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。     

5型磷酸二酯酶抑制剂治疗各种勃起功能障碍的勃起维持时间

Dunn ME等人进行了一项研究,磷酸二酯酶5型(PDE_5)抑制剂,西地那非,他达拉非和伐地那非,是一类安全有效的治疗勃起功能障碍(ED)的药物。然而,男性、性伴侣及他们之间的关系经过一段因ED的无性生活后再次恢复性活动可能会出现焦虑情绪,使性生活成为一个有压力的事件。医疗专业人员成功     

每日一次他达拉非对勃起功能及伴侣双方性生活质量的影响:一项双盲、随机化、安慰剂对照试验

有关勃起功能障碍（ED）的临床研究主要集中在男性患者以及各种治疗方法对患者勃起功能（EF）和性生活质量影响方面。但是,ED对男性患者及其女性伴侣的生活质量都产生了巨大影响。目前,研究男性ED治疗对女性伴侣影响的文献相当有限。确定他达拉非5mg每日一次在改善男性ED患者勃起功能和性生活质量方面的疗效,及这种治疗对其女性伴侣性生活质量的影响。     

服用他达拉非后第一个月的治疗反应可预示勃起功能障碍患者12个月内治疗的可持续性:来自DETECT试验的研究结果

DETECT试验是一项前瞻性、欧洲多中心观察性研究，共为期12个月，入选的勃起功能障碍（ED）患者在常规临床实践中开始或改用他达拉非进行治疗。该研究的目的是：在第12个月时，确定他达拉非的疗效以及患者持续使用他达拉非进行ED治疗的相关因素。共有年龄等于或大于18岁的1900例男性入选该研究，所有受试者均有ED病史，并将开始或改用他达拉非进行治疗。     

他达拉非治疗合并心血管疾病的ED研究进展

勃起功能障碍(ED)是严重影响男性性生活质量的疾病。近来发现,ED与心血管疾病关系密切,它们之间具有许多相似的致病机制和共同的危险因素。他达拉非是治疗ED的有效药物,大量的研究已经证实了其在ED患者中的显著疗效。其独特的长达36 h的时间窗不仅增强了患者的自信心,更改善了患者及其伴侣的生活质量。     

希爱力专栏

他达拉非治疗接受抗抑郁药治疗的勃起功能障碍患者的疗效J Clin Psychopharmacol,2007,27(1):62-66.Segraves等进行了一项事后分析(post hoc analysis),评估勃起功能障碍(ED)治疗药物———他达拉非对接受抗抑郁药治疗的患者的疗效。这项回顾性的汇总分析包括19项双盲、安慰剂对照的研究(n=3 864),其中男性ED患者205例,平均年龄55岁(27~79岁),患者在接受抗抑郁药治疗的同时服用他达拉非10 mg(n=38)、20 mg(n=113),或者安慰剂(n=54)。疗效评估以国际勃起功能指数(IIEF)、患者性生活日记(SEP)和全球评估问卷(GAQ)为准。他达拉非耐受性…     

他达拉非治疗效应不在6个月的治疗周期内发生耐药:一项来自ED患者的随机化、双盲、安慰剂对照研究结果

因为对ED治疗耐药可造成ED慢性治疗过程中药物疗效的降低，并可能造成治疗失败和患者放弃治疗，所以研究者进行了一项临床试验，在为期6个月的治疗周期内确定ED患者是否会对他达拉非的治疗效应产生耐药。该研究是一项多中心性、双盲、随机化、安慰剂对照、平行分组研究，并进一步对试验数据进行了事后分析。所有ED患者（年龄不小于18岁）经随机分组后，分别服用安慰剂（47例）或20mg他达拉非（93例），按需服用，但不允许患者调整药物剂量或加用其他治疗方法，     

