从更好的勃起到更好的性生活:万艾可研究进展

万艾可(枸橼酸西地那非)起效快,使患者达到和维持坚硬的勃起,已被证实为首选的勃起功能障碍(ED)治疗药物。近年来,有关万艾可疗效的研究越来越多地关注其对整体性生活的改善,即对患者心理因素的影响。通过应用心理学评价工具,如勃起功能障碍治疗满意度量表、自尊心和性关系问卷、勃起功能障碍心理影响评分等,研究发现万艾可显著改善以下心理性因素:ED患者及其伴侣对性交和性关系的满意度、患者的自信心和自尊心、与伴侣亲近和进行性交的欲望等。服用万艾可的ED患者性交尝试次数显著增加,健康相关的生活质量显著提高。因此,万艾可产生更好的勃起,进一步促进更好的性生活良性循环。     

万艾可改善勃起功能和勃起硬度与患者心理、满意度等改善相关

为确定勃起功能障碍(ED)患者服用万艾可(枸橼酸西地那非)后勃起功能、勃起硬度与心理学评价(健康情绪、性满意度和治疗满意度)是否呈正相关。Montorsi F等从全球33项共计1万名ED患者服用西地那非的2、3、4期临床试验中采集数据进行研究。大多试验(n=27)都是随机、双盲、安慰剂对照设计,有32项试验根据有效性和耐受性可将剂量由50mg调整为25mg或100mg。预计性生活前1h服用万艾可,每天服用不超过1次。使用IIEF勃起功能域评分、阴茎硬度等级评分(EHGS)     

万艾可治疗男性勃起功能障碍

万艾可在全球范围内的广泛应用，证明了该药治疗勃起功能障碍（ED）是有效、安全的!Huang ST等人在我国台湾地区的研究再次证明了上述观点（Chang Gung Med J．2001 Feb；24（2）：91—96）。他们使用国际勃起功能评分（IIEF）中的3—4个问题作为客观评价。患者使用家庭日记记录服用万艾可的有效性和副作用以及他们的性伴侣对药物的满意程度。     

复方玄驹胶囊联合万艾可治疗万艾可渐进性失效勃起功能障碍的临床观察

目的:探讨复方玄驹胶囊联合万艾可治疗万艾可渐进性失效勃起功能障碍(ED)的临床疗效。方法:将符合万艾可渐进性失效ED诊断标准的36例患者随机分成两组,每组各18例。其中治疗组给予复方玄驹胶囊(口服,2粒/次,3次/日)和万艾可50 mg(性生活前1 h口服)口服;对照组单纯口服万艾可100 mg(性生活前1 h口服)。两组性生活频率1～2次/周,观察期2个月,对用药前后患者国际勃起功能评分(IIEF-5)及TSS伴侣评分进行对比分析。结果:两组每次使用万艾可对勃起功能改善的有效率比较,治疗组总有效率94.44%,对照组88.89%,两组对比差异无显著性意义(P>0.05)。IIEF-5评分治疗组治疗前后分别为(13.166 7±3.601 5)和(20.888 9±3.833 1),而对照组治疗前后分别为(13.055 6±2775 4)和(18.777 8±4.008 2),每组治疗前后对比差异有显著性意义(P<0.05);治疗后两组IIEF-5评分及TSS伴侣评分比较,治疗组的效果均比对照组好,且差异具有显著性意义(P<0.05)。结论:复方玄驹胶囊联合万艾可治疗万艾可渐进性失效ED疗效显著。     

糖尿病并勃起功能障碍的中西医结合治疗

目的：观察糖尿病并勃起功能障碍的中西医结合治疗临床疗效。方法：将120名患者随机分为两组,观察组使用万艾可加中药治疗,对照组使用万艾可治疗。分别记录治疗前及治疗后3个月时的国际勃起功能指数评分（IIEF）及睾酮（T）的变化。结果：观察组IIEF评分及T的变化显著优于对照组（P〈0．05）。结论：通过辨证论治,利用中药偏性,施以六味地黄汤加减进行中西医结合治疗,可较好地改善患者睾酮水平及IIEF指数。     

