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1.
目的:观察小剂量十一酸睾酮联合他达拉非治疗迟发性性腺功能低下(LOH)伴勃起功能障碍(ED)患者的临床疗效。方法:符合纳入标准的90例LOH伴ED患者随机分为对照组(他达拉非治疗)、联合组(小剂量十一酸睾酮+他达拉非治疗),分别比较组内和组间治疗前后的LOH症状、IIEF-5评分、SEP评分、总睾酮(TT)、游离睾酮(FT)、PSA、前列腺体积等变化。结果:联合组治疗后IIEF-5评分、SEP评分、TT、FT分别为(20.6±3.8)分、(4.02±1.08)分、(15.4±3.4)nmol/L、(0.391±0.062)nmol/L,均显著高于治疗前[(15.7±3.9)分、(1.49±0.82)分、(10.1±1.2)nmol/L、(0.200±0.045)nmol/L,P均<0.01],且改善明显优于对照组治疗后[(8.6±3.6)分、(3.50±1.21)分、(10.2±1.2)nmol/L、(0.210±0.051)nmol/L,P均<0.01]。结论:小剂量十一酸睾酮联合他达拉非治疗LOH伴ED患者疗效确切,未见明显的补充雄激素带来的不良反应。  相似文献   

2.
目的:观察口服十一酸睾酮胶丸联合麒麟丸治疗男性迟发性性腺功能减退症(LOH)患者的临床疗效。方法:符合纳入标准的63例LOH患者随机分为对照组和试验组,对照组口服十一酸睾酮胶丸,试验组口服十一酸睾酮胶丸和麒麟丸。十一酸睾酮胶丸用法:80 mg/次,1次/d,连续服用3个月;麒麟丸用法:6 g/次,3次/d,连续服用3个月。比较组内和组间治疗前后的IIEF-5评分、老年男性症状问卷(AMS)评分及血清总睾酮(TT)水平的变化。结果:两组间各项数据无明显差异(P0.05)。但治疗后试验组IIEF-5评分(21.7±5.8)分和TT值(16.7±2.2)nmol/L均显著高于对照组(15.9±4.7)分和(13.1±2.8)nmol/L(P0.05);且AMS评分(20.7±5.7)分显著低于对照组(31.3±6.5)分(P0.05)。结论:麒麟丸联合十一酸睾酮胶丸治疗LOH的疗效比单用十一酸睾酮胶丸治疗效果更显著,且不增加不良反应发生率,有一定的临床应用前景。  相似文献   

3.
目的:评价夜间勃起功能监测(NPT)结果与他达拉非疗效的相关性。方法:188例ED患者,根据NPT结果分为NPT正常组(n=136)和NPT异常组(n=52),2组患者均给予他达拉非治疗,3次/周,每次20mg。治疗前及治疗1个月后,分别评价IIEF-5评分、阴茎插入成功率(SEP2)、完成性交成功率(SEP3)以及总体评价问卷(GAQ),比较2组间治疗前后各项指标的变化。结果:2组患者用药后其IIEF-5评分、SEP2、SEP3均显著高于用药前(P<0.01)。NPT正常组患者治疗后的IIEF-5评分、SEP2、SEP3及GAQ均显著高于NPT异常组患者治疗后结果(P<0.05,P<0.01)。结论:经过他达拉非治疗1个月后,NPT正常组患者勃起功能(包括IIEF-5评分、SEP2及SEP3)较NPT异常组改善更为显著,即NPT正常组患者行他达拉非治疗疗效更佳。  相似文献   

4.
目的:通过对1例雄激素缺乏的ED患者行65个月的睾酮替代治疗观察,探讨长期睾酮替代治疗的可行性及雄激素缺乏ED的机制,为其合理治疗提供参考。方法:跟踪1例雄激素缺乏的ED患者应用睾酮替代治疗65个月的治疗效果、IIEF-5评分,雄激素变化,PSA、Hb及RBC变化及长期应用睾酮的不良反应监测,并结合相关文献进行分析。结果:46岁男性,IIEF评分7分,在未治疗前血清总睾酮(TT)2.79 ng/ml,反复多次应用多种PDE5抑制剂均无效,诊断为LOH,予以睾酮替代疗法,补充十一酸睾酮胶囊,开始2周80 mg,2次/日,后改为40 mg,2次/日,2个月后TT正常达3.45 ng/ml,体能、焦虑等症状明显好转,但是性功能无明显改善,予以PDE5抑制剂按需服用,感觉应用有效,IIEF评分21分,坚持联合用药45个月后停用PDE5抑制剂,单用睾酮替代治疗18个月,阴茎勃起坚挺,性功能满意,IIEF评分21分,定期复查性激素水平、PSA和血常规未见明显异常。结论:睾酮替代治疗可以改善PDE5抑制剂治疗雄激素缺乏的ED的效果,长期睾酮治疗雄激素缺乏症是安全、有效的。  相似文献   

