Use of combined intracorporal injection and a phosphodiesterase-5 inhibitor therapy for men with a suboptimal response to sildenafil and/or vardenafil monotherapy after radical retropubic prostatectomy

OBJECTIVE: To report experience with combined therapy using intracorporal injection (ICI) of alprostadil and oral phosphodiesterase 5 (PDE-5) inhibitors for the minimally invasive treatment of erectile dysfunction (ED) after radical prostatectomy (RP), as PDE-5 inhibitors are effective but a few patients may have a suboptimal response. PATIENTS AND METHODS: In a retrospective study, 34 men (aged 46-66 years) had a nerve-sparing retropubic RP and subsequent ED. Patients were titrated on sildenafil citrate or vardenafil to maximum doses. All had a suboptimal response after a maximum of eight doses of oral therapy and were then treated with ICI therapy using 15 or 20 microg alprostadil. Erectile function was assessed with the Sexual Health Inventory for Men (SHIM). RESULTS: Of the 32 patients who continued combined therapy, 22 (68%) had an improvement in erectile function after ICI therapy, as assessed by the SHIM score. On follow-up, 36% of these patients used ICI therapy only intermittently, instead of regularly, as they felt that this was adequate enough for good results. CONCLUSIONS: PDE-5 oral pharmacotherapy is the most commonly used effective therapy for ED but may not be as effective in patients who have radical surgery; the addition of testosterone patches may have side-effects or be considered a risk in patients with a history of prostate cancer. The use of ICI therapy as an adjunct or maintenance therapy to their oral medication may be another alternative in these patients.     

Erectile dysfunction secondary to nerve-sparing radical retropubic prostatectomy: Comparative phosphodiesterase-5 inhibitor efficacy for therapy and novel prevention strategies

Postprostatectomy erectile dysfunction appears to be initiated by neuropraxia and perpetuated by cavernosal smooth muscle apoptosis. Phosphodiesterase-5 (PDE-5) inhibitor therapy is the current cornerstone of erectile dysfunction (ED) therapy in this population. Although no head-to-head trials have been performed with sildenafil, vardenafil, and tadalafil in this population, there are numerous studies in the general ED population. The results of these studies demonstrate that neither of the new PDE-5 inhibitors met statistical noninferiority to sildenafil. Sildenafil has been studied in a novel primary prevention modality using nightly administration after a bilateral nerve-sparing prostatectomy. In this novel approach, it effected a sevenfold improvement in return of spontaneous, normal erectile function 2 months after drug discontinuation. This effect appears to be mediated by properties unique to sildenafil that include improved endothelial function and neuronal regeneration and neuroprotection. In primary prevention, unlike ED therapy, one has only “one shot” by definition. Therefore, it is even more critical to apply evidence-based medicine.     

Synergetic effect of testosterone and phophodiesterase-5 inhibitors in hypogonadal men with erectile dysfunction: A systematic review

Testosterone deficiency seems to impair the clinical response to phophodiesterase-5 (PDE-5) inhibitors in patients with erectile dysfunction (ED). In hypogonadal men, testosterone repletion was associated with enhanced sexual function in patients who failed initial treatment with sildenafil or tadalafil. We conducted a systematic review of studies that evaluated combination therapy of testosterone and PDE-5 inhibitors in patients with ED and low, low-normal testosterone levels who failed monotherapy. The studies we examine are heterogeneous with several methodological drawbacks and that, overall, the addition of testosterone to PDE-5 inhibitors might benefit patients with ED associated with testosterone <300 ng/dL (10.4 nmol/L) who failed monotherapy. Further studies, with a randomized placebo-controlled and double blind design, are needed to describe the appropriate target patient group, testosterone cut-off and to define the optimal dose and duration of combination therapy.     

Vardenafil: A new approach to the treatment of erectile dysfunction

Vardenafil is a phosphodiesterase type-5 (PDE-5) inhibitor developed as an oral therapy for erectile dysfunction (ED). Multiple phase 3 clinical trials have been completed and vardenafil is expected to launch worldwide in 2003. Two pivotal, randomized, double-blind, multicenter studies have evaluated the use of vardenafil in men with ED. Vardenafil improved the rate of achieving and maintaining an erection during sexual intercourse. Improvement also was noted in other aspects of sexual function, including confidence, orgasmic function, and overall satisfaction. Vardenafil produces clinically and statistically significant improvements in erectile function regardless of age, baseline severity, and etiology and is efficacious for the treatment of ED in diabetic and postprostatectomy patients. Vardenafil has a rapid onset of action and completion of successful sexual intercourse is possible for some patients 16 minutes after its administration. Twenty milligrams of vardenafil has sustained long-term efficacy by providing up to 92% of patients with improved erections during more than 2 years of treatment. Vardenafil is well tolerated, with an adverse event profile typical of the class of PDE-5 inhibitors. The most common adverse events were headache, flushing, rhinitis, and dyspepsia, which were mild or moderate and generally decreased with continued treatment. Vardenafil may be associated with transient reductions in blood pressure and commensurate increases in heart rate, with the overall incidence of cardiovascular-related adverse events similar to that of placebo.     

