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1.
目的:评价按需服用达泊西汀对早泄的疗效,为临床决策提供依据。方法:检索PubMed、Embase、BIOSIS Previews、Cochrane Library、CNKI数据库、万方资源数据库有关按需服用达泊西汀治疗早泄的研究文献,并进行Meta分析;主要评价阴道内射精潜伏时间(intravaginal ejaculatory latency time,IELT)、患者总体感觉改善情况(patient-reported global impression of change,PGI)、综合临床受益(composite PRO criteria for clinical benefit,CCCB)3项结局指标。结果:检索出相关文献159篇,剔除142篇,共有4篇文献符合纳入标准,累计患者6 081例。Meta分析结果显示:与安慰剂相比,按需服用达泊西汀在IELT[WMD=1.39,95%CI(1.23,1.55),P<0.000 01],PGI[OR=2.59,95%CI(2.21,3.04),P<0.000 01],CCCB[OR=2.59,95%CI(1.98,3.39),P<0.00001]方面差异均有显著性意义;达泊西汀60 mg与30 mg治疗组间比较,60 mg组在IELT[WMD=0.46,95%CI(0.19,0.74),P=0.0010],PGI[OR=1.32,95%CI(1.06,1.64),P=0.01]方面差异有显著性意义,在CCCB[OR=1.39,95%CI(0.90,2.15),P=0.13]方面无显著性差异。结论:本研究表明按需服用达泊西汀60 mg及30 mg均能延长早泄患者IELT,提高其PGI及改善CCCB;其中60 mg较30 mg剂量在延长早泄患者IELT及提高PGI方面效果更佳。  相似文献   

2.
目的:比较丁卡因胶浆单用与坦索罗辛不同剂量联用治疗早泄的疗效。方法:将126例确诊为早泄的患者随机分成三组,A组使用丁卡因胶浆外用,B组使用丁卡因胶浆同时每次性生活前4~6小时服用盐酸坦索罗辛0.2mg,C组使用丁卡因胶浆同时每晚服用盐酸坦索罗辛0.2mg。观察三组患者治疗前及治疗8周及停药4周后的平均阴道内射精潜伏期(IELT)评分、性交满意度评分等。结果:三组患者IELT评分、性交满意度评分治疗前与治疗8周后比较,差异均有统计学意义(P〈O.01);而治疗8周后三组间两两比较,差异均有统计学意义(P〈0.01),停药4周后两评分明显下降,接近治疗前水平。结论:丁卡因胶浆与坦索罗辛联用可以提高早泄的疗效,且可按需使用。  相似文献   

3.
目的比较盐酸达泊西汀按时服用与按需服用治疗原发性早泄的效果。方法本研究为前瞻性随机对照研究。纳入2018年9月至2019年6月在西安交通大学第二附属医院男科门诊确诊的原发性早泄患者。纳入标准:①年龄≥ 18周岁, 非同性恋患者;②有固定性伴侣且与性伴侣关系融洽1年以上;③治疗前3个月内未使用5-羟色胺再摄取抑制剂;④在阴茎进入阴道后2 min内射精, 且该现象持续>6个月;⑤最近6个月未参加过其他类似试验;⑥性生活次数≥ 2次/周。排除标准:①勃起硬度评分< 3分;②生殖器官畸形或发育不良;③泌尿生殖系统感染者;④严重心脏病、高血压病、糖尿病患者;⑤性腺功能低下者;⑥对盐酸达泊西汀及辅料过敏;⑦中、重度肝损伤患者。采用随机数字表法将患者随机分为按时服药组和按需服药组。按时服药组患者给予盐酸达泊西汀30 mg/次, 1次/日, 晚饭后即刻服用;按需服药组予盐酸达泊西汀30 mg/次, 同房前2 ~ 3 h服用。观察两组患者治疗8周及停药8周后的阴道内射精潜伏期(IELT)、早泄诊断工具(PEDT)评分、早泄指数(IPE)评分、焦虑自评量表(SAS)评分。结果本研究共纳入136...  相似文献   

