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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 evaluate the efficacy and safety of fluoxetine in the treatment of premature ejaculation. Methods The randomized controlled trials of fluoxetine in the treatment of premature ejaculation were searched by MEDLINE, EMbase, PubMed, Ovid, CENTRAL, CBM and CNKI. The search time was from July 1996 to May 2012. Two reviewers independently screened the literature according to inclusion and exclusion criteria, extracted data and evaluated the quality, and then used RevMan5.0 software to conduct meta-analysis. The results eventually included 6 studies, a total of 221 patients. Meta-analysis showed that there was no significant difference in IELT between the two groups before treatment (WMD = -0.21, 95% CI (-4.79, 4.37), P = 0.93] after treatment The IELT in fluoxetine group (treatment group) was significantly longer than that in placebo group (control group). The difference was statistically significant [WMD = 134.54, 95% CI (79.78, 189.30), P <0.000 01]. Sensitivity analysis showed that the IELT in the treatment group was longer than that in the control group, and the difference was statistically significant [WMD = 155.19, 95% CI (130.64, 179.75), P <0.000 01]. In terms of safety, the incidence of adverse reactions in the treatment group was higher than that in the control group, with significant difference [OR = 5.49,95% CI (2.43, 12.38), P <0.0001]. Conclusion The existing studies show that fluoxetine can improve the symptoms of patients with premature ejaculation, significantly prolong the latent time of vaginal ejaculation and improve the sexual life quality, and the side effects are mild, tolerable and suitable for long-term use. Due to the limited number of studies included, we think it is necessary to further clarify the criteria for diagnosis and treatment of premature ejaculation, to use current international indices to assist in the design and implementation of more multicenter and large sample clinical studies and to conduct long-term follow-up to obtain more More evidence.