枸橼酸西地那非和他达拉非治疗未经5型磷酸二酯酶抑制剂治疗男性勃起功能障碍患者的开放式、多中心、随机化、交叉比较研究

为了比较未经5型磷酸二酯酶（PDE5）抑制剂治疗的男性勃起功能障碍（ED）患者对治疗药物-枸橼酸西地那非（西地那非）和他达拉非的偏好性以及治疗药物的疗效和耐受性，有研究者进行了一项有关西地那非和他达拉非（按需服药）的开放式、交叉临床研究。在为期4周的基线评估后，入选的367例男性勃起功能障碍患者（平均年龄为54岁）经随机化分组，一组先服用西地那非12周，之后再服用他达拉非12周；     

西地那非治疗选择性5-羟色胺再摄取抑制剂引发的老年男性勃起功能障碍

抗抑郁治疗尤其是5-羟色胺再摄取抑制剂治疗常有性功能障碍的不良的反应。勃起功能障碍（ED）治疗的一线口服药西地那非对此类患者是否有效呢？Aizenberg等人研究了西地那非对抗抑郁药物所致老年ED的治疗作用。符合条件的患者在抗抑郁治疗时增加西地那非（25～50mg／d），在开始给药及4周后评估ED状况。所有患者皆反映勃起功能得到改善，10例中有7例勃起功能恢复正常。     

枸缘酸西地那非治疗男性Ⅰ型糖尿病患者勃起功能障碍

5％～10％男性Ⅰ型糖尿病患者并发勃起功能障碍（ED），这是一种常见并严重影响患者生活质量的并发症。因此，枸缘酸西地那非对男性Ⅰ型糖尿病患者ED的治疗作用显得非常重要。Stuckey等人进行了相关研究。共185例患者随机分组，应用枸缘酸西地那非（25～100mg，n=95）或安慰剂（n=95）治疗12周。疗效评估应用国际勃起功能障碍评分标准（IIEF）问题3（能否勃起）和问题4（勃起持续时间），     

固定剂量西地那非治疗不同病因ED有效且安全

为评价口服固定剂量的西地那非治疗不同病因勃起功能障碍(ED)的有效性和安全性。Montorsi F等进行了一个双盲、随机、安慰剂对照、固定剂量、为期12周的研究。514名ED男性(平均年龄56岁)随机接受25mg、50mg、100mg的西地那非或安慰剂治疗。患者中,器质性ED为32％,精神性ED25％,混合性ED为43％。西地那非或安慰剂在性生活前大约1小时服用,每天不超过一次。根据国际勃起功能指数(IIEF)问题3(能否达到勃起)和问题4(能否维持勃起)来确定治疗的有效性。其他     

枸橼酸西地那非治疗勃起功能障碍的疗效和安全性评价

枸橼酸西地那非在广泛的临床应用中，被证明对治疗勃起功能障碍（ED）有效且安全。Benchekroun A等人通过对71名18岁以上ED患者的研究，进一步评估了西地那非的疗效和安全性。在这项对照、开放式、剂量可变的研究中，患者在服用安慰剂4周后，使用西地那非（25～100mg）治疗8周。评价指标包括国际勃起功能指数（IIEF）的第3、4个问题、其他IIEF项目、患者事件记录以及生活质量（QOL）评价。结果显示，IIEF各项评分均比治疗前或安慰剂治疗显著改善，总体QOL和特定性关系及社会关系也有明显改善。西地那非耐受性良好，仅一例因不良反应终止治疗。研究表明，口服西地那非是安全的，并对勃起功能和生活质量均有益。     

西地那非(万艾可)治疗勃起功能障碍的有效性和安全性

作为治疗勃起功能障碍的口服制剂，枸橼酸西地那非（万艾可）的有效性已经在全世界范围内得到认可。Levinson等对埃及和南非地区患有勃起功能障碍的患者进行了为期12周的随机、双盲、安慰剂对照、可调整剂量的平行对照研究，以评估西地那非的有效性和安全性。将不同病因的ED患者随机分为两组，一组服用西地那非50mg（n=128），另一组服用安慰剂（n=126），剂量从25mg到100mg进行调整。     