4.
目的:比较盐酸达泊西汀及舍曲林治疗早泄患者的疗效及不良反应。方法:门诊就诊的早泄患者按2∶1比例随机分配接受盐酸达泊西汀(30 mg,按需服用,n=78)或舍曲林(50 mg,每日1次,n=39)治疗,4周后随访,记录用药前后的阴道内射精潜伏时间(IELT),用药后临床总体印象变化(CGIC)评分,并记录不良反应。结果:经治疗后盐酸达泊西汀组及舍曲林组IELT均显著增加[盐酸达泊西汀:(0.87±0.31)min延长至(2.84±0.86)min;舍曲林:(0.84±0.28)min延长至(2.71±0.92)min]。应用CGIC评分,用药后效果很好或好的比率分别为36.5%及37.5%(盐酸达泊西汀vs舍曲林);CGIC评价有效(很好、好、稍好)的比率分别为63.5%和71.9%。舍曲林组头晕、恶心、头痛及腹泻的发生率稍高于盐酸达泊西汀组但差异不具显著性,但舍曲林组疲劳、嗜睡以及口干的发生率显著高于盐酸达泊西汀组(P0.05)。结论:按需口服盐酸达泊西汀治疗早泄患者安全有效。  相似文献   

5.
目的:探讨达泊西汀用于治疗早泄(PE)的临床疗效。方法:PE患者116例,随机分为观察组(60例)和对照组(56例),观察组年龄23~49(33.1±1.4)岁,病程0.5~5(1.83±0.22)年,对照组年龄24~46(35.0±1.5)岁,病程1~7(1.97±0.25)年,2组年龄和病程差异无显著性(P0.05)。观察组按需口服达泊西汀,30 mg/次;对照组予以氟西汀口服,20 mg/次,1次/d。对比2组的临床总体印象变化(CGIC)、早泄评估量表(PEP)、平均阴道内射精潜伏期(IELT)及不良反应。结果:治疗前后IELT观察组[(0.86±0.17)min vs(4.32±2.23)min]和对照组[(0.88±0.15)min vs(4.17±2.26)min],较治疗前均显著延长(P0.05),组间无显著性差异(P0.05);观察组与对照组治疗后的CGIC总有效率分别为85.00%、82.14%,组间比较无显著性差异(P0.05);治疗后2组PEP量表中控制射精能力(PCOE)、早泄相关苦恼得分(ERPD)、性交满意度(SSI)及早泄相关良性沟通困难得分(ERID)均显著提高(P0.05),组间比较无显著性差异(P0.05);观察组的不良反应明显低于对照组(3.33%vs 30.36%,P0.05)。结论:达泊西汀治疗PE疗效显著,能够延长阴道内射精潜伏期,提高性生活质量,且不良反应较少。  相似文献   

6.
目的:评价盐酸达泊西汀联合小剂量他达拉非治疗原发性早泄(PE)的临床疗效。方法:收集原发性PE患者97例,随机分成对照组(n=46)和治疗组(n=51),对照组性交前按需口服盐酸达泊西汀30mg;治疗组性交前按需口服盐酸达泊西汀片30mg,同时每日服用(OAD)小剂量他达拉非片5mg,疗程12周。嘱患者在治疗期间规律性生活,每月性生活≥4次,治疗前后行中国早泄患者性功能评价表5(CIPE-5)评分及阴道内射精潜伏期(IELT)测评并做好相关记录。结果:与治疗前比较,治疗后两组CIPE-5评分及IELT均明显提高,差异有统计学意义(P0.05)。与对照组比较,治疗后治疗组的CIPE-5评分及IELT改善更为明显,差异有统计学意义(P0.05)。两组患者治疗期间不良事件发生率差异无统计学意义(P0.05),不良事件可自行缓解。结论:盐酸达泊西汀联合小剂量他达拉非治疗原发性PE安全有效。  相似文献   

