氟西汀治疗早泄有效性和安全性的Meta分析

Effectiveness and Safety of Fluoxetine for Premature Ejaculation: A Meta-Analysis

目的系统评价氟西汀治疗早泄的有效性和安全性。方法计算机检索MEDLINE、EMbase、PubMed、Ovid、CENTRAL、CBM和CNKI,收集氟西汀治疗早泄的随机对照试验,检索时限均从1996年7月至2012年5月。由2位评价员按照纳入与排除标准独立筛选文献、提取资料和评价质量后,采用RevMan5.0软件进行Meta分析。结果最终纳入6个研究,共221例患者。Meta分析结果显示在疗效方面,治疗前两组患者的阴道内射精潜伏时间(IELT)差异无统计学意义[WMD=–0.21,95%CI(–4.79,4.37),P=0.93],治疗后氟西汀组(治疗组)患者的IELT明显长于安慰剂组(对照组),其差异有统计学意义[WMD=134.54,95%CI(79.78,189.30),P<0.000 01]。敏感性分析结果显示,治疗组患者的IELT长于对照组,其差异有统计学意义[WMD=155.19,95%CI(130.64,179.75),P<0.000 01]。在安全性方面,治疗组患者的不良反应发生率较对照组高,其差异有统计学意义[OR=5.49,95%CI(2.43,12.38),P<0.000 1]。结论现有研究表明,氟西汀能改善早泄患者症状,明显延长患者阴道内射精潜伏时间,提高性生活质量,且不良反应较轻,能够耐受,适合长期服用。受纳入研究的数量限制,我们认为有必要进一步明确早泄的诊断及治疗标准,使用目前国际通用的指标来辅助设计和开展更多多中心、大样本的临床研究,并进行长期随访,以获取更多证据。

Objective To systematically evaluate the effectiveness and safety of fluoxetine in treating premature ejaculation （PE）. Methods All randomized controlled trials （RCTs） on nuoxetine treating PE published from luly 1996 to May 2012 were collected in the following databases： MEDLINE, EMbase, PubMed, Ovid, The Cochrane Central Register of Controlled Trials, CBM and CKNI. According to the inclusion and exclusion criteria, literature screening, data extraction and quality assessment were conducted independently by two reviewers. Then meta-analysis was performed using RevMan 5.0 software. Results A total of 6 RCTs involving 221 patients were included finally. The results of meta-analysis showed that, as for effectiveness, there was no significant difference in the intravaginal e）aculatory latency time （IELT） between the two groups before the treatment （WMD=-0.21, 95%CI -4.79 to 4.37, P=0.93）, but the IELT of the fluoxetine group was obviously longer than that of the control group after the treatment, with a significant difference （WMD： 134.54, 95%CI 79.78 to 189.30, P〈0.000 01）. The results of sensitivity analysis indicated that the IELT of the fluoxetine group was longer than that of the control group, with a significant difference （WMD=155.19, 95%CI 130.64 to 179.75, P〈0.000 01）. As for safety, the fluoxetine group was higher in the incidence of adverse reaction than the control group, with a signifi- cant difference （OR=5.49, 95%CI 2.43 to 12.38, P〈0.000 1）. Conclusion Current evidence indicates that fluoxetine can improve the symptoms of PE patients, obviously prolong the IELT, and improve the quality of sexual life; and it is tolerable to patients with mild adverse reactions and is suitable for long-term intake. For the limited quantity of the included studies, we herein believe that, to obtain more evidence, it is necessary to further confirm the diagnosis and therapeutic criteria of PE, to design and conduct more multicenter and large scale clinical studies by adopting the internationally recognized indexes, and to perform a longg-term follow-up.