阿达帕林-过氧化苯甲酰凝胶治疗成年女性痤疮有效且安全，其表现与青少年女性相当。
Adapalene-benzoyl Peroxide Gel is Efficacious and Safe in Adult Female Acne, with a Profile Comparable to that Seen in Teen-aged Females.
作者信息
Gold Linda Stein, Baldwin Hilary, Rueda Maria Jose, Kerrouche Nabil, DrÉno Brigitte
机构信息
Henry Ford Hospital, Detroit, Michigan.
Acne Treatment and Research Center, Morristown, New Jersey.
出版信息
J Clin Aesthet Dermatol. 2016 Jul;9(7):23-29. Epub 2016 Jul 1.
To evaluate the efficacy and safety of adapalene 0.1% benzoyl peroxide 2.5% gel in women aged 25 years or older via subgroup analysis of existing Phase 2 and 3 study data. Meta-analysis of pooled data from three multicenter, randomized, double-blind, vehicle-controlled, parallel-group, clinical trials compared results of treatment with either adapalene 0.1% benzoyl peroxide 2.5% gel or vehicle gel in adult females and teen-aged females. Efficacy assessments included investigator's global assessment and median percent change in acne lesions. Safety assessments included skin tolerability and adverse events. Two hundred fifty-four adult females and 488 teen-aged females were included in the analyses, and baseline characteristics were comparable between subjects receiving adapalene 0.1% benzoyl peroxide 2.5% or vehicle. Both adult females and teen-aged females in the adapalene 0.1% benzoyl peroxide 2.5% arm were significantly more often rated clear/almost clear compared with those in the vehicle arm at Weeks 8 (=0.016) and 12 (<0.001); at endpoint, success was achieved in 39.2 percent with adapalene 0.1% benzoyl peroxide 2.5% and 18.5 percent with vehicle. Comparison of the amount of difference between active and vehicle reductions in investigator's global assessment showed that efficacy was similar for adult females versus teen-aged females (20.7% vs. 19.9%, respectively). Adapalene 0.1% benzoyl peroxide 2.5% had a rapid onset of action, with statistically significant reductions in all acne lesion types versus vehicle observed by Week 1. Adapalene 0.1% benzoyl peroxide 2.5% was safe and well-tolerated by adult females with a tolerability profile consistent with that seen in teen-aged females. The once-daily fixed-dose combination product adapalene 0.1% benzoyl peroxide 2.5% is an efficacious, safe, and well-tolerated treatment for adult female acne, with a profile similar to that in teen-aged females.
通过对现有2期和3期研究数据进行亚组分析，评估0.1%阿达帕林2.5%过氧化苯甲酰凝胶在25岁及以上女性中的疗效和安全性。对来自三项多中心、随机、双盲、赋形剂对照、平行组临床试验的汇总数据进行荟萃分析，比较了0.1%阿达帕林2.5%过氧化苯甲酰凝胶或赋形剂凝胶治疗成年女性和青少年女性的结果。疗效评估包括研究者整体评估和痤疮皮损的中位百分比变化。安全性评估包括皮肤耐受性和不良事件。分析纳入了254名成年女性和488名青少年女性，接受0.1%阿达帕林2.5%过氧化苯甲酰或赋形剂的受试者之间的基线特征具有可比性。在第8周（P=0.016）和第12周（P<0.001）时，与赋形剂组相比，0.1%阿达帕林2.5%过氧化苯甲酰组的成年女性和青少年女性被评为清除/几乎清除的比例显著更高；在终点时，0.1%阿达帕林2.5%过氧化苯甲酰组的成功率为39.2%，赋形剂组为18.5%。活性药物与赋形剂在研究者整体评估中减少量的差异比较显示，成年女性与青少年女性的疗效相似（分别为20.7%和19.9%）。0.1%阿达帕林2.5%过氧化苯甲酰起效迅速，在第1周时与赋形剂相比，所有痤疮皮损类型均有统计学意义的减少。0.1%阿达帕林2.5%过氧化苯甲酰对成年女性安全且耐受性良好，其耐受性与青少年女性相似。每日一次的固定剂量复方产品0.1%阿达帕林2.5%过氧化苯甲酰是一种有效、安全且耐受性良好的成年女性痤疮治疗药物，其情况与青少年女性相似。
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