Department of Medicine, Division of Dermatology, University of Toronto , Toronto , Canada.
J Dermatolog Treat. 2014 Apr;25(2):156-61. doi: 10.3109/09546634.2013.813011. Epub 2013 Jul 5.
In the light of post-marketing reports of persistent sexual dysfunction with the use of finasteride, analysis of the extent of risk associated with 5α-reductase inhibitor treatment for androgenetic alopecia (AGA) is warranted. This study sought to evaluate the efficacy of 5α-reductase inhibitors using the outcomes hair count, global photographic assessment and patient self-assessment and evaluate the benefits of treatment versus the risk of global sexual dysfunction.
A systematic review identified all relevant randomized controlled trials of finasteride 1 mg, 5 mg and dutasteride 0.5 mg. The efficacy outcome hair count was analyzed using pair-wise meta-analysis, while the efficacy outcomes global photographic assessment and patient self-assessment as well as the safety outcome global sexual dysfunction were analyzed through network meta-analyses. A benefit-risk assessment was also performed.
The active interventions were not significantly different than each other in efficacy and were not significantly different from placebo in eliciting sexual dysfunction. Benefit-risk analysis resulted in an arbitrary ranking due to the lack of statistically significant difference between active treatments.
Analysis results reiterate the efficacy and safety of 5α-reductase inhibitors for the treatment of AGA and may support the approval of dutasteride 0.5 mg as an additional treatment option, following further study.
鉴于非那雄胺(finasteride)上市后出现持续性性功能障碍的报告,有必要分析 5α-还原酶抑制剂治疗雄激素性脱发(AGA)的相关风险程度。本研究旨在通过头发计数、全球照片评估和患者自我评估等结局指标评估 5α-还原酶抑制剂的疗效,并评估治疗的益处与全球性功能障碍风险的关系。
系统检索了所有关于非那雄胺 1mg、5mg 和度他雄胺 0.5mg 的随机对照试验。使用两两荟萃分析分析头发计数的疗效结局,使用网络荟萃分析分析全球照片评估和患者自我评估等疗效结局以及全球性功能障碍等安全性结局。还进行了获益-风险评估。
与安慰剂相比,活性干预措施在疗效方面彼此之间没有显著差异,也没有在引起性功能障碍方面存在显著差异。由于活性治疗之间缺乏统计学意义上的差异,因此获益-风险分析得出了任意排序。
分析结果重申了 5α-还原酶抑制剂治疗 AGA 的疗效和安全性,并可能支持进一步研究后批准度他雄胺 0.5mg 作为额外的治疗选择。