枸橼酸西地那非片治疗男性阴茎勃起功能障碍有效性及安全性的临床研究

目的:评估国产枸橼酸西地那非片用于治疗男性勃起功能障碍的有效性及安全性。方法:采用随机双盲、安慰剂平行对照、剂量可调的持续8周的临床研究,例受试者参加本研究。72结果:临床有效率西地那非组为,安慰剂组为88.89%;西地那非组有的受试者认为研究药物改善了其勃起功能,显著高于安慰剂组的;西地那非组的所有受22.22?.71 .00%试者的性交成功率为,显著高于安慰剂组);发生不良事件中西地那非组较安慰剂组高,但均为轻度和短暂82.01%(20.31%的。结论:国产枸橼酸西地那非片为一种安全、有效的治疗男性勃起功能障碍的药物。     

Sildenafil for Treatment of Erectile Dysfunction in Men With Diabetes: A Randomized Controlled Trial

Context  Erectile dysfunction is common in men with diabetes. Objective  To assess the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction in men with diabetes. Design  A multicenter, randomized, double-blind, placebo-controlled, flexible dose-escalation study conducted May through November 1996. Setting  Patients' homes and 19 clinical practice centers in the United States. Patients  A total of 268 men (mean age, 57 years) with erectile dysfunction (mean duration, 5.6 years) and diabetes (mean duration, 12 years). Interventions  Patients were randomized to receive sildenafil (n=136) or placebo (n=132) as needed, but not more than once daily, for 12 weeks. Patients took the study drug or placebo 1 hour before anticipated sexual activity. The starting dose of sildenafil citrate was 50 mg, with the option to adjust the dose to 100 mg or 25 mg based on efficacy and tolerability, to be taken as needed. Main Outcome Measures  Self-reported ability to achieve and maintain an erection for sexual intercourse according to the International Index of Erectile Function and adverse events. Results  Two hundred fifty-two patients (94%) completed the study (131/136 in the sildenafil group, 121/132 in the placebo group). By intention-to-treat analysis, at 12 weeks, 74 (56%) of 131 patients in the sildenafil group reported improved erections compared with 13 (10%) of 127 patients in the placebo group (P<.001). The proportion of men with at least 1 successful attempt at sexual intercourse was 61% (71/117) for the sildenafil group vs 22% (25/114) for the placebo group (P<.001). Adverse events related to treatment were reported for 22 (16%) of 136 patients taking sildenafil and 1 (1%) of 132 patients receiving placebo. The most common adverse events were headache (11% sildenafil, 2% placebo), dyspepsia (9% sildenafil, 0% placebo), and respiratory tract disorder (6% sildenafil, 2% placebo), predominantly sinus congestion or drainage. The incidence of cardiovascular adverse events was comparable for both groups (3% sildenafil, 5% placebo). Conclusion  Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction in men with diabetes.      

连续口服枸橼酸西地那非治疗顽固性及心因性勃起功能障碍的疗效分析

目的探讨枸橼酸西地那非（商品名为万艾可）在治疗顽固性、心因性勃起功能障碍中的地位。方法2002年3月至2005年1月我院男科门诊共收治54例顽固性、心因性勃起功能障碍患者,随机均分为治疗组和对照组。治疗组患者均给予枸橼酸西地那非100mg隔天连续口服,10d为1个疗程,服药时间不超过2个疗程;对照组给予六昧地黄丸口服,10d为1个疗程,服药时间不超过20d。两组患者均在疗程结束后随访3个月,患者治疗前和治疗结束后1周、3个月进行国际勃起功能指数（IIEF-5）评分,并进行夫妻间性生活满意度的简单测评。结果治疗组患者治疗前、后IIEF-5积分的差异有显著性（P〈0．01）,对照组治疗前、后IIEF-5积分的差异无显著性（P〉0．05）;治疗后3个月,治疗组IIEF-5积分与对照组的差异有显著性（P〈0．01）。治疗前、后治疗组夫妇双方性生活满意度的差异有显著性（P〈0．01）,而对照组性生活满意度的差异无显著性（P〉0．05）。结论连续口服枸橼酸西地那非治疗顽固性、心因性勃起功能障碍有效,值得临床进一步探讨。     