7.
早泄(PE)是男性最为常见的性功能障碍疾病之一。而盐酸达泊西汀是目前唯一被芬兰和瑞典2009年批准用于治疗早泄的口服药物,现在已在包括中国在内的60多个国家和地区应用。它是一种强效选择性5-羟色胺再摄取抑制剂(SSRIs),其吸收快、起效快、半衰期短,支持按需服用。临床试验及应用表明,在各地区及不同人群中皆能有效延长PE患者的阴道内射精潜伏期(IELT),改善患者整体情况。与传统的SSRIs相比具有更好的安全性和耐受性,最常见的不良反应是恶心、腹泻、头痛、眩晕。严重不良事件罕见。总之,盐酸达泊西汀是一种有效,安全和耐受性良好的按需治疗早泄的药物。  相似文献   

8.
目的 研究单独使用伊木萨克片或达泊西汀与两种药物联合治疗早泄(PE)的临床效果。方法 根据所服用药物的不同将患者分为伊木萨克片组40例,达泊西汀组40例,联合组40例,记录并统计治疗前后阴道内射精潜伏期(IELT)、早泄量表(PEDT)及药物副作用。结果 联合组的IELT、5羟色胺(5-HT)浓度和各项得分明显大于伊木萨克片组和帕罗西汀组(P0.05)。3组均有不良反应发生,差异无统计学意义(P0.05),在不停药的状况下2d内即可自愈。结论 联合使用伊木萨克片、达泊西汀治疗PE较两种药物单独使用的方案在延长患者的IELT上有明显的优势,可以提高射精控制力,降低个人苦恼,增加性交满意程度。  相似文献   

9.
盐酸氟西汀每日用药与按需给药在早泄治疗中的比较研究   总被引:1,自引:0,他引:1  
目的 比较盐酸氟西汀每日用药与按需给药在早泄治疗中的不同疗效.方法 早泄患者84例,随机分成A和B组,每组42例.A组患者每口服用盐酸氟两汀,20 mg/d.B组患者按需给药盐酸氟西汀,30 mg/次.两组患者连续口服3月后,比较其治疗前后的平均阴道内射精潜伏期、国际勃起功能指数(IIEF)问卷中的配偶性交满意度评分及治疗期间的不良反应.结果 两组患者平均阴道内射精潜伏期,患者及其配偶的性交满意度评分在治疗后均显著增加(P<0.01),盐酸氟两汀按需给药在射精潜伏期和性交满意度评分上比每日用药好些,但没有显著差异(P>0.05).按需给药不良反应少于每日用药.结论 盐酸氟西汀可有效治疗早泄,按需给药优于每日用药.  相似文献   

10.
目的 研究伊木萨克片和盐酸氟西汀联合治疗早泄的可行性和效果.方法 将114例早泄患者随机分为3组,每组38例.A组患者单用伊木萨克片,1.5 g/d;B组患者单用盐酸氟西汀,20 mg/d;C组患者同时服用伊木萨克片和盐酸氟西汀,剂量同A、B组,连续服用4周.比较3组治疗前后的平均阴道内射精潜伏期(IELT)、国际勃起功能指数(IIEF)问卷中的患者及配偶性交满意度评分,观察治疗期间的不良反应.结果 114例早泄患者全部完成临床研究,所有患者平均IELT、患者及其配偶的性交满意度评分在治疗后较治疗前均显著增加,差异具统计学意义(P<0.01),单用盐酸氟西汀B组患者的IELT和性交满意度评分略好于单用药伊木萨克片A组,但两组间差异无统计学意义(P>0.05).联合用药C组患者的IELT和性交满意度评分则显著高于单用药A组和B组,差异均具有统计学意义(P<0.05).联合用药患者出现不良反应7例(18.4%),与单用药组比较差异无统计学意义.结论 联合应用伊木萨克片和盐酸氟西汀治疗早泄,疗效显著高于单用两种药物.  相似文献   

