前列腺素E_1乳膏治疗勃起功能障碍

目的 :探讨前列腺素E1(PGE1)乳膏尿道口给药治疗勃起功能障碍的疗效。　方法 :采用随机、双盲 /开放、多中心的方法观察其安全性、有效性。在双盲组中 6 4例病人 ,每位随机给予PGE1乳膏和安慰剂乳膏各 1支 ,尿道口给药。在开放试验组中 ,79例病人各 1支PGE1乳膏尿道口给药。　结果 :双盲试验PGE1乳膏组有效 5 6例(87.5 % ) ,安慰剂乳膏组有效 3例 (4 .7% ) ,两者有显著性差异 (P <0 .0 1) ;开放试验组有效 5 1例 (6 4.6 % )。结论 :PGE1乳膏尿道口给药治疗勃起功能障碍是安全、有效的。     

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     

前列腺素E1与西地那非治疗ED的比较

目的 :比较口服西地那非与阴茎海绵体内注射前列腺素E1(PGE1)治疗勃起功能障碍 (ED)的疗效。　方法 :5 4例ED病人随机分为两组 ,A组口服西地那非 ,B组行海绵体内注射PGE1,均治疗 4～ 9个月 ,平均 6个月。结果 :A、B两组的有效率分别为 80 0 %和 83 3% ,两者差异无显著性 (P >0 0 5 )。A组 6例无效病人经海绵体内注射PGE1治疗 ,2例获得满意勃起 ;而B组 4例无效病人经口服西地那非治疗 ,无 1例勃起。　结论 :口服西地那非与海绵体内注射PGE1对各种病因所致的ED均有良好的治疗作用 ,对西地那非治疗无效者 ,可试用海绵体内注射PGE1,有时也能获得满意的效果     

西地那非显著改善伴有心血管危险因素患者的勃起功能

Kwak KW等研究口服西地那非对伴有不同数目心血管危险因素患者勃起功能障碍(ED)的疗效。入选了195例ED患者(年龄57.9±8.9岁),均口服西地那非≥4次,比较服药前后IIEFQ3(勃起能力)与Q4(勃     

阴茎背深静脉包埋术治疗勃起功能障碍5例

目的 :评价阴茎背深静脉包埋术治疗勃起功能障碍 (ED)的疗效。　方法 :对 3例静脉性和 2例动静脉混合性ED病人施行阴茎背深静脉包埋术 ,术后随访疗效。　结果 :术后 2个月首次随访 ,3例静脉性ED病人获得满意性交 ,2例动静脉混合性ED病人基本能勃起 ,口服西地那非 5 0mg后可以完成性交。 5例术后随访 3～ 12个月(平均 7个月 )保持以上疗效。　结论 :阴茎背深静脉包埋术创伤小 ,几乎无并发症 ,是治疗静脉性ED的有效疗法     

他达那非不同给药方法治疗勃起功能障碍的疗效观察

目的:评估他达那非按需给药和每日给药1次治疗勃起功能障碍(ED)的疗效。方法:随机将ED男性分为按需给药组、每天5 mg他达那非组及每天10 mg他达那非组,治疗周期42 d,应用"性活动日志"来评估疗效,同时监测药物不良反应及重要迹象来评估药物安全性。结果:共53例患者完成研究,3组均对ED有较好的疗效,能显著提高性交成功率,并且药物的不良反应相当,均可以耐受。每日给药1次组SEP的5个问题阳性结果与按需给药组类似。结论:每日给药1次与按需给药在增加患者的勃起次数以及性体验满意度方面没有差异。     

应用前列腺素E1注射治疗勃起功能障碍8年经验

目的观察前列腺素E1(PGE1)注射治疗勃起功能障碍(ED)的长期疗效、副作用及预后。方法使用PGE1行阴茎海绵体注射,阴茎硬度检查仪(Rigiscan)连续记录1h,并根据观察结果,调查PGE1注射剂量,确定每例患者合适的注射量,掌握注射方法后回家自行注射。共筛选出ED患者410例,随访患者阴茎勃起情况、药量调整和副作用。结果410例ED患者中,心理性139例,静脉性83例,动脉性36例,神经性78例,混合性74例。对治疗满意的患者有256例(62.44%),其中21例(5.1%)在使用PGE15次后停用,并能达到满意的性生活而治愈。293例(71.46%)患者自述注射时有胀痛感。171例(43.17%)因疼痛(105例)、操作不便(25例)、副作用顾虑(37例)和其他原因(4例)而于6个月后放弃治疗。204例(49.76%)患者使用时间已超过1年,24例(5.85%)患者使用时间已超过5年,7例(1.7%)使用已有8年。未发现阴茎异常勃起和阴茎海绵体纤维化。注射损伤阴茎表面血管致瘀斑者有20例。有27例患者失访。结论PGE1是治疗ED的一种安全有效的药物,可以长期使用。其最常见的副作用是阴茎疼痛。Rigiscan能帮助确定PGE1的注射剂量。     

