伴侣的自信心、感知到的勃起容易度、性快感、对勃起功能、高潮和药物治疗的满意度。