他达那非治疗勃起功能障碍的有效性与安全性评价

Tadalafil for Erectile Dysfunction:a Systematic Reviewof Randomized Trials

目的对他达那非治疗勃起功能障碍的疗效及安全性进行系统评价。方法通过电子检索和手工检索尽可能全面地收集他达那非治疗勃起功能障碍的临床试验,进行系统评价。结果本评价共纳入11篇质量较高的随机对照试验。“漏斗图”显示不对称图形,表明可能存在发表偏倚,结果表明他达那非治疗使50%的患者国际勃起功能指数中有关勃起的评分达到正常(≥26分),与安慰剂相比,能提高评分7.52分,增加插入成功率25%、性交成功率40%,提高勃起功能改善率209%,提高国际勃起功能指数中性交满意度、治疗总体满意度评分分别达3.20分和3.08分。结论虽然潜在的发表偏倚不可避免,纳入的研究质量不一,但目前的Meta分析结果显示他达那非治疗勃起功能障碍有效,并且耐受性较好。

Objective To assess the efficacy and safety of Tadalafil for erectile dysfunction. Methods Electronic searches and manual searches were conducted in order to acquire all randomized controlled trials on Tadalafil for erectile dysfunction, and then assessed these trials systematically. Results Eleven randomized trials were included, with all being of high quality. The funnel plot is asymmetry which indicates the exiting of potential publication bias. The results indicate that 50% of Tadalafil-treated patients had an International Index of Erectile Function （IIEF） erectile function domain score ≥ 26 and compared with placebo, Tadalafil can enhance the score by 7.52,increase the RD of successful penetration and sexual intercourse by 25% and 40% respectively, enhance the RR of improved erections by 209%, enhance the IIEF Intercourse Satisfaction Domain and Overall Satisfaction Domain Score 3.20 and 3.08 respectively. Conclusion Although the potential publication bias was unavoidable and the imcompatible quality of the RCT was included, now the meta-analysis indicates the efficacy and high tolerance to Tadalafd for erectile dysfunction.