安特尔加枸橼酸西地那非治疗中老年勃起功能障碍的价值

目的探讨安特尔加枸橼酸西地那非治疗男性勃起功能障碍的价值.方法随机开放120名受试者在2周筛选期后进入4周的治疗期,A组安特尔加枸橼酸西地那非,安特尔120mg/d,枸橼酸西地那非4周内至少服用4次.B组单用枸橼酸西地那非.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.结果增加安特尔后并不提高枸橼酸西地那非的临床总有效率,总评题及性交成功率,但明显改善了病人的性欲,提高了性满足感及性高潮的次数,两组差距有统计学意义.服药后无严重不良事件发生.结论对于性欲较低的ED患者,安特尔加枸橼酸西地那非治疗是有价值的.     

甲磺酸酚妥拉明片/胶囊治疗阴茎勃起功能障碍的临床研究

目的 :为了解甲磺酸酚妥拉明在治疗阴茎勃起功能障碍 ( ED)中的有效性和安全性。方法 :采用随机安慰剂对照试验研究的方法进行分析。试验分为片剂组 ( A组 )、胶囊组 ( B组 )、安慰剂的片剂和胶囊组并为一组 ( C组 )。组间比例为 1∶ 1∶ 1 ( A∶B∶C)。共有 2 41例参加了临床试验 ,其中 2 1 7例完成试验。试验药物 (片剂或胶囊 )必须在性交前 1h服用 ,每次服 1片 ( 4 0 mg) ;两周内至少有 3次服药并尝试性交以保证达到统计学要求 ,但服药不能超过 8次 ;整个试验持续 1 0周。药物的有效性按国际性功能量表 ( IIEF)衡量 ,安全性以监测试验过程中的不良反应来反映。结果 :有效率 ,A组为 6 8% ,B组为 6 2 % ,C组为 45%。 A、B组和 C组比效有显著性差异。整个试验未发生严重不良反应。结论 :甲磺酸酚妥拉明片和胶囊是一种治疗勃起功能障碍的有效且安全的药物     

万艾可治疗勃起功能障碍的疗效和安全性

目的 :评估万艾可 (Viagra○R)治疗男性勃起功能障碍 (ED)的有效性和安全性。　方法 :本试验为双盲、随机(安慰剂 :西地那非 ,1:3)、安慰剂对照、剂量可调整 (2 5、5 0和 10 0mg)、持续 12周的临床研究。共有 84名受试者参与本研究。　结果 :对主要疗效指标 (IIEF问题 3、4)的分析结果显示 ,万艾可对ED病人达到和维持勃起能力的改善作用显著优于安慰剂 (P <0 .0 0 0 1) ,万艾可的临床总有效率为 86 % ,显著高于安慰剂 (37% ) ;对心理性、器质性和混合性ED的有效率分别为 83%、79%和 81% (安慰剂组分别为 5 0 %、33%和 30 % )。同时 ,对次要疗效指标评估 (IIEF其余 13个问题、记事表和总评题 )亦显示 ,万艾可改善性生活的作用明显优于安慰剂 ;万艾可组性交成功率平均为71.8% ,显著高于安慰剂组 (17.0 % ) ;有 87.3%的万艾可组受试者认为研究药物改善了其勃起功能 ,显著高于安慰剂组 (36 .8% )。无 1名受试者因不良事件而中断研究 ,万艾可组的不良事件发生率 (33.3% )较安慰剂组高(19.0 % ) ,但绝大多数为轻度、一过性的。　结论 :口服万艾可是一种可治疗各种病因导致的勃起功能障碍安全有效的药物 ,按需服用时能很好耐受。     

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     

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。     

枸橼酸西地那非治疗男子多发性硬化症患者ED

多发性硬化(MS)可导致勃起功能障碍(ED),枸橼酸西地那非对于此类患者的治疗效果怎样呢?Fowler CJ等人进行了相关研究。一共有217个患者接受了西地那非(25～100mg；n=104)或者安慰剂(n=113)治疗,为期12周。疗效根据国际勃起功能指数问卷(IIEF)中的获得勃起(Q3)和维持勃起(Q4)问题,以及总评题(GEQ)进行评价,同时也评估生活质量。12周后,西地那非组的IIEF Q3和Q4的平均分值比安慰剂组高(P＜0．0001),西地那非组有89%(92/103)的患者报     

