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。     

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。     

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。     

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。     

伐地那非治疗难治性勃起功能障碍的最新进展

5型磷酸二酯酶(phosphodiesterase 5,PDE5)在阴茎勃起功能中所起的作用越来越引起人们的关注。环磷酸鸟苷(cGMP)信号通路介导的一氧化氮平滑肌舒张效应是正常勃起功能的必要条件,这个信号通路的下调能引起勃起功能障碍(erectile dysfunction,ED)的许多病理状态,并导致一些慢性疾病的发生。本文回顾了伐地那非治疗ED患者的有效性和安全性。结果表明,伐地那非对于合并异常脂蛋白血症和高血压、糖尿病、抑郁症、前列腺切除术后、外伤性脊髓损伤、西地那非治疗无效、肾移植术后、慢性前列腺炎和早泄的ED患者安全有效,为这些难治性ED患者提供了一种合理的治疗选择。另外,伐地那非还能延长ED患者的勃起时间。     

伐地那非治疗勃起功能障碍的有效性和安全性

伐地那非是一种有效的、高选择性的口服磷酸二酯酶(PDE5)抑制剂。它对各种病因、各种程度、各年龄段的男性勃起功能障碍(ED)患者均有良好疗效，可显著改善勃起功能。该药口服后最快10min即可起效，长期使用仍能保持疗效，不良反应少，耐受性好。因此，伐地那非是治疗男性ED患者的有效、安全的药物。     

伐地那非治疗糖尿病患者的勃起功能障碍

勃起功能障碍 (erectiledysfunction ,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     

伐地那非治疗抑郁症合并勃起功能障碍的有效性和安全性

勃起功能障碍(erectile dysfunction，ED)与抑郁症常合并存在，两者可相互恶化，给患者带来更大的痛苦，因而更加需要迫切、有效的治疗方法?最近的DRIVER(Depression Related Improvement with vardenafil for Erectile Response)试验结果表明，磷酸二酯酶5(PDE5)抑制剂伐地那非不仅能改善ED合并抑郁症男性的勃起功能，而且能减轻抑郁症状，改善生活质量；且使用安全，耐受性好。     

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.     

Impact of penile rehabilitation with low-dose vardenafil on recovery of erectile function in Japanese men following nerve-sparing radical prostatectomy

Erectile dysfunction （ED） is a major complication after radical prostatectomy （RP）; however, debatecontinues regarding the efficacy of penile rehabilitation in the recovery of the postoperative erectile function （EF）. This study includeda total of 103 consecutive sexually active Japanese men with localized prostate cancer undergoing nerve-sparing RP, and analyzed the postoperative EF, focusing on the significance of penile rehabilitation. In this series, 24 and 79 patients underwent bilateral and unilateral nerve-sparing RPs, respectively, and 10 or 20 mg of vardenafil was administered to 35 patients at least once weekly, who agreed to undergo penile rehabilitation. Twelve months after RP, 48 （46.6%） of the 103 patients were judged to have recovered EF sufficient for sexual intercourse without any assistance. The proportion of patients who recovered EF in those undergoing penile rehabilitation （60.0%） was significantly greater than that in those without penile rehabilitation （38.2%）. Of several parameters examined, the preoperative International Index of Erectile Function-5 （IIEF-5） score and nerve-sparing procedure were significantly associated with the postoperative EF recovery rates in patients with and without management by penile rehabilitation, respectively. Furthermore, univariate analysis identified the preoperative IIEF-5 score, nerve-sparing procedure and penile rehabilitation as significant predictors of EF recovery, among which the preoperative IIEF-5 score and nerve-sparing procedure appeared to be independently associated with EF recovery. Considering these findings, despite the lack of independent significance, penile rehabilitation with low-dose vardenafil could exert a beneficial effect on EF recovery in Japanese men following nerve-sparing RP.     

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.     

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...     

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.     

Early use of a phosphodiesterase inhibitor after brachytherapy restores and preserves erectile function

OBJECTIVE: To investigate whether the early use of phosphodiesterase inhibitors (PDEIs) after brachytherapy (BT) is associated with better erectile function, as of men potent before BT 38-70% have erectile dysfunction afterward. PATIENTS AND METHODS: We evaluated a prospectively created database of 2500 patients who had had BT at our institution since 1992. We measured baseline age, cancer stage, Gleason grade, prostate specific antigen (PSA) level at diagnosis, implant type, use of neoadjuvant and adjuvant hormonal suppression therapy, use of external beam radiotherapy in conjunction with interstitial therapy, and follow-up PSA levels. Men were stratified by their use of PDEIs at <1 year (early group) or >1 year after implantation (late group). We excluded all men who did not have baseline Sexual Health Inventory for Men (SHIM) scores and at least one follow-up SHIM score; the latter were obtained at 6-month intervals after BT. Data were analysed using the Mann-Whitney U-test. RESULTS: In all, 210 men met the inclusion criteria; 85 began using PDEIs within a year of BT, and 125 started after a year. The mean time to PDEI use was 191 days in the early and 595 days in the late group. The median age was 62 years in the early and 63 years in the late group (P = 0.02). Baseline Gleason scores did not differ, nor did PSA levels between the groups. Of men in the early group, 48% received neoadjuvant and/or adjuvant hormonal suppression therapy, vs half of men in the late group. Baseline SHIM scores were not significantly different, nor were scores at the first two follow-up assessments, but the scores at 18-36 months after BT were significantly different. CONCLUSION: The early use of PDEIs after BT is associated with a significant improvement in and maintenance of erectile function compared with late use. Men undergoing BT should be encouraged to use PDEIs early after implantation, to preserve erectile function.     