11.
Premature ejaculation (PE) is the most common male sexual disorder. We compared pelvic floor muscle rehabilitation to on-demand treatment with the selective serotonin reuptake inhibitor dapoxetine in 40 men with lifelong PE (baseline intra-vaginal ejaculatory latency time (IELT) ≤1 min). Subjects were randomized into the following two treatment groups: (1) PFM rehabilitation or (2) 30 or 60 mg of on-demand dapoxetine. Total treatment time for both groups was 12 weeks, at the end of which, IELT mean values were calculated to compare the effectiveness of the two different therapeutic approaches. At the end of treatment, 11 of the 19 patients (57%) treated with rehabilitation were able to control the ejaculation reflex, with a mean IELT of 126.6 sec (range: 123.6-152.4 sec). In the dapoxetine group, after 12 weeks of therapy, 5 of 8 (62.5%) patients in the 30 mg subgroup and five of seven (72%) in the 60 mg subgroup had an IELT >180 sec (mean: 178.2 and 202.8 sec, respectively). The results obtained in the group treated with pelvic floor rehabilitation are promising, and this treatment represents an important cost reduction if compared to dapoxetine on-demand treatment. The present study confirms the data that are previously available in the literature on the efficacy and safety of the new inhibitor of serotonin reuptake, dapoxetine, as well as proposes and evaluates a new type of physical treatment that may be a viable therapeutic option for treatment of PE.  相似文献   

12.

Background

Dapoxetine is being developed for the on-demand treatment of premature ejaculation (PE). Previous clinical trials have demonstrated its safety and efficacy.

Objective

To evaluate the long-term efficacy and safety of dapoxetine in men with PE.

Design, setting, and participants

This randomized, double-blind, parallel-group, placebo-controlled, phase 3 trial, conducted in 22 countries, enrolled men (N = 1162) ≥18 yr of age who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for PE for ≥6 mo, with an intravaginal ejaculatory latency time (IELT) ≤2 min in ≥75% of intercourse episodes at baseline.

Intervention

Dapoxetine 30 mg or dapoxetine 60 mg or placebo on demand (1–3 h before intercourse) for 24 wk.

Measurements

Stopwatch-measured IELT, Premature Ejaculation Profile (PEP), Clinical Global Impression (CGI) of change, adverse events (AEs).

Results and limitations

The study was completed by 618 men. Mean average IELT increased from 0.9 min at baseline (all groups) to 1.9 min, 3.2 min, and 3.5 min with placebo and dapoxetine 30 mg and dapoxetine 60 mg, respectively, at study end point; geometric mean IELT increased from 0.7 min at baseline to 1.1 min, 1.8 min, and 2.3 min, respectively, at study end point. All PEP measures and IELTs improved significantly with dapoxetine versus placebo at week 12 and week 24 (p < 0.001 for all). The most common AEs were nausea, dizziness, diarrhea, and headache. AEs led to discontinuation in 1.3%, 3.9%, and 8.2% of subjects with placebo and dapoxetine 30 mg and dapoxetine 60 mg, respectively. Limitations of this study included the exclusion of men who were not in long-term monogamous relationships.

Conclusions

Dapoxetine significantly improved all aspects of PE and was generally well tolerated in this broad population.  相似文献   

13.
The aim of the study was to compare the clinical efficacy and safety of the on‐demand use of paroxetine, dapoxetine, sildenafil and combined dapoxetine with sildenafil in treatment of patients with premature ejaculation (PE). In a single‐blind placebo‐controlled clinical study, 150 PE patients without erectile dysfunction (ED) were included during the period of March 2015 to May 2016. Patients were randomly divided into five groups (30 patients each). On demand placebo, paroxetine (30 mg), dapoxetine (30 mg), sildenafil citrate (50 mg) and combined dapoxetine (30 mg) with sildenafil citrate (50 mg) were given for patients for 6 weeks in each group respectively. All patients were instructed to record intravaginal ejaculatory latency time (IELT) and evaluated with Premature Ejaculation Diagnostic Tool (PEDT) and the patient satisfaction score before and after treatment. The mean of IELT, satisfaction score and PEDT in all groups was significantly improved after treatment (p value = .001). Combined dapoxetine with sildenafil group had the best values of IELT, satisfaction scores and PEDT in comparison with other treatment groups (p value <.001). The combined dapoxetine with sildenafil therapy could significantly improve PE patients without ED as compared to paroxetine alone or dapoxetine alone or sildenafil alone with tolerated adverse effects.  相似文献   

