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。     

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...     

口服伐地那非联合中药疏肝活血汤治疗勃起功能障碍的疗效观察

勃起功能障碍(erectile dysfunction,ED)是成年男性一种常见疾病。估计全世界范围内超过1.5亿的男性有不同程度的ED。我们于2005年2月~2006年4月应用德国拜耳公司生产的伐地那非(商品名:艾力达)联合中药疏肝活血汤治疗ED,取得满意疗效。现报告如下。1资料与方法1.1一般资料共选择来自我科门诊就诊的ED患者84例,采用随机分组、单盲观察的方法,其中治疗组54例给予伐地那非联合中药疏肝活血汤治疗,患者年龄23~72岁,平均49.2岁,ED病程0.6~28年,平均4.8年。对照组30例单纯口服伐地那非,患者年龄22~69岁,平均47.8岁,ED病程0.6~26.5年,平均4.3…     

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。     

伐地那非治疗勃起功能障碍的可靠性

疗效的可靠性对于ED患者坚持治疗非常重要。伐地那非是一种强效、高选择性的磷酸二酯酶5(PDE5)抑制剂,其疗效和安全性已得到了大量临床研究的证实。本文分析了伐地那非在临床试验中和实际应用中的疗效可靠性,得出结论认为其在主要的勃起功能参数方面(包括阴道插入、维持勃起、勃起硬度满意度和总体满意度等)能提供可靠的疗效,提高治疗依从性。     

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。     

盐酸伐地那非治疗男性勃起功能障碍临床研究

目的 观察盐酸伐地那非治疗男性勃起功能障碍的安全性和有效性。方法 随机、双盲、安慰剂对照，对88例勃起功能障碍口服伐地那非治疗的患者进行了为期7个月的观察随访。结果 主要疗效指标的统计学分析结果，显示出5mg、10mg和20mg三个剂量组的伐地那非疗效均优于安慰剂组。次要疗效指标的分析结果与主要疗效指标一致。与药物相关的不良事件依次为潮红、头痛、眼胀、鼻塞、头晕和背痛，多为轻度，且可以自行缓解。结论 盐酸伐地那非治疗勃起功能障碍安全、有效、耐受性好。     

伐地那非治疗糖尿病患者的勃起功能障碍

勃起功能障碍(erectile dysfunction，ED)在糖尿病患者中发生率要高于非糖尿病人群，而且更难治疗。伐地那非是一种高选择性的新型磷酸二酯酶5抑制剂，是广泛ED人群的一线治疗药物。最近发表的大型临床试验表明，无论糖尿病合并ED的患者基线时的病情严重程度如何，也无论他们的血糖控制情况如何，伐地那非都能有效地改善其勃起功能，而且使用安全，耐受性良好。     

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。     

伐地那非联合阿昔莫司治疗糖尿病性勃起功能障碍的疗效探讨

目的 探讨伐地那非联合阿昔莫司治疗糖尿病性勃起功能障碍(ED)的疗效.方法 180例在我院泌尿外科门诊治疗的2型糖尿病性ED患者,随机分为试验组和对照组各90例,两组患者均用常规方法控制血糖,试验组患者给予伐地那非联合阿昔莫司,对照组仅用伐地那非;用国际勃起功能障碍指数问卷(IIEF-5)评估治疗前后的疗效,同时记录夫妻对性生活的满意程度和不良反应.结果 所有患者均顺利完成治疗,试验组和对照组治疗后IIEF-5评分分别为20.2±4.1和15.9±4.4(F=12.48,P＜0.01),总有效率分别为78.9％和70.0％(x2 =9.02,P=0.03);试验组血脂下降程度大于对照组(P＜0.05);夫妻性生活满意率试验组和对照组分别为73.3％、63.3％,组间比较差异无统计学意义(x2=4.49,P=0.11);两组不良反应发生率分别为27.8％和24.4％,差异无统计学意义(x2=0.26,P=0.61).结论 伐地那非联合阿昔莫司治疗糖尿病性ED的疗效优于单纯伐地那非,但长期使用的安全性需要更多研究支持.     

The Russian experience of studying vardenafil efficacy and safety in men with erectile dysfunction of various aetiologies

BackgroundVardenafil is a first-line drug in the therapy for erectile dysfunction (ED) of various aetiologies.MethodsAn open, multi-centre study assessing the efficacy and safety of vardenafil prescribed in flexible doses for 12 weeks to men with ED from various aetiologies was performed in Moscow in 2003–2004. A total of 129 patients aged from 22 to 76 years (mean = 45.7 ± 12.9) were enrolled into the study. The efficacy of the drug was evaluated using the International Index of Erectile Function (IIEF) Questionnaire, individual patients’ diaries and the Global Assessment Questionnaire (GAQ).ResultsScores for erectile function, maintenance of erection, satisfaction with sexual experience and satisfaction with overall sexual life all increased between the beginning and the end of this study, which has thus shown vardenafil's high efficacy and safety for patients.ConclusionAlongside its cardiovascular safety, one of the advantages of vardenafil is the opportunity for flexible dosing owing to the variety of dosages available.     

Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy

BACKGROUND: To date, no data have been available from large, well-designed trials comparing on demand and nightly dosing of phosphodiesterase type 5 (PDE5) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction (ED). OBJECTIVE: To investigate the effect of early postoperative dosing with vardenafil, administered either nightly or on demand, compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy (NSRP) surgery. DESIGN, SETTING, AND PARTICIPANTS: A randomised, double-blind, double-dummy, multicentre, parallel group study conducted at 87 centres across Europe, Canada, South Africa, and the United States. For inclusion, patients had to be scheduled to undergo bilateral NSRP within 1 mo of screening and have a normal International Index of Erectile Function erectile function domain (IIEF-EF) score of >/=26 at screening. A total of 628 men, aged 18-64 yr, were randomised to treatment. Study design consisted of a 9-mo double-blind treatment period, a 2-mo single-blind washout period, and an optional 2-mo open-label period. INTERVENTION: Patients received placebo, nightly vardenafil, or on demand vardenafil. MEASUREMENTS: Primary outcome measure was the percentage of subjects with an IIEF-EF score of >/=22 after the 2-mo washout period. Secondary variables included mean per-patient success rates for Sexual Encounter Profile (SEP) questions 2 and 3. RESULTS AND LIMITATIONS: No statistically significant differences were observed among treatment groups in the proportion of patients with an IIEF-EF score of >/=22 or in SEP3 success rates after the washout period. On-demand vardenafil treatment resulted in significantly greater IIEF-EF scores and better SEP3 response rates than placebo over the entire treatment period. CONCLUSIONS: In this study of men with ED following bilateral NSRP, vardenafil was efficacious when used on demand, supporting a paradigm shift towards on demand dosing with PDE5 inhibitors in this patient group. TRIAL REGISTRATION: European clinical trials database (EudraCT; available at http://eudract.emea.europa.eu/). Trial registration number: 11336.     

伐地那非治疗勃起功能障碍的多中心、随机、双盲、对照研究

目的　观察伐地那非治疗勃起功能障碍的安全性和有效性。　方法　采用多中心、随机、双盲、安慰剂对照的方法 ,在国内 7家中心对 6 2 4例勃起功能障碍者口服伐地那非的勃起功能改善情况进行临床观察。患者随机按 1∶1∶1∶1进入安慰剂组及伐地那非 5、10、2 0mg组 ,每组各 15 6例 ,完成 4周洗脱期和 12周治疗期。患者按需在性交前 1h服用 1片研究药物。每日最多服用 1次研究药物。观察治疗 12周后国际勃起功能指数 (IIEF)问卷中有关勃起功能部分 (问题 1～ 5和 15 )的得分 ,患者日记中有关插入的成功率及成功保持勃起的成功率。　结果　共有 6 0 2例 (96 .5 % )进入安全性评估和意向性分析 ,各组分别为安慰剂组 14 8例 (94 .9% )、5mg组 15 1例 (96 .8% )、10mg组 15 0例 (96 .2 % )、2 0mg组 15 3例 (98.1% )。完全符合方案人群共 4 6 8例 (75 .0 % ) ,各组分别为 :安慰剂组 12 0例 (76 .9% )、5mg组 118例 (75 .6 % )、10mg组 10 6例 (6 8.0 % )、2 0mg组 12 4例 (79.5 % )。意向性分析人群的IIEF勃起功能部分 (问题 1～ 5 ,15 )得分的统计结果 ,用药 12周后 ,伐地那非 5mg组、10mg组和 2 0mg组的平均得分基线分别为 13.3分、14 .1分和 13.6分 ,分别增加到 2 2 .2分、2 2 .8分和 2 3.6分 ,与安慰剂组     

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.     

Positive effect of counseling and dose adjustment in patients with erectile dysfunction who failed treatment with sildenafil