5.
目的:评价佳蓉片联合十一酸睾酮胶丸治疗男性迟发性性腺功能减退(LOH)的安全性和有效性。方法:采用随机、开放、多中心的临床研究方法,选取200例符合纳入标准的LOH患者,按照数字表法随机分为试验组和对照组各100例,对照组给予患者口服十一酸睾酮胶丸,40 mg/次,2次/d;试验组在此基础上加用佳蓉片,4片/次,3次/d,两组均连续服用12周。分别记录基线期及治疗后两组患者AMS评分、IIEF-5评分、血清TT以及安全性指标(红细胞计数、肝功能、肾功能、血糖以及总前列腺特异性抗原)。结果:191例符合纳入标准的LOH患者完成试验,以AMS评分、血清TT以及IIEF-5评分作为疗效评价指标,经过3个月治疗后,试验组在AMS评分(20.6±5.7)、血清TT(16.1±3.9) nmol/L以及IIEF-5评分(20.3±3.1)方面均优于对照组(31.9±6.1)、(12.7±3.4) nmol/L、(16.3±3.8),差异具有统计学意义(P<0.05)。两组患者治疗前后红细胞计数、肝功能、肾功能、血糖以及tPSA均未发现异常,也无明显的不良反应事件。结论:佳蓉片联合十一酸睾酮胶丸治疗LOH优于单一使用十一酸睾酮胶丸,安全有效,值得临床推广应用。  相似文献   

6.
目的:评价左卡尼汀联合他达拉非治疗迟发性性腺功能低下(LOH)合并勃功能起障碍(ED)的安全性和有效性。方法:140例性腺功能低下合并ED患者随机分为治疗组和对照组,治疗组给予左卡尼汀联合他达拉非治疗,对照组给予十一酸睾酮联合他达拉非治疗,8周后分别评价治疗前后IIEF-5和老年男子症状测评表(AMS)评分、生殖激素水平等有效性指标变化以及血常规、PSA、前列腺指检或体积等安全性指标变化。结果:最终有效病例110例,治疗组60例,对照组50例;治疗8周后IIEF-5评分治疗组为(17.7±3.5)分,对照组为(16.7±2.6)分,均较治疗前[(10.2±2.7)分和(9.3±2.4)分]明显改善(P0.05);两组AMS评分治疗后8周较治疗前亦有明显改善[(36.2±6.5)vs(48.8±5.8)分;(35.8±6.6)vs(50.7±5.0)分](P0.05),但两组之间疗效无显著性差异(P0.05)。两组治疗前后及两组之间,安全性比较无明显差异(P0.05),但对照组有2例患者PSA﹥4μg/L,进一步随访确定因前列腺炎症导致。结论:左卡尼汀联合他达拉非治疗LOH合并ED安全、有效。  相似文献   

7.
神经功能的改善在糖尿病性勃起障碍治疗中的作用   总被引:1,自引:0,他引:1  
目的探讨改善神经功能在糖尿病性勃起障碍(ED)治疗中的作用。方法:将70名糖尿病性ED患者随机分为Ⅰ组(空白对照组)、Ⅱ组(给予甲钴胺、西洛他唑和十一酸睾酮口服治疗),采用随机、对照试验方法,观察患者神经传导速度和勃起功能的变化。结果:治疗3个月后,Ⅱ组患者腓总神经和胫神经的传导速度较治疗前及对照组患者明显增快,神经功能明显改善(P<0.01),患者的国际勃起功能指数(IIEF)评分明显上升,勃起功能较治疗前及对照组明显改善(与治疗前相比P<0.01,与对照组相比P<0.05),IIEF评分与腓总神经和胫神经的传导速度呈明显正相关。结论:改善神经功能可明显改善糖尿病性ED患者的勃起功能,在治疗ED患者时,应关注患者神经功能的改善。  相似文献   