同期内使用3种PDE5抑制剂治疗ED的经验

目的:观察与比较同期内使用3种PDE5抑制剂治疗ED患者的疗效,满意情况和不良反应。分析影响患者疗效、接受度、倾向性的因素。方法:11个月在门诊应用3种PDE5抑制剂治疗ED患者331例。使用西地那非134例,他达拉非88例,及伐地那非109例。医师详细指导药物的应用,注意事项,观察的内容等,并互留电话,列表登记、随访。结果:复诊或电话随访时间,结果为:①获得良好的疗效及满意率为西地那非72例(79.12%),他达拉非52例(78.78%),伐地那非63例(81.81%)。②PDE5抑制剂单纯或交叉应用的资料分析显示:青年患者或新婚者,偏好伐地那非;③中青年患者倾向于他达拉非;中老年及较长期应用PDE5抑制剂的患者多选用西地那非。3种PDE5抑制剂用于早泄均有一定疗效。④对不能继续用此类药治疗ED的原因进行了分析,分别为:价高,不治本,效果差,耽心不良反应。结论:①同期3种PDE5抑制剂治疗ED的疗效基本相近。亦各有一些优势和特点。②3种PDE5抑制剂的安全性均好,一般、轻度不良反应相近,中度、特殊的不良反应少,严重不良反应均无发生。③PDE5抑制剂的疗效观察,目前众多的问卷、量表实际均仍以主观的感受为主。对同一个人以相同形式、相同问题、繁简一致阐述,获得的有关疗效满意情况、感受等简易回答是有可比性、可信度和实用性的。     

Effects of testosterone on erectile function: implications for the therapy of erectile dysfunction

Sexual potency declines with age, as does the efficiency of erection. Many studies show that different patterns of erectile dysfunction (ED), varying from occasional inability to obtain a full erection, impairment throughout intercourse and total absence of erectile response, might not be triggered by psychological factors only. Recent research indicates that ED relies on organic causes, and has challenged the development of new therapies. One therapeutic approach in patients who have testosterone deficiency is based on androgen therapy. Thus, we reviewed data on testosterone-induced effects relative to erectile function, summarizing the results from studies reported in 1991-2006 on testosterone therapy in patients with ED and hypogonadism, with a special focus on men not responding to phosphodiesterase-5 (PDE-5) inhibitors. We searched several computerized databases parallel with printed bibliographic references. Many studies have established animal models, which confirm that testosterone is important in modulating the central and peripheral regulation of ED. Testosterone deprivation has a strong negative impact on the structure of penile tissues and erectile nerves, which can be prevented by androgen administration. Combined therapy regimens with PDE-5 inhibitors and testosterone might improve ED in patients with hypogonadism of different causes. Thus, androgen treatment in hypogonadic patients, including those unresponsive to PDE-5 inhibitors, often results in an improvement of ED. Testosterone therapy is safe and convenient, while rapidly correcting low testosterone levels.     

Testosterone and erectile dysfunction

Aging is associated with a decline in several important health factors in men, including libido. Serum testosterone concentrations also decrease with age, and many age-related clinical features are closely associated with androgen deficiency, including erectile function (ED). Approximately 70% of ED is of organic origin, with the major risk factors being diabetes mellitus, hypercholesterolemia, smoking and chronic medical illnesses. These are also established risk factors for atherosclerosis, which is the predominant predisposing factor of vasculogenic ED. The introduction of phosphodiasterase-5 (PDE-5) inhibitors for the treatment of ED made a significant impact both in terms of clinical efficacy, and increasing the awareness of the condition. In spite of this, some patients fail to respond to PDE-5 inhibitors alone. Both animal and clinical studies indicate that testosterone therapy improves both erectile function and the response to PDE-5 inhibitors in patients with ED and hypogonadism. Indeed, interventional studies demonstrate that testosterone replacement therapy improves erectile function in hypogonadal men who have previously failed to respond to PDE-5 inhibitors alone. Furthermore, it has been demonstrated that the full therapeutic potential of PDE5 inhibitors will only become manifest in a eugonadal state. Recent studies have demonstrated a close relationship between testosterone and ED and suggest that testosterone therapy may be a valuable option for an increasing number of affected men. European guidelines recommend that all men presenting with ED should have their testosterone concentrations measured.     