前列地尔尿道栓治疗勃起功能障碍附78例随机、双盲、安慰剂对照、剂量可调的临床研究

为了解前列地尔飞道栓（ＡＵＳ）治疗勃起功能障碍（ＥＤ）的疗效。作者对７８例ＥＤ患者进行随机、双盲（前列地尔：安慰剂为２：１）、安慰剂对照、剂量可调、持续６调 的临床研究；结果主要疗效指标ＩＩＥＦ中问题３和４显示，ＡＵＳ对ＥＤ患者达到和维持勃起能力的改善作用显著地安慰剂组（Ｐ〈０．０１），ＡＵＳ总有效率为５５．５５％，显著高于安慰剂组的２５．００％，受试者记事表数据显示ＡＵＳ组受试者在研究结束时性交     

枸橼酸西地那非与酚妥拉明口服治疗勃起功能障碍的疗效和安全性比较

枸橼酸西地那非是第一个治疗勃起功能障碍(ED)的5型磷酸二酯酶抑制剂,而酚妥拉明是治疗ED的传统口服药物,二者的疗效和安全性有何差别呢?Ugarte F等人在墨西哥进行的一项多中心研究,回答了上述问题。该研究中,患者服用西地那非(25~100 mg;n=123)或酚妥拉明(40 mg;n=119)8周,采用国际勃起功能指数(IIEF)和整体疗效问卷进行评估。结果显示,IIEF量表勃起功能方面的评分,西地那非组[(27.23±0.62)分]显著高于酚妥拉明组[(19.35±0.66)分]。西地那非组在下列方面的有效率均多出酚妥拉明组1倍左右,如成功性交、勃起改善和性交能力改善。最常…     

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     

口服西地那非治疗勃起功能障碍疗效和安全性的临床研究

目的：评估西地那非（艾艾可）治疗男性勃起功能障碍（ED）的有效性和安全性。方法：采用多中心，双盲，安慰剂平行随机对照,剂量可调整（25，50和100mg)方法，对628例ED患者进行为期8周的临床治疗观察。结果：西地那非使ED患者达到和维持壳起的临床总有效率为80．8％，显著高于安慰剂组的40．1％（P＜0．0001）；对心理性，器质性和混合性ED的有效率分别为80．8％，84．2％和79．4，同时对次要疗效指标评估（国际壳起功能指数中其余13个问题，记事表和总评题） 显示西地那非改善性生活的作用明显优于安慰剂，西地那非组性交成功率为69．0％，显著高于安慰剂组的27．5％，有89．2％，的西地那非组受试者认为药物改善了壳起功能，显著高于安慰剂组的37．4％，因各种原因中断研究的比例仅占2．3％，西地那非组与药物有关的不良事件发生率（28．4％）较安慰剂组高（12．2％），均为轻－中度，呈一过性。结论：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，按需服用时能很好耐受。     

Safety and efficacy of vardenafil in patients with erectile dysfunction: Result of a bridging study in Japan

