Kaufman K D, Olsen E A, Whiting D, Savin R, DeVillez R, Bergfeld W, Price V H, Van Neste D, Roberts J L, Hordinsky M, Shapiro J, Binkowitz B, Gormley G J
Department of Clinical Research, Merck Research Laboratories, Rahway, NJ 07065, USA.
J Am Acad Dermatol. 1998 Oct;39(4 Pt 1):578-89. doi: 10.1016/s0190-9622(98)70007-6.
Androgenetic alopecia (male pattern hair loss) is caused by androgen-dependent miniaturization of scalp hair follicles, with scalp dihydrotestosterone (DHT) implicated as a contributing cause. Finasteride, an inhibitor of type II 5alpha-reductase, decreases serum and scalp DHT by inhibiting conversion of testosterone to DHT.
Our purpose was to determine whether finasteride treatment leads to clinical improvement in men with male pattern hair loss.
In two 1-year trials, 1553 men (18 to 41 years of age) with male pattern hair loss received oral finasteride 1 mg/d or placebo, and 1215 men continued in blinded extension studies for a second year. Efficacy was evaluated by scalp hair counts, patient and investigator assessments, and review of photographs by an expert panel.
Finasteride treatment improved scalp hair by all evaluation techniques at 1 and 2 years (P < .001 vs placebo, all comparisons). Clinically significant increases in hair count (baseline = 876 hairs), measured in a 1-inch diameter circular area (5.1 cm2) of balding vertex scalp, were observed with finasteride treatment (107 and 138 hairs vs placebo at 1 and 2 years, respectively; P < .001). Treatment with placebo resulted in progressive hair loss. Patients' self-assessment demonstrated that finasteride treatment slowed hair loss, increased hair growth, and improved appearance of hair. These improvements were corroborated by investigator assessments and assessments of photographs. Adverse effects were minimal.
In men with male pattern hair loss, finasteride 1 mg/d slowed the progression of hair loss and increased hair growth in clinical trials over 2 years.
雄激素性脱发（男性型脱发）是由雄激素依赖的头皮毛囊微型化引起的，头皮双氢睾酮（DHT）被认为是一个促成因素。非那雄胺是一种II型5α-还原酶抑制剂，通过抑制睾酮向DHT的转化来降低血清和头皮中的DHT。
我们的目的是确定非那雄胺治疗是否能使男性型脱发患者在临床上得到改善。
在两项为期1年的试验中，1553名年龄在18至41岁之间的男性型脱发患者接受了每日1毫克的口服非那雄胺或安慰剂治疗，1215名男性继续参加了为期第二年的双盲扩展研究。通过头皮毛发计数、患者和研究者评估以及专家小组对照片的审查来评估疗效。
在1年和2年时，通过所有评估技术，非那雄胺治疗均改善了头皮毛发情况（与安慰剂相比，所有比较的P值均<0.001）。在秃发头顶头皮直径1英寸（5.1平方厘米）的圆形区域测量，非那雄胺治疗可观察到临床上显著的毛发数量增加（基线为876根毛发）（1年和2年时分别为107根和138根毛发，而安慰剂组分别为[未提及具体数字]；P<0.001）。安慰剂治疗导致脱发逐渐加重。患者的自我评估表明，非那雄胺治疗减缓了脱发速度，促进了头发生长，并改善了头发外观。这些改善得到了研究者评估和照片评估的证实。不良反应极小。
在男性型脱发患者中，在超过2年的临床试验中，每日1毫克非那雄胺减缓了脱发进程并促进了头发生长。
