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治疗早泄的干预措施:一项系统评价简短报告

Interventions to treat premature ejaculation: a systematic review short report.

作者信息

Cooper Katy, Martyn-St James Marrissa, Kaltenthaler Eva, Dickinson Kath, Cantrell Anna

机构信息

School of Health and Related Research (ScHARR) Technology Assessment Group, The University of Sheffield, Sheffield, UK.

出版信息

Health Technol Assess. 2015 Mar;19(21):1-180, v-vi. doi: 10.3310/hta19210.

Abstract

BACKGROUND

Premature ejaculation (PE) is commonly defined as ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the person wishes it. PE can be either lifelong and present since first sexual experiences (primary), or acquired (secondary), beginning later (Godpodinoff ML. Premature ejaculation: clinical subgroups and etiology. J Sex Marital Ther 1989;15:130-4). Treatments include behavioural and pharmacological interventions.

OBJECTIVE

To systematically review evidence for clinical effectiveness of behavioural, topical and systemic treatments for PE.

DATA SOURCES

The following databases were searched from inception to 6 August 2013 for published and unpublished research evidence: MEDLINE; EMBASE; Cumulative Index to Nursing and Allied Health Literature; The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects and the Health Technology Assessment database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science. The US Food and Drug Administration website and the European Medicines Agency (EMA) website were also searched.

METHODS

Randomised controlled trials (RCTs) in adult men with PE were eligible (or non-RCTs in the absence of RCTs). RCT data were extrapolated from review articles when available. The primary outcome was intravaginal ejaculatory latency time (IELT). Data were meta-analysed when possible. Other outcomes included sexual satisfaction, control over ejaculation, relationship satisfaction, self-esteem, quality of life, treatment acceptability and adverse events (AEs).

RESULTS

A total of 103 studies (102 RCTs, 65 from reviews) were included. RCTs were available for all interventions except yoga. The following interventions demonstrated significant improvements (p < 0.05) in arithmetic mean difference in IELT compared with placebo: topical anaesthetics - eutectic mixture of local anaesthetics (EMLA(®), AstraZeneca), topical eutectic mixture for PE (Plethora Solutions Ltd) spray; selective serotonin reuptake inhibitors (SSRIs) - citalopram (Cipramil(®), Lundbeck), escitalopram (Cipralex(®), Lundbeck), fluoxetine, paroxetine, sertraline, dapoxetine (Priligy(®), Menarini), 30 mg or 60 mg; serotonin-noradrenaline reuptake inhibitors - duloxetine (Cymbalta(®), Eli Lilly & Co Ltd); tricyclic antidepressants - inhaled clomipramine 4 mg; phosphodiesterase-5 (PDE5) inhibitors - vardenafil (Levitra(®), Bayer), tadalafil (Cialis(®), Eli Lilly & Co Ltd); opioid analgesics - tramadol (Zydol SR(®), Grünenthal). Improvements in sexual satisfaction and other outcomes compared with placebo were evident for SSRIs, PDE5 inhibitors and tramadol. Outcomes for interventions not compared with placebo were as follows: behavioural therapies - improvements over wait list control in IELT and other outcomes, behavioural therapy plus pharmacotherapy better than either therapy alone; alpha blockers - terazosin (Hytrin(®), AMCO) not significantly different to antidepressants in ejaculation control; acupuncture - improvements over sham acupuncture in IELT, conflicting results for comparisons with SSRIs; Chinese medicine - improvements over treatment as usual; delay device - improvements in IELT when added to stop-start technique; yoga - improved IELT over baseline, fluoxetine better than yoga. Treatment-related AEs were evident with most pharmacological interventions.

LIMITATIONS

Although data extraction from reviews was optimised when more than one review reported data for the same RCT, the reliability of the data extraction within these reviews cannot be guaranteed by this assessment report.

CONCLUSIONS

Several interventions significantly improved IELT. Many interventions also improved sexual satisfaction and other outcomes. However, assessment of longer-term safety and effectiveness is required to evaluate whether or not initial treatment effects are maintained long term, whether or not dose escalation is required, how soon treatment effects end following treatment cessation and whether or not treatments can be stopped and resumed at a later time. In addition, assessment of the AEs associated with long-term treatment and whether or not different doses have differing AE profiles is required.