14.
IntroductionIt has been described varied definitions of premature ejaculation (PE), which has determined different prevalences and rates of success for the different therapies with selective serotonin re-uptake inhibitors. Our goal was evaluate the effectiveness of paroxetine like treatment of premature ejaculation administered ondemand (4-6 hours previous to intercourse) compared to the scheme of daily dose.Patients and methodA prospective study type crossover was designed with 14 patients. Grupo A: 7 patient received paroxetine 20 mg /d by three weeks followed by paroxetine 20 mg 4-6 hours before the intercourse by three weeks. Group B: the other 7 patients received the same scheme but replacing by placebo. Later to three weeks of therapy suspension, crossover was made.ResultsThe intravaginal ejaculatory latency time (IELT) pre-treatment was 0,4 minutes. In the group A the IELT average was of 4,3 minutes in the treatment with daily paroxetine; 5,8 minutes when they received paroxetine on-demanad; 0.9 with daily placebo and 0,6 with placebo on-demand (p < 0.001). For group B the IELT during the daily placebo was 0,8 minutes and with placebo on-demand it was of 1,1 . When they received daily paroxetine the IELT was 3,3 minutes and during the phase of paroxetine on-demand it was increased to 6,1 (p<0.001).ConclusionsThe treatment of premature ejaculation with paroxetine in daily dose and scheme on-demand appears similar like effective options.  相似文献   

15.
This study compared the safety and efficacy of the on-demand (OD) use of sertraline (50 mg), sertraline (100 mg) and dapoxetine (30 mg), and the daily use of sertraline (50 mg) in the treatment of patients with premature ejaculation (PE). This prospective randomised study involved 120 lifelong PE patients (intravaginal ejaculatory latency time [IELT]: <1 min; Arabic Index of Premature Ejaculation [AIPE] score: < 30) without secondary causes of PE, identified between March 2018 and May 2020. Patients were divided into 4 groups (30 patients per group) and treated for 8 weeks. Assessments were conducted using the AIPE form as a diagnostic tool. Sertraline (50 mg, daily; 196.7 ± 115.5 s) and sertraline (100 mg, OD; 173.3 ± 97.0 s) had similar IELT and AIPE scores. The latter groups had better results in comparison with sertraline (50 mg, OD; 100.5 ± 54.4 s) and dapoxetine (93.7 ± 53.5 s; p < 0.01). Sertraline (100 mg, OD) had a similar efficacy to that of sertraline (50 mg, daily) and was more effective than sertraline (50 mg, OD) and dapoxetine (30 mg, OD). Sertraline (100 mg, OD) can be considered in the treatment of lifelong PE treatment, having tolerable side effects.  相似文献   

16.
The investigation of the etiology and treatment of premature ejaculation (PE), a common and significant problem for men and their partners, has been limited by the lack of defined outcomes and differences in clinical trial designs. Currently, no medication has been approved for the treatment for PE worldwide. Recognition of serotonin as a key mediator in ejaculatory signaling has raised interest in the utility of pharmacologic intervention for treating PE. Selective serotonin reuptake inhibitors (SSRIs) have been used off-label for PE, with varied results. However, treatment with currently available SSRIs typically requires chronic dosing that increases drug accumulation and the attendant risk of adverse events. Dapoxetine is an SSRI with a short half-life (1.2 h), developed specifically for the treatment of men with PE. This agent has a unique pharmacokinetic profile characterized by rapid absorption and elimination. Dapoxetine is metabolized by multiple pathways, and no clinically relevant drug–drug interactions have been identified. Furthermore, dapoxetine pharmacokinetics do not appear to be affected by food, age, alcohol, or phosphodiesterase type 5 (PDE5) inhibitors to a relevant degree. In two placebo-controlled phase 3 trials involving >2600 men with PE, dapoxetine 60 mg given as needed over 12 wk significantly prolonged the stopwatch-assessed intravaginal ejaculatory latency time (IELT) from 0.91 min at baseline to 3.32 min (p < 0.0001), increased control over ejaculation, and increased sexual satisfaction for men and their partners compared with placebo (both p < 0.0001). These results suggest that dapoxetine may meet the medical need for on-demand therapy for PE.  相似文献   

