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。     

前列腺素E1乳膏治疗勃起功能障碍的疗效和安全性

目的 :评估前列腺素E1(PGE1)乳膏治疗男性勃起功能障碍 (ED)的有效性和安全性。　方法 :按 1∶1(安慰剂∶乳膏 )双盲、随机、安慰剂对照的临床研究 ,共有 4 2例符合标准的各种病因的ED病人入选。研究结束时 ,根据受试者对勃起功能国际指数 (IIEF) 2次回答的得分差值、临床疗效评估 (记事表 )及总体疗效评估 (总评题 )、不良事件登记和实验室检查等 ,对受试者用药的有效性和安全性进行综合分析。　结果 :主要疗效评估显示 :使用本研究药物后病人阴茎勃起程度达到显效和有效改善的 ,在乳膏组与安慰剂组分别为 6 3.16 %和 9.5 2 % (P <0 .0 1) ;同时总体疗效评估 (乳膏组与安慰剂组分别为 73.6 8%和 19.0 5 % ,P <0 .0 1)的分析结果 ,也支持主要疗效评估。 2例中止试验 (4 .76 % ) ,不良事件发生乳膏组 6例 (30 .0 0 % )、安慰剂组 1例 (4 .76 % ) ,均为轻度、一过性的 ,以泌尿生殖道刺激症状为主。结论 :PGE1乳膏是一种可治疗各种病因导致ED的安全有效的药物 ,按需使用时能很好耐受     

国产枸橼酸西地那非治疗男性勃起功能障碍的安全性和有效性研究

目的:评价国产枸橼酸西地那非(金戈)治疗男性勃起功能障碍(ED)的安全性、有效性和耐受性。方法:采用多中心、随机、双盲、安慰剂对照研究方法,在国内5家医院泌尿外科或男科门诊纳入222例ED患者,随机分为西地那非组(111例)和安慰剂组(111例),进行为期8周的临床治疗观察。以国际勃起功能问卷(IIEF)评分、性交成功率作为有效性评价指标,以不良事件发生率作为安全性评价指标。结果:西地那非组和安慰剂组患者年龄分别为(47.20±11.32)岁和(46.67±13.08)岁(P0.05),ED病因分别为心理性(27.93% vs 23.42%)、器质性(21.62% vs 29.73%)和混合性ED(50.45% vs 46.85%)(P均0.05),其他流行病学数据如身高、体重、民族、吸烟、饮酒、药物过敏史等一般情况也均无统计学差异。对主要疗效指标的分析结果显示,西地那非组与安慰剂组对勃起功能显著有效率分别为78.90%和29.91%(P0.01);西地那非组性交成功率和总体疗效分别为63.87%和77.98%,均明显高于安慰剂组的29.16%和34.58%(P均0.01)。在对于不同种类ED的治疗上,西地那非对心理性、器质性和混合性ED的有效率分别为64.52%、83.33%和82.14%,明显高于安慰剂组的46.15%、21.21%和25.00%(P均0.01)。安全性评价结果显示,共有45例(20.27%)受试者出现了各种不良事件(西地那非组有32例,安慰剂组有13例),所出现的不良事件大多数为轻度、一过性的。结论:国产枸橼酸西地那非是一种可治疗各种病因导致ED的安全有效的药物,且患者耐受性较好。     

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。     

持续气道正压通气对睡眠呼吸暂停综合征合并勃起功能障碍的治疗

目的 :探讨经鼻持续气道正压通气 (nCPAP)对睡眠呼吸暂停综合征 (SAS)合并勃起功能障碍 (ED)患者勃起功能的影响。　方法 :SAS合并ED患者 2 7例 ,随机分为治疗组 15例和对照组 12例 ,治疗组使用BIPAP呼吸机以nCPAP治疗 1个月 ,比较两组治疗前后睡眠呼吸暂停低通气指数 (AHI)、最低SaO2 和勃起功能国际问卷 5 (IIEF 5 )评分的变化。　结果 :两组患者治疗前AHI、最低SaO2 、勃起功能、IIEF 5评分无明显差异 ,治疗组在治疗后比治疗前、对照组均有明显改善 ,差异均有显著性 (P <0 .0 5 )。而对照组在治疗前后上述指标无明显变化 (P >0 .0 5 )。结论 :nCPAP可改善SAS合并ED患者的勃起功能。     