8.
目的:评估他达拉非3种不同给药方案对初次性生活失败的年轻男性勃起功能障碍(ED)患者疗效。方法:将夜间阴茎勃起硬度检查正常、心理治疗无效的初次性生活失败的年轻男性ED患者分为他达拉非每日小剂量口服组(每日夜间睡前1~2 h口服他达拉非5 mg)、按需治疗组(性生活前1~2 h口服他达拉非10~20 mg,根据勃起硬度调整剂量)、每日小剂量与按需治疗联合组(无性生活时每日夜间口服他达拉非5 mg,性生活当日于性生活前1~2 h一次性服用他达拉非10~20 mg、其剂量根据勃起硬度确定)共3组,分别给予相应治疗2~3个月。以国际勃起功能指数(IIEF)5个专项评分分别评估疗效。结果:3组IIEF勃起功能、性高潮、插入满意度、总体满意度专项评分较治疗前均显著提高(P均0.05或0.01);按需治疗较每日小剂量治疗显著提高勃起功能和性高潮专项评分(P0.05),但在性欲专项评分方面,其效果低于每日小剂量治疗;当给予联合治疗时,5个专项评分均得到了最佳改善(P均0.05)。结论:由于缺乏专业的性心理治疗机构和医生,单纯心理治疗对心理性ED患者疗效较差,以每日小剂量口服联合按需服用他达拉非可明显提高初次性生活失败的年轻男性ED患者疗效。  相似文献   

9.
目的:观察糖尿病并勃起功能障碍的中西医结合治疗临床疗效。方法:将120名患者随机分为两组,观察组使用万艾可加中药治疗,对照组使用万艾可治疗。分别记录治疗前及治疗后3个月时的国际勃起功能指数评分(IIEF)及睾酮(T)的变化。结果:观察组IIEF评分及T的变化显著优于对照组(P〈0.05)。结论:通过辨证论治,利用中药偏性,施以六味地黄汤加减进行中西医结合治疗,可较好地改善患者睾酮水平及IIEF指数。  相似文献   

10.
目的:研究雄激素受体基因(AR)重复序列(CAG)n多态性与迟发性性腺功能减退症(LOH)的关系,探讨LOH的发病机制。方法:共调查1 000例40~70岁中老年男性,其中19例迟发性性腺功能减退症患者,随机抽取127例正常健康中老年男性,测定甘油三酯(TG)、空腹血糖(FBG)、血清总睾酮(TT)、游离睾酮(fT),测量身高、体重、腰围(WC)、血压,并采用DNA测序方法进行AR基因外显子1氨基端转录调节区(CAG)n重复序列长度测定,比较两组各指标之间的差异。结果:(CAG)n重复次数为15~32(23.05±2.95)。正常健康中老年男性的体重指数(BMI)、FBG较LOH患者显著下降(P<0.01),而TG、TT及fT较LOH患者显著升高(P<0.01)。正常健康中老年男性AR基因(CAG)n重复数为22.54±3.06;LOH患者AR基因(CAG)n重复数为23.23±2.24;LOH患者(CAG)n重复数略高于正常健康人群,但两者比较无统计学意义(P=0.946)。(CAG)n重复长度显示:长组(n≥22)AR基因(CAG)n在LOH组和正常健康中老年男性组的频率分别为73.68%和48.82%(P<0.05)。相关分析显示:TT、fT与(CAG)n重复序列无明显相关性(r=0.04和r=0.025,P>0.05)。结论:LOH男性AR基因(CAG)n重复序列呈现多态性,长(CAG)n重复多态可能是LOH发病的遗传因素,但仍需进一步扩大样本量证实。  相似文献   

11.
This study aimed to evaluate the efficacy and safety of long‐term and low‐dose tadalafil combined with sildenafil as needed at the early stage of treatment for erectile dysfunction (ED). We enrolled 180 patients with ED 1 : 1 to tadalafil 5 mg once daily or once‐a‐day tadalafil 5 mg combined with sildenafil 50 mg as needed. The efficacy measures included the 5‐item version of the International Index of Erectile Function (IIEF‐5) and the Sexual Encounter Profile (SEP). The safety was assessed by observing drug tolerability and adverse events. Total IIEF‐5 scores of patients with severe ED in combined medication group were significantly higher than in tadalafil alone group. Question 2 scores of IIEF‐5 of patients with moderate and severe ED in combined medication group were significantly higher than in tadalafil alone group. The significant improvement in question 3 scores of IIEF‐5 existed only in patients with severe ED receiving combined medication. The percentage of ‘yes’ responses to SEP4, SEP5 and partner's SEP3 were improved significantly in combined medication group. There was no difference between two groups in the incidence of adverse events. Our results suggest that combined medication can better improve erectile function, especially for patients with severe ED.  相似文献   

