0.2mg Finasteride的效果研究

摘要
Finasteride is a type 2 5 alpha-reductase inhibitor that inhibits conversion of testosterone to dihydrotestosterone, a key mediator of male pattern hair loss (androgenetic alopecia). The objective of this study was to identify the optimal dosage of finasteride and to evaluate its efficacy and safety in the treatment of Japanese men with male pattern hair loss. In this double- blind randomized study, 414 Japanese men with male pattern hair loss received finasteride 1 mg (n = 139), finasteride 0.2 mg (n = 137), or placebo (n = 38) once daily for 48 weeks. Efficacy was evaluated by global photographic assessment, patient self-assessment, and investigator assessment. All efficacy endpoints showed significant improvement with finasteride therapy by 12 weeks (p < 0.05 versus placebo). At 48 weeks, 58%, 54%, and 6% of men in the finasteride 1 mg, finasteride 0.2 mg, and placebo groups, respectively, had improved based on assessments of global photographs. All efficacy endpoints were numerically superior for the 1 mg dose over the 0.2 mg dose at 48 weeks. Finasteride treatment was generally well tolerated. Finasteride 1 mg\day slows hair loss and improves hair growth in Japanese men with male pattern hair loss.

非那雄胺是一种第二型 5α-还原酶的抑制剂，抑制睾固酮转化为二氢睾固酮DHT，DHT也就是造成典型男性掉发的关键所在 。本研究的目的是为了确定非那雄胺的最加剂量，并评估以非那雄胺治疗的日本雄性秃男性的疗效与安全性。在这个双盲随机研究中， 总共414个日本雄性秃男性参与研究，服用非那雄胺1毫克的有139位，服用非那雄胺0.2毫克的有137位，服用安慰剂有38位，每天服用一次，为期 48周。

疗 效评估采用整体摄影评估、病人自我评估、和计划研究者评估。 在第12周的时候，显示所有服用非那雄胺的受试者都有显著的改善效果（P < 0.05 vs 安慰剂） 。在第48周， 透过照片评估，显示服用1mg受试者中有58%有效；服用0.2mg受试者中有54%有效；服用安慰剂受试者中有6%有效。 但在效果的差异上，48周后数量规模为服用1mg剂量者是优于服用0.2mg剂量的。非那雄胺的耐受性良好。非那雄胺1mg可以缓和掉发，改善日本雄性秃 男性掉发。