JEADV:局部非那雄胺喷雾剂治疗男性雄激素性脱发研究

2021-12-02 医路坦克 MedSci原创

雄激素性脱发(AGA)最常发生在头皮顶部。研究发现外用非那雄胺的毛发数量与开始相比的变化明显大于安慰剂,与口服非那雄胺的观察结果相似。

     雄激素性脱发(AGA)最常发生在头皮顶部。50岁以下的男性中,超过一半的人会受到影响。即使在临床上难以察觉的脱发也与生活质量下降有关。易患AGA的男性在毛囊内睾酮转化为双氢睾酮(DHT)的速率增加,这一过程涉及II5a-还原酶。4非那雄胺,一种抑制II型5a-还原酶的合成抗雄激素,最初被批准以片剂形式用于治疗男性AGA。

     口服非那雄胺治疗AGA的临床疗效肯定。尽管口服非那雄胺一般耐受性良好,在一些患者中,5a-还原酶抑制与性不良反应(勃起功能障碍、射精问题、性欲下降)有关,并增加了抑郁的风险,外用非那雄胺治疗AGA的初步结果令人振奋。在睾酮诱导的白化脱发小鼠模型中,观察到外用2%非那雄胺溶液组的卵泡密度和生长期与终末原比率更高。在人类中,Mazarella和他的同事首先探索了外用非那雄胺治疗AGA的方法,这项研究涉及52名AGA患者(28名男性)。从6个月开始,与安慰剂组相比,外用非那雄胺组的脱发率逐渐显著下降,治疗组之间的血浆总睾酮、游离睾酮和二羟色胺水平没有显著变化。目前的第三阶段研究旨在评估外用非那雄胺(每天使用一次0.25%溶液,体积在50µL至200µL之间)与安慰剂的疗效、安全性、药代动力学(PK)和药效学(PD),并在24周时评估外用非那雄胺相对于口服非那雄胺的总体患者益处。

     这项随机、双盲、双模拟、平行分组的研究在欧洲45个地点的成年男性AGA门诊患者中进行,为期24周。实验药物是外用0.25%非那雄胺(w/w)(浓度为2.275 mg/mL),外用安慰剂比较器含有与实验溶液相同的辅料(乙醇、丙二醇、羟丙基壳聚糖和纯净水),使用计算机生成的名单,符合条件的患者按2:2:1的比例随机分配到三个治疗组之一:外用非那雄胺和口服安慰剂(“外用非那雄胺”组)、外用安慰剂和口服安慰剂(“安慰剂组”),或外用安慰剂和口服非那雄胺(“口服非那雄胺”组)。所有患者每天早晨都按照研究医生推荐的剂量在干燥的头皮上进行局部喷雾(1-4次喷雾,或50-200µL溶液,视脱发程度而定)。第一次喷洒在头皮顶点的目标1平方厘米的圆形区域上,用一个小圆点纹身来标识,以进行重复的疗效评估。如果研究医生推荐的话,可以使用额外的喷雾剂(2-4)来覆盖秃顶的其余部分。外用喷雾剂放置至少6-8小时,然后用洗发水冲洗干净。对其疗效和安全性进行评价。测定非那雄胺、睾酮和双氢睾酮(DHT)浓度。

    在458名随机患者中,323名完成了研究,446名接受了安全性评估。第24周(主要疗效终点)时靶区毛发计数(TAHC)较基线的变化,局部非那雄胺组显著大于安慰剂组(调整后平均变化20.2vs.6.7根毛发;P<0.001),外用组和口服非那雄胺组在数值上相似。与安慰剂相比,服用局部非那雄胺的患者在第12周观察到了与基线相比的显著差异,在第24周观察到了患者头发生长/脱落与基线相比的变化。在局部非那雄胺和安慰剂之间,不良事件的发生率、类型和停药原因没有显著差异。没有与治疗相关的严重不良事件。由于最大血浆非那雄胺浓度比口服非那雄胺低100倍以上,局部用药与口服非那雄胺相比,平均血清DHT浓度比基线下降更低(34.5%比55.6%),与局部非那雄胺降低DHT有关的全身性不良反应的可能性较小。

    研究发现外用非那雄胺的毛发数量与开始相比的变化明显大于安慰剂,与口服非那雄胺的观察结果相似。与口服非那雄胺相比,全身暴露于非那雄胺的剂量明显较低,对血清DHT浓度的影响也较小。外用非那雄胺耐受性良好,安全性与安慰剂无显著差异。因此,外用非那雄胺似乎是治疗男性AGA的有效选择。进一步的研究将有助于证明外用非那雄胺的长期疗效。

文献来源: Piraccini BM,  Blume-Peytavi U,  Scarci F, Efficacy and safety of topicalfinasteride spray solution for male androgenetic alopecia: a phase III, randomized, controlled clinical trial,J Eur Acad Dermatol Venereol 2021 Oct 11;

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