磷酸二酯酶5抑制剂治疗勃起功能障碍的疗效和安全性比较

磷酸二酯酶 5 (PDE 5 )抑制剂西地那非的问世使男性勃起功能障碍 (ED)的治疗手段发生了根本性的改变。1998年以来有 10 0多个国家的 2 0 0 0多万患者使用了西地那非 ,患者的死亡率与总体人群的死亡率差异无显著性。西地那非治疗ED平均有效率达 80 %以上 ,成为治疗ED的首选手段。随着新的PDE 5抑制剂伐地那非和泰地那非在国外先后进入临床使用 ,药物治疗ED有了更多的选择。本文通过比较 3种PDE 5抑制剂的药效学、药动学及不良反应以评价其疗效和安全性。     

Predictors of erectile function improvement in obstructive sleep apnea patients with long-term CPAP treatment

The long-term effect of treatment with continuous positive airway pressure (CPAP) on erectile function was assessed in 60 patients with obstructive sleep apnea syndrome (OSAS). Severity of OSAS was evaluated by respiratory disturbance index (RDI) and minimal oxygen saturation (OxiMin). Severity of erectile dysfunction (ED) was assessed with the five question International Index of Erectile Function (IIEF-5) before and after CPAP treatment. Subjects were categorized into three groups on the basis of the change in IIEF-5 score: Group 1, no change (n=37); Group 2, improvement from 10+/-5.65 to 19.1+/-5.7, P<0.01 (n=12); Group 3, worsening from 19.9+/-4.7 to 9.5+/-7.8, P<0.01 (n=11). Group 2 had significantly higher RDI and lower OxiMin than the other groups, and was also more compliant and satisfied with CPAP. Change in IIEF-5 with CPAP treatment was negatively correlated (Pearson coefficient) with OxiMin (r=-0.374), and positively correlated with adherence to CPAP treatment (r=0.689). In conclusion, in selected patients, CPAP treatment for OSAS may by itself have a positive effect on erectile function by improving respiration during sleep. Predictors of erectile improvement include high RDI, low OxiMin, and CPAP compliance.     

持续气道正压通气对阻塞性睡眠呼吸暂停综合征患者勃起功能障碍疗效的meta分析

目的:评价持续气道正压通气(CPAP)对阻塞性睡眠呼吸暂停综合征(OSAS)患者勃起功能障碍(ED)的影响。方法:计算机检索Cochrane Library、PubMed、中国学术期刊全文数据库、中国生物医学文献数据库、万方资源数据库和中国重要会议论文全文数据库并手工检索相关期刊,全面收集CPAP对OSAS合并性功能障碍的临床研究,按照纳入、排除标准选择实验研究并评价质量,而后提取有效数据进行meta分析。结果:最终纳入4篇文献,1篇中文,3篇英文,包括77例患者。meta分析结果显示各研究间无统计学异质性(P=0.80;I2=0%),故采用固定效应模型进行meta分析。结果显示经CPAP治疗后,IIEF-5增高[WMD=4.19,95%(3.01,5.36),P<0.001]。结论:现有临床研究证据显示,对于OSAS合并ED患者,CPAP治疗能明显减轻ED。但因研究质量及研究样本存在明显局限性,期待更多高质量、大规模的临床随机对照研究加以验证。     

The COUPLES-project: a pooled analysis of patient and partner treatment satisfaction scale (TSS) outcomes following vardenafil treatment