前列腺素E1乳膏对勃起功能障碍患者阴茎血流的影响

我院于2001年11月至2005年1月采用前列腺素E1（PGE1）乳膏经尿道内给药，使用彩色多普勒超声波显像仪观察了109例勃起功能障碍（ED）患者用药前后阴茎背动脉，左、右海绵体动脉峰值血流速度（PSV）和海绵体周径变化，报告如下。     

多普勒超声技术动态观察血管性勃起功能障碍患者阴茎血流动力学的变化

目的动态观察多普勒超声技术配合阴茎海绵体注射在血管性勃起功能障碍患者诊断中的价值。方法120例疑血管性ED患者在阴茎注射PGE1后5min、10min和20min应用多普勒超声技术测量阴茎血流动力学变化,指标包括:收缩期峰值流速(PSV)、舒张末期峰值流速(EDV)、血流阻力指数(RI)。另100例心因性ED设为对照组。第一次注射后勃起不佳的患者3d后增加PGE1剂量重新检测。结果120例患者可以观察到明显的血流动力学变化,其中有动脉性ED者34例,静脉性ED 55例,混合血管性31例。ICI后不同时间的多普勒测量其血流动力学变化有一定差异。结论多普勒超声技术诊断血管性勃起功能障碍有一定意义。阴茎海绵体注射药物后须动态观察阴茎血流动力学的变化。     

经尿道注入前列地尔治疗勃起功能障碍的研究

为评价经尿道使用前列地尔（PGE1）对ED的治疗作用。作者对40例年龄29－65岁的ED患者，在门诊选用4种剂量的前列地尔进行测试（125、250、500、1000μg），对前列地尔有充分反应者被指定接受有效剂量的前列地尔，在家治疗1个月。结果40例中32例在家使用前列地尔治疗时，至少有1次成功的性交。平均反应时间在7－9min，恢复到完全无勃起状态在50－72min。最常见的副反应是阴茎有轻微的疼痛，但没有人因此而退出研究。没有阴茎异常勃起和阴茎纤维化发生。作者认为尿道使用前列地尔能使大部分ED病人产生阴茎勃起，而且能进行性交。     

Feline penile erection induced by topical glans penis application of combination alprostadil and SEPA (Topiglan)

The objective of this study was to evaluate the efficacy of topically applied prostaglandin E1 (PGE(1))+5% SEPA (soft enhancement of percutaneous absorption) on the glans penis in a feline erection model. Erectile response after glans penis administration of PGE(1)+5% SEPA cream (Topiglan, MacroChem Co., Lexington, MA, USA) was compared to the erectile response after intracavernosal administration of the triple-drug combination (1.65 mg papaverine, 25 microg phentolamine, and 0.5 microg PGE(1)). The placebo cream and increasing concentrations (0.25%, 2.5 mg/ml; 0.5%, 5 mg/ml; and 1%, 10 mg/ml) of PGE(1)+5% SEPA were applied in a total volume of 0.1 ml via a plastic needle-less syringe. The control triple-drug combination was administrated intracavernosally via a 30-gauge needle at the completion of each experiment to serve as a control reference. With each application of placebo, PGE(1)+SEPA, and the triple-drug combination, changes in intracavernosal pressure and systemic blood pressure were continuously monitored. Topical application of PGE(1)+SEPA induced increases in intracavernosal pressure in a dose-dependent manner, with minimal effects on systemic blood pressure. The increases obtained with 1% PGE(1) Topiglan cream were similar to the intracavernosal pressure values elicited by the standard intracavernosal triple-drug combination. These data demonstrate that topical glans penis application of PGE(1)+SEPA can induce an erectile response in cats with minimal systemic adverse effects. Oral pharmacological agents are the first-line treatment for male ED. Studies investigating the effectiveness of noninvasive modalities such as topical therapy should continue, because these agents have the potential to avoid the systemic effects commonly seen with oral therapies. Additionally, topical therapy may also benefit patients who are unresponsive to oral agents or have explicit contraindications. Topical PGE(1) application to the glans penis may become an important treatment option in selected patients suffering from erectile dysfunction.     