STUDY REGISTRATION

This study is registered as PROSPERO CRD42013005289.

FUNDING

The National Institute for Health Research Health Technology Assessment programme.

摘要

背景

早泄(PE)通常被定义为在插入前、插入时或插入后不久,在极少性刺激下且早于个人期望的情况下射精。早泄可以是原发性的,即从首次性经历开始就存在(终身性),也可以是继发性的,即后来才开始出现(Godpodinoff ML.早泄:临床亚组与病因。《性与婚姻治疗杂志》1989年;15:130 - 4)。治疗方法包括行为干预和药物干预。

目的

系统评价行为疗法、局部治疗和全身治疗早泄的临床有效性证据。

数据来源

检索了以下数据库从建库至2013年8月6日发表和未发表的研究证据:医学文献数据库(MEDLINE);荷兰医学文摘数据库(EMBASE);护理及相关健康文献累积索引;考克兰图书馆,包括考克兰系统评价数据库、考克兰对照试验注册库、效应评价摘要数据库和卫生技术评估数据库;科学引文索引(ISI)科学网,包括科学引文索引和会议论文引文索引 - 科学版。还检索了美国食品药品监督管理局网站和欧洲药品管理局(EMA)网站。

方法

纳入成年早泄男性的随机对照试验(RCT)(若无RCT则纳入非RCT)。如有可用,RCT数据从综述文章中提取。主要结局是阴道内射精潜伏期(IELT)。如有可能,对数据进行荟萃分析。其他结局包括性满意度、射精控制能力、关系满意度、自尊、生活质量、治疗可接受性和不良事件(AE)。

结果

共纳入103项研究(102项RCT,65项来自综述)。除瑜伽外,所有干预措施均有RCT可用。与安慰剂相比,以下干预措施在IELT算术平均差方面有显著改善(p < 0.05):局部麻醉药 - 复方利多卡因乳膏(EMLA(®),阿斯利康)、早泄局部用复方制剂(Plethora Solutions Ltd)喷雾剂;选择性5 - 羟色胺再摄取抑制剂(SSRI) - 西酞普兰(Cipramil(®),伦德贝克)、艾司西酞普兰(Cipralex(®),伦德贝克)、氟西汀、帕罗西汀、舍曲林、达泊西汀(Priligy(®),美纳里尼),30毫克或60毫克;5 - 羟色胺 - 去甲肾上腺素再摄取抑制剂 - 度洛西汀(Cymbalta(®),礼来公司);三环类抗抑郁药 - 吸入氯米帕明4毫克;磷酸二酯酶5(PDE5)抑制剂 - 伐地那非(Levitra(®),拜耳)、他达拉非(Cialis(®),礼来公司);阿片类镇痛药 - 曲马多(Zydol SR(®),格伦泰)。与安慰剂相比,SSRI、PDE5抑制剂和曲马多在性满意度和其他结局方面有明显改善。未与安慰剂比较的干预措施结局如下:行为疗法 - IELT和其他结局优于等待名单对照,行为疗法加药物疗法优于单独任何一种疗法;α受体阻滞剂 - 特拉唑嗪(Hytrin(®),AMCO)在射精控制方面与抗抑郁药无显著差异;针灸 - IELT优于假针灸,与SSRI比较结果相互矛盾;中药 - 优于常规治疗;延时装置 - 与间断刺激技术联合使用时IELT改善;瑜伽 - IELT较基线改善,氟西汀优于瑜伽。大多数药物干预措施有明显的治疗相关AE。

局限性

尽管当不止一篇综述报告同一RCT的数据时对数据提取进行了优化,但本评估报告无法保证这些综述内数据提取的可靠性。

结论

几种干预措施显著改善了IELT。许多干预措施还改善了性满意度和其他结局。然而,需要评估长期安全性和有效性,以确定初始治疗效果是否能长期维持,是否需要增加剂量,治疗停止后治疗效果多久结束,以及治疗是否可以停止并在以后恢复。此外,需要评估与长期治疗相关的AE以及不同剂量是否有不同的AE特征。

研究注册

本研究注册为PROSPERO CRD42013005289。

资助

英国国家卫生研究院卫生技术评估项目。

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