酚妥拉明治疗勃起功能障碍安全性和有效性的多中心评价

目的 :评价甲磺酸酚妥拉明胶囊 (MP)治疗男性勃起功能障碍 (ED)的安全性和有效性。　方法 :采用随机、双盲、安慰剂对照多中心临床试验 ,入选 168例病人 ,分别服用试验药物MP和安慰剂 ,4 0mg/次。观察服药后国际勃起功能指数 (IIEF)得分变化及夜间记录表。　结果 :试验组IIEF观察表中Q3、Q4及Q3+Q4得分增加明显高于对照组 (P <0 .0 0 1) ,试验组治疗ED显效率 10 .12 %、有效率 67.4 2 % ,对照组显效率 0 ,有效率 14 .2 9% (P均 <0 .0 1) ;试验组不良反应率 4 .76% ,对照组为 1.19% (P >0 .0 5 ) ,不良反应均不需特殊处置。　结论 :MP治疗ED安全、有效。     

甲磺酸酚妥拉明片治疗男性勃起功能障碍Ⅱ期临床报告

目的评价甲磺酸酚妥拉明片治疗男性勃起功能障碍的有效性及安全性和耐受性。方法220例受试者(试验组112例、对照组108例),采用多中心、随机双盲、安慰剂平行对照、剂量视情增减的设计方案,在2周筛选期后进入4周的治疗期,在筛选期及研究结束时填写国际勃起功能问卷(IIEF)。研究者根据受试者记事表、IIEF和总评题对受试者进行疗效评价。结果主要疗效指标临床总有效率甲磺酸酚妥拉明组(A组)50．94%,安慰剂组(B组)16．82%：总评题：A组有57．55%的受试者认为研究药物改善了其勃起功能,B组22．43%。受试者记事表显示：A组受试者的性生活成功率为49．46%,B组17．88%。,不良反应发生率A组26．17%,B组7．62%,表现为轻度和短暂的鼻塞、面部潮红、心率快、口干、胸闷、胃不适、瘙痒、头痛、头晕、低血压。仅3名受试者因不良事件而终止研究。结论甲磺酸酚妥明片为一种安全、有效的治疗ED的药物。     

西地那非治疗勃起功能障碍的临床疗效

目的 :观察西地那非对不同年龄和病因勃起功能障碍 (ED)病人的疗效。　方法 :88例ED病人口服不同剂量的西地那非 4～ 2 2周 ,以国际勃起功能指数 5 (IIEF 5 )评分为评估标准判断疗效 ,设对照组作比较。　结果 :西地那非治疗ED病人的总疗效率为 80 .7% ,IIEF 5值上升幅度与西地那非疗效呈正相关。不同年龄ED病人的疗效无明显差异。神经性ED病人的显效率和IIEF 5值与心因性病人差异显著。　结论 :西地那非治疗ED是安全有效的 ,IIEF 5可作为评判ED疗效的可靠指标。     

夜间阴茎勃起参数、IIEF系统评分和患者对万艾可反应之间的关系

为评估ED患者中IIEF分数,夜间阴茎勃起参数及对万艾可反应三者之间的关系。Murad Basar M等人进行了一项研究,研究入选97名无任何高危因素的ED患者,完成IIEF问卷调查后,监测全部受试者一或两个夜间的阴茎勃起情况,根据观察结果给予50mg或100mg万艾可。使用Pearson’s chi2检验方法评估夜间阴茎勃起结果、根据IIEF问卷调查出的勃起功能障碍严重程度、及对万艾可的反应三者之间的联系。结果显     

盐酸曲唑酮治疗勃起功能障碍的随机对照研究

目的　为了观察盐酸曲唑酮治疗阴茎勃起障碍的疗效和安全性。方法　入选 6 5例轻、中度阴茎勃起功能障碍 (ED)患者 ,随机分 2组 :盐酸曲唑酮组 5 0mg每日一次口服 ,逐日增加至 15 0mg后维持 ;对照组给安慰剂。治疗前与治疗后 4周 ,以勃起功能国际指标评分问卷 (IIEF 5 )得分之和作为判断标准。结果　显效 3例(10 % ) ,有效 9例 (30 % ) ,总有效率为 4 0 % ,无效 18例 (6 0例 ) ;对照组有效 6例 (16 .7% ) ,曲唑酮组治疗前后比较差异有显著性 (P <0 .0 5 )。副作用为头晕、嗜睡。结论　本研究初步证明曲唑酮治疗轻、中度勃起功能障碍有一定疗效     

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.     