前列腺素E1透皮乳膏局部用药扩血管效应的实验研究

目的　探讨前列腺素E1 (PGE1 )透皮乳膏剂局部应用的扩血管效果 ,为临床开发理想的局部扩血管药物提供实验依据。方法　新西兰成年兔 60只 ,分为 6组 (每组 10只 ) :实验 1组 (含透皮剂的 0 .1%PGE1 乳膏组 ) ,实验 2组 (含透皮剂的 0 .2 %PGE1 乳膏组 ) ,实验 3组 (含透皮剂的 0 .4%PGE1 乳膏组 ) ,实验 4组 (含透皮剂的 0 .8%PGE1 乳膏组 ) ,不含透皮剂的 0 .4%PGE1 乳膏的药物对照组及空白对照组。全麻后 ,用 0 .1%盐酸肾上腺素注射于兔耳部制成血管痉挛模型 ,出现典型血管痉挛后于每只兔耳皮肤表面抹药。测量注射肾上腺素前、痉挛后 10min时及用药后 10 ,15 ,3 0 ,60 ,90和12 0min各时间点血管管径及血液灌流量的变化。结果　同一组内各时间段血管管径与血液灌流量成正比关系。实验 3 ,4组在用药 10min起血管管径及血液流量均已恢复注射肾素前的水平 ,且在各时间段的结果与实验 1,2组、药物对照组及空白对照组相比均有显著性差异 (P <0 .0 1) ,而第 3 ,4组间各时间段结果无显著性差异 (P >0 .0 5 )。结论　PGE1 在透皮剂作用下可透过皮肤有效缓解肾上腺素所致的血管痉挛 ,其扩血管效果与药物浓度成依赖关系。该药作为局部扩血管药物具有适应证广 ,显效快 ,副作用小 ,作用持久等特点 ,可能会成为一种     

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.     

Long-term efficacy and safety of self-intracavernous injection of prostaglandin E1 for treatment of erectile dysfunction in China

The study evaluated the long-term efficacy and safety profiles of self-intracavernous injection of prostaglandin E1 (PGE1) for erectile dysfunction (ED). Four hundred and sixteen ED patients were treated with self-intracavernous injection of PGE1 from January 1998 to December 2007 in our outpatient service. Follow-up was made to investigate the efficacy and side effects of this treatment. It was found that 261 patients (62.7%) felt satisfied and kept using this treatment due to its advantages of satisfactory efficacy and reasonable expense. Twenty-seven of them (6.5%) got rid of PGE1 treatment after five times injections and did not need any other drugs to maintain satisfactory sexual lives. Two hundred and fourteen (51.4%) patients kept using this treatment for over 1 year, 26 (6.2%) over 5 years, 12 (2.9%) over 8 years and 7 (1.7%) over 10 years. The major complications of self-intracavernous injection of PGE1 include fibrosis of corpus cavernosum (three cases), ecchymosis associated with vascular injury due to injection (23 cases) and pain associated with injection (295 cases). There were no patients displaying priapism. It is concluded that self-intracavernous injection of PGE1 is a safe and effective treatment for ED with various aetiologies and a broad range of severity, and no serious complications were observed after long-term application.     

Diabetes and vascular impotence: does insulin dependence increase the relative severity?

AIM OF THE STUDY: Diabetes is a well documented risk factor for vascular erectile dysfunction (ED). We evaluated the relative roles of insulin dependence (IDDM) vs oral agent controlled diabetes (NIDDM) in predicting the etiologies and severity of ED: arterial insufficiency (AI), venous leakage (CVOD), and mixed vascular disease. The impact of additional risk factors were also analyzed: hypertension (HTN), coronary artery disease (CAD), and smoking (SM). METHODS: Retrospective data on 105 patients complaining of impotence who underwent pharmacotesting with PGE1 (Caverject) and color duplex Doppler was reviewed. Penile blood flow study (PBFS) data following a period of privacy and self-stimulation was compared. PBFS diagnostic criteria were: AI for peak systolic velocity (PSV) < 25 cm/s; CVOD for PSV > or = 35 cm/s and resistive index (RI) < 0.9; mixed vascular disease for PSV > or = 25 cm/s, PSV < 35 cm/s and RI > 0.9. Consistent dosing of PGE1 was used; 6 mcg for age < 60 y and 10 mcg for age > or = 60 y. Patients were NIDDM (79 out of 105) and IDDM (26 out of 105). Mean ages for NIDDM and IDDM were respectively 60, and 55 y. The relative significance of insulin dependence was assessed by Student's t-test. RESULTS: The most common etiology of ED was arterial insufficiency: mean PSV's did not significantly vary and were: 23.5 cm/s for NIDDM, and 21.6 cm/s for IDDM. PBFS parameters did not vary significantly for the risk factors of SM or HTN and diabetes. Mean peak systolic velocities were significantly different among diabetics with coronary artery disease: NIDDM/CAD, 22.9 cm/s compared to IDDM/CAD, 14.8 cm/s (P = 0.006). CONCLUSIONS: We found among the 105 diabetics the most common etiology of vascular ED based on Doppler criteria was arterial insufficiency, 64%. Statistical analysis of additional risk factors (SM, HTN, CAD) suggested that patients with IDDM and CAD have more severe cavernosal arterial insufficiency than patients with NIDDM and CAD. This data tends to support the theory that microangiopathy is the predominant factor in diabetic impotence, and that insulin dependent diabetes with 'large vessel' coronary heart disease have a similar pathology in the 'small vessels' regulating penile inflow which is unfortunately worse than their non-insulin dependent counterparts.     