西地那非显著改善良性前列腺增生合并ED患者的勃起功能

为评价良性前列腺增生（BPH）伴下尿路症状（LUTS）的勃起功能障碍（ED）患者，每日一次口服100mg西地那非治疗ED的效果，McVary等进行了一项研究。试验的前12周采用随机双盲对照，后8周采用开放性研究的方法，入选年龄45岁及以上的男性患者，患者国际勃起功能评分（IIEF）≤25且国际前列腺症状评分≥112。     

西地那非治疗前列腺癌放疗后勃起功能障碍的前瞻性研究

勃起功能障碍（ED）是前列腺癌患者接受外照射治疗后常见的晚期并发症。为了解西地那非治疗此类ED患者的有效性和安全性，Weber等进行了一项包括35例患者的前瞻性研究。采用基于国际性功能指数问卷（IISF）的25分量表每周评估勃起功能，在此期间患者每周口服100mg西地那非，连续6周。     

西地那非的慢性疗法可改善2型糖尿病患者的血管内皮功能

糖尿病患者对PDE-5抑制剂的血管内皮反应有所降低。为研究西地那非长期治疗对2型糖尿病患者的血管内皮的改善作用，AversaA等人进行了一项双盲、安慰剂对照研究[DiabetMed，2008，25（1）：37—443。研究人选20例有勃起功能障碍的糖尿病患者，随机给予患者服用西地那非100mg3d，随后服用西地那非25mg每日3次连续服用4周。另一组患者服用西地那非25mg每日3次，共服4d，后改服安慰剂3周，每日3次。     

老年ED患者使用西地那非的临床疗效及安全性

勃起功能障碍(ED)是一种影响老年男性的常见疾患,枸橼酸西地那非在治疗广谱病因的男性ED时显示了良好的有效性及耐受性。而老年男性伴随的健康问题比普通人群更多,西地那非在此类人群中的效果和安全性如何呢?FujisawaM等人对老年ED患者服用枸橼酸西地那非的有效性及安全性进行了研究。44名广谱病因的老年ED患者(60至78岁)使用25~50mg的枸橼酸西地那非进行治疗,平均随访(12.3±6.5)个月,治疗前检测血睾酮水平,在治疗前和治疗至少4周后进行IIEF-5评分。结果显示,在使用枸橼酸西地那非后,患者的IIEF-5评分从平均(8.2±3.6)分增高至(21.…     

维持性血液透析患者勃起功能障碍的初步研究

目的 明确维持性血液透析（MHD）男性患者勃起障碍的发病率，及评价西地那非的疗效与副作用。方法 以国际勃起功能指数（IIEF）对22例HD男患者进行评分。勃起障碍者给予西地那非，每次从25mg/d开始，最高为100mg/d，治疗12周，对比治疗前后IIEF分值变化。结果 MHD勃起障碍发病率为72.73%。西地那非总有效率为87.5%。常见的副作用为头痛，面色潮红等。结论 西地那非对于正在接近血液透析治疗的肾衰患者安全性和有效性等同于其它人群。     

Early sildenafil dose optimization and personalized instruction improves the frequency, flexibility, and success of sexual intercourse in men with erectile dysfunction

We investigated the effect of early sildenafil dose optimization and personalized instructions on sexual intercourse success in 1109 men beginning sildenafil therapy for erectile dysfunction. In phase 1 (4 weeks), patients followed the instructions contained in the sildenafil (50 mg) sample pack and had 1.4 sexual intercourse attempts per week with 82% success. Patients (17%) had a second intercourse attempt (80% successful): 58% occurred within 4 h, 20% within 5-8 h, and 22% within 9-24 h of the first attempt. In phase 2 (4 weeks), sildenafil was adjusted as needed (53% to 100 mg, and 2% to 25 mg), and investigators provided personalized instructions to facilitate patient success. Sexual intercourse attempts increased to 1.7 per week, with 91% success, and 18% were followed by a second attempt, of which 91% were successful. Most patients requested the 100-mg dose, which helped improve sexual intercourse frequency, flexibility and success.     