他达拉非按需口服在台湾勃起功能障碍患者中的疗效及安全性:随机、双盲、平行、安慰剂对照的临床研究

他达拉非为5-磷酸二脂酶抑制剂，是治疗勃起功能障碍（ED）的药物。众多临床研究已评估了它在西方人群中的疗效及安全性，但他达拉非在东南亚人群中的大型临床研究尚不多见。Chen等在台湾开展了他达拉非按需治疗的研究，以评估它的疗效和安全性。该研究为期12周，是一项双盲、安慰剂对照的试验。研究纳入各种病因的轻至重度ED患者，他们随机、按需接受安慰剂、他达拉非10mg或他达拉非20mg（最大剂量为每日一次）治疗。研究的疗效评估指标包括：国际勃起功能指数、性活动日记（SEP）及综合评估问卷（GAQ）。结果显示，他达拉非与安慰剂比较显著改善了勃起功能（P〈0．005）。终点时，与安慰剂比较接受他达拉非治疗的患者平均性交成功率（SEP3：10mg70．0％，20mg78．0％，安慰剂42．8％）和勃起功能改善率均更高（GAQ：他达拉非分别为92．3％和84．6％，安慰剂1154.5％）。治疗中的不良事件大多为轻到中度。最常见的不良事件为背痛、消化不良和肌痛。这一研究证实，他达拉非对不同病因及严重程度的台湾ED患者的治疗安全有效。     

勃起功能障碍患者及其伴侣偏好他达拉非治疗

5型磷酸二酯酶(phosphodiesterase type 5,PDE5)抑制剂———西地那非、他达拉非和伐地那非是治疗勃起功能障碍(erectile dysfunction,ED)的一线药物。给予患者尝试所有三种药物的机会可以大大提高患者的治疗依从性,同时大多数患者会偏好使用其中一种药物。ED患者普遍偏好使用他达拉非,而且不受ED病情、病因、给药顺序、患者年龄以及剂量的影响。女性伴侣与ED患者的药物选择偏好基本一致,并影响男性伴侣的药物选择。他达拉非起效时间长达36 h,患者可以在较为自由的治疗时间窗内达到勃起,无需刻意安排服药与性活动尝试,性活动时压力明显下降,有助于改善患者的心理状态以及与伴侣的关系。女性伴侣感到回归轻松、自然的性活动,性生活质量得到了整体改善。临床医师开具PDE5抑制剂处方时应考虑患者及其伴侣的药物选择偏好。     

单用他达拉非及联用硫辛酸治疗2型糖尿病性ED的比较

目的探讨单用他达拉非5mg/日以及联用硫辛酸治疗糖尿病性ED的临床疗效。方法选择2017年1月至2018年12月就诊我科的糖尿病性ED患者181例,经第一阶段他达拉非5mg/日治疗12周后,仍诉勃起功能障碍及部分合并射精功能障碍的43例患者纳入最终研究统计并接受第二阶段治疗;第二阶段采用他达拉非5mg/日联合硫辛酸治疗12周。最终纳入研究统计患者在治疗前及第一、第二阶段治疗后均使用IIEF-5、Rigiscan及男性射精功能评分量表分别评估勃起满意度、勃起功能、射精功能等并记录。通过三次结果分析单用他达拉非5mg/日及联用硫辛酸治疗糖尿病性勃起功能障碍及合并射精功能障碍的疗效。结果他达拉非5mg/日联合硫辛酸治疗较单用他达拉非5mg/日及治疗前均显著提高患者IIEF-5分值,差异有统计学意义(P<0.05);单用他达拉非5mg/日及联合硫辛酸治疗较治疗前Rigiscan检测参数均有提高,差异有统计学意义(P<0.05),他达拉非5mg/日联合硫辛酸相比单用他达拉非5mg/日除阴茎头部胀大活力单位(Tumescence Activity Units TAU)差异无统计学意义(P>0.05),其余参数差异均有统计学意义(P<0.05)。糖尿病性ED伴Ej D患者单用他达拉非5mg/日治疗后男性射精功能评分较治疗前差异无统计学意义(P>0.05);联用硫辛酸治疗后部分射精功能评分项改善,较治疗前及单用他达拉非5mg/日治疗差异有统计学意义(P<0.05)。结论单用他达拉非5mg/日或联用硫辛酸均可改善糖尿病性ED患者的勃起功能,联用硫辛酸可改善部分射精功能。     