万艾可长期治疗ED有效且耐受性好

为评估万艾可长期治疗勃起功能障碍(ED)的有效性和安全性。McMurray JG等在患有勃起功能障碍的人群中进行一项双盲、开放性延展期的研究,这些患者患有ED4年,服用过25mg～100mg的万艾可。在治疗后,问卷调查患者对勃起功能和性生活的满意度。结果,共有979例患者,平均年龄58岁,ED平均持续时间为4.5年。这些患者中,器质性ED占72％,混合性17％,心理性的11％。其中,伴发高血压的占28％,合并糖尿病占22％,合并高脂血症占14％,有心脏病史占9％。平均服用万艾可的时间为47个月。≥95％的患者在年末评估时,表示服用万艾可治疗改善了性生活和勃起功能。在四年的资料中,有6．3％的患者由于对     

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。     

安特尔对糖尿病患者阴茎勃起功能障碍的影响

目的:探讨安特尔治疗糖尿病患者阴茎勃起功能障碍的效果。方法:将80例阴茎勃起功能障碍、且经万艾可治疗无效的2型糖尿病患者,随机分为两组。安万组:40 例,在用万艾可治疗的同时加用安特尔(120mg/d);维万组:40例,在用万艾可治疗的同时加用维生素E(30 mg/d)。两组均治疗1 个月,观察患者治疗前后血清睾酮水平、IIEF 5评分和阴茎海绵体血流量的变化。结果:安万组较治疗前血清睾酮明显升高(P<0.01),IIEF 5评分显著提高(P<0.05),阴茎海绵体血流量明显增加(P<0.05);其中30例(75%)患者性交时阴茎能满意地勃起;未出现任何不良反应。维万组治疗前后上述指标无明显变化(均P>0.05)。结论:安特尔能显著改善经用万艾可治疗无效的糖尿病患者的阴茎勃起功能,且安全性好。     

万艾可治疗后ED患者勃起硬度改善与情感满意度的关系

为了阐述ED患者的勃起硬度与其他相关结果的关系，King等进行了一项研究，综合分析了对全球27组随机双盲安慰剂对照研究和6组开放性研究。评价主观硬度分级，国际勃起功能指数问卷（erectile dys-function inventory，IIEF）中的硬度与性满意度评分，自尊心和性关系（Self-Esteem And Relationship，SEAR）问卷中的总体评分与性生活评分，勃起功能障碍问卷及治疗的满意度。硬度的改善（在合适的量效关系下达到完全的坚挺状态）与其他指标变化有明确的关联性。西地那非100mg可以成就大部分ED患者达到理想的硬度（完全的坚挺）。理想的勃起硬度，可促进主观上的幸福与满足，西地那非100mg是绝大部分ED患者的合适剂量。     

万艾可增加性前亲昵行为、提高夫妻间的性生活满意度

万艾可(西地那非)是非常有效的治疗勃起功能障碍(ED)的药物,能提高性生活满意度。Swierzewski M等进行一项研究,评估了万艾可对婚后ED患者对性前亲昵行为的渴望度(拥抱,抚摸,亲吻等)和性生活要求的影响。入选的患者先回答SHIM量表,分值为0分(重度ED)到25分(无ED)。同时,问卷评估患者对性前亲昵行为及性交的渴望度。患者被分组后,每周应用50mg万艾可2～3次,持续3个月。结果,117例患者(平均年龄39．8岁)参与了评估。SHIM量表的平均评分为11．9,提示他们患有中度勃起功能障碍。服用药物后,评估患者对性亲昵行为(拥抱,亲吻等)的渴望度,平均增加了27％。性交的渴望度增加了48％,所     

Efficacy of sildenafil citrate in treatment of erectile dysfunction: effect of type 2 diabetes

PURPOSE: To assess efficacy of sildenafil citrate in treatment of erectile dysfunction: effect of type 2 diabetes. MATERIALS AND METHODS: A total of 466 male patients with erectile dysfunction (ED) were enrolled in this study. Of them 382 were diabetic and 84 were non-diabetic. Patients were screened for ED using the erectile function domain of the International Index for Erectile Function (IIEF). Patients underwent routine laboratory investigations, in addition to total testosterone and prolactin assessment. To assess the effect of diabetes on efficacy of sildenafil, we compared the pre and post sildenafil responses to erectile function domain, Q3, Q4. Overall satisfaction and global efficacy question (GEQ) were also assessed. RESULTS: Mean age +/- S.D. was 53 +/- 8.4 and 49.7 +/- 10.6 years for patients with and without diabetes respectively. There were significant associations between increased severity of ED and longer duration, poor metabolic control and presence of more than one diabetes-related complication (p < 0.05 for each). Differences were significant between pre and post sildenafil administration regarding erectile function domain, Q3, Q4 (p < 0.05 for each). In the non-diabetic patients the GEQ and the overall satisfaction were significantly higher than in diabetics (p < 0.05 for each). Global efficacy question was significantly low in patients with fair and poor metabolic control, longer duration of diabetes, and patients with diabetic complications (p < 0.05 for each). CONCLUSIONS: Sildenafil is an effective treatment for diabetic patients with ED. Although the efficacy of sildenafil was negatively affected by factors as poor control and longer duration of diabetes and presence of more than one diabetes-related complication, however, the global efficacy and the overall patients' satisfaction were high.     