西地那非和育亨宾治疗勃起功能障碍疗效比较

为了对照性研究应用西地那非（Ｓｉｌｄｅｎａｆｉｌ,Ｖｉａｇｒａ＾ＴＭ）和育亨宾治疗男子阴茎勃起功能障碍（ＥＤ）的疗效。把２３４例ＥＤ（器质性４１％,心理性４６％,混合性１３％）随机双盲分为两组,西地那非组１３４例,用西地那非５０～１００ｍｇ,性交前６０分钟口服,每天一次,连服２天后,改为２～３天服一次,连用４～１２周。育亨宾组１００例,用育亨宾（Ｙｏｈｉｍｂｉｎｅ）５．４～１０．８ｍｇ,每天服３次     

A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction

OBJECTIVE: To assess the efficacy and safety of sildenafil citrate (Viagra, Pfizer Inc., USA) in a double-blind, placebo-controlled, dose-escalation study over a period of 26 weeks in men with erectile dysfunction of a broad spectrum of aetiology. PATIENTS AND METHODS: In all, 315 patients from five countries were randomized to receive treatment with placebo (156 men) or sildenafil (159 men). Significant concomitant medical conditions were hypertension (20%), a history of pelvic surgery (19%), diabetes mellitus (15%), and ischaemic heart disease (10%). Patients randomized to treatment received a starting dose of 25 mg of sildenafil or matching placebo, which could be increased to 50 mg and then to 100 mg of sildenafil, based on efficacy and tolerability. Assessments of efficacy comprised the 15-item International Index of Erectile Function (IIEF), including question three (ability to achieve an erection) and question four (ability to maintain an erection), a partner questionnaire, an overall efficacy question, and event-log data. RESULTS: After 12 weeks of treatment, 26%, 32% and 42% of patients were taking 25, 50 and 100 mg of sildenafil, respectively. A similar distribution of doses was reported after 26 weeks of treatment. Treatment with sildenafil significantly improved the patients' abilities to achieve and maintain an erection compared with treatment with placebo (P < 0.001). Scores for four of the five sexual function domains of the IIEF (erectile function, orgasmic function, intercourse satisfaction and overall satisfaction) also improved significantly (P < 0.001). There was a significant improvement in the mean score for the erectile function domain, regardless of the aetiology of erectile dysfunction (P < 0.001). After 12 weeks and 26 weeks of treatment, 82% and 79% of patients receiving sildenafil reported improved erections, compared with 24% and 23% of patients receiving placebo, respectively (P < 0.001). Treatment-related adverse events were mild to moderate and occurred in 27% of patients receiving sildenafil, compared with 8% of patients receiving placebo. CONCLUSION: Sildenafil is an effective and well-tolerated treatment for men with erectile dysfunction of a broad spectrum of aetiology.     

High dose sildenafil citrate as a salvage therapy for severe erectile dysfunction