Erectile dysfunction: comparison of efficacy and side effects of the PDE-5 inhibitors sildenafil,vardenafil and tadalafil--review of the literature

Since introduction of the PDE-5 inhibitor sildenafil 4 years ago, there has been a fundamental change in the treatment of erectile dysfunction (ED). Intracavernosal or intraurethral injections of vasoactive substances or penile implants as mechanical aids now play hardly any part in it. - The development of the PDE-5 inhibitors vardenafil and tadalafil prompts the question of whether and how these three substances differ in terms of their efficacy and adverse effects. - Sildenafil has proven to be a very effective medicinal product. Studies with a follow-up period of up to 6 years have been conducted. The success rate of sildenafil varies in the group of ED patients with an organic underlying disease from 43% in patients who have undergone radical prostatectomy to 85% in patients with a neurological underlying disease, and amounts to an average 82% (range 43-85%, 100mg). - In an evaluation of spontaneous reports of deaths associated with sildenafil, the FDA concluded that there was no deducible evidence of an increase in the mortality rate among sildenafil users compared to the general population. In fact, fewer deaths associated in time with the ingestion of sildenafil were reported than might have been expected purely statistically on the basis of the normal mortality rate for men in this age group. - According to the initial studies conducted, vardenafil and tadalafil demonstrate efficacy data approximately comparable to those of sildenafil. As yet, insufficient data are available to evaluate the adverse effects of vardenafil and tadalafil, particularly their long-term use and use in high-risk groups. - Sildenafil has already been used by over 20 million men in over 110 countries and is one of the best-studied pharmacological substances available. This adventage in terms of knowledge and safety data makes sildenafil a safe and reliable treatment for patients with erectile dysfunction.     

Analogues of erectile dysfunction drugs: an under-recognised threat.

OBJECTIVES: To investigate the problem of drug analogue adulteration in male erectile dysfunction health products. DESIGN: Survey of over-the-counter male erectile dysfunction health products available in convenience stores and pharmacies in Hong Kong. SETTING: Tertiary referral centre for clinical toxicology analysis in Hong Kong. MAIN OUTCOME MEASURES: The pattern and extent of adulteration of male erectile dysfunction health products with sildenafil, tadalafil, and vardenafil as well as their structurally modified analogues. RESULTS: Of 26 products studied, one (4%) was found to contain undeclared sildenafil, while 14 (54%) contained drug analogues of different kinds. The latter included acetildenafil, hydroxyacetildenafil, hydroxyhomosildenafil, and piperidenafil. The first three were analogues of sildenafil and the last was an analogue of vardenafil. One young patient presented with ataxia after taking an acetildenafil-containing product. CONCLUSIONS: The positive rate of concealed drug analogues in male erectile dysfunction health products is alarmingly high. Such analogues are difficult to detect by ordinary laboratory methods, and might be used in an attempt to evade regulatory inspection. Without going through the stringent drug testing process, the adverse effects of these chemicals remain largely unknown and unpredictable. Effective surveillance system and control measures are needed urgently. The medical profession and the public should be alerted to this under-recognised threat.     

输精管结扎术后勃起功能障碍的调查研究

目的探讨男性输精管结扎术后患者并发勃起功能障碍的情况。方法对诊断为输精管结扎术后勃起功能障碍的患者采用国际勃起功能问卷表-5(IIEF-5)及一般资料调查表进行问卷调查,对其性欲、勃起功能、性交频率和持续时间等数据采用SPSS 15.0统计软件进行处理并分析结果。结果本次研究对216例受术者进行综合测评,发生勃起功能障碍的共46例,占总调查例数的21.3%,其中轻度障碍的患者24例(占52.2%),轻度到中度障碍的患者13例,(占28.2%),中度障碍的患者8例(占17.4%),严重障碍的患者1例(占2.2%)。结论并发症发病率较高,且与年龄成正相关,在以后的治疗中应加强教育,规范治疗方案,严格执行适应症要求,减少输精管结扎术对患者的生活影响,提高我院的经济和社会效益。     