780例海绵体内注射在排除血管性阳萎的应用体会

对780例阳萎患者进行了阴茎海绵体注射以排除血管性阳萎。97％的非血管性阳萎患者在应用罂粟碱30mg加酚妥拉明1mg后可获充分勃起,还有1.7％在罂粟碱加至60mg时可充分勃起。而对罂粟碱注射反应不佳的行PGE_1 20～25μg注射后有1.1％可充分勃起,加至50μg时又有0.2％获得勃起,提示不应以某种单一剂量或药物来排除血管性阳萎。应用罂粟碱的患者6.7％出现异常勃起,而应用PGE_1的42.1％出现阴茎疼痛,讨论了上述并发症的原因,解决对策。     

Switching from long-term treatment with self-injections to oral sildenafil in diabetic patients with severe erectile dysfunction

OBJECTIVE: To assess the efficacy of oral sildenafil in diabetic men with severe erectile dysfunction (ED), who are successfully treated with intracavernous injections of vasoactive drugs. METHODS: 81 impotent diabetic men (29 with type 1 and 52 with type 2) were treated for 1-7 years with self-injections. 13 men were treated with 10 microg and 15 with 20 microg of prostaglandin E1 (PGE1), and 53 with a mixture of PGE1 20 microg and papaverine 7.5-40 mg (MIX). After a 1-week washout period, they changed to oral sildenafil in titrating doses up to 100mg. The change was successful if the man achieved an erection and penetration even once. RESULTS: Sildenafil was discontinued in 23 men because of insufficiency. Eleven men (13.6%), all with type 2 diabetes, responded to sildenafil (10 previously treated with 10 microg and 1 with 20 microg of PGE1, none treated with MIX). Thus, 39.2% of the treated with PGE1 responded to oral sildenafil. The response was influenced by the age, the type of diabetes (type 2) and the kind of the previously injected drug (PGE1 10 microg); it was not influenced by the duration of diabetes, ED and treatment with self-injections. CONCLUSIONS: Despite the well documented efficacy of sildenafil, self-injections continue to be the solely effective therapeutic modality in many diabetic men afflicted by severe ED. Only the younger men with non-insulin-dependent diabetes, treated with low doses of PGE1 are more likely to respond to oral sildenafil and change treatment. Men with insulin-dependent diabetes or treated with mixtures of vasoactive drugs are not likely to respond to oral sildenafil.     

阴茎勃起功能障碍治疗方法探讨

目的 :探讨阴茎勃起功能障碍 (ED)的治疗方法 ,提高该病的治疗水平。　方法 :对 2 2 7例ED病人分别采取心理治疗 (31例 )、雄激素补充 (30例 )、万艾可口服 (12 1例 )、心理治疗 +万艾可口服 (16例 )、比法尔尿道滴注 (8例 )和海绵体血管活性药物注射 (2 1例 )等治疗。　结果 :治疗后 ,14 2例 (6 2 .6 % )病人勃起功能改善。其中心理治疗 12例 (38 7% ) ,雄激素补充治疗 9例 (30 0 % ) ,万艾可治疗 91例 (75 2 % ) ,心理治疗 +万艾可 13例 (81 3% ) ,比法尔 2例 (2 5 0 % ) ,海绵体注射治疗 15例 (71 4 % )。　结论 :ED是一个高度个性化的疾病 ,针对不同病人情况采取相应的治疗方法 ,有利于其接受高效、经济、安全的治疗方法