OBJECTIVE: To assess the influence of vardenafil on treatment satisfaction in men with erectile dysfunction (ED) and their female partners. PATIENTS AND METHODS: This was a pooled analysis of three randomized, double-blind, placebo-controlled, 12-week studies of flexible-dose vardenafil vs placebo, in men with ED for >/=6 months (n = 788) and their untreated female partners. Measures of efficacy included the Treatment Satisfaction Scale (TSS), International Index of Erectile Function, Erectile Function domain (IIEF-EF), and Sexual Encounter Profile (SEP) questions 2 and 3 (SEP-2, 'Were you able to insert your penis into your partner's vagina?'; and SEP-3, 'Did your erection last long enough for you to have sexual intercourse?'). In addition to the overall analysis, there was a subgroup analysis for potential moderators of response, e.g. whether patients who had undergone previous phosphodiesterase type 5 (PDE-5) treatment. RESULTS: At baseline, least-squares (LS) mean scores for all TSS domains were similar in the vardenafil and placebo groups. After 12 weeks of treatment, vardenafil significantly improved the LS mean score for all domains compared with placebo, among both patients and their female partners (P < 0.0001, 'last'-observation-carried- forward analysis). Absolute between- group differences in LS mean TSS scores (vardenafil - placebo) were: ease of erection (patients 23.4, partners 24.9), erectile function satisfaction (36.7 and 32.9), pleasure from sexual activity (23.0, 23.7), satisfaction with orgasm (27.6, 21.8), confidence to complete sexual activity (28.2, 32.5), and satisfaction with medication (37.4, 35.6). The benefits of vardenafil were greater in men who had undergone previous PDE-5-inhibitor treatment and men aged <45 years, while the overall pattern of benefit was similar in all examined subgroups. There were significant benefits with vardenafil in all other variables (IIEF-EF scores and positive response rates to SEP-2 and SEP-3). CONCLUSIONS: Vardenafil significantly improved treatment satisfaction in men with ED, and in their partners. The results provide further evidence of the validity of the TSS.     

阴茎负压吸引治疗PDE5i无效型勃起功能障碍疗效分析(附70例报告)

目的:探讨使用Osbon助勃器阴茎负压治疗磷酸二酯酶抑制剂-5(PDE-5i)无效型勃起功能障碍(ED)患者的有效性和安全性。方法:收集口服PDE-5i无效ED患者70例,年龄25～66(38.9±9.1)岁,指导患者使用Osbon助勃器(美国Timm Medical公司)负压锻炼1个月;负压锻炼结束后,使用紧缩张力环进行性生活治疗,比较负压治疗前和治疗后3个月IIEF-5评分变化,以及患者和性伴侣的满意度,评价负压应用的安全性和有效性。结果:PDE-5i治疗无效的ED患者负压治疗后3个月IIEF-5评分较负压治疗前有显著提高(P<0.05),IIEF-5评分由治疗前(10.2±4.0)分上升到(13.3±4.7)分。负压治疗口服PDE-5i无效ED患者的有效率77.1%(54/70)。负压治疗后PDE-5i无效ED患者及性伴侣性生活满意率分别为64.3%(45/70)和65.7%(46/70)。结论:PDE-5i治疗无效型ED患者行阴茎负压治疗,可显著改善患者勃起功能及夫妻双方性生活满意率,值得临床应用。     

Efficacy and tolerability of vardenafil in Asian men with erectile dysfunction

Aim： To evaluate the efficacy and tolerability of vardenafil, a phosphodiesterase type-5 （PDE-5） inhibitor, in men of Asian ethnicity with erectile dysfunction （ED）. Methods： In this prospective, double-blind, multinational study, Asian men were randomized to receive vardenafil （10 mg） or placebo （4：1 ratio） for 12 weeks. The primary efficacy variables were the International Index of Erectile Function erectile function domain （IIEF-EF）, and Sexual Encounter Profile （SEP） questions related to penetration and intercourse completion. Significant mean improvements were required in all three measures to show positive benefits of vardenafil treatment. Secondary efficacy variables included the Global Assessment Question （GAQ） on erection improvement. Results： Least-squares mean baseline IIEF-EF domain scores （vardenafil 14.6, placebo 13.4） were consistent with moderate ED. After 12 weeks, vardenafil treatment was associated with significant increases from the baseline in IIEF-EF domain scores compared with the placebo （22.4 vs. 14.3; P 〈 0.001）. Vardenafil was associated with significant improvements from baseline in least squares （LS） mean success rates for SEP-2 （vardenafil 82.2 vs. placebo 43.6; P 〈 0.001） and SEP-3 （vardenafil 66.1 vs. placebo 24.0; P 〈 0.001）. Positive GAQ responses were reported by 81.8% of vardenafil recipients vs. 24.3% of placebo recipients. Adverse events were reported by 25.4% of the vardenafil group, the majority mild and transient. Conclusion： Vardenafil （10 mg） is a highly effective and well-tolerated treatment for moderate ED in Asian men. These results add to the increasing amount of data demonstrating the safety and efficacy of vardenafil for the treatment of ED in a range of patient populations.     