连续与间断西地那非干预对糖尿病大鼠阴茎海绵体影响的实验研究

目的观察并比较连续及间断西地那非（SDF）干预对糖尿病大鼠阴茎勃起功能及组织病变影响的异同。方法雄性SD大鼠70只,60只腹腔注射STZ诱发糖尿病,10只注射生理盐水作正常对照。成功诱发糖尿病大鼠53只,分为糖尿病组（DM组,25只）、SDF连续治疗组（SDL组,14只）,SDF间断治疗组（SDS组,14只）。SDL组大鼠给予SDF 2mg·（kg·d）^-1灌胃,连续给药12周,SDS组大鼠在阿朴吗啡（APO）诱导阴茎勃起实验前给予SDF 20mg·（kg·d）^-1灌胃,连续给药3d。分别在糖尿病造模成功后的第4、8、12周进行APO诱导阴茎勃起试验,12周时光镜、透射电镜下观察各组大鼠阴茎组织病变情况。结果 DM组阴茎勃起功能随病程延长进行性下降,与正常对照组相比勃起率及勃起次数差异均有统计学意义（P〈0.05或P〈0.01）。SDL组及SDS组大鼠阴茎勃起功能变化趋势同DM组,但与DM组相比,4周、8周时SDL组及SDS组各期勃起次数及勃起率均有不同程度改善;4周时SDL组及SDS组勃起次数均高于DM组（SDL组P〈0.05,SDS组P〈0.01）;8周时仅SDS组勃起次数高于DM组（P〈0.01）。SDS组与SDL组相比各期阴茎勃起指标差异无统计学意义（P〉0.05）。DM组阴茎组织光镜、电镜下病理损坏明显,与之相比SDL组损伤程度更为严重,SDS组较DM组无明显变化。结论连续及间断SDF干预对早期糖尿病大鼠勃起功能均有显著改善作用,但随病程延长此作用明显下降,且连续SDF干预的改善作用消减更为明显。间断SDF干预对糖尿病大鼠阴茎组织病理改变无明显影响,而长期连续SDF干预则加重糖尿病大鼠阴茎海绵体病理损害程度。     

Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized controlled trial

Context  Sexual dysfunction is a common adverse effect of antidepressants that frequently results in treatment noncompliance. Objective  To assess the efficacy of sildenafil citrate in men with sexual dysfunction associated with the use of selective and nonselective serotonin reuptake inhibitor (SRI) antidepressants. Design, Setting, and Patients  Prospective, parallel-group, randomized, double-blind, placebo-controlled trial conducted between November 1, 2000, and January 1, 2001, at 3 US university medical centers among 90 male outpatients (mean [SD] age, 45 [8] years) with major depression in remission and sexual dysfunction associated with SRI antidepressant treatment. Intervention  Patients were randomly assigned to take sildenafil (n = 45) or placebo (n = 45) at a flexible dose starting at 50 mg and adjustable to 100 mg before sexual activity for 6 weeks. Main Outcome Measures  The primary outcome measure was score on the Clinical Global Impression-Sexual Function (CGI-SF); secondary measures were scores on the International Index of Erectile Function, Arizona Sexual Experience Scale, Massachusetts General Hospital-Sexual Functioning Questionnaire, and Hamilton Rating Scale for Depression (HAM-D). Results  Among the 90 randomized patients, 93% (83/89) of patients treated per protocol took at least 1 dose of study drug and 85% (76/89) completed week 6 end-point assessments with last observation carried forward analyses. At a CGI-SF score of 2 or lower, 54.5% (24/44) of sildenafil compared with 4.4% (2/45) of placebo patients were much or very much improved (P<.001). Erectile function, arousal, ejaculation, orgasm, and overall satisfaction domain measures improved significantly in sildenafil compared with placebo patients. Mean depression scores remained consistent with remission (HAM-D score 10) in both groups for the study duration. Conclusion  In our study, sildenafil effectively improved erectile function and other aspects of sexual function in men with sexual dysfunction associated with the use of SRI antidepressants. These improvements may allow patients to maintain adherence with effective antidepressant treatment.      

