Martyn-St James Marrissa, Cooper Katy, Ren Kate, Kaltenthaler Eva, Dickinson Kath, Cantrell Anna, Wylie Kevan, Frodsham Leila, Hood Catherine
School for Health and Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
Porterbrook Clinic, Sexual Medicine, 9 Sunderland Street, Sheffield, S11 8HN, UK.
Sex Health. 2016 Apr;13(2):114-23. doi: 10.1071/SH15042.
Eutectic Mixture of Local Anaesthetics (EMLA) is recommended for use off-label as a treatment for premature ejaculation (PE). Other topical anaesthetics are available, some of which have been evaluated against oral treatments. The purpose of this systematic review was to evaluate the evidence from randomised controlled trials (RCTs) for topical anaesthetics in the management of PE. Bibliographic databases including MEDLINE were searched to August 2014. The primary outcome was intra-vaginal ejaculatory latency time (IELT). Methodological quality of RCTs was assessed. IELT and other outcomes were pooled across RCTs in a meta-analysis. Between-trial heterogeneity was assessed. Nine RCTs were included. Seven were of unclear methodological quality. Pooled evidence (two RCTs, 43 participants) suggests that EMLA is significantly more effective than placebo at increasing IELT (P<0.00001). Individual RCT evidence also suggests that Topical Eutectic-like Mixture for Premature Ejaculation (TEMPE) spray and lidocaine gel are both significantly more effective than placebo (P=0.003; P<0.00001); and lidocaine gel is significantly more effective than sildenafil or paroxetine (P=0.01; P=0.0001). TEMPE spray is associated with significantly more adverse events than placebo (P=0.003). More systemic adverse events are reported with tramadol, sildenafil and paroxetine than with lidocaine gel. Diverse methods of assessing sexual satisfaction and ejaculatory control with topical anaesthetics are reported and evidence is conflicting. Topical anaesthetics appear more effective than placebo, paroxetine and sildenafil at increasing IELT in men with PE. However, the methodological quality of the existing RCT evidence base is uncertain.
复方局部麻醉剂（EMLA）被推荐用于早泄（PE）治疗的非适应证用药。还有其他局部麻醉剂可供使用，其中一些已与口服治疗药物进行了对比评估。本系统评价的目的是评估随机对照试验（RCT）中关于局部麻醉剂治疗PE的证据。检索了包括MEDLINE在内的文献数据库，截至2014年8月。主要结局指标为阴道内射精潜伏期（IELT）。评估了RCT的方法学质量。在一项荟萃分析中汇总了各RCT的IELT及其他结局指标。评估了试验间的异质性。纳入了9项RCT。其中7项的方法学质量不明确。汇总证据（2项RCT，43名参与者）表明，在增加IELT方面，EMLA比安慰剂显著更有效（P<0.00001）。个别RCT的证据还表明，早泄用类复方制剂（TEMPE）喷雾剂和利多卡因凝胶均比安慰剂显著更有效（P=0.003；P<0.00001）；且利多卡因凝胶比西地那非或帕罗西汀显著更有效（P=0.01；P=0.0001）。TEMPE喷雾剂比安慰剂有更多的不良事件（P=0.003）。与利多卡因凝胶相比，曲马多、西地那非和帕罗西汀报告的全身性不良事件更多。报告了多种评估局部麻醉剂性满意度和射精控制能力的方法，证据相互矛盾。在增加PE男性的IELT方面，局部麻醉剂似乎比安慰剂、帕罗西汀和西地那非更有效。然而，现有RCT证据基础的方法学质量尚不确定。