枸橼酸西地那非治疗男性肾移植受者勃起功能障碍

目的 :评价枸橼酸西地那非治疗肾移植术后勃起功能障碍 (ED)的有效性和安全性。　方法 :随机选择 2 6～ 5 0岁、术后 6月以上及血肌酐 133μmol/L以下的已婚男性肾移植受者 170例 ,对他们肾移植术后的性功能状况行国际勃起功能指数 5 (IIEF 5 )评分 ,存在ED者首先进行心理治疗 3个月 ,无效者用枸橼酸西地那非治疗 6个月 ,对他们的性生活情况进行随访并作出评分。　结果 :170例肾移植受者中 ,5 3例存在经心理治疗无效的ED ,枸橼酸西地那非治疗半年后IIEF 5评分中的各项参数均明显改善 ,对血肌酐、环孢素A谷值浓度无影响 ,不良反应轻微且短暂。　结论 :枸橼酸西地那非治疗肾移植术后ED安全、有效。     

Daily use of sildenafil improves endothelial function in men with type 2 diabetes

Diminished vascular endothelial function results in decreased vasodilator capacity and is associated with erectile dysfunction (ED) in patients afflicted with type 2 diabetes. The current study was designed to evaluate whether daily use of sildenafil could alter endothelial function and improve penile rigidity in a group of patients with diabetic ED. A double-blind, placebo-controlled, prospective trial was conducted with 24 men with type 2 diabetes who were randomized into 2 groups: one receiving daily sildenafil (50 mg, n = 12) and the other placebo (n = 12) for 10 weeks. Erectile function was captured subjectively using the International Index of Erectile Function (IIEF-5), and endothelial function was objectively monitored via brachial artery flow-mediated dilation. Among the placebo and sildenafil groups, there were no significant differences in average patient age, time from type 2 diabetes diagnosis, duration of ED, or baseline IIEF-5 scores. Past medical histories, including smoking, alcohol consumption, hypertension, and hyperlipidemia, were also similar. At the conclusion of the 10-week trial, patients who received daily sildenafil had significantly improved erectile rigidity as captured by IIEF-5 (P < .001) and increased endothelial function via brachial artery flow-mediated dilation (P < .01). Endothelial function in men with type 2 diabetes was enhanced with daily sildenafil. Improved erectile rigidity and enhanced vascular circulation was noted after 10 weeks of daily sildenafil use.     

An open-label, randomized, flexible-dose, crossover study to assess the comparative efficacy and safety of sildenafil citrate and apomorphine hydrochloride in men with erectile dysfunction

Two papers in this section deal with well‐known pharmacological agents used to treat male erectile dysfunction. In the first of these, authors from the UK compared the efficacy and safety of sildenafil and apomorphine in such patients. This open‐label crossover trial suggested that sildenafil was better than apomorphine, where the primary endpoint was the erectile function domain of the International Index of Erectile Function. The second paper is an update on the efficacy and safety of tadalafil. It describes the results of its use in a large number of men with erectile dysfunction, compared to placebo. Once again, the erectile function domain was one of the primary endpoints. Tadalafil was an effective and well tolerated treatment for this condition.

OBJECTIVE

To compare the efficacy and safety of sildenafil and apomorphine in the treatment of men with erectile dysfunction (ED).

PATIENTS AND METHODS

In all, 139 men with ED who were naïve to treatment were entered into an open‐label crossover trial with two treatment periods, each of 8 weeks, separated by a 2‐week washout period. Men were randomized to receive either sildenafil then apomorphine or apomorphine then sildenafil, and were allowed to titrate the dose on both drugs. The primary endpoint was the erectile function (EF) domain of the International Index of Erectile Function (IIEF), and other endpoints included diary data, the other domains of the IIEF, overall assessment questions and the Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire.