伐地那非治疗男性勃起功能障碍的临床研究

目的：探讨伐地那非在ED患者诊治中的有效性和安全性。方法：对我院90例ED患者服用伐地那非1周,观察治疗后性功能指标变化、疗效及不良反应。结果：伐地那非治疗后性生活持续时间、性生活满意度和IIEF评分各项指标均显著高于治疗前（P〈0.01）,总有效率为94.44%,且无明显不良反应。结论：伐地那非治疗ED安全有效且耐受性良好,为ED的药物治疗提供了更多的选择。     

东升扶桑饮对痰湿型勃起功能障碍患者内皮功能保护作用的临床研究

目的 探讨东升扶桑饮对痰湿型勃起功能障碍患者内皮功能的保护作用。 方法 选取2018年3—7月来江苏省中医院就诊的痰湿型勃起功能障碍患者60例,采用随机数字表法分为对照组和观察组,各30例,对照组口服他达那非治疗,观察组在对照组基础上加入东升扶桑饮,比较2组治疗前后的临床疗效、内皮功能相关指标和不良反应发生率。 结果 治疗前,2组患者国际勃起功能评分表(IIEF-5)评分、中医症状评分和最大勃起硬度比较差异无统计学意义(均P>0.05),治疗后,2组的IIEF-5评分、中医症状评分和最大勃起硬度明显优于治疗前(均P<0.05),且观察组的上述指标明显优于对照组(均P<0.05)。治疗前,2组的血管扩张功能(FMD)、一氧化氮(NO)、内皮素-1(ET-1)水平比较差异无统计学意义(均P>0.05),治疗后,2组的FMD和NO水平明显高于治疗前(均P<0.05),且观察组的FMD和NO水平明显高于对照组(均P<0.05),2组的ET-1水平明显低于治疗前(P<0.05),且观察组的ET-1水平明显低于对照组(P<0.05)。2组患者治疗期间均未出现头痛、视线模糊及药物过敏等明显不良反应,观察组仅有1例患者出现轻微胃肠道不适症状,2组患者不良反应发生情况差异无统计学意义(P>0.05)。 结论 东升扶桑饮能够显著改善痰湿型勃起功能障碍患者的临床症状,并对患者的内皮功能具有一定的保护作用,且安全性较高。      

曲唑酮治疗缓解期男性抑郁症性功能障碍的临床研究简

目的 探讨曲唑酮对5羟色胺再摄取抑制剂（SSRI）维持治疗抑郁症所致的男性性功能障碍的效果.方法 选取荆州市精神卫生中心120例男性抑郁症患者,采用单一SSRI类抗抑郁药治疗6个月后,进行汉密尔顿抑郁量表17项（HAMD-17）评分,对其中评分小于7分的康复期患者再进行亚利桑那性经验量表（ASEX）调查,筛选出性功能障碍（SD）者45例,再将此45例患者随机分为研究组（n=23）和对照组（n=22）,分别采用SSRI类抗抑郁药联合曲唑酮和安慰剂继续治疗8周,于治疗前及治疗后1、2、4、8周采用ASEX和国际勃起功能指数问卷（IIEF-5）进行疗效评定.结果 治疗4周末及8周末,研究组ASEX总分均低于对照组,差异有统计学意义（P＜0.05）;治疗8周末,IIEF-5总分明显高于对照组（P＜0.05）.结论 曲唑酮联合SSRI类抗抑郁药对由SSRI类抗抑郁药引起的男性性功能障碍疗效确切.     

Erectile dysfunction, sildenafil and cardiovascular risk

Cardiovascular risk factors are commonly associated with erectile dysfunction and should be identified and treated. Patients with cardiovascular diseases should be assessed and counselled regarding their fitness for sexual activity. The danger of concurrent use of sildenafil and nitrates under any circumstances, regardless of age and sex, must be highlighted at all levels of the community. Sildenafil is absolutely contraindicated in patients receiving treatment with long-acting nitrates for ischaemic heart disease. Patients who need sublingual short-acting nitrates infrequently should not be precluded from taking sildenafil, provided they are aware that sildenafil is not to be taken within 24 h of taking the nitrate.     