The objectives of this study were to evaluate the efficacy and tolerability of high dose sildenafil as a salvage therapy for patients refractory to the maximum recommended dose of sildenafil. Fifty four fully evaluated patients with chronic erectile failure (ED) who had previously failed to respond to a home trial of sildenafil (100 mg) with erections suitable for sexual intercourse were studied. Each man was treated at home with sildenafil at escalating doses of up to 200 mg until either maximal response or intolerable adverse effects occurred. Erectile function was quantified using the erectile function domain of the International Index of Erectile Function (IIEF) before treatment, with sildenafil 100 mg and with maximal dose of sildenafil and a global efficacy question after 4 weeks of treatment.The mean age of the study group was 59.6+/-11.2 y. 13/54 (24%) had arteriogenic ED, 16/54 (30%) had mixed vasculogenic ED, 9/54 (17%) had cavernosal veno-occlusive dysfunction, 11/54 (20%) had post radical retropubic prostatectomy ED and 5/54 (9%) had psychogenic ED. 13/54 (24.1%) responded to sildenafil at a median maximal dose of 200 mg, 4/13 required 150 mg and 9/13 required 200 mg. 41/54 (76%) failed to respond to sildenafil. Mean IIEF question 3 and 4 scores were 1.5 and 1.4 at baseline, 2.2 and 1.9 with sildenafil 100 mg, 2.8 and 2.5 with sildenafil 150 mg and 3.0 and 2.9 with sildenafil 200 mg, respectively. After 4 weeks, treatment was regarded as having improved their erections by 37%, 46.3% and 68% of patients with sildenafil 100 mg, 150 mg and 200 mg, respectively. 34/54 (63%) reported adverse effects with maximal dose sildenafil comprising headache (19), facial flushing (32), dyspepsia (14), nasal congestion (11), dizziness (5) and visual disturbances (5). 4/13 (31%) responders refused to continue treatment due to adverse effects.In conclusion, sildenafil at doses of up to 200 mg is an effective salvage therapy for 24.1% of previous sildenafil non-responders but is limited by a significantly higher incidence of adverse effects and a 31% treatment discontinuation rate.     

Role of sildenafil citrate in treatment of erectile dysfunction after radical retropubic prostatectomy

BACKGROUND: Sildenafil citrate was introduced as a treatment for erectile dysfunction in April 1998 in the United States and has been available since March 1999 in Japan. In this article, we assess the efficacy of sildenafil in the treatment of erectile dysfunction in Japanese men after radical retropubic prostatectomy for localized prostate cancer. METHODS: Of 106 men who underwent radical retropubic prostatectomy between January 1994 and March 2000, 43 were prescribed sildenafil at their request after radical retropubic prostatectomy. Medication was initiated at 25 mg, and if this was ineffective, the dose was increased to 50 mg. Of the patients, 18 underwent bilateral and 21 unilateral nerve sparing (NS) procedures, while in 4 patients, a non-NS procedure was performed. These patients were interviewed using a questionnaire about their response to sildenafil and using the 5-item International Index of Erectile Function (IIEF-5) questionnaire. RESULTS: Thirty-three of the 43 patients were eligible for evaluation of the efficacy of sildenafil and 27 completed the IIEF-5 questionnaires. Sildenafil at 50 mg had a better effect on sexual function than 25 mg in most Japanese patients. Of the 16 patients who underwent bilateral NS procedures, 10 (62.5%) had improved ability for intercourse and 3 (18.8%) had improved erections. Of the 13 patients who underwent unilateral NS procedures, 7 (53.8%) had improved ability for intercourse and 4 (30.8%) had improved erections. None of the 4 patients who underwent non-NS procedures had a positive response. Of 24 patients with positive response to sildenafil, 3 (12.5%) did not have to take sildenafil after receiving it because they did not require it for intercourse. Mean IIEF-5 score increased from 4.3 to 11.4 (P < 0.0001). Patient age, time since surgery, PSA and pathological stage did not have statistically significant effects on outcome. The most commonly cited adverse effect was headache (21%). CONCLUSION: Sildenafil is equally effective for erectile dysfunction in Japanese patients who have undergone bilateral and unilateral NS procedures, and aids recovery of natural erectile function after radical retropubic prostatectomy. However, non-NS procedure patients had no response to sildenafil. This study suggested that sildenafil is well tolerated and should be initially used for treatment of Japanese men with erectile dysfunction after radical retropubic prostatectomy.     

Erectile dysfunction and the effects of sildenafil treatment in patients on haemodialysis and continuous ambulatory peritoneal dialysis.