RESULTS

The EF domain score after treatment was 25.2 for sildenafil and 15.9 for apomorphine. The treatment difference of the adjusted means was 9.3 points (95% confidence interval 7.6–11.1; P < 0.001). After sildenafil the successful intercourse rate was 75%, vs 35% for apomorphine (P < 0.001), and the EDITS scores were 82.5 for sildenafil and 46.8 for apomorphine (P < 0.001). Of the men, 96% expressed a preference for sildenafil as a treatment for their ED. The side‐effect profiles for both drugs were in keeping with published data.

CONCLUSION

By all measurable endpoints sildenafil was superior to apomorphine in this open‐label crossover study of men with ED who were naïve to therapy

     

Post-marketing surveillance study of the safety and efficacy of sildenafil prescribed in primary care to erectile dysfunction patients

In order to investigate the safety and efficacy of sildenafil prescribed in primary care, a post-marketing surveillance study was undertaken. A total of 651 men with erectile dysfunction (ED) were enrolled from 31 family physicians in Korea from December 1999 to July 2002. Patients were regularly followed up to ascertain the safety and efficacy of sildenafil. Of the 651 patients enrolled, 572 (87.9%) returned for safety evaluation and efficacy assessment. In all, 458 (80.1%) of 572 patients reported improved erectile function with sildenafil. Hypertension, diabetes and low-dose sildenafil were associated with poor efficacy. A total of 71 adverse events were reported among 56 patients (8.6%), with the most frequent being hot flushes (5.6%), followed by headache (2.6%), palpitation (1.0%), anxiety (0.5%) and elevated ALT (0.5%). Only six patients (1.0%) discontinued sildenafil as a direct result of adverse events. These results suggest that sildenafil prescribed by primary care physicians was well tolerated and improved erectile function in patients with ED.     

The utility of sildenafil citrate for infertile men with sexual dysfunction: a pilot study

OBJECTIVE: To investigate the use the sildenafil citrate, recognized as a first-line therapy for men with erectile dysfunction (ED), and which is safe and effective in men with various causes and severity of ED, including psychogenic ED, in a population of infertile men with sexual dysfunction. PATIENTS AND METHODS: Infertility is a major source of life stress and might be associated with sexual dysfunction through the erosion of self-esteem and self-confidence, and in stimulating discord in a relationship. Men presenting for evaluation of fertility who on questioning by the physician reported the recent onset of sexual dysfunction, had a history taken, a physical examination, hormonal profile, and completed the International Index of Erectile Function (IIEF), a validated inventory for assessing sexual dysfunction. Thirty men with a score of <26 on the erectile function domain of the IIEF, or who complained of new onset rapid or delayed ejaculation, were treated with sildenafil with no randomization or placebo control. The evaluation was repeated and the IIEF completed again > or =3 months after starting treatment. RESULTS: For men complaining of ED, subjective erectile rigidity, duration of erection, and the percentage of successful penetration attempts significantly improved with sildenafil. The mean (sd) IIEF domain scores for erection and satisfaction, at 18 (4) vs 27 (3), and 12 (2) vs 16 (3) (both P = 0.01), and orgasm, at 4 (1) vs 6 (3) (P = 0.001), respectively, significantly improved after treatment. In patients with ejaculatory dysfunction, the function improved in 64% after sildenafil therapy. CONCLUSIONS: We identified the nature of sexual dysfunction associated with male-factor infertility, and showed the efficacy of sildenafil therapy in men with this condition.     

Analysis of the efficacy and safety of sildenafil citrate in the geriatric population