12.
The chronological distribution of sexual intercourses in a group of patients treated with tadalafil versus placebo for 3 months was evaluated. In total, 120 patients with ED were randomized in two groups and treated, respectively, with one pill of tadalafil 20 mg or placebo on Tuesday and on Friday. After 3 months, we collected data using IIEF and SEP diaries. After 3 months, IIEF score and percentages of success SEP diaries increased in the tadalafil group (<0.01) versus placebo group. Considering all the successful intercourses of the 3 months of tadalafil assumption, the highest percentages were reported within 6-12 h range (35%) and 12-24 h range (28%). In tadalafil group, 41% of patients reported their first successful intercourse between 1 and 6 h and 78% of patients reported the recovery of spontaneous erections. In conclusion, after carrying out the first sexual attempt between 1 and 6 h, patients engaged in sexual activity between 6 and 24 h.  相似文献   

13.
To show that tadalafil is efficacious in Black American and Hispanic men with erectile dysfunction (ED) and efficacy is noninferior to that in Caucasian men. Multiple observations in men with ED in national tadalafil study in the US, a multicenter, open-label study, assessed the efficacy of tadalafil 20 mg taken as needed (maximum one dose/day before sexual activity) for 12 weeks by patients with ED in various populations. This analysis focuses on three groups: Caucasian (Reference group), Black American, and Hispanic men. Primary measurement of efficacy was change from baseline in erectile function (EF) domain of the International Index of Erectile Function (IIEF) and the primary analysis was whether efficacy in Black American and Hispanic groups was noninferior to efficacy in the Caucasian group. Secondary efficacy measures included sexual encounter profile (SEP), IIEF intercourse satisfaction (IS) and overall satisfaction (OS) domains, Global Assessment Question (GAQ), and Psychological and Interpersonal Relationship Scale (PAIRS). Safety was assessed from adverse events (AEs) reported by all enrolled patients. The increase in IIEF EF domain score (>or=9.5) from baseline for each group was statistically significant (P<0.001) and clinically relevant. Efficacy of tadalafil in Black American and Hispanic patients was noninferior to the Caucasian group. IS and OS domains of IIEF had a statistically significant increase from baseline (P<0.001). Change from baseline in positive responses to SEP questions for each group was significant (P<0.001). At least 77% of intercourse attempts were successful over various time intervals up to 36 h postdose. At least 88% of patients in the various groups had a positive response to GAQ1. Improvement from baseline in Sexual Self-Confidence and Spontaneity domains of PAIRS was statistically significant (P<0.001). A low number of AEs and a low AE-related discontinuation rate (2.3%) were reported in all groups. Tadalafil 20 mg was as efficacious in Black American and Hispanic men with ED as in Caucasian patients and was well tolerated.  相似文献   

14.
BACKGROUND: Erectile dysfunction (ED) is a chronic disease; however, therapy is currently administered as needed with oral phosphodiesterase 5 (PDE5) inhibitors like tadalafil. Because the 17.5-h half-life of tadalafil enables therapeutic plasma levels to be sustained with daily administration, tadalafil is a good candidate for once daily dosing therapy. METHODS: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, 12-week study enrolled 268 men 1:2:2 to placebo, tadalafil 5mg, and tadalafil 10mg taken once daily. Primary efficacy measures included changes in the International Index of Erectile Function Erectile Function domain (IIEF EF), Sexual Encounter Profile diary Questions 2 (SEP2: successful penetration), and 3 (SEP3: successful completion of intercourse), and tolerability. Secondary measures included percentage of patients at endpoint who reported improved erectile function (EF), and percentage who reported "no ED" (IIEF EF score 26-30). RESULTS: For patients who took placebo, tadalafil 5mg, and tadalafil 10mg, changes from baseline to endpoint were, respectively, 0.9, 9.7, and 9.4 for IIEF EF; 11.2, 36.5, and 39.4 for SEP2; and 13.2, 45.5, and 50.1 for SEP3. At endpoint, 28.3%, 84.5%, and 84.6% reported improved erections, and 8.3%, 51.5%, and 50.5% reported "no ED," respectively. All comparisons between tadalafil and placebo were significant (p<0.001). Adverse events that occurred in at least 5% of patients were dyspepsia, headache, back pain, upper abdominal pain, and myalgia; nine patients (3.4%) discontinued because of adverse events. CONCLUSIONS: Once-a-day tadalafil 5mg or 10mg was well tolerated and significantly improved EF in men with ED.  相似文献   