沙利度胺联合VAD治疗难治或复发性多发性骨髓瘤的临床观察

目的观察沙利度胺联合VAD治疗难治性或复发性多发性骨髓瘤(MM)的临床疗效及不良反应。方法 49例患者难治性或复发性MM患者随机分为沙利度胺联合VAD组(n=25)和VAD组(n=24)。A组:25例患者接受沙利度胺联合VAD化疗方案(VAD:(长春新碱0.4 mg/d静脉注射,第1～4 d;多柔比星10 mg/d静脉注射,第1～4 d;地塞米松40 mg/d口服,第1～4d,9-12 d和第17～20 d);沙利度胺200 mg/d口服)。B组:24例患者接受VAD方案(同上)。每治疗周期为28 d,持续4个周期后评价治疗效果。结果 A组和B组最终病例数分别为25例和23例(B组1例男性患者死亡)。2组的治疗有效率分别为80%和47.8%,A组的疗效明显优于B组(P<0.05)。A组较B组更容易产生便秘、嗜睡(P<0.05),2组患者的副反应程度均可耐受。结论沙利度胺联合VAD较单纯VAD方案治疗难治性或复发性MM具有更好的治疗效果,患者能够很好的耐受。     

彩色多普勒超声分度诊断对男性勃起功能障碍治疗的价值

目的 探讨彩色多普勒超声检查(CDFI)分度诊断对男性勃起功能障碍(ED)治疗的价值.方法 198例ED患者,行阴茎海绵体内血管活性物质注射(ICI)后,结合CDFI检测血流参数,根据其硬度分为Ⅱ～Ⅴ度组4个级别.根据不同的分度向患者推荐包括抗炎治疗、口服西地那非、内分泌治疗、真空负压吸引装置(VCD)、静脉瘘手术、阴茎假体植入、增强型体外反搏(EECP)在内的患者愿意接受的治疗方式.结果 198例ED患者,其注射前阴茎海绵体动脉血流峰值速度(peak systolic velocity,PSV),舒张末期速度(end diastolic velocity,EDV)、阻力指数(resistant index,RI)在四度组间差异无统计学意义(P＞0.05),而注射后阴茎海绵体动脉的PSV、EDV、RI在四度组别之间差异均有统计学意义(均P＜0.05),其中RI为每两组内差异均有统计学意义(均P＜0.05).按照ICI后阴茎海绵体动脉CDFI检测血流参数进行分度,选择合适的治疗措施,可提高ED患者的治疗满意率达91.91%(182/198).结论 ICI后CDFI测量阴茎海绵体动脉血流参数为依据,结合Schramck分度,向患者推荐其可接受的治疗方式,能显著提高ED治疗的临床满意率,是ED目标性诊断与治疗的一种合理模式.     

勃起功能障碍的心理因素分析

目的调查阴茎勃起功能障碍的心理致病因素及心理治疗方法。方法对 80例患者采用Hawton分类法作心理易患因素、促成因素、维持因素的调查 ,并进行单因素和多因素非条件Logistic回归分析。结果压制性教育、性教育缺乏、不合理的期望、性交流缺乏为本次调查中发生率最高者 ,分别为 62人次 (占 77.5 % )、78人次 ( 97.5 % )、70人次 ( 87.5 % )及 78人次 ( 97.5 % )。进行多因素非条件Logistic回归分析 ,进入回归模型的有压制性教育、性教育缺乏、性交流缺乏、性交焦虑、性创伤、害怕亲近、生活方式。结论阴茎勃起功能障碍与心理因素密切相关 ,应注意改善和治疗勃起功能障碍患者的心理致病因素。     

中医药治疗勃起功能障碍研究进展

勃起功能障碍属于一种常见的男性疾病,出现这类疾病患者阴茎不能持续获得充分勃起,难以完成令人满意的性交,给患者的正常生活带来较大的不利影响,患者也承受着巨大的精神压力,对生活的满意度明显降低,易出现抑郁等不良情绪,因此这类疾病应当得到重视。临床上对勃起功能障碍的治疗主要是针对原发病的防治及心理上的疏导,其长期疗效不甚理想,从而严重影响患者的生活质量,降低工作效率,增加医疗费用。这既给患者的身心健康带来严重影响,同时也给临床治疗带来了严峻挑战。因此,提供有效的治疗手段是当务之急。随着对勃起功能障碍研究的不断深入,中医治疗逐渐广泛应用到勃起功能障碍的治疗中并取得了显著临床疗效,文章从中国知网上搜索了近年来勃起功能障碍中医药治疗现状的文献,且对文献资料进行了归纳、总结与分析。从中医病因病机、辨证论治、专方专药运用、中成药治疗及其他疗法等方面对治疗勃起功能障碍近年的发展作一简要概述,并分析中医药在治疗该病方面的优势及不足。通过分析近年来勃起功能障碍中医药治疗现状的文献,发现中医治疗勃起功能障碍的临床疗效确切,具有独特优势,不良反应小。      