17.
This trial aimed to assess the efficacy of on-demand oral dapoxetine versus topical lidocaine treatments for lifelong PE. Cases with lifelong PE were randomised to start treatment by oral dapoxetine 60 mg or topical lidocaine 10% spray. The intravaginal ejaculatory latency time (ILET), validated Arabic Index for PE (AIPE), Sexual Health Inventory for Men (SHIM) and frequency of intercourse/week were recorded at the baseline and after 12 weeks treatment period of the first medication before two weeks washout period and then crossing over to the other one for another 12 weeks. Results showed that both medications significantly increased both IELT and AIPE scores compared with the baseline being significantly better with topical lidocaine (63.44 s, 179.4 s versus 21.87 s, p < .05). Significant decrease of SHIM score was recorded with lidocaine but not with dapoxetine. Global Efficacy Question for the patient's assessment of the effectiveness of drugs showed that lidocaine was described as being effective by 43 cases and ineffective by 12 cases, oral dapoxetine was described as being effective by 16 cases and ineffective by 39 cases. From these accumulated data, it is concluded that topical lidocaine is more effective on-demand therapy for lifelong PE compared with oral dapoxetine.  相似文献   

18.
Previous studies have investigated whether physical activity increases serotonin hormone levels. Serotonin receptor dysfunction is one of the frequently accused factors of premature ejaculation (PE). Nevertheless, no studies up to date have demonstrated that the association between physical activity and premature ejaculation. We aimed to investigate the relationship between physical activity and PE and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE. A total of 105 patients diagnosed with PE were enrolled in this study. Of the patients, 35 were treated with dapoxetine, (30 mg) on demand (Group 1), 35 performed moderate physical activities (Group 2), and 35 performed minimal physical activity (Group 3‐sham). Demographic characteristics, metabolic equivalents (MET), premature ejaculation diagnostic tool (PEDT) and intravaginal ejaculatory latency time (IELT) were recorded. There were no significant differences among three groups in terms of age, BMI, MET, PEDT or IELT before treatment. At the end of the study, there was significant decrease in PEDT scores, and increase in IELT in groups 1 and 2 as compared to Group 3. In conclusion, a moderate physical activity longer than 30 min at least 5 times a week leads to ejaculation delay, and appears as an alternative to dapoxetine on demand for the treatment of PE.  相似文献   

19.
PURPOSE: Pudendal motoneuron reflex discharges elicited by bilateral electrical stimulation of the dorsal nerves of the penis were used as an experimental model of the expulsion reflex of ejaculation to investigate the effect of acute intravenous delivery of dapoxetine, a short acting selective serotonin reuptake inhibitor, in anesthetized rats. Dapoxetine was compared with paroxetine, the selective serotonin reuptake inhibitor of reference. MATERIALS AND METHODS: Stimulating electrodes were placed bilaterally on the dorsal nerves of the penis and a recording electrode was placed on the motor branch of the pudendal nerve to monitor pudendal motoneuron reflex discharges in urethane anesthetized rats. Pudendal motoneuron reflex discharges induced by penile dorsal nerve stimulation were measured before and 60 minutes after a single intravenous injection of dapoxetine or paroxetine, each tested at 3 doses (1, 3 and 10 mg/kg) or after a single injection of vehicle. RESULTS: At all doses tested dapoxetine significantly lengthened the latency of pudendal motoneuron reflex discharges following bilateral stimulation of the dorsal nerves of the penis in comparison with vehicle, whereas only the 1 mg/kg dose of paroxetine was effective. The amplitudes of pudendal motoneuron reflex discharges were significantly decreased only in rats treated with 3 mg/kg dapoxetine compared to vehicle. CONCLUSIONS: Acute systemic delivery of selective serotonin reuptake inhibitors is capable of modulating the expulsion reflex of ejaculation in anesthetized rats with dapoxetine appearing to be more effective than paroxetine. These findings support the beneficial effect of on-demand administration of dapoxetine for premature ejaculation.  相似文献   

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