AIM: Vardenafil is a selective and highly potent phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED. The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED. METHODS: This was a prospective, double blind, randomized clinical trial designed to evaluate the efficacy and safety of vardenafil. Following a 4-week treatment-free observation period, 283 eligible patients were randomized to 12 weeks treatment with vardenafil 5 mg, 10 mg, 20 mg, or placebo. Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function (IIEF). RESULTS: All three vardenafil doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF questionnaire, either at 12 weeks or at the 'last observation carried forward' (LOCF, P < 0.0001). Q3 scores were improved to 4.06 with vardenafil 5 mg, 4.53 with vardenafil 10 mg, and 4.64 with vardenafil 20 mg, versus 3.17 with placebo. Comparable scores for Q4 were 3.47, 4.15 and 4.31 versus 2.31 for placebo. Up to 86% of patients achieved improved erections as assessed by the global assessment question (GAQ). Reported adverse event rates were 35.3%, 45.3% and 54.5% with vardenafil 5 mg, 10 mg and 20 mg, respectively, versus 21.1% in the placebo group. No serious adverse drug reactions were reported. The most common treatment-emergent adverse events were transient headache, flushing and rhinitis, which were mostly mild. CONCLUSION: Vardenafil is an effective and well-tolerated treatment for ED and provides improvement in key indices of erectile function among Japanese men with ED. The results of our trial show that up to nearly 90% of patients achieve improved erections with the administration of vardenafil.     

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。     

Sildenafil citrate (Viagra) in erectile dysfunction: near normalization in men with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects

OBJECTIVES: To evaluate the efficacy, safety, and tolerability of sildenafil in men with broad-spectrum erectile dysfunction (ED), with reference to age-matched healthy control subjects. METHODS: One hundred eleven patients were enrolled in a randomized, double-blind, placebo-controlled, parallel-group, 12-week, flexible-dose study. Efficacy assessments included the International Index of Erectile Function (IIEF), a global assessment question, and patient event log data. In a separate, nontreatment study, 109 control subjects also completed the IIEF. RESULTS: Mean IIEF scores at baseline were significantly lower for patients with ED than for control subjects without a history of ED. After treatment, mean IIEF scores for patients receiving sildenafil approached values observed in control subjects and were significantly higher than mean scores for patients receiving placebo (P<0.01). Responses to the global assessment question and patient log data corroborated the IIEF results. Sildenafil was well tolerated, with no discontinuations because of adverse events. CONCLUSIONS: The results indicate that sildenafil, an effective oral therapy for the treatment of broad-spectrum ED, is associated with a near normalization of patient erectile function.     

Efficacy and safety of on-demand tadalafil for the treatment of erectile dysfunction in South-East Asian men

AIM: Tadalafil is an inhibitor of phosphodiesterase type 5 used for the treatment of erectile dysfunction (ED). The efficacy and safety of tadalafil have been evaluated extensively in Western populations. Our aim was to assess the efficacy and safety of on-demand tadalafil for the treatment of ED in South-East Asian men. METHODS: This was a randomized, double-blind, placebo-controlled study of men with mild to severe ED of various etiologies randomized to receive placebo (n = 122), tadalafil 10 mg (n = 120), or tadalafil 20 mg (n = 125), taken as needed (maximum once daily) for 12 weeks. Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). RESULTS: Men from China, Singapore, and the Philippines participated in this trial (n = 367). Compared with placebo, tadalafil significantly improved erectile dysfunction on all efficacy outcomes (P < 0.001). Patients receiving tadalafil 10 mg and 20 mg experienced a significant mean improvement of 8.1 and 8.7, respectively, in the IIEF Erectile Function (IIEF-EF) domain score from baseline (vs placebo 2.4, P < 0.001). In patients receiving tadalafil 10 mg and 20 mg, the mean per-patient success rate for intercourse attempts (SEP3) was 62% and 70%, respectively, compared with 32% for the placebo group (P < 0.001). Of patients who received tadalafil 10 mg and 20 mg, 81% and 86% reported improved erections at endpoint (GAQ) compared with 44% in the placebo group (P < 0.001). The most common adverse events reported by patients were headache, back pain, dyspepsia, and dizziness. CONCLUSIONS: Tadalafil was an effective and well-tolerated treatment for South-East Asian men with ED.     