Physician attitudes and behaviour regarding erectile dysfunction in at-risk patients from a rural community

Erectile dysfunction affects many men in the United States. A 34% prevalence is estimated among male family practice patients. It is associated with a loss of self-image, self-confidence, and even chronic anger. Several risk factors increases the risk of erectile dysfunction. Prevalence is increased by 20-40% in patients with diabetes, hypertension, and those over 65 years old. While erectile dysfunction is generally acknowledged as an important health problem, misconceptions remain as to the need for clinician-initiated discussion regarding the issue. A retrospective chart review of patients at three health clinics in a predominately rural area was conducted. Subjects (n=102) were those at risk of erectile dysfunction who had undergone a complete physical exam between October 1995 and December 1996. All physician encounters were examined for documentation of physician inquiry about erectile dysfunction. A survey of physician perceptions on initiating discussions of erectile dysfunction was also conducted. Physician-initiated discussion of erectile dysfunction was documented in 17% of patients with hypertension, 18% with diabetes mellitus, and 30% of patients > 65 years. The physician survey (11 respondents) showed 27% reported asking all male patients about erectile dysfunction at routine physical, while 45% reported asking 80% of their male patients. A `lack of time'' or belief that the `patient will initiate discussions'' was cited by several practitioners as reasons why inquiries were not initiated. All physicians in the study agreed that sexual function is an integral part of overall health. They either overestimated the percentage of patients asked about erectile dysfunction or they had not documented results consistently.     

不同剂量西地那非治疗新生儿肺动脉高压合并下肢深静脉血栓的疗效

目的观察不同剂量西地那非在新生儿肺动脉高压合并患者中的临床效果。方法取2015年3月至2016年10月医院收治新生儿肺动脉高压合并下肢深静脉血栓患者80例,随机数字法分为对照组(n=40)和观察组(n=40)。对照组采用1.0 mg/(kg·d)西地那非治疗,观察组采用2.0 mg/(kg·d)西地那非治疗,比较两组临床疗效。结果两组治疗前肺动脉压及二氧化碳血氧分压水平比较差异无统计学意义(P0.05);观察组治疗后肺动脉压及二氧化碳血氧分压水平,低于对照组(P0.05);观察组治疗后药物不良反应发生率为7.50%,对照组为5.00%(P0.05)。结论新生儿肺动脉高压合并下肢深静脉血栓患儿采用2.0 mg/(kg·d)西地那非治疗效果较为理想。     

颈椎病与男性勃起功能障碍的临床观察

目的 对颈椎病与男性勃起功能障碍进行初步的临床研究,探讨两者间的关系.方法 对2008年3月至2009年3月手术的55岁以下男性颈椎病患者进行临床观察,患病后出现不同程度的勃起功能减退的病例共19例.对其临床特点进行初步探讨,并统计术前和术后随访时勃起功能障碍评分(IIEF-5)和JOA评分的改善率及两者相关性.结果 本组病例平均年龄48.8岁,其中12例行前路手术,7例行后路手术.随访5～18个月,平均11.8个月.所有勃起功能障碍的男性颈椎病患者术前临床及影像学上均有脊髓受压表现.IIEF-5评分为(12.1±5.6)分.术后末次随访时84.2%的病例勃起功能较术前明显改善,IIEF-5为(17.6±5.5)分,两者差异有统计学意义(P=0.002).术后勃起功能改善率平均为39.8%,而同期JOA评分改善率平均为59.3%,但相关分析显示两者间无相关性(P=0.172).另外不同的手术入路间勃起功能障碍改善率差异无统计学意义(P=0.934).结论 颈椎病脊髓压迫除了可导致常见的运动和感觉神经功能受损外,还可能与男性勃起功能障碍相关.手术减压则可能有助于改善该功能,但反应神经脊髓功能的JOA评分和勃起功能障碍评分两者的改善率没有相关性.上述结论尚待大样本研究进一步证实并深入研究其机制.