15.
目的:调查乡村中老年男性迟发性性腺功能减退症(LOH)的流行病学情况。方法:2012年4~10月在浙江省嘉兴市嘉善县魏塘乡村采用年龄分层抽样选取996例40~80岁的中老年男性进行中老年男子雄激素缺乏(ADAM)、老年男子症状(AMS)和国际勃起功能问卷-5(IIEF-5)调查,同时测定血清中总睾酮(TT)、性激素结合球蛋白(SHBG)及白蛋白(ALB)水平,Vermeulen公式计算游离睾酮(cFT)及生物可利用睾酮(Bio-T)水平,超声检测前列腺、睾丸体积。结果:研究对象年龄(56.22±8.82)岁,ADAM及AMS筛查LOH的患病率分别为62.86%和23.05%;ED阳性率为68.83%,SHBG、LH、cFT及Bio-T筛查LOH各组之间存在统计学差异。结论:浙江省嘉善县魏塘乡村中老年男性LOH筛查率较国内其他报告(特别是大中城市)LOH筛查率低,ED患病率接近。城乡中老年LOH患病率有差别,值得进一步研究。  相似文献   

16.
Skoumal R  Chen J  Kula K  Breza J  Calomfirescu N  Basson BR  Kopernicky V 《European urology》2004,46(3):362-9; discussion 369
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.  相似文献   

17.
OBJECTIVES: To determine if baseline characteristics, treatment efficacy, psychosocial outcomes or tolerability were associated with patient preference for sildenafil citrate (sildenafil) or tadalafil for treating erectile dysfunction (ED) in men naive to phosphodiesterase 5 inhibitor therapy. PATIENTS AND METHODS: In an open-label, crossover study of sildenafil (25, 50 or 100 mg) and tadalafil (10 or 20 mg), dosed as needed, after a 4-week baseline assessment, 367 men with ED were randomly assigned to sildenafil followed by tadalafil or vice versa (8-week dose optimization and 4-week assessment phase for each treatment period). Patients completing both periods chose which treatment they preferred for an 8-week extension phase. Bivariate logistic regression and stepwise logistic regression were used to determine if any baseline characteristics or post-baseline measurements were associated with the patients' treatment preference. Baseline variables examined were age, race, ED aetiology/duration, body mass index, smoking status, alcohol consumption, vital signs, comorbid medical conditions, and baseline scores for the International Index of Erectile Function (IIEF) domains, Psychological and Interpersonal Relationship Scales (PAIRS) domains, and Sexual Encounter Profile (SEP) diary questions. Post-baseline variables examined were therapy sequence, dosage, and differences in IIEF and PAIRS domains, SEP scores, in number/timing of sexual attempts and in the severity of side-effects (overall patient perception). RESULTS: Of 291 patients completing both treatments and indicating a preference, 85 (29%) preferred sildenafil and 206 (71%) preferred tadalafil. Variables were individually analysed using bivariate analysis; one baseline characteristic (presence/absence of hyperlipidaemia) and 13 post-baseline measurements were significantly associated with the patients' treatment preference. Variables were analysed as a group using stepwise logistic regression; a set of six post-baseline factors was identified as significantly associated with patient preference. Dosage choice, reductions in the PAIRS time concerns domain, IIEF intercourse satisfaction domain improvements, smaller side-effect severity scores, more sexual attempts, and increased SEP4 scores (satisfaction with erection hardness) during the tadalafil or sildenafil treatment periods were all significantly associated with preference for tadalafil or sildenafil. CONCLUSIONS: We identified no baseline characteristics that prospectively distinguish patients who will prefer tadalafil or sildenafil. Patient differences in time concerns, dosage choice, intercourse satisfaction, treatment tolerability, number of sexual attempts and satisfaction with erection hardness were the set of factors most significantly associated with treatment preference, and the preference observed for tadalafil (71%) or sildenafil (29%) might be substantially accounted for by differences in these factors during the tadalafil and sildenafil treatment periods.  相似文献   

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