BACKGROUND: Sexual dysfunction, including erectile dysfunction, is common in patients with uraemia. Despite successful treatment of male sexual dysfunction with sildenafil in non-uraemic population, its efficacy in dialysis patients is unknown. PATIENTS AND METHODS: In this study, 35 male HD patients (mean age 48+/-12 years) and 15 male CAPD patients (mean age 44+/-12 years) were included. In the baseline period, haemoglobin, serum urea, and albumin, Kt/V, several hormonal parameters, Beck depression scale, and penile Doppler blood flow, (peak systolic velocity after intracavernous papaverine administration) were measured. The international index of erectile function (IIEF) form was used to evaluate erectile dysfunction. Sildenafil was given to patients with erectile dysfunction at a dose of 50-100 mg/day twice a week. RESULTS: The percentage of erectile dysfunction was similar between patients on HD (71%) and those on CAPD (80%). Patients with erectile dysfunction were significantly older and had lower free-testosterone serum levels and penile blood flow than those without. In linear regression analysis for baseline IIEF score, penile blood flow was the only independent variable associated with erectile dysfunction. IIEF score increased to a similar extent after sildenafil treatment in both HD patients (from 8.10+/-5.54 to 21.70+/-9.61, P<0.001) and CAPD patients (from 9.90+/-3.87 to 21.60+/-10.18, P=0.011). Changes in IIEF scores after sildenafil treatment were associated with baseline penile blood flow as an independent variable by linear regression analysis. Adverse events observed during sildenafil treatment were dyspepsia in two patients and headache in one patient. CONCLUSION: The rate of erectile dysfunction is high in dialysis patients. Penile blood flow is the most important factor for predicting both the development of erectile dysfunction and the response to sildenafil therapy in such patients. Oral sildenafil is an effective, reliable, well-tolerated treatment for uraemic patients with erectile dysfunction.     

Comparison of the efficacy and safety of sildenafil citrate (Viagra) and oral phentolamine for the treatment of erectile dysfunction

This open-label, multi-center study from Mexico compared the efficacy and safety of oral sildenafil and phentolamine in men with erectile dysfunction. Patients received sildenafil (25-100 mg; n=123) or phentolamine (40 mg; n=119) for 8 weeks, and efficacy was assessed using the International Index of Erectile Function (IIEF) as well as two global efficacy questions. Mean scores for the erectile function domain of the IIEF were significantly higher for sildenafil (27.23 +/- 0.62; P=0.0001) than for phentolamine (19.35 +/- 0.66). Approximately twice as many men receiving sildenafil had successful attempts at sexual intercourse (88% vs 42%), improved erections (95% vs 51.1%), and improved ability to have sexual intercourse (94.4% vs 46.4%) compared with phentolamine. The most common adverse events included rhinitis, headache, tachycardia, and nausea, with a higher frequency reported in patients receiving phentolamine than sildenafil (41% vs 33%), with the exception of headache, which was reported more frequently in sildenafil users. Overall, sildenafil was more effective and appeared to be better tolerated than phentolamine for the treatment of erectile dysfunction.     

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.     

Sildenafil response is influenced by the G protein beta 3 subunit GNB3 C825T polymorphism: a pilot study

PURPOSE: Sildenafil is the oral phosphodiesterase-5 inhibitor that revolutionized treatment for erectile dysfunction. We investigated a potential association of the G protein beta 3 subunit (GNB3) C825T polymorphism, a determinant of intracellular signal transduction, with the drug response to sildenafil in patients with erectile dysfunction. MATERIALS AND METHODS: In 113 men with erectile dysfunction and 111 healthy male controls genotype status of the GNB3 C825T polymorphism was determined by polymerase chain reaction and restriction analysis. Patients with erectile dysfunction received sildenafil at a dose of 25 to 100 mg. according to the individual erectile response. Drug response was measured by interviewing the patient according to the erection scale of 0 to 5. RESULTS: The GNB3 genotype distribution of patients with erectile dysfunction exactly matched that of healthy controls. Analysis of the response to sildenafil revealed a significant association of C825T allele status with the erectile response to sildenafil. In the group with TT genotype we observed a 90.9% response but only a 50.9% and 48.9% response in patients with the CC and TC genotype, respectively. The odds ratio for a positive erectile response was 10.0 (95% CI 1.2 to 81.1) for patients with the TT versus the TC/CC genotype (p = 0.01). CONCLUSIONS: The response to sildenafil is significantly associated with GNB3 C825T genotype status in patients with erectile dysfunction.