盐酸达泊西汀治疗男性早泄的荟萃分析

A Meta-analysis and systematic review of dapoxetine for treatment of premature ejaculation

目的:按照循证医学标准对盐酸达泊西汀治疗早泄的有效性和安全性进行系统评价。方法:以阴道内射精潜伏时间(intravaginal ejaculatory latency time,IELT)、患者总体感觉改善情况(patientreported global impression of change,PGI)、射精感觉控制(perceived control over ejaculation,PCOE)和中医证侯积分等改善情况作为指标,系统检索Pub Med、Embase、BIOSIS Previews、Cochrane Library、CNKI、万方资源数据库、中国生物医学文献、中文科技期刊全文数据库等,纳入有关盐酸达泊西汀治疗早泄的临床随机对照试验,进行质量评价和提取数据资料,采用Review Manager5.3软件进行荟萃分析。结果:共有12篇文献符合纳入标准,早泄患者累计达13341例。经方法学质量评价12篇都为高质量文献。Meta分析结果显示:经盐酸达泊西汀治疗4周后,患者IELT[WMD=1.02,95%CI为(0.65,1.39),P<0.01],PGI[RR=1.76,95%CI为(1.39,2.22),P<0.01]以及PCOE[RR=2.09,95%CI为(1.84,2.38),P<0.01]方面与对照组相比差异有统计学意义;盐酸达泊西汀60mg与30mg治疗组比较时,60mg组在IELT[WMD=0.40,95%CI为(0.25,0.55),P<0.01],PGI[RR=1.17,95%CI为(1.09,1.25),P<0.01]以及PCOE[RR=1.16,95%CI为(1.06,1.28),P<0.01]方面的差异具有统计学意义。本研究所纳入的文献均报告无严重不良反应发生,且绝大部分患者能耐受试验。结论:盐酸达泊西汀能够明显延长早泄患者IELT,改善患者PGI以及PCOE;其中60mg剂量较30mg在延长早泄患者IELT,改善患者PGI以及PCOE方面效果更佳。

Objectives：To evaluate the efficacy and safety of dapoxetine in treatment of premature ejaculation（PE） by meta-analysis.Methods：Pub Med,Embase,BIOSIS Previews,Cochrane Library,CNKI Database and Wanfang Database was searcher for literatures on dapoxetine in the treatment of PE,with key words of intravaginal ejaculatory latency time（IELT）,patient-reported global impression of change（PGI）,perceived control over ejaculation（PCOE） and TCM scores.Then meta-analysis was performed using the Review Manager 5.3 and the therapeutic efficacy and safety in relevant studies was summarized.Results：12 relevant trials were included which involving about 13341 cases of PE.Compared with placebo controls,the patients treated with dapoxetine showed significant improvement in IELT [WMD = 1.02,95% CI（0.65,1.39）,P 〈 0.01],PGI [RR = 1.76,95% CI（1.39,2.22）,P 〈 0.01]and PCOE [RR = 2.09,95% CI（1.84,2.38）,P 〈 0.01].Meanwhile,there were significant differences between the 60 mg and 30 mg dapoxetine groups in IELT [WMD = 0.40,95% CI（0.25,0.55）,P 〈 0.01],PGI [RR = 1.17,95% CI（1.09,1.25）,P 〈 0.01]and PCOE [RR = 1.16,95% CI（1.06,1.28）,P 〈 0.01].Conclusion：Both 60 mg and 30 mg dapoxetine can significantly prolong IELT and greatly improve PGI and PCOE,with better effect for 60 mg dose.