The efficacy and safety of tadalafil: an update

OBJECTIVE: To provide an update on the efficacy and safety of tadalafil, a phosphodiesterase-5 inhibitor, in the treatment of erectile dysfunction (ED). PATIENTS AND METHODS: In all, 2102 men (mean age 56 years) with mild-to-severe ED of various causes were randomized to placebo or tadalafil, taken as needed with no food restrictions, at fixed 'on-demand' doses of 10 or 20 mg in 11 randomized, double-blind, placebo-controlled trials lasting 12 weeks. The three co-primary outcomes were changes from baseline in the erectile function domain of the International Index of Erectile Function (IIEF) and the proportion of 'yes' responses to questions 2 and 3 of the Sexual Encounter Profile (SEP). Additional efficacy instruments included a Global Assessment Question (GAQ). RESULTS: Compared with placebo, tadalafil gave significantly better outcomes. Patients receiving either dose of tadalafil had a significant mean improvement of 6.5 and 8.6, respectively, in the IIEF erectile function domain score from baseline (P < 0.001 vs placebo). At both doses the mean success rate for intercourse attempts (SEP-Q3) was 58% and 68%, respectively, compared with 31% in the placebo group (P < 0.001), and 71% and 84% reported improved erections at the endpoint (GAQ), vs 33% on placebo (P < 0.001). Tadalafil was effective up to 36 h after dosing and was effective regardless of disease severity and causes, and in patients of all ages. The most frequent adverse events were headache, dyspepsia, back pain and myalgia. CONCLUSION: Tadalafil was an effective and well-tolerated treatment for ED.     

On-demand IC351 (Cialis) enhances erectile function in patients with erectile dysfunction

IC351 (Cialis) is a selective inhibitor of PDE5. The efficacy and safety of on-demand dosing of IC351 in men with erectile dysfunction was assessed in a multicenter, double-blind, placebo-controlled study. One hundred seventy-nine men (mean age: 56 y) were randomized to receive placebo or IC351 at doses of 2, 5, 10 or 25 mg, taken on demand over a 3-week period. The primary endpoints were change from baseline in responses to Questions 3 (Q3) and 4 (Q4) of the International Index of Erectile Function (IIEF). IC351 significantly improved IIEF Q3 scores at all doses vs placebo (P < or =0.003). IC351 also significantly improved IIEF Q4 scores in all but the 2 mg group (P < or =0.0003). No significant changes in laboratory values, ECGs, or blood pressure were observed. The most common adverse events were headache and dyspepsia. The conclusion of this study was that on-demand IC351 at doses up to 25 mg was well tolerated and significantly improved erectile function.     

A baseline-controlled,open-label,flexible dose-escalation study to assess the safety and efficacy of sildenafil citrate (Viagra) in patients with erectile dysfunction

Although sildenafil citrate (Viagra) has demonstrated effectiveness in the treatment of erectile dysfunction (ED), the dosing regimens often used in clinical trials may not always match those employed in clinical practice. This study was undertaken to further assess the efficacy and safety of sildenafil taken as required in male outpatients 18 years of age and older with ED (n=71). It was conducted as a placebo-baseline-controlled, open-label, flexible dose-escalation study, with sildenafil (25,50, or 100 mg) administered for 8 weeks following a 4-week placebo run-in. Efficacy variables included questions 3 and 4 of the International Index of Erectile Function (IIEF), other IIEF domains, patient event logs, and quality-of-life (QOL) assessments. Treatment with sildenafil resulted in improvements from baseline in all IIEF domains analyzed (all P<0.0001), as well as overall QOL and amelioration of specific sexual and social relationships (all P&<0.0001). Sildenafil was well tolerated. One participant discontinued treatment because of adverse events. Results suggest that flexible dosing with oral sildenafil is safe and has beneficial effects on all indices of erectile function and QOL.     

Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction in Brazilian and Mexican men

A 12-week, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of flexible-dose sildenafil citrate (Viagra) treatment (25, 50 or 100 mg) in Brazilian and Mexican men with erectile dysfunction (ED) of broad-spectrum etiology. Efficacy was assessed on the basis of responses to the 15-item International Index of Erectile Function (IIEF) questionnaire, completed at baseline and after 12 weeks of treatment. At end point, mean scores for all IIEF domains of sexual function (erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction) were significantly (P<0.0001) higher in the sildenafil group (n=109) than in the placebo group (n=105). These findings confirm the significant increases in frequency of penetration and frequency of maintained erections reported previously. Sildenafil treatment was well tolerated. The most common adverse events were headache and flushing. In conclusion, sildenafil is a well-tolerated and effective treatment for ED of broad-spectrum etiology in Latin American men.     

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.     

Sildenafil citrate (Viagra) in the treatment of men with erectile dysfunction in southern Latin America: a double-blind,randomized, placebo-controlled,parallel-group,multicenter, flexible-dose escalation study

Our objectives were: (1) to determine the efficacy, safety, and tolerability of sildenafil citrate (Viagra) administered to men with broad-spectrum erectile dysfunction (ED) in southern Latin America; and (2) to correlate Rigiscan measurements assessing ED etiology with the investigator's assessment. A total of 141 men with broad-spectrum ED (mean age 57) were enrolled in a randomized, 12-week, double-blind, placebo-controlled, flexible-dose escalation study of sildenafil. After the 12-week treatment period, the mean score for the primary efficacy variables had risen significantly: for the sildenafil group, 66.2% from baseline for question 3 of the International Index of Erectile Function and 77.6% for question 4, vs 15.1% and 21.2% for the placebo group, respectively (P<0.0001). Rigiscan data confirmed investigator assessments of etiology. Headache and flushing, usually mild and transient, were the most common adverse events. Sildenafil was an effective, well-tolerated treatment for men in southern Latin America with broad-spectrum ED.     

Efficacy and treatment satisfaction with on-demand tadalafil (Cialis) in men with erectile dysfunction

OBJECTIVE: Tadalafil (Cialis) is an inhibitor of phosphodiesterase type 5, which mediates relaxation of vascular smooth muscle in the corpus cavernosum thus facilitating erection. The purpose of this multicentre, randomized, double-blind, parallel group, placebo-controlled study was to evaluate efficacy and treatment satisfaction of on-demand Cialis in men with mild-to-severe erectile dysfunction (ED). METHODS: Following a 4-week treatment-free run in period, patients stratified into three severity groups by the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score were randomized to receive either placebo or Cialis 20 mg taken on demand over a 12-week period. Efficacy endpoints were change from baseline in IIEF EF domain scores, responses to Sexual Encounter Profile diary (SEP) questions, and responses to the Global Assessment Questions (GAQ). Treatment satisfaction was evaluated using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire in two of seven participating countries where validated translations were available. RESULTS: Of the 443 men who entered the trial, 409 (mean age, 52 years) formed the intent-to-treat population. Mean baseline demographics and ED severity measures were balanced between treatment groups except for a higher percentage of patients na?ve to sildenafil in the tadalafil group compared to placebo (50% versus 36%). The percentage of patients in each IIEF EF severity class (mild, moderate and severe) was 47%, 30% and 23% for placebo patients and 48%, 29% and 23% for tadalafil patients, respectively. Tadalafil was significantly superior to placebo on all primary efficacy measures (IIEF EF domain scores, SEP15, GAQ1; p < 0.001); notably 64% of tadalafil patients achieved a normal IIEF EF domain score at endpoint compared to 16% of placebo patients (p < 0.001). Of the 185 patients completing the EDITS questionnaire (137 receiving Cialis and 48 receiving placebo), tadalafil-treated patients had a median EDITS score of 84 (95%CI 80, 86), which was significantly higher than the median score for placebo-treated patients of 41 (95%CI 32, 59; p < 0.001; Wilcoxon test). The proportion of patients satisfied with treatment (defined as final EDITS score greater than 50) was 87% for the tadalafil-treated group and 46% for the placebo-treated group (p < 0.001; exact test). Adverse events were significantly more common with tadalafil than placebo (p < 0.01) and included primarily headache (7.2% versus 1.9%) and flushing (4.6% versus 0%). One patient discontinued tadalafil treatment due to back pain. CONCLUSION: In men with mild-to-severe ED, tadalafil 20 mg significantly improves erectile function, demonstrates superior treatment satisfaction relative to placebo, and is well tolerated. This is the first study to yield efficacy data on tadalafil in an Eastern European population of men with erectile dysfunction, and the first to measure satisfaction with the EDITS questionnaire in any study population of men with this condition using tadalafil.