OBJECTIVE: To define the efficacy and tolerability of sildenafil in elderly men, as epidemiological data show an increasing life-expectancy of the population, and age is not only correlated with increasing morbidity but also an increase in the prevalence of erectile dysfunction (ED), for which sildenafil, available for >8 years, is effective and safe across a wide variety of medical comorbidities, severity and causes of ED. PATIENTS AND METHODS: A database was generated from all sildenafil users in one sexual medicine practice, and data were extracted for men aged >60 years. The database included data on patient demographics, comorbidities, International Index of Erectile Function (IIEF) scores and adverse events (AEs). The patients were subdivided into those aged 60-69 (group 1), 70-79 (group 2), and > or = 80 years (group 3). Analysis of variance was used to assess differences among the three groups for several variables of demographics and erectile response. RESULTS: In all, 167 patients were analysed; there were no significant differences in the duration of ED (5 +/- 3 years) or presence of comorbidities among the three groups. With a mean of two risk factors, the overall incidence of comorbidities was hypertension in 37%, dyslipidaemia in 28%, diabetes in 26%, coronary artery disease in 18% and lower urinary tract symptoms in 46%. The efficacy data showed that overall, 54% of men responded to sildenafil, with a mean increase in IIEF EF domain score of 5.7. Within the three groups there was a significant age-related decrease in response rate and IIEF EF domain score with age. However, there was no difference in AE incidence among the three groups, with an overall profile of 18% headache, 8% flushing, 8% dyspepsia, 5% nasal congestion and 2% visual changes. No overt cardiovascular events were reported. CONCLUSIONS: From these data, sildenafil is an effective agent in elderly men, but had a lower efficacy rate with increasing age, especially in men aged >80 years. The incidence of side-effects was similar to that in the general population taking sildenafil, with no difference in AEs among the different age groups.     

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.     

DOES SILDENAFIL COMBINED WITH TESTOSTERONE GEL IMPROVE ERECTILE DYSFUNCTION IN HYPOGONADAL MEN IN WHOM TESTOSTERONE SUPPLEMENT THERAPY ALONE FAILED?

PURPOSE: We evaluated the efficacy of testosterone gel (T-gel) alone and in combination with sildenafil in hypogonadal patients with erectile dysfunction (ED). MATERIALS AND METHODS: A total of 49 hypogonadal men (mean age 60.7 years) with ED participated for a mean of 20.2 months. Blood was tested for total and bioavailable testosterone, and prostate specific antigen. Sexual function was assessed using the International Index of Erectile Function questionnaire and a global assessment question (GAQ). Men received 1% 5 gm T-gel for 6 months, and 100 mg sildenafil was added to those with a "no" response to the GAQ after 3 months on testosterone supplement. RESULTS: A total of 31 patients reported significant improvement in the sexual desire domain (from a mean +/- SD of 4.2 +/- 0.8 to 8.6 +/- 0.4) and erectile function (EF) domain (from 13.6 +/- 1.9 to 27 +/- 0.8) following treatment with testosterone supplement alone. One patient was excluded from study after urinary retention developed and 9 reported irritation at the gel application site. In spite of normalization of total and bioavailable testosterone values, and significant improvement of sexual desire domain scores, the EF of 17 men remained less than 26 or they responded "no" to the GAQ. These men received combined T-gel and sildenafil, after which all graded EF greater than 26 and responded positively to the GAQ. CONCLUSIONS: Combined treatment with sildenafil and T-gel has a beneficial effect on ED in hypogonadal patients in whom treatment with testosterone supplement alone failed.     

Risk factors in predicting a poor response to sildenafil citrate in elderly men with erectile dysfunction

OBJECTIVE: To assess the clinical efficacy of sildenafil and the potential predictors of poor response to sildenafil in elderly patients with erectile dysfunction (ED). PATIENTS AND METHODS: The study included 162 patients (aged > or = 60 years) treated with sildenafil for at least 8 weeks; all patients were evaluated with a history, physical examination, measurement of total testosterone and a pharmacological erection test. Sexual function before and 8 weeks after treatment was assessed using the self-administered International Index of Erectile Function (IIEF). Treatment was considered successful when the patient attained a higher grade on the erectile function (EF) domain score, and an affirmative response to the overall assessment question. Factors influencing treatment outcome were evaluated by univariate and multivariate statistical analysis. RESULTS: The overall efficacy with sildenafil was 47% (76/162). On univariate analysis, uncontrolled diabetes, current smoking, hypogonadism (<3 microg/L testosterone) and low pretreatment EF domain score (<17) were selected as predictors of a poor response. On multivariate logistic regression, a low pretreatment EF domain score was the strongest independent prognostic factor for a poor response (odds ratio 2.25, 95% confidence interval, 1.45-7.33), and this was followed by hypogonadism (1.89, 1.12-3.16) and current smoking (1.34, 1.04-3.52). CONCLUSION: In a real clinical setting, sildenafil was effective for about half of the elderly men. The baseline EF domain score, hypogonadism and current smoking were significantly associated with failure of sildenafil. These results suggest that modifying reversible risk factors, e.g. stopping smoking and replacing testosterone, would be beneficial in augmenting the efficacy of sildenafil in elderly men.