OBJECTIVE: Many patients with erectile dysfunction (ED) stop using sildenafil due to subjective failure. This study examined whether counseling and maximal dosing (100 mg) could achieve better treatment compliance and could possibly improve treatment outcome. MATERIAL AND METHODS: Patients were recruited by newspaper advertisements and referred to 5 ED centers throughout the country. Details about their previous experiences with sildenafil were recorded and following an explicit explanation about the nature and action of the drug, were offered to enter the study. Instructions on drug use were provided during each visit in which four 100 mg Sildenafil tablets were provided. Treatment outcomes were assessed by the international index of erectile function (IIEF) questionnaire after taking 4 and 8 tablets. In 2 ED centers a short video with sexual counseling content was added in between visits. RESULTS: The study cohort was comprised of 220 patients aged 27-88 years. The majority reported having received limited or no instructions on drug use when sildenafil was first prescribed. A significant increase in IIEF erectile function domain scores (EFDS) between visits 1, 2 and 3 was observed (10.96+/-0.40, 16.73+/-0.51 and 17.82+/-0.55 mean+/-SE, respectively), with 23.6% of the study patients achieving normal erectile function at the end of the study. The parameters of age and initial severity of ED most influenced treatment success. CONCLUSIONS: Counseling and dose adjustment were directly influential in achieving an excellent response to a second trial of sildenafil in patients with ED who had previously failed treatment with the drug, and obviated their needing to seek more invasive measures.     

Currenttreatm entfor erectile dysfunction and the future

国家级医学继续教育项目——生殖医学实用新技术培训班（卫继９９－０４－１３－００１）特邀国际阳痿研究学会主席，美国男性学杂志主编，国际阳痿研究杂志主编，美国乔治亚医学院泌尿外科主任Ｒｏｎａｌｄ Ｗ．Ｌｅｗ ｉｓ，ＭＤ讲授男性性功能障碍的现代治疗及未来展望，全文刊登于本刊，以餮读者。     

Clinical update on phosphodiesterase type-5 inhibitors for erectile dysfunction

Erectile dysfunction (ED) affects the sexual lives of millions of men. The first-line oral pharmacotherapy for most ED patients is phosphodiesterase type-5 (PDE-5) inhibitors, of which three are available. Sildenafil is the most widely prescribed oral agent for ED and has a very satisfactory efficacy–safety profile in all patient categories. Tadalafil and vardenafil were introduced in the European Union and in the United States in 2003 and 2004, respectively. The three PDE-5 inhibitors share many pharmacological and clinical characteristics, and each has unique features. This review, which is based on the contemporary literature on PDE-5 inhibitors, describes the chemical, pharmacological, and clinical features of sildenafil, vardenafil, and tadalafil. The first section reviews the pathophysiology of penile erection and PDE-5 inhibitor pharmacology. The second section summarizes data regarding efficacy and safety of the three drugs in treating ED in the general population as well as in selected patient categories.     

Female sexual dysfunction, voiding symptoms and depression: common findings in partners of men with erectile dysfunction

The aim of this study was to investigate the prevalence of female sexual dysfunction (FSD), urinary symptoms, and depressive symptoms in female partners of men presenting with erectile dysfunction (ED). A multi-component questionnaire was administered to female partners of men with erectile dysfunction presenting to a urology center. It contained a standardized sexual function component (the Brief Index of Sexual Function for Women), a depression scale (Centers for Epidemiologic Studies-Depression, CES-D), a demographics questionnaire and a general medical questionnaire. A total of 73 consecutive female partners of male patients presenting with ED, were surveyed using the questionnaire at their counterpart’s visit. Fifty-two women responded, of whom 50 filled out the questionnaire adequately for proper evaluation. This indicated a response rate of 68% (50/73). The mean age was 44.8 years (range 20.0–83.0). Thirty-eight of the 50 women (76%) reported being sexually active. A variety of sexual behaviors were reported including 40% (20/50) of women engaging in vaginal intercourse. Sexual dysfunction symptoms included: anxiety/inhibition (26%), hypoactive desire (20%), arousal/lubrication difficulty (30%), orgasmic difficulty (24%), dyspareunia (18%), incontinence during intercourse (8%), and sexual dissatisfaction (34%). Eight women (16%) reported difficulty communicating sexual issues with their partners. Forty-one women (82%) rated sexual activity as an important part of their lives. Urinary symptoms of frequency and urgency were reported by 18/50 (36%). Depressive symptoms were present in 22/50 (44%). FSD disorders, urinary symptoms and depressive symptoms are common in partners of men with erectile dysfunction.     

The treatment of erectile dysfunction in patients with neurogenic disease

Erectile dysfunction (ED) related to compromise of the nervous system is an increasingly common occurrence. This may be due to the multifactorial nature of ED, the myriad of disorders affecting the neurotransmission of erectogenic signals, and improved awareness and diagnosis of ED. Nevertheless, neurogenic ED remains poorly understood and characterized. Disease related factors such as depression, decreased physical and mental function, the burden of chronic illness, and loss of independence may preclude sexual intimacy and lead to ED as well. The amount of data regarding treatment options in subpopulations of differing neurologic disorders remains scarce except for men with spinal cord injury. The treatment options including phosphodiesterase inhibitors, intracavernosal or intraurethral vasoactive agents, vacuum erection devices (VED) and penile prosthetic implantation remain constant. This review discusses the options in specific neurologic conditions, and briefly provides insight into new and future developments that may reshape the management of neurogenic ED.