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Oral agents for the treatment of premature ejaculation: review of efficacy and safety in the context of the recent International Society for Sexual Medicine criteria for lifelong premature ejaculation.

机译:口服药物治疗早泄:根据国际性医学协会关于终生早泄的最新标准,回顾疗效和安全性。

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INTRODUCTION: New diagnostic criteria for lifelong premature ejaculation (PE) have been proposed by the International Society of Sexual Medicine (ISSM), including an intravaginal ejaculatory latency time (IELT) of less than about 1 minute, lack of control over ejaculation, and PE-related distress or bother. AIM: The aim of this study was to review evidence supporting the efficacy and safety of oral agents for the treatment of PE in the context of the new ISSM criteria. METHODS: The PubMed database was searched for randomized, double-blind, placebo-controlled studies of oral agents in PE that included stopwatch measurements of IELT. MAIN OUTCOME MEASURES: The main outcome measure used for this study was a review of the efficacy and safety data of oral agents for PE aligned with ISSM criteria. RESULTS: Since the latest meta-analyses using similar criteria (conducted in 2004 and 2005 for selective serotonin reuptake inhibitors [SSRIs] and phosphodiesterase type 5 [PDE-5] inhibitors, respectively), eight studies evaluated SSRIs vs. placebo, one compared SSRIs, two evaluated PDE-5 inhibitors, and one evaluated an SSRI/PDE-5 inhibitor combination. New agents included dapoxetine (five studies) and tramadol (one study). Six studies enrolled men who met an approximation of the ISSM criteria. Although evidence suggests that most SSRIs, tramadol, and dapoxetine increase IELT to varying degrees, few studies included control over ejaculation and PE-related distress or bother as enrollment criteria or used validated patient-reported outcome instruments to evaluate these parameters. Among studies that provided comprehensive adverse event data, safety and tolerability observations in men with PE were generally similar to those observed in other populations; however, with the exception of dapoxetine, known SSRI-class effects (e.g., withdrawal syndrome) were not evaluated in men with PE. CONCLUSIONS: This systematic review of well-controlled clinical trials in PE has demonstrated that while many oral agents, particularly SSRIs, tramadol, and dapoxetine, have proven effective and safe for the treatment of men with PE, few have been evaluated for their effects on the specific elements of the ISSM criteria.
机译:简介:国际性医学协会(ISSM)提出了终生早泄(PE)的新诊断标准,其中包括阴道内射精潜伏时间(IELT)小于约1分钟,对射精缺乏控制以及PE相关的困扰或困扰。目的:本研究的目的是在新的ISSM标准的背景下,回顾支持口服药物治疗PE的有效性和安全性的证据。方法:在PubMed数据库中搜索PE中口服药物的随机,双盲,安慰剂对照研究,包括IELT的秒表测量。主要观察指标:用于本研究的主要观察指标是对符合ISSM标准的PE口服制剂的疗效和安全性数据进行回顾。结果:自从最新的荟萃分析使用相似的标准(分别于2004年和2005年对选择性5-羟色胺再摄取抑制剂[SSRI]和5型磷酸二酯酶[PDE-5]抑制剂进行)之后,八项研究评估了SSRI与安慰剂的比较,其中一项比较了SSRI ,其中两种评估了PDE-5抑制剂,一种评估了SSRI / PDE-5抑制剂组合。新药包括达泊西汀(五项研究)和曲马多(一项研究)。六项研究招募了符合ISSM标准的男性。尽管有证据表明大多数SSRI,曲马多和达泊西汀会不同程度地提高IELT,但很少有研究包括对射精和与PE相关的困扰的控制或作为入院标准,或使用经过验证的患者报告的结局手段来评估这些参数。在提供全面不良事件数据的研究中,PE男性的安全性和耐受性观察结果与其他人群中观察到的相似。但是,除达泊西汀外,未对PE男性评估已知的SSRI类效应(例如戒断综合症)。结论:对PE中良好对照的临床试验的系统评价表明,尽管许多口服药物,尤其是SSRI,曲马多和达泊西汀,已被证明对治疗PE男性有效且安全,但很少有人评估它们对PE的作用。 ISSM标准的特定元素。

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