Up-titration of vardenafil dose from 10 mg to 20 mg improved erectile function in men with spinal cord injury

AIM: Vardenafil is a highly selective phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction (ED). Efficacy of vardenafil has been demonstrated in various ED populations, but that in Japanese patients with spinal cord injury (SCI) has not been assessed. METHODS: This was an open-label, multicenter, flexible dose, 12-week study in patients with ED due to SCI. Following a 4-week observation period, patients received vardenafil 10 mg for 4 weeks, and based on efficacy, tolerability and patient preference, doses for the remaining 8 weeks were decided by investigators. The primary efficacy parameter was erectile function domain score of the International Index of Erectile Function. RESULTS: Ten patients took 10 mg all through the study, while 22 patients took 20 mg after completing 4 weeks' treatment with 10 mg. The erectile function domain score increased from 12.2 at baseline to 25.0 at Last Observation Carried Forward (LOCF) in the former group and from 10.3 to 22.5 in the latter group, respectively. Importantly, there was a 5.0 point increase in erectile function domain score after up-titration in the latter group. Drug-related adverse events were observed in 22% of patients including hot flushes (9%) and headache (6%), but these were transient and mild in intensity. Serious adverse events and adverse events leading to discontinuation of the study drug were not reported. CONCLUSIONS: Vardenafil 10 and 20 mg was well tolerated and improved erectile function in patients with SCI. Of interest, erectile function was further improved by 20 mg in patients who were not sufficiently treated with 10 mg.     

髂内动脉与移植肾动脉端端吻合对肾移植受者阴茎血流及勃起功能的影响

目的:对髂内动脉与移植肾动脉端端吻合是否影响阴茎血供及勃起功能是有争议的,通过检测移植前后阴茎动脉血流,前瞻性评估髂内动脉与移植肾动脉端端吻合对受者阴茎血供及勃起功能的影响。方法:33例维持性血液透析(MHD)患者,接受了活体肾移植,移植术中使用右侧髂内动脉与移植肾动脉端端吻合。在移植前和移植后6个月,接受了国际勃起功能指数为主的问卷调查,记录移植前后阴茎多普勒血流、血肌酐、血红蛋白、胆固醇水平及移植后免疫抑制治疗方案。结果:33例MHD患者,年龄21~55岁,血液透析期间,36%的患者存在勃起功能障碍,移植后33%的患者存在勃起功能障碍。主诉中67%患者移植后勃起功能没有改变,15%患者勃起功能变差,18%患者勃起功能改善,其中包括2例术前勃起功能障碍患者。移植前后勃起功能方面的评分分别为(24.6±5.1)和(24.2±6.2),两者无显著差异(P>0.05)。移植前后患者在射精功能、插入满意度和总体满意度方面没有显著差异;然而在性欲方面,移植后患者性欲评分明显高于尿毒症期(6.2±1.6vs8.9±0.9,P<0.01)。所有患者在尿毒症期阴茎海绵体药物注射后均获得充分勃起,超声多普勒结果表明不存在阴茎动脉供血不足;6例患者舒张期血流速度(EDV)及阻力指数(R I)异常。移植后收缩期血流峰值(PSV)明显低于移植前(左侧45.9±8.9vs41.3±8.0,P<0.01;右侧46.5±8.6vs41.5±8.1,P<0.01),但无1例患者出现阴茎动脉供血不足;8例受者EDV及R I异常。结论:单侧髂内动脉阻断显著降低阴茎动脉血流,但通过对侧髂内动脉的补偿不会因为阴茎血供不足而导致ED的发生;男性肾移植受者使用髂内动脉与移植肾动脉端端吻合,对阴茎勃起功能没有负面影响。     

Outcome of penile prosthesis implantation for treating erectile dysfunction: experience with 504 procedures

OBJECTIVE: To evaluate the outcome of penile prosthesis surgery for different types of prosthesis. PATIENTS AND METHODS: The notes of 447 men who had 504 penile prosthesis implanted between August 1975 and December 2000 were evaluated. Of the prostheses inserted, 393 were malleable, 81 were three-piece inflatable and 30 were self-contained hydraulic prostheses. The mean (range) age of the men was 52 (21-78) years; 404 men had primary implants and 43 had revision surgery after operations at other institutions. The mean follow-up was 50 (1-297) months. RESULTS: Of the 447 men, 22 were lost to follow-up immediately after surgery. The most serious postoperative complications were infection (8%) and erosion (5%), which was more common in diabetic patients (10%) and after pelvic trauma with a urethral injury (21%). Of 482 prostheses, 21 failed mechanically (4%) and revision surgery was needed for 5% of the prostheses inserted (24/482). Overall, 89% (377/425) of men could have sexual intercourse and 344 (81%) were satisfied with the results. CONCLUSIONS: Of the men implanted with a penile prosthesis, 81% were satisfied with the outcome and an even higher proportion were satisfied with the inflatable prostheses. Dissatisfaction was mainly due to complications that resulted in removal of the prosthesis.