【 文献重点摘要 】

BACKGROUND

The aesthetic use of botulinum toxins is widely accepted in routine treatment of glabellar lines.

OBJECTIVE

To strengthen existing efficacy and safety data, and examine subject satisfaction concerning abobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines.

MATERIALS AND METHODS

A 150-day prospective, single-dose, multicenter, randomized, parallel-group, placebo-controlled, double-blind study of 300 subjects treated with ABO (50 Units [U]). Response was defined as having no or mild glabellar lines after treatment (primary objective was Day 30 response). Glabellar line severity, onset and duration of effect, satisfaction, treatment emergent adverse events (TEAEs), and treatment-related adverse events (TRAEs) were assessed.

RESULTS

Median time to onset of effect was 2 days. Day 30, ABO treatment response was 89% and 85% for investigator and subject assessments, respectively (p < .001 vs placebo). At Day 120, 60% of subjects demonstrated ≧1 grade improvement and 45% at Day 150. Subject satisfaction concerning glabellar line appearance was high (93%) at Day 14 and maintained by 35% through Day 150 with ABO treatment. No serious AEs were related to study treatment.

CONCLUSION

Most ABO-treated subjects sustained ≧1 grade glabellar line improvements over 120 days, and satisfaction was maintained by >30% of subjects throughout 150 days. ABO was well tolerated.

背景

肉毒杆菌毒素的美学应用在眉间纹的常规治疗中被广泛接受。

目的

加强现有的疗效和安全性数据，并检查受试者对中到重度眉间纹abobotulumtoxinA (ABO)治疗的满意度。

材料和方法

一项为期150天的前瞻性、单剂量、多中心、随机、平行组、安慰剂对照、双盲研究，300名受试者接受了ABO治疗(50单位)。应答被定义为治疗后没有或有轻度眉间纹(主要目标是第30天应答)。评估眉间纹严重程度、起效和持续时间、满意度、治疗紧急不良事件和治疗相关不良事件。

结果

起效时间中位数为2天。第30天，研究者和受试者评估的ABO治疗反应分别为89%和85%(p < .001 vs安慰剂)。在第120天，60%的受试者表现出≥1的成绩提高，45%的受试者在第150天表现出≥1的成绩提高。受试者对眉间纹外观的满意度在第14天很高(93%)，通过ABO治疗在第150天保持在35%。没有与研究治疗相关的严重不良事件。

结论

大多数接受ABO治疗的受试者在120天内保持≥1级眉间纹改善，并且在150天内超过30%的受试者保持满意。ABO耐受性良好。