Testosterone improves erectile function in hypogonadal patients with venous leakage

The goal of this study was to assess the therapeutic benefits of long-acting testosterone therapy in hypogonadal patients with erectile dysfunction (ED). We recruited 29 patients with ED, ranging in age from 32 to 65 years (mean +/- SD, 47 +/- 9.7 years), with low plasma testosterone, who did not respond to phosphodiesterase type 5 inhibitor therapy. To evaluate penile arterial and venous blood flow, we employed duplex Doppler ultrasonography. For confirmation of diagnosis of venous leakage, pharmacocavernosography was carried out in 9 patients and magnetic resonance imaging with intracavernous contrast enhancement was carried out in 8 patients. All patients were treated with 1000 mg injectable testosterone undecanoate on day 1, followed by another injection after 6 weeks and every 3 months thereafter, in accordance with Nebido therapy protocol. Plasma testosterone levels were determined in all patients at baseline and after 18 and 30 weeks of testosterone treatment. The International Index of Erectile Function (IIEF-5) was administered at baseline and after 18 and 30 weeks of testosterone treatment. At baseline total testosterone ranged from 7 to 11.8 nmol/L (200 to 345 ng/dL) in 25 patients. Eighteen and 30 weeks after testosterone treatment, the mean testosterone plasma levels were 18 and 21.5 nmol/L (520 and 625 ng/dL), respectively. After 18 and 30 weeks of testosterone treatment, 20 out of the 29 patients demonstrated marked improvement in erectile function domain, as assessed by the IIEF-5. This was also associated with diminution of venous leakage. We suggest that, in hypogonadal men with ED, testosterone therapy improves erectile function in patients with ED and venous leakage.     

Does the clinical efficacy of vardenafil correlate with its effect on the endothelial function of cavernosal arteries? A pilot study

OBJECTIVE: To investigate whether the results of the ultrasonographic (US) measurement of post-occlusive changes in the diameters of cavernosal arteries after administering phosphodiesterase type 5 (PDE-5) inhibitor vardenafil could be associated with the response to vardenafil in patients with erectile dysfunction (ED), as currently there are no reliable methods for predicting the success rate of oral PDE-5 inhibitors. PATIENTS AND METHODS: The study included 122 men with ED; after a complex evaluation, the endothelial function of the cavernosal arteries was assessed in all patients before and 1 h after oral ingestion of vardenafil (20 mg), using our modification of the US assessment of post-occlusive changes in the diameter of cavernosal arteries. After the evaluation, all patients received vardenafil 20 mg on demand for 4 weeks. A successful response was defined using two endpoints, i.e. the normalization of the International Index of Erectile Function Erectile Function domain score (> or = 26) and positive answers to both Sexual Encounter Profile questions 2 and 3 on > or = 75% of occasions, based on the diary data collected. RESULTS: In all patients the mean (sd) initial percentage increase in the cavernosal artery diameter (PICAD) in responders and nonresponders was not statistically different, at 49 (24) and 43 (26), respectively (P = 0.168), but PICAD values after vardenafil were significantly greater in responders, at 73 (16) vs 55 (23) (P < 0.001). Analysis of data from patients with different causes of ED showed statistically significant differences in PICAD between responders and nonresponders only in those with arteriogenic ED. The sensitivity and specificity of a PICAD of > or = 50% after taking vardenafil 20 mg for predicting a positive response to the same dose of the drug in patients with arteriogenic ED were 94.9% and 91.3%, respectively. CONCLUSION: The results of the US assessment of post-occlusive changes in the diameter of cavernosal arteries after vardenafil administration are significantly associated with the clinical efficacy of the drug in patients with arteriogenic ED.     

Effects of sildenafil and vardenafil treatments on sleep quality and depression in hemodialysis patients with erectile dysfunction

ED is prevalent in hemodialysis (HD) patients, and closely related to poor sleep and depression. Efficacy of treating ED either with sildenafil or vardenafil has been shown to be beneficial in ameliorating concomitant depression in non-HD patients. It is yet to be shown whether treatment of ED with a PDE-5 inhibitor would improve poor sleep in HD patients. We aimed to compare the effects of sildenafil and vardenafil on sleep quality and depression in HD patients with ED. A total of 32 maintenance HD patients with ED randomized into two groups to receive either sildenafil or vardenafil for 4 weeks. After a 2-week washout and a crossover, each group received the other drug for another 4-week period. Sleep quality and depression were evaluated via post-sleep inventory (PSI) and Beck's depression inventory (BDI), respectively, at baseline and at the end of the treatment. Sildenafil and vardenafil both improved PSI and BDI scores significantly compared with pretreatment values. However, there was no difference between sildenafil and vardenafil with respect to these parameters. PDE-5 inhibitors, sildenafil and vardenafil, caused a significant improvement in sleep quality and depression in this cohort of HD patients with ED.     