他达拉非治疗勃起功能障碍:卓越的36小时疗效

磷酸二酯酶5(PDE5)抑制剂是治疗勃起功能障碍(ED)的一线口服药物,与其他两种PDE5抑制剂(西地那非和伐地那非)相比,他达拉非有着起效快、服用方便和疗效显著的特点,但更为突出的是其较长的血浆清除半衰期带来的36h的持续药效,可以使患者和伴侣能更加自由地安排用药时间。患者和伴侣对他达拉非治疗的高满意度可能主要源于对用药时间顾虑的减少和对性生活时程关注度下降等社会心理收益。同时,他达拉非的安全性和耐受性良好,符合安全、有效、方便的用药原则,使其成为大多数ED患者及其伴侣偏爱的首选用药。     

他达拉非在阴茎勃起功能障碍中的疗效评价

他达拉非是一种口服治疗勃起功能障碍的PDE-5抑制剂药物,其作用时间可以维持到服用药物后36h,具有良好的有效性和安全性,并且可以改善由其它疾病导致的勃起功能障碍,本文对他达拉非治疗阴茎勃起功能障碍的疗效进行综述。     

他达拉非独特的时间顾虑收益

社会心理因素在勃起功能障碍(ED)的发病过程中占到了十分重要的地位。一种理想的治疗药物应能给患者及其伴侣带来满意的社会心理收益。"心理与人际关系量表"(PAIRS量表)既能评价ED对患者及其伴侣的心理及人际关系影响,又能预测ED患者对治疗的满意度。利用PAIRS量表对5型磷酸二酯酶(phosphodies-terasetype5,PDE5)抑制剂治疗ED的疗效进行评估,发现在降低ED患者性活动相关性时间顾虑方面,他达拉非明显优于西地那非和伐地那非。这也正是ED患者及其伴侣在临床治疗条件下偏好使用他达拉非的深层原因。与此相关的药物属性则是他达拉非长达36h的卓越疗效。     

Sildenafil: A 4-year update in the treatment of 20 million erectile dysfunction patients

Sildenafil citrate, the first internationally approved and widely used oral agent for the treatment of erectile dysfunction (ED), has revolutionized the treatment of ED throughout the past 5 years. This phosphodiesterase type-5 (PDE-5) inhibitor is selective for corpus cavernosum smooth muscle tissue and produces excellent erectile function. Its efficacy and safety over a wide variety of etiologies of ED and severities of ED demonstrates its usefulness in the clinical treatment of these patients. More than 20 million men have been treated worldwide with sildenafil with excellent results. ED caused by difficult-to-treat etiologies such as radical prostatectomy, severe diabetes, and spinal cord injury have demonstrated efficacy. Although sildenafil citrate, like all PDE-5 inhibitors, is contraindicated in patients taking nitrate medications for cardiac disease, it is effective and safe for those cardiovascular patients who are not taking nitrate medications. The incidence of adverse cardiovascular events in patients taking sildenafil does not differ from those of the general population. Investigations into the pharmacologic effect of sildenafil on coronary myocardial tissue further supports the safety of this medication. Sildenafil has been safe and effective in patients taking various medications including multiple antihypertensive drugs, selective serotonin reuptake inhibitors, cardiac, and diabetic medications.     

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

     

Therapeutic effectiveness and patient satisfaction after 6 months of treatment with tadalafil, sildenafil, and vardenafil: results from the erectile dysfunction observational study (EDOS)

OBJECTIVE: This observational study was conducted across Europe to assess health outcomes in men with erectile dysfunction (ED) who took tadalafil, sildenafil citrate (sildenafil), or vardenafil HCl (vardenafil) for 6 mo. METHODS: Therapy effectiveness and patient satisfaction were evaluated using established and new questions on erectile function. Behavioural, psychological, and relationship outcomes were assessed using the short form of the Psychological and Interpersonal Relationship Scales (SF-PAIRS). RESULTS: In nine European countries at 904 sites, 8047 patients were enrolled and 94% (7560) selected either tadalafil (5315), sildenafil (1252), or vardenafil (993) for treatment at baseline. Of the 7560, 3998 (52.9%) took the same drug for 6 mo. Baseline characteristics across the three treatment groups were comparable: mean age approximately 56 yr, moderate or severe ED, and mean International Index of Erectile Function-Erectile Function domain score about 13. Tadalafil, sildenafil, and vardenafil were therapeutically effective and improved patient satisfaction in the 40-58% of men who completed 6 mo of a single therapy. Patients taking tadalafil consistently had numerically higher levels of therapeutic effectiveness and satisfaction compared with patients who took sildenafil or vardenafil. The three cohorts had statistically significant changes from baseline in response to SF-PAIRS and there were significant differences, in favour of tadalafil, among cohorts in the Time Concerns domain. CONCLUSION: In a large observational study that mimics a routine clinical setting, most patients selected an inhibitor of phosphodiesterase 5 to treat ED, which resulted in a high level of therapeutic effectiveness and patient satisfaction.     

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。     

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.     

The future of erectile dysfunction (ED)

About 30-40 % of ED patients are non-responders to PDE 5 inhibitor monotherapy. Lifestyle modifications and physical activity with weight loss enhance PDE 5 inhibitor responsiveness. The same applies for combination therapies such PDE 5 inhibitors + L-Arginine 3.000mg, PDE 5 inhibitors + statins and PDE 5 inhibitors + Yohimbine. Combination of daily dosing with Tadalafil 5 mg and on demand application of sildenafil or vardenafil can improve responsiveness and erection hardness (personal experiences). Guanylate cyclase activators or RhoA-kinase inhibitors, either as monotherapy or in combination with PDE 5 inhibitors have shown in preclinical settings the potential to improve erectile function and represent targets for new ED drugs in the future. Immunophilin ligands were able to ameliorate erectile function after cavernous nerve injury due to pelvic surgery. Although having shown convincing efficacy both in animals and humans the centrally acting Melanocortin Receptor (MCR) Agonists were given up for ED treatment because of unfavorable side-effects.Promising targets for ED therapy in the future is gene therapy with several targets as well as stem cell therapy with adipose-derived or muscle-derived stem cells.     

Erectile dysfunction following nerve-sparing radical retropubic prostatectomy and its treatment with sildenafil

BACKGROUND: We retrospectively evaluated the erectile function after nerve-sparing radical retropubic prostatectomy (RRP) and the efficacy of sildenafil for erectile dysfunction (ED) following RRP according to the preoperative erectile function. METHODS: We evaluated 48 Japanese patients who underwent nerve-sparing RRP at the Sapporo Medical University School of Medicine, Sapporo, Japan, between January 1996 and December 2001. Erectile function following nerve-sparing RRP was assessed by a simple mailed questionnaire that was constructed for the study. RESULTS: Of the 48 patients, 36 had normal erectile function preoperatively, but for 12, function was not sufficient to penetrate. The overall estimated recovery rates of any degree of erection were 50.6% at 36 months and 94.3% at 60 months. However, that of erection sufficient to penetrate was only 17.7% at 36 months and was only seen in bilateral nerve-sparing patients. Sildenafil was effective in 9 of 13 ED patients (69.2%) in both nerve-sparing groups. When patients were divided according to preoperative erectile function, no difference was found in the efficacy rate between patients with normal function and those with ED. CONCLUSIONS: Even bilateral nerve-sparing RRP can not always guarantee a sufficient erection. However, sildenafil is effective for ED following nerve-sparing RRP regardless of the nerve-sparing procedure or preoperative erectile function. Thus, preoperative function alone, although depending on its severity, may not necessarily be a reason for exclusion from receiving nerve-sparing RRP if patients want to have the operation.