Clinical efficacy and safety of sildenafil in elderly patients with erectile dysfunction

Erectile dysfunction (ED) is a common medical disorder affecting elderly men. Sildenafil citrate has been shown to be an effective and well-tolerated oral agent for treating ED in the general population of adult men with ED of broad-spectrum etiology. Elderly men are more likely to have concomitant medical problems than the general population of men with ED. In this study, we examined the efficacy and safety of sildenafil administration in elderly patients with ED. Forty-four elderly men with ED (> or = 60 years old) of broad-spectrum etiology were treated with 25 mg or 50 mg doses of sildenafil citrate. Age ranged from 60 to 78 years (65 +/- 4.5; means +/- S.D.). Mean follow-up period was 12.3 +/- 6.5 months, with a range of 1 to 25 months. Primary efficacy assessments were performed using the International Index of Erectile Function 5 (IIEF5) before their first dose of sildenafil and after at least 4 weeks of therapy. Serum testosterone was measured before treatment. The mean IIEF5 among all patients increased from 8.5 +/- 3.9 to 20 +/- 4.2 after sildenafil use (P < 0.0001). In patients younger than 70 years, the IIEF5 score increased from 9.5 +/- 5.0 to 17 +/- 4.3 while in patients 70 years and older, the score increased from 8.2 +/- 3.6 to 21 +/- 3.9, a near normalization. The rate of improvement in younger men was higher than in older men. Serum testosterone before treatment was similar in the two groups. The most commonly experienced adverse events were flushing and dyspepsia, which occurred in 6.8% and 2.3%, respectively. No patients discontinued sildenafil treatment due to adverse events. In conclusion, oral sildenafil is efficacious and well tolerated by elderly men with ED, even among those older than 70 years.     

Efficacy and safety of oral SK3530 for the treatment of erectile dysfunction in Korean men: a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group clinical trial

Aim： To evaluate the efficacy and safety of SK3530, a newly developed type 5 phosphodiesterase inhibitor （PDE5I）, in Korean men with erectile dysfunction （ED）. Methods： A total of 119 patients were randomized at 10 centers in Korea to receive either SK3530 （50, 100, or 150 mg; n = 89） or placebo （n = 30） taken 1 h before anticipated sexual activity for an 8-week period. The patients were evaluated at baseline and 4 and 8 weeks after beginning therapy. Efficacy was assessed using the International Index of Erectile Function （IIEF）, Sexual Encounter Profile （SEP）, and the Global Assessment Question （GAQ）. Safety was analyzed by adverse events, laboratory values and vital signs. Results： At the end of the study, all the primary and secondary efficacy end-points were statistically significantly improved by SK3530 compared with placebo （P 〈 0.05）. Of the 89 patients in the treatment arm, 36 （42.3 %） achieved normal erectile function after treatment, including six patients with severe ED. Treatment-related adverse events occurred in 32 patients. The most common adverse events were flushing, headache, dizziness and eye redness （10.9%, 7.6%, 2.5% and 2.5%, respectively）, and most were mild. Only two patients discontinued treatment during the study period because of adverse events. Conclusion： The results of our phase Ⅱ study have confirmed the efficacy and safety of SK3530 in a broad population of men with ED of various etiologies and severity. The optimal doses in terms of efficacy and safety were determined to be 50 mg and 100 mg, respectively.     

Efficacy and safety of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in Egypt and South Africa

The efficacy of sildenafil citrate (Viagra), an oral agent for the treatment of erectile dysfunction (ED), has been demonstrated in global studies. This 12-week randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study assessed the efficacy and safety of sildenafil to treat ED in men in Egypt and South Africa. Men with ED of varied etiology were randomized to receive sildenafil 50 mg (n=128) or placebo (n=126); doses could be adjusted to 100 or 25 mg. Questions from the International Index of Erectile Function (IIEF) assessing the ability to achieve (Q3) and maintain (Q4) erections demonstrated a significant improvement with sildenafil compared with placebo (P<0.0001). Improved erections were reported by 74% of patients receiving sildenafil and 27% of those receiving placebo (P<0.0001). Headache, dyspepsia, and flushing were the most common adverse events in sildenafil-treated patients. These results are consistent with clinical trials in other countries. We conclude that sildenafil is an efficacious and well-tolerated treatment for men with ED in Egypt and South Africa.     

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.