The effects of chronic phosphodiesterase-5 inhibitor use on different organ systems

Phosphodiesterase-5 (PDE-5) inhibitors selectively inhibit PDE-5 enzymes that are present in various tissues like penile tissue, platelets, vascular, and smooth muscle tissue. The drug's actions on these tissues have lead to the successful therapeutic use in patients suffering from conditions such as erectile dysfunction (ED) and pulmonary hypertension. PDE-5 inhibitors (PDE-5i) act on the erectile tissue causing penile smooth muscle relaxation and vasodilatation leading to penile erection. In addition, in particular when used in conjunction with prostaglandin inhibitors, PDE-5i cause vasodilatation in pulmonary vasculature hence decreasing both the pulmonary arterial pressure and resistance. PDE-5i have also shown to mildly decrease blood pressure, increase cardiac index, and increase coronary blood flow in experimental animals as well as in human studies. The Food and Drug Administration (FDA) has approved three PDE-5i for the treatment of ED: sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis) and one for pulmonary hypertension: sildenafil (Revatio). These agents are highly selective for PDE-5 enzymes as compared to other subclasses of PDE enzymes and have the almost identical pharmacological action but slightly different pharmacokinetics. Only little data exist about long-term use of PDE-5i and their effects on different organ system. This paper reviews the current information available on chronic PDE-5 inhibitor use.     

Testosterone and erectile dysfunction

The role of testosterone on sexual desire, interest and motivation is well established, but its effects on erectile function remain controversial. Animal data show that experimental or medical castration results in loss of the intracavernosal pressure, smooth muscle/connective tissue balance, and penile tissue concentration of nitric oxide synthase-containing nerves, which alter the fibroelastic properties of penile tissue compliance, leading to veno-occlusive dysfunction and therefore erectile dysfunction. Castration also induces apoptosis of penile erectile tissue, and new DNA synthesis is induced by treatment with testosterone. In an animal model of venogenic erectile dysfunction, intracavernous vascular endothelial growth factor (VEGF), in addition to testosterone, restores the smooth muscle/connective tissue balance, endothelial cell hypertrophy and hyperplasia and normalizes the diameter of the dorsal nerve fibres, thereby preventing veno-occlusive dysfunction. There is some evidence that treatment with testosterone may be beneficial to men with erectile dysfunction who have low baseline testosterone levels. Androgens may also control the expression and activity of phosphodiesterase type-5 (PDE-5) in the penile corpus cavernosum. Oral drug therapy with PDE-5 inhibitors fails in some patients with erectile dysfunction. However, when testosterone is used together with a PDE-5 inhibitor, sexual function is restored in these patients, creating the potential for pharmacological combination therapy with testosterone for the treatment of erectile dysfunction.     

Drug Insight: oral phosphodiesterase type 5 inhibitors for erectile dysfunction

Erectile dysfunction (ED) is a common medical condition that affects the sexual life of millions of men. At present, first-line oral pharmacotherapy for most patients with ED is a phosphodiesterase type 5 (PDE-5) inhibitor, of which three are currently available worldwide. Sildenafil (Viagra, Pfizer) has a very satisfactory efficacy-safety profile in all patient categories. The first PDE-5 inhibitor to reach the market, it is now the most widely prescribed oral agent for ED. Tadalafil (Cialis, Lilly ICOS) and vardenafil (Levitra, Bayer/GlaxoSmithKline) were introduced to the European Union and the US in 2003 and 2004, respectively. These three PDE-5 inhibitors share many characteristics, but each has unique features. This review describes the chemical, pharmacologic and clinical features of sildenafil, vardenafil and tadalafil as oral first-line treatments for ED. First, we describe the physiology of penile erection and PDE-5 inhibitor pharmacology, including chemistry, PDE selectivity, pharmacokinetics, and possible drug interactions. We then summarize data on the efficacy and safety profiles of the three PDE-5 inhibitors for the treatment of ED in the general population, in patients with diabetes mellitus and in men that have undergone bilateral nerve-sparing retropubic